Newslettershttps://www.robinskaplan.com/feeds/newslettersLegal Update Newslettersen{1C92E70A-C8C5-414B-98F9-80721C462C18}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2024/spotlight-march-2024/do-we-have-to-share-that-information-attorney-client-privilege-in-the-multi-entity-contextDo We Have to Share That Information? Attorney-Client Privilege in the Multi-Entity Context<p> A bedrock feature of the attorney-client relationship is the privilege protecting legal-advice communications from prying eyes. Confidential communications between a client and her lawyer are protected to a degree not found in almost any other relationship. The same is true even when the client is a corporation—although, as the Supreme Court has recognized, “The administration of the attorney-client privilege in the case of corporations . . . presents special problems.”<sup><span style="font-size: 8px;">1</span></sup> While a corporation is a person for purposes of the law, it is not a person in the practical sense. An attorney cannot talk directly to a corporate entity; she must speak to the corporation’s representatives. Thus, in the seminal case <em>Upjohn v. United States</em>, 449 U.S. 383 (1981), the Supreme Court held that, in the corporate context, the attorney-client privilege extends to any communication between counsel and a corporate employee that was made for the purpose of obtaining legal advice on behalf of the corporation, regardless of the employee’s seniority within the corporation. And the directors of a corporation generally have a near-absolute right to information concerning the corporation, including privileged information.</p> <p> But what happens when the same individuals who serve as directors of an entity become adverse or arguably adverse to the entity? In such a scenario, the question of who holds the privilege and who is entitled to access privileged information become more complicated to answer. </p> <p> Take, for example, the case of a joint venture (“Umbrella Venture”) between two closely held corporations, “Acme Co.” and “Beta Co.” Adams is the owner and a director of Acme, while Brown is the owner and a director of Beta. Both Adams and Brown, on behalf of Acme and Beta, respectively, decide to form Umbrella Venture and become the directors of the new entity. In the course of Umbrella’s business, it enters into contracts with both Acme and Beta. As long as the parties get along, attorney-client-privilege (not to mention competing fiduciary-duty) issues should not arise, despite Adams’ and Brown’s dual roles serving as directors of separate corporate entities. To the extent Umbrella Venture seeks legal counsel, Adams and Brown would both fall within the scope of Umbrella’s attorney-client privilege and be entitled to access all communications, including legal advice, received by Umbrella Venture.</p> <p> However, as so often happens in corporate relationships (and life), matters can go awry. What if Acme sues Umbrella Venture, alleging breach of the contract between the two entities? Or what if Brown decides that Adams’ actions constitute a breach of his fiduciary duty to Umbrella Venture and wants Umbrella’s counsel to undertake an investigation of Adams? What entitlement to Umbrella’s privileged communications with corporate counsel does Adams, as simultaneous director of Umbrella Venture and owner and director of Acme, have?</p> <p> The answer may not always be clear. In Delaware, for example, the Court of Chancery recognizes only three limitations on a director’s ability to access privileged information: First, a director’s access can be limited by <em>ex ante</em> agreement. Second, a board of directors can appoint a special (sub)committee of the full board, which would be free to retain separate legal counsel and whose communications with that counsel would be privileged from the remainder of the board. Third, a board of directors “can withhold privileged information once sufficient adversity exists between the director and the corporation such that the director could no longer have a reasonable expectation that he was a client of the board’s counsel.” <em>Kalisman v. Friedman</em>, C.A. No.  8447-VCL, 2013 WL 1668205, at *5 (Del. Ch. Apr. 17, 2013). </p> <p> If <em>Kalisman</em> applied to our breach-of-contract hypothetical case, Brown might argue that Adams is not entitled to Umbrella’s privileged communications with counsel because Acme’s suit against Umbrella Venture created “sufficient adversity” between Adams and Umbrella Venture. Nevertheless, relying on a determination of “sufficient adversity” could be a risky position, especially in the context of a hotly contested dispute. And the breach-of-fiduciary-duty scenario is even more fraught because the adversity is less clear. Therefore, Brown and the rest of the board would be wise to appoint a special committee to investigate Adams’ conduct so as to better protect the privilege (and the integrity of the investigation). </p> <p> As always, the better way to prevent Adams from accessing Umbrella’s privileged communications during an investigation or adverse litigation is by having such contingencies already anticipated in Umbrella Venture’s operating agreement—i.e., by forming an <em>ex ante</em> contract about each director’s entitlement to privileged information in the event of adversity arising between a director and/or their respective company on the one hand and Umbrella Venture on the other.</p> <p> As these examples illustrate, an attorney representing an individual or entity in a messy scenario like this should proceed with caution, examining the operative documents, researching the caselaw in the applicable jurisdiction, and, if appropriate, discussing the scope of privilege with opposing counsel as soon as possible. Perhaps more importantly, though, attorneys who assist with the drafting of such corporate documents should include provisions that govern corporate privilege with the understanding that even the best-laid plans of corporations and men often go awry.</p>Tue, 12 Mar 2024 00:00:00 -0500{B73B6487-8F80-4944-B956-CCEAB4ED12D7}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2024/spotlight-march-2024/sellers-of-a-business-know-thyselfSellers of a Business: Know Thyself.<p>So, you have decided to sell your business. Often this process starts with an inward reflection. You may have identified a good reason to sell, but many questions remain. Sellers at this early point often look to hire a broker or financial advisor to help get answers to their major questions. Don’t stop the introspection here. Continue to think hard about what your business looks like from the inside and what additional advisor can help you get the best return. Retaining legal counsel early in the process – preferably before a letter of intent or term sheet is signed – can help you scrutinize major aspects of your business and secure a deal in your desired price range. </p> <p>Experienced counsel can guide you through an effective presale internal diligence process to spot issues before a potential buyer does and deliver maximum return on what you have built. Any sophisticated buyer will do the same. Identifying issues early on can help reduce negotiating points, avoid unwanted holdbacks, and get to a closing with reduced tension. Here are some of the major areas where presale seller-side legal diligence can help identify and fix problems to avoid unintended consequences such as a buyer demanding a lower price, or worse, walking away.  </p> <p><strong>It All Starts at the Top – Address Ownership Issues</strong></p> <p>You may want to sell, but are you the only owner? Are you sure all your co-owners or other equity holders are on board? Any hint of problems or dissent at the ownership level can cause significant disruption to business operations during a sales process. </p> <p>For instance, do some want to stay on as advisors or employees when a new buyer takes over? Do some have a preferred buyer in mind? Is there a sentimental or emotional issue at play that will require some level of insight or control into the business post-closing, such as retention of a board seat? Are there any company loans, bonuses, or other monies owed to or by an owner? Does everyone understand exactly how the sale proceeds will be divided under the governing documents of your company? These questions are just some of the issues that can cause a deal to fall apart if not fully vetted before a buyer starts negotiating. </p> <p>A good strategy is to have experienced counsel on hand to help address these issues behind closed doors. A united front and a clear list of conditions for a buyer’s consideration as the parties negotiate the term sheet will set the stage for an honest and direct negotiation process. Big asks like post-closing employee or consulting agreements, retention of favored employees, or exclusion of certain assets from the deal will need to be factored into the asking price. Dealing with these disparate interests among your ownership group at an early stage can avoid an embarrassing fracture in front of the buyer.</p> <p>Other ownership-level issues sometimes overlooked are corporate records and registration. Counsel can clean up any required corporate resolutions, assemble board minutes, and ensure all prior equity transfers are properly documented so a buyer cannot question who rightfully owns the business and can authorize the sale. Counsel can also assist in ensuring your business is registered in all jurisdictions where it operates, and in reviewing any license or permitting issues. </p> <p><strong>Handshakes Backed by Hard Copy – Review Your Key Relationships</strong></p> <p>For many companies, their strategic relationships with suppliers, vendors, customers, distributors, or service providers are critical to profitability. Before allowing those relationships to come under a buyer’s scrutiny, think about whether all your relationships are properly documented, and if so, whether you need to renegotiate or update terms. It is possible, for instance, that a years-long master services agreement has grown obsolete and needs updating to reflect a changed business environment. Make sure you’ve documented any favorable terms, such as volume or bulk discounts from key suppliers, because a buyer cannot count on a handshake deal to last. Another important consideration is whether any of these agreements prevent assignment to a new buyer without written consent. Many leases, for instance, contain strict prohibitions on assignment without landlord’s express written consent, which can be triggered either in an asset sale or equity deal where a substantial portion of the ownership equity is changing hands. </p> <p><strong>Secure the Secret Sauce – Protect Your Intellectual Property</strong></p> <p>For many startups and technology businesses, intellectual property is the crown jewel of the company. Any problems uncovered by a buyer in this area will likely affect the closing process. Depending on the nature of your business, an expert can help you navigate a variety of legal issues, with some examples including registering (or renewing) your major trademarks or copyrights, ensuring you have legal right or title to use your website domains or licensed software, analyzing your patent portfolio’s strength to withstand a challenge, and evaluating security measures (cyber and physical) in place to protect customer lists or other trade secrets. A robust review of the legal protections in place over your IP can instill confidence in a buyer and ensure that the purchaser can utilize these assets to their fullest post-closing potential. Strong protections here can lead to higher returns.</p> <p><strong>Prepare Your People – Employee Considerations</strong></p> <p>The sale process can make many employees feel uneasy about their future at the company and could lead to departures or early retirements. One possible mitigation plan is having top managers or other crucial talent sign confidentiality and invention assignment agreements. Keep in mind that non-compete clauses may only be enforceable under limited circumstances, or perhaps not at all in your jurisdiction, so it is important to confer with legal counsel to understand whether you can or should include these clauses or whether your existing agreements offer effective protections. If you want certain individuals to stay on through a transition period, perhaps you need to think about incentive bonuses or an earn-out at closing. </p> <p><strong>Conclusion </strong></p> <p>Due diligence is not just a buyer’s purview. A small upfront investment on the seller side can shield buyers from latent problems lurking beneath the surface and avoid an unintended consequence of a less-than-optimal deal for the sale of your business. A good attorney will help you deal with these issues and command top dollar for your business.  </p>Tue, 12 Mar 2024 00:00:00 -0500{6F5613E3-D63B-4C9F-9746-0AF1DE120F7B}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2024/spotlight-march-2024/unintended-consequences-dont-forget-the-litigation-risks-when-getting-a-deal-doneUnintended Consequences: Don’t Forget the Litigation Risks When Getting a Deal Done<p> Transactional attorneys play a key strategic role in drafting essential documents, such as corporate formations and contracts, on behalf of corporate clients. With a client’s current needs at the forefront—often accompanied by the excitement and pressures of getting a deal done—a drafting attorney's priority may not be on future, hypothetical litigation. And drafting decisions without an adequate eye toward litigation may inadvertently create challenges and complexities in litigation that could have been mitigated at the drafting stage.</p> <p> Large (and even not-so-large) corporate deals often involve multiple entities, some of which are affiliated with other parties and nonparties to the deal; multiple owners, officers, and directors; and multiple legal documents to effectuate the deal. Often these multiple documents are compiled and circulated in a “deal book.” The attorneys sometimes even make themselves “deal toys” to commemorate the “deal” (sometimes to the envy of trial attorneys, where such toys aren’t a thing).</p> <p> Behind this plethora of documents usually lie complex legal and business reasons involving tax benefits, IP ownership, investor requirements, other strategic decisions, and sometimes good old-fashioned horse trading that drive the ultimate structure of a deal. Yet the justification for these well-thought-out strategies and their corresponding effects on the documentation of the ultimate deal often disappear over time.</p> <p> For example, years after an exciting deal has consummated, it sours, and disputes arise. Party A to the deal wants to sue Party B. Enter the litigator, who—after carefully considering her client’s identity and how to ensure privilege protection<sup><span style="font-size: 8px;">1</span></sup>—analyzes the operative documents and develops a legal theory under one of the contracts, noting the agreement requires that Illinois law apply to any disputes arising from the contract and that the exclusive resolution venue be the Northern District or state courts of Illinois. But the litigator also discovers a viable fiduciary-duty claim against a Party A director who’s also affiliated with Party B, complicated by Party A’s certificate of incorporation requiring that all fiduciary claims against directors be brought in Delaware. So where should she file suit?</p> <p> Not wanting to voluntarily enter a two-front war, she advises the client to move forward with just the fiduciary-duty claim in the Delaware Court of Chancery and hold fire on the contract claim for now. But litigation is not a game of solitaire, and one’s adversary often has a say in which battles will be fought. And—looking for leverage—the adverse party, Party B, decides it has a claim against an affiliate of Party A, under yet a third agreement in the deal book that contains a nonexclusive venue provision allowing claims to be brought in Minnesota, Party B’s home state. So, Party B files suit against A’s affiliate in Minnesota. Now our intrepid counsel, who represents Party A and now A’s affiliate, is effectively fighting a two-front war while reserving A’s unfiled contract claim against B, which must be filed in Illinois.</p> <p> Even assuming that, as a legal matter, all parties have diligently maintained and respected the corporate distinctions among the various entities and no basis exists for piercing the client-privilege barrier, as a practical matter, two sides clearly exist: those aligned with Party A and those aligned with Party B—regardless of which individuals or affiliates are named in the various lawsuits. And no settlement will get done without a global resolution of all the disputes between Party A and Party B and all their respective affiliates. But a global resolution often does not happen immediately. Usually, a certain amount of motion practice and discovery must happen before both parties are ready to come to the table at all—let alone be willing to come to a deal. </p> <p>In the meantime, litigation is costly. And litigating on multiple fronts is even worse. Depending on whether the case is in federal or state court, a court might consider transferring venue so the cases can be either consolidated or, at least, coordinated. But transfer may not be possible when issues of personal jurisdiction or exclusive jurisdiction render one of the venues inappropriate. It also may not be an option if one or more cases are in state court, without the ability to remove to federal court where there might be more venue-transfer mechanisms. And a judge may deny a motion to stay when parties, though aligned, are not identical with those of the other matter. Even with the means to make such motions, you are fighting about where to have a fight—and, even if you win this battle, you still must win the actual war.</p> <p> For unavoidable multiple-front wars, it usually makes sense to assign one lead counsel to oversee all matters, but there will likely be a need to hire local counsel in one or more jurisdictions. The alternative is to hire separate counsel for each matter, but it will require close coordination to ensure counsel takes consistent positions. Coordination will also result in higher fees.</p> <p> Likewise, discovery is often the most expensive part of litigation, and undertaking it and paying for it twice or more is not an efficient use of anyone’s capital. Further, the ability to coordinate discovery could be limited if the cases come before different judges with different timelines. In addition to direct costs, your officers and employees may have to sit for multiple depositions, further taking time away from running the actual business. And since some of the factual issues will likely overlap, inconsistent rulings and findings from the courts become a risk, as well.</p> <p> Looking back, was there a strategy behind the venue decision? Or was it just a remnant from an earlier version used as a template or thrown in without much thought? Perhaps there was a reason for this decision. But if the drafting parties and counsel cannot identify strategic rationale for varying venue and jurisdiction provisions, then they should think twice and consider making them consistent. Otherwise, all the other benefits they so carefully structured could be undermined by the unnecessary cost of a multifront conflict. While the war may not be avoidable, with some advance forethought and planning, you can contain the theater in which you fight it.</p>Tue, 12 Mar 2024 00:00:00 -0500{7C4F00F0-8650-4AD5-B5D2-2CA7AD5873EE}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-justice-report/2024/the-robins-kaplan-justice-report-february-2024/advocating-for-justice-beyond-the-courtroomTony Schrank: Advocating for Justice Beyond the Courtroom<p>In the legal arena, where the pursuit of justice for the injured and the grieving is paramount, Tony Schrank stands as a formidable advocate. As a partner at Robins Kaplan, Tony has dedicated his career to helping individuals who have been injured and families who have lost loved ones due to wrongful death. His recent triumph in securing a $1.79 million verdict for a client who suffered a traumatic brain injury in a car crash is just one testament to the impact he makes on the lives of those he represents.</p> <p><strong>A Journey Rooted in Passion</strong></p> <p> Tony’s journey into law began with a deep-rooted interest in the legal system. During his undergraduate years, he interned at a company that administered class action lawsuits. This early exposure ignited his passion for the law, leading him to law school, where he found his calling in personal injury law. Before joining Robins Kaplan in 2017, Tony spent three years running a private practice in Anoka, Minnesota. His solo practitioner days were marked by a diverse range of civil litigation cases. Although about half of his caseload was dedicated to personal injury, his interest in the work led him to explore his options for practicing exclusively in the field. He decided to transition to a larger firm that could provide the support and resources required for a more concentrated focus on personal injury and wrongful death.</p> <p><strong>"The Rest Was History"</strong></p> <p> The decision to join Robins Kaplan was a natural progression for Tony. From his law school days, he admired the firm's commitment to handling significant cases. His desire to practice law in the same impactful way brought him to the doors of the firm, and “the rest was history,” he said. Since joining Robins Kaplan, Tony has amassed an impressive track record of successful results. In one notable case, he represented a 72-year-old man injured in a ski lift incident in Michigan, securing a substantial $2.25 million settlement. He obtained a $1,250,000 recovery on behalf of a minor who was electrocuted while climbing a tree after the Court granted a motion for punitive damages. He also secured a significant $1.75 million settlement on behalf of a bicyclist who suffered a traumatic brain injury after being struck by a truck.</p> <p><strong>A Verdict Beyond Medical Bills</strong></p> <p> Tony's recent success in obtaining a $1.79 million jury verdict for a car crash victim not only marked a legal victory but allowed his client to embrace an improved way of life. What made this result truly exceptional is that the client had only $9,000 in medical bills. The substantial award reflects the jury's recognition of the profound impact on the client's quality of life. The client, now with a "new brain" due to the crash, faced significant challenges, including a reduced ability to work and a complete shift in lifestyle. The client also had a brother with disabilities whom she intended to care for after her mother was no longer able to. Because the client’s income was reduced, she was no longer able to afford her "dream home" which had the necessary accommodations for her brother. With this verdict, she can now revisit purchasing a home like this again.</p> <p><strong>A Decade of Impactful Cases</strong></p> <p> With over a decade of experience and a history of achieving favorable outcomes in difficult cases, Tony attributes all his success to his wife, who has supported each step of his career, and his three children. When asked about the most impactful cases of his career, he does not point to the ones with the largest rewards or the most shocking details. Instead, he says that the most meaningful cases are the ones he is currently working on – because those are the lives he is focused on affecting right now, and in turn, they affect him. His dedication to his work is evident in his pursuit of justice for each new client he represents. </p>Wed, 28 Feb 2024 00:00:00 -0600{A8179750-7216-4CBA-84F3-A4DC4138EAF5}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-quarterly-business-litigation-update/2024/the-robins-kaplan-quarterly-business-update/navigating-the-legal-landscapeNavigating the Legal Landscape: Generative AI and Copyright Law<p>Generative artificial intelligence captivated the world in 2023 and is firmly positioned to remain center stage in the coming year. In the United States, the introduction and early-stage use of generative AI have been plagued with legal disputes and speculation. This presents challenges for companies protecting their generative AI innovations as well as for users understanding rights and risks associated with generative AI tools.</p> <p> In this Q&A, Robins Kaplan LLP attorney Bryan J. Mechell provides some guidance to understanding the many copyright controversies that have accompanied the introduction of generative AI systems and take-aways for technology companies leveraging and licensing generative AI innovations.</p> <p style="margin-left: 40px;"><strong>1. There have been two primary copyright questions that everyone is asking with regard to AI and intellectual property. The first is: Can something created with AI be protected by copyright law?</strong></p> <p>In short, yes, content created using a generative AI tool can likely be protected by copyright law—but the scope of how much human input is necessary to qualify the user of an AI system as an “author” of the generated work is still an open question subject to substantial ongoing legal and regulatory discussion. The U.S. District Court for the District of Columbia considered aspects of this question in the August 2023 <em>Thaler v. Perlmutter</em> decision. In that case, the court affirmed the U.S. Copyright Office’s denial of an application for an AI-generated image that was generated autonomously by an AI system called the “Creativity Machine.” Noting that “human authorship is an essential part of a valid copyright claim,” the court highlighted Section 102 of the Copyright Act, which provides copyright protection to “original works of authorship fixed in any tangible medium of expression, now known or later developed, from which they can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device.” 17 U.S.C. §102(a). Section 101 of the Act further provides that the work of authorship must be fixed “by or under the authority of the author.” This “authorship” requirement, the court noted, was “presumptively human” and centered on “acts of human creativity.” The court noted that “Copyright has never stretched so far, however, as to protect works generated by new forms of technology operating absent any guiding human hand.” </p> <p> Notably, however, the <em>Thaler</em> decision left the critical and more fact-specific question unanswered of <em>how much</em> human input would have been needed to qualify the work for protection. While courts have long recognized that technological tools can be used by authors as part of the creative process, generative AI highlights important questions about how a technological tool can be used by a human author and the extent of human decision-making required. With the right amount of human input and creativity, it stands to reason that works containing outputs from advanced technological tools may qualify for copyright protection. Courts and the U.S. Copyright Office are likely to provide useful guidance as they explore the contours of this issue in the coming year. </p> <p style="margin-left: 40px;"> <strong>2. The second question concerns whether generative AI companies such as OpenAI are violating copyright law, as some class actions have been filed recently over infringement and related issues. Who are waging these suits and what are these plaintiffs claiming?</strong></p> <p>Proposed class action lawsuits filed last year against GitHub, Stability AI, OpenAI, and Meta—including actions filed by George R.R. Martin, John Grisham, Pulitzer Prize winner Michael Chabon, comedian and author Sarah Silverman, and various other authors against OpenAI and Meta—raise important questions about liability for unauthorized use of copyrighted materials to train generative AI models without consent, credit, or compensation, as well as questions about ownership of generative AI outputs. </p> <p> These actions include allegations that generative AI companies trained their generative AI tools on protected materials without proper attribution or compensation. For example, the class action complaint filed against GitHub, Microsoft, OpenAI, and related corporate groups in November 2022 alleges that the defendants trained Codex and Copilot (coder-assisting generative AI programs) on public code that was protected by open-source licenses, but the AI does not provide attribution of authorship or copyright when outputting that code. These are alleged Digital Millennium Copyright Act (DMCA) violations.</p> <p> The various class action litigations filed against OpenAI and Meta allege that the generative AI tool uses copyrighted works in its vast <em>training datasets</em> that are built by scraping the internet for text data—which necessarily leads the tool to capture, download, and copy copyrighted written works, plays, and articles. The complaints also assert that the <em>outputs</em> of the generative AI model—i.e., the text-generated responses to a user input query—constitute copyright infringement.</p> <p> And to round out the year, <em>The New York Times</em> sued OpenAI and Microsoft, alleging millions of the newspaper’s articles were used without permission to train AI chatbots that interact with users.<br /> For intellectual property owners protecting their generative AI innovations, as well as end users licensing generative AI tools, these lawsuits underscore the importance of closely monitoring the composition of generative AI training data sets, scope and content of outputs, and license terms regulating the use of these rapidly evolving technologies. </p> <p style="margin-left: 40px;"><strong>3. What are the defendants claiming gives them the right to use copyrighted content to train their systems? </strong></p> <p>OpenAI has moved to dismiss the bulk of the claims in the class action filed by Sarah Silverman and others—the “heart” of which it argues are copyright claims—on the basis that they “misconceive the scope of copyright, failing to take into account the limitations and exceptions (including fair use) that properly leave room for innovations like the large language models now at the forefront of artificial intelligence.” Motion to Dismiss, Dkt. 32, <em>Silverman v. OpenAI, Inc.</em>, No. 3:23-cv-03417 (N.D. Cal. Aug. 28, 2023) (Dkt. No. 32). The Copyright Act grants a limited monopoly in service of a broader goal to—as the U.S. Constitution states—“promote the Progress of Science and useful Arts.” U.S. CONST. Art. 1, § 8, cl. 8. But this protection has limits, including the “fair use” doctrine, which OpenAI argues should be adapted to account for “rapid technological change” and, in short, to protect the use of large sets of training data for generative AI models. OpenAI argues in its motion to dismiss that current judicial precedent supports the conclusion that it is not an infringement to create “wholesale cop[ies] of [a work] as a preliminary step” to develop a new, non-infringing product, even if the new product competes with the original. <em>Oracle</em>, 141 S. Ct. at 1199 (summarizing <em>Accolade</em>, 977 F.2d at 1521– 27); <em>see also Connectix</em>, 203 F.3d at 603–08. </p> <p style="margin-left: 40px;"><strong>4. You mention the potential liability of those training their AI models, but how are technology companies addressing the risk of developing and using generative AI models? </strong></p> <p>Technology and software license disputes involving intellectual property and contract rights carry significant risk in terms of potential business disruption and damages. While generative AI models that learn from datasets as large as the internet can be exceptionally powerful, those datasets are heavily interspersed with copyrighted and other protected material. The increasing implementation and use of generative AI at software and technology companies could, therefore, lead to increased disputes over the use of copyrighted data to train generative AI models as well as ownership of outputs. </p> <p> It is likely going to be some time before we get solid guidance from courts, regulations, and potentially Congress on the scope of various IP rights in generative AI tools. In the meantime, it is critical that technology companies developing and licensing generative AI innovations closely monitor, catalog, and assess training data used by generative AI tools. This includes maintaining a detailed record of the sources, libraries, metadata, and the compositions of each—which provides the basic materials needed to assess risks associated with an AI system trained on protected materials. All aspects of the generative AI ecosystem are important to consider from a risk management perspective, including the training set, the AI algorithm or model itself, the input query, and the output result. One strategy is to develop a cross-functional team tasked with monitoring use and compliance. As part of this assessment, companies should pay close attention to license terms that outline authorized uses and protect IP rights, assess how generative AI outputs are being used (and modify licenses accordingly), and develop a robust review process for monitoring compliance with developing laws and regulations. </p> <p style="margin-left: 40px;"><strong>5. What are some strategies for crafting effective license terms in software license agreements to maximize benefits of IP protection for generative AI innovations?</strong></p> <p>One important take-away for technology companies leveraging generative AI innovations is to take a wholistic approach to licensing that acknowledges how any generative AI tools interact with licensed software. This includes drafting terms that clearly articulate what rights are licensed, authorized uses, restrictions, and warranties—all of which can vary based on the specific piece of the generative AI ecosystem under consideration. For example, license agreements should identify the scope and content of training data used by any generative AI tools, and how (or if) user data is used to train the model. Similarly, license agreements should define ownership and authorized uses of the generative AI outputs, and articulate restrictions on how the overall tool can be used. It is important to remain mindful of internal goals for IP protection in generative AI and implement intentional processes for refining licensing practices as the laws applicable to generative AI evolve.</p>Mon, 29 Jan 2024 00:00:00 -0600{4FD52DC2-D17A-4CAC-BF3F-7E5F9D2B7C41}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2024/generically-speaking-q4/corcept-therapeutics-v-teva-pharms<i>Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.</em>, No. 18-CV-03632 (RMB/LDW), 2023 WL 9017081 (D.N.J. Dec. 29, 2023) (Bumb, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Korlym® (mifepristone); U.S. Patents Nos. 10,195,214 (“the ’214 patent”) and 10,842,800 (“the ’800 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Corcept asserted a number of patents against Teva’s ANDA product, two of which remained in suit through a bench trial. Those patents (the ’214 and ’800 patents) cover methods of controlling hyperglycemia in certain patients with Cushing’s syndrome.</span></p> <p style="margin-bottom: 12pt;"><span>The parties presented one issue during the bench trial: whether Teva induces infringement of the ’214 patent and the ’800 patent. The court determined that Corcept had not carried its burden: “it has not demonstrated that there is a likelihood of direct infringement of the asserted claims in the future because it has not established that physicians are likely to coadminister mifepristone with a strong CYP3A inhibitor at an infringing sequence and/or dosage now or in the future. Indeed, Corcept failed to introduce credible record evidence that anyone has ever previously infringed the asserted claims.” Further, Corcept failed to show that Teva possesses the requisite intent to induce—its proposed label does not “encourage, recommend, or promote” infringement.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Teva Prevailed: </span></strong><span>After a fact-intensive analysis, the court determined that Corcept did not satisfy its burden of proof because the evidence did not show that <em>anyone</em> has ever practiced the claimed methods (over a ten-year period since FDA approved Korlym). The court (and Teva) relied on the <em>Genentech </em>case, in which the Federal Circuit considered certain patented methods that, based on the record evidence, no physicians had ever practiced or would ever practice. Here, the court did not find that it <em>must</em> credit the lack of evidence of past infringement in finding no likelihood of future infringement. But the lack of evidence is relevant.</span></p> <p style="margin-bottom: 12pt;"><span>The court also cited record evidence demonstrating that future infringement is unlikely—physicians generally avoid the claimed method (co-administering mifepristone and strong CYP3A inhibitors). Indeed, Teva’s label cautions <em>against</em> coadministration. And at least one non-infringing alternative suggested that physicians are not likely to directly infringe in the future.</span></p> <p style="margin-bottom: 12pt;"><span>The Court separately determined that Teva’s label does not encourage physicians to practice the asserted claims. “The label only provides instructions <em>how</em> to coadminister the substances to achieve an efficacious result <em>if</em> a physician determines that it is medically necessary.” And even if a physician decided to co-administer, the label provides non-infringing options. Thus, the court declined to infer specific intent to induce infringement.</span></p>Fri, 29 Dec 2023 00:00:00 -0600{2ED44FA1-FA1A-47E6-9465-DE245E7B83E2}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2024/generically-speaking-q4/acadia-pharms-v-aurobindo-pharma<i>Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.</em>, </span><span>No. 20-985-GBW, 2023 WL 8622048 (D. Del. Dec. 13, 2023) (Williams, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Nuplazid® (pimavanserin tartrate); U.S. Patent No. 7,601,740 (“the ’740 patent”) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>The only disputed issue was the validity of claim 26 of the </span><span>’</span><span>740 patent, which recited a tartrate salt of </span><span>pimavanserin. The </span><span>’</span><span>740 patent issued on October 13, 2009, from U.S. Patent Application No. 10/759,561 (“the </span><span>’</span><span>561 application”), which was filed January 15, 2004. The USPTO calculated 980 days of patent term adjustment (“PTA”) for the </span><span>’</span><span>740 patent. The </span><span>’</span><span>740 patent also received a 1,315-day patent term extension (“PTE”) for FDA delay.</span></p> <p style="margin-bottom: 12pt;"><span>Defendant argued that claim 5 of U.S. Patent 9,566,271 (“the ’271 patent”)—that recited a method for treating hallucinations by administering the tartrate salt of pimavanserin—rendered claim 26 of the </span><span>’</span><span>740 patent invalid for obvious-type double patenting (“OTDP”). The </span><span>’</span><span>271 patent issued from U.S. Patent Application</span><span> </span><span>No. 11/416,527 (“the </span><span>’</span><span>527 application”), filed on May 3, 2006. The </span><span>’</span><span>527 application initially was a continuation of the </span><span>’</span><span>561 application. During prosecution, on July 1, 2009, Acadia changed the </span><span>’</span><span>527 application to a divisional of the </span><span>’</span><span>561 application. The </span><span>’</span><span>271 patent issued on February 14, 2017, and expires on January 15, 2024. The parties cross moved for summary judgment. The court granted Acadia’s summary judgment motion.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Acadia Prevailed:</span></strong><span> The parties disputed the proper interpretation of 35 U.S.C. § 121. That statute creates a safe harbor—for a parent application and its divisional application claiming overlapping subject matter—to protect from OTDP. The court framed the issue as follows: “whether the language in § 121, which requires the divisional patent be filed ‘before the issuance of the patent on the other application’ and ‘as a result’ of a restriction requirement, applies when the challenged patent is the original patent, not the divisional patent”?</span></p> <p style="margin-bottom: 12pt;"><span>Arcadia argued that § 121 discusses two types of reference patents: (i) a patent issuing on an application with respect to which a requirement for restriction has been made; and (ii) a patent issuing on an application filed as a result of such a requirement. Conversely, MSN argued that “the divisional application” refers to the reference patent, which is “filed as a result of a restriction requirement.” In other words, § 121 applies only when the reference patent is filed as a result of a restriction requirement “before the issuance of the patent on the other application.”</span></p> <p style="margin-bottom: 12pt;"><span>The court explained that the best guidance on § 121 was a Federal Circuit decision stating that the statute was meant to “shelter[] from attack a divisional application or … the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.” Based on that dicta, the court agreed with Acadia’s interpretation that the “divisional application” that must be filed pre-issuance is a challenged patent, not a reference patent. The court found that the </span><span>’</span><span>271 patent was filed “as a result of” the original </span><span>’</span><span>740 patent. For this reason, the </span><span>’</span><span>740 patent was not invalid for OTDP.</span></p>Wed, 13 Dec 2023 00:00:00 -0600{EF88B375-8098-4710-8C57-699366D83C8B}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-december-2023/advancement-proceedingsAdvancement Proceedings: A Litigation Expense Your Client Might Not Have Anticipated<p>When representing a client, it is helpful when law and logic align in an obvious manner. But alignment of law and logic sometimes appears murky at best, and often directly at odds. An example of this is when you need to explain that your client must pay for the defense of the officer and director it sued for wrongdoing. </p> <p> A corporation is often obligated under the corporation’s bylaws or by contract to advance defense costs, including attorney’s fees, when its officer or director is sued in that capacity—even if the corporation is doing the suing. The logic behind the obligation is that corporations would be hard pressed to find qualified individuals to serve as officers and directors if those individuals then faced risks of being sued for acts they took while serving in those capacities. As the Delaware Supreme Court explained in <em>Stifel Financial Corp. v. Cochran</em>, the purpose of advancement is to “promote the desirable end that corporate officials will resist what they consider unjustified suits and claims, secure in the knowledge that their reasonable expenses will be borne by the corporation they have served if they are vindicated,” and to “encourage capable women and men to serve as corporate directors and officers, secure in the knowledge that the corporation will absorb the costs of defending their honesty and integrity.” 809 A.2d 555, 561 (Del. 2002).</p> <p> And indemnification rights alone are not necessarily sufficient to protect officers and directors if the right to indemnification often cannot be assessed—or accessed—until a litigation matter concludes. In the meantime, a defendant can incur hundreds of thousands, if not millions of dollars in legal fees defending against such claims. Therefore, a corporation agreeing to not only indemnify but provide advancement of defense costs can give its corporate officer or director comfort that those fees will be paid as they are incurred as opposed to waiting years until the matter is resolved and a final right to indemnification is determined.</p> <p> But what happens when those officers or directors act wrongfully toward the company, and the company decides to sue them? Then the officers and directors make a request for advancement—from the very same party that is suing them. And, generally, the corporation will have to agree to do so—especially if it is a Delaware corporation. Under Delaware law, very rarely does a corporation have a defense to paying advancement. Only if it can show that no causal connection exists between the underlying proceedings and the defendant’s official corporate capacity, as defined by the bylaws or contract, can a corporation evade a request for advancement. But that is rarely the case. </p> <p> For the cases where Delaware corporations refuse advancement, Delaware has established summary proceedings that make it relatively simple to get fees awarded. The Delaware Chancery Court, where such proceedings are brought, will give priority to advancement suits and schedule them for a prompt hearing. And few defenses apply at this stage. If the contract or bylaws provide for advancement, the likelihood of avoiding advancement costs are slim. The only comfort a company takes is that the individual seeking advancement must provide “an undertaking to repay such amount if it shall ultimately be determined that such person is not entitled to be indemnified by the corporation[.]” 8 Del. C. Section 145(e). But that determination will not be made in the company’s favor for months or years, if ever.</p> <p> Making things more treacherous for the company refusing to pay advancement expenses is the fact that the officer or director can also seek fees for having to bring the claim for advancement, creating an upward spiral of attorneys’ fees for the corporation. Therefore, companies rarely dispute the right to advancement in Delaware. The availability of D&O insurance—which generally covers these advancement costs—also helps corporations swallow this bitter pill.</p> <p>While corporations are hard pressed to dispute the <em>right </em>to advancement, they can dispute the <em>amount</em> of those advanced expenses—at least to some degree. For instance, if a defendant is represented by counsel who is also representing other defendants who are not entitled to advancement from the corporation, the corporation is only required to advance those fees and expenses that would have been incurred if the corporate officer or director were the sole defendant. If a defense or litigation activity only partially benefits the individual, then counsel must accordingly make a good-faith allocation of those costs and fees. And, of course, if a litigation activity only benefits the other non-entitled defendants, no advancement on those fees is required.</p> <p> That said, these types of determinations are often hard for a corporation to win at the advancement stage. Under what has become known as the “<em>Fitracks</em> Procedures,” first set forth in <em>Danenberg v. Fitracks, Inc</em>., a senior Delaware counsel for the party seeking advancement prepares a detailed submission, certifying to the correctness of the amount of the advancement request. Senior Delaware counsel for the opposing party may then object to the amounts requested, certifying the detailed reasons why the amounts sought are not advanceable.</p> <p>But a Delaware court will not engage in a detailed or granular review of “persnickety disputes” over fees at the advancement stage. After all, until it is clear which claims are indemnifiable and for whom, the court can’t decide a proper allocation on expenses. Therefore, “fights about details” should be left to the final indemnification proceeding.</p> <p> In sum, before a corporation sues one of its officers or directors, it should be very confident that it will prevail. Otherwise, not only will the corporation suffer the expense of pursuing its unsuccessful claims, but it will suffer the expense of defending them, too.</p>Wed, 13 Dec 2023 00:00:00 -0600{A17474CE-78C6-4FC2-822C-27229B2DF118}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-december-2023/can-the-threat-of-fees-discourage-unnecessary-fiduciary-disputesCan the Threat of Fees Discourage Unnecessary Fiduciary Disputes? Maybe...<p>The early stages of partner and shareholder relationships are about hope and promise, not discord and dispute. Yet, the earliest stage—and during the drafting of the partner or shareholder agreement—offer real opportunities to address and potentially discourage disputes. </p> <p> One often-utilized approach comes in the form of fee- and cost-shifting provisions. At the highest level, such provisions are designed to force a potential litigant to thoroughly assess the likelihood of success prior to starting a legal dispute. But, as the case with most legal tools, the level of efficacy is somewhat nuanced. </p> <p><span style="text-decoration: underline;">A Typical Fee-Shifting Provision</span> </p> <p> Fee-shifting provisions will generally incorporate a range of potential legal proceedings and allow the prevailing party to recover reasonable fees and costs if such a proceeding is initiated. A common and not necessarily recommended example follows: </p> <p style="margin-left: 40px;"><strong>Fee Shifting</strong>: Should any legal action, arbitration, or proceeding be brought to enforce or interpret any provision of this Agreement, the prevailing party shall be entitled to recover reasonable attorney fees, court costs, and other expenses incurred in connection with such action, in addition to any other relief to which the prevailing party may be entitled. </p> <p> Typically provisions like this are boilerplate and passed along, cut-and-pasted, without much thought or reflection. Yet, even in those cases, the provisions can provide some benefit, although tailoring them to individual circumstances can improve their relative value. </p> <p><span style="text-decoration: underline;">The Potential Benefit of Fee-Shifting Provisions</span> </p> <p> Attorney fee-shifting provisions telegraph the risks and costs associated with a legal dispute. Consequently, such provisions can discourage the most frivolous litigation because the parties to the agreement become motivated to engage in a meaningful risk assessment that includes the financial implications of the dispute if the matter is litigated to a final resolution. Such assessments provide a level of rationality in situations that are often highly emotional and driven by personal animosity. </p> <p style="margin-left: 40px;"><em>Drafting Tip</em>: Include some language that calls out the risks to the parties. For example, fee-shifting provisions should reference legal costs incurred from mediation, arbitration, litigation, and appeals until a final, non-appealable judgment is reached. The costs identified in this provision should also include, without limitation, attorney fees, expert fees, and court costs. These lists of examples declare what is at stake when a party wants to go to court. </p> <p>Even when litigation is initiated, these provisions can have a “reasonableness influence” in that they can encourage parties to act more reasonable within the litigation to increase the likelihood that parties can recover their fees should they prevail and protect against losses should they not. When such provisions are most effective, they can lead to more efficient legal strategy and disincentivize petty legal tactics. </p> <p style="margin-left: 40px;"><em>Drafting Tip</em>: Most jurisdictions imply a covenant of good faith and fair dealing in every contract, which requires all contracting parties to act reasonable with one another. As a reminder of this obligation, fee shifting provisions should include clauses that require parties to act reasonably when prosecuting claims against one another and incur only those legal fees and expenses that are proportional to the needs of the case. A reasonableness standard also increases the odds of courts enforcing fee shifting provisions.</p> <p>Fee-shifting provisions can also encourage settlement at many stages of litigation. Early phases of the proceedings present the parties with the opportunity to preserve unspent resources and control the outcome. In later phases, each party needs to assess the reality that the fees and costs incurred over the entire litigation could become their responsibility. Such uncertainty can encourage a pragmatic rationality that leads to the parties taking the outcome into their own hands and working together to minimize the looming risk that could become any respective party’s ultimate responsibility. </p> <p><span style="text-decoration: underline;">The Maybe</span></p> <p> Some aspects of fee-shifting provisions are more nuanced. Most notably, many laud fee-shifting provisions for accomplishing a sort of “leveling the playing field” and potentially balancing financial burdens where a party with a viable claim is under-resourced. That said, a party can only realize this benefit by seeing a matter through to the end, prevailing, and then convincing a court that their fees and costs were reasonable. In addition, in some cases, the party with more financial resources might use fee shifting as a strategic advantage, pressuring the other party to settle despite the merits of the case.</p> <p> Common aspects of fee-shifting provisions can also implicate their efficacy. For example, the deceptively simple question of what it means to be a prevailing party can present myriad complications. If you prevailed on three of your five claims, are you wholly a prevailing party? If you prevailed on all your claims, but your damages were <em>de minimis</em>, are you wholly a prevailing party? If you were found to have breached a duty, but there is no damage, who is the prevailing party? </p> <p> And then there is the related question of what constitutes reasonable fees and costs and whether they were incurred in connection with the action on which one has prevailed. Practically speaking, for the small percentage of cases tried to a verdict, determination of fees and costs presents an additional and potentially onerous stage of the litigation with a range of attendant risks. Such risks include limited fee recovery and a round of expensive appellate proceedings associated with the fee award, among other things. </p> <p><span style="text-decoration: underline;">Conclusion</span></p> <p>Ultimately, fee-shifting agreements can discourage frivolous litigation, promote a degree of fairness, incentivize settlement, and encourage reasonable behavior during disputes. That said, they are not a panacea, and parties and potential parties should not be overly taken in by their ultimate impact. In addition, depending on the specific circumstances, careful attention to aspects of such provisions can increase the likelihood that they are a net positive for all parties to the agreement should things not turn out the way they had hoped. </p>Wed, 13 Dec 2023 00:00:00 -0600{650D19C5-DDB5-4821-A47C-EB45334D10EF}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-december-2023/who-pays-when-you-fight-over-a-trustWho Pays When You Fight Over a Trust?<p>Litigation is often expensive. When a client considers filing a lawsuit or must decide how to handle a lawsuit someone else started, one of the most fundamental questions to ask is: Who pays the lawyers?  </p> <p>Under the American Rule, the default rule in litigation is that each party to a case must pay for its own attorneys. In trust litigation, though, the trust may end up paying the legal fees for multiple parties involved in the litigation, ultimately leaving a much smaller pot of money for the beneficiaries than originally anticipated. As a result, a beneficiary might be surprised to find out that the trust is paying to defend a trustee that the beneficiary is suing. Conversely, a trustee may receive distribution requests from a beneficiary even though the beneficiary is suing the trust. </p> <p>Given the significance of legal fees, how should trustees and beneficiaries plan for legal expenses when dealing with trust litigation? </p> <p>Look first to the trust document. The settlor of a trust is unlikely to want to burden a trustee with payment of legal expenses incurred in administering the trust (and a potential trustee is very unlikely to accept that role if it risks exposure to paying legal fees). As a predicable result, most trust documents permit a trustee to hire lawyers, and many will also indemnify a trustee for any expenses that do not result from intentional wrongful conduct—even if that conduct is later determined to be a breach of a fiduciary duty.<sup><span style="font-size: 10px;">1</span></sup> All parties will want to know the extent to which the trust is responsible for paying the trustee’s legal fees. </p> <p>The fact that a trust instrument allows a trustee to hire lawyers does not give the trustee a blank check. The legal fees incurred will still need to be reasonable to accomplish the purpose of the trust and defend the trustee. And if the trustee loses in litigation, particularly if the claim was for a breach of fiduciary duty, a beneficiary may surcharge the trustee to try to recover the decreased value of the trust resulting from the breach, which may include a reimbursement of the trustee’s legal fees. In some instances, a beneficiary may even seek a court order prohibiting a trustee from defending itself using trust funds. Those requests, which are similar to seeking a preliminary injunction, are difficult to win and should be reserved for rare circumstances involving significant evidence of intentionally wrongful conduct, not as leverage in run-of-the-mill disputes between a beneficiary and a trustee.  </p> <p>Beneficiaries or others involved in trust litigation can sometimes recover their legal fees from the trust as well. To do so, the party asking for reimbursement generally must show that the litigation was of significant benefit to the trust—whether by recouping money lost, removing a fiduciary who is a bad actor, or otherwise preserving the assets of the trust. The standard for recovery will vary based on the trust instrument and on the law of the jurisdiction in question and is often discretionary and fact-dependent. That is why a beneficiary should not assume the trust will foot the bill for legal fees. </p> <p>Beneficiaries—even beneficiaries with a significant net worth—may also lack direct access to assets to pay legal fees. And even if a beneficiary can pay lawyers, those expenses might take up resources that would be used to pay other expenses. Beneficiaries may end up making additional requests for distributions from the trust—whether explicitly for legal fees, or to make up other shortfalls resulting from legal bills. While a trustee might be tempted to cut off all distributions to a beneficiary when the beneficiary is suing the trust, it is often better to consider such distribution requests in the ordinary course of business independent of the litigation. Ultimately, an exercise of discretion that is not tied to litigation positions is more likely to be upheld. </p> <p>A final backstop is the equitable power of a supervising court. In instances where a trust instrument is vague or where circumstances are particularly compelling, a court can determine whether the trust should pay (or not pay) legal bills as a matter of equity. Like with other discretionary requests, no trustee or beneficiary should assume that a court will invoke its equitable authority to order payment of legal bills .  </p> <p>Some trusts have so much money that legal bills do not put a dent in them. But for most trusts, legal fees from a protracted fight can significantly reduce the assets available for supporting beneficiaries. All sides should be aware of how legal fees might be paid in a dispute and should continue to evaluate the payment of fees as the dispute evolves. And if you have questions or concerns about payment of legal fees or a trust dispute, please do not hesitate to contact one of our Wealth Planning and Fiduciary Disputes attorneys. </p>Wed, 13 Dec 2023 00:00:00 -0600{DB9E3F34-237A-440E-B31A-E053B7535599}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2024/generically-speaking-q4/h-lundbeck-v-lupin-ltd<i>H. Lundbeck A/S v. Lupin Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>H. Lundbeck A/S v. Lupin Ltd.</span></em><span>, 87 F.4th 1361, 2023 WL 8462010 (Fed. Cir. Dec. 7, 2023) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Dyk, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Trintellix® (vortioxetine); U.S. Patents Nos. 9,278,096 (“the ’096 patent”), 9,125,910 (“the ’910 patent”), and 9,101,626 (“the ’626 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> Plaintiffs asserted three patents against Defendants’ ANDAs: two method-of-use patents (’096 and ’910) and one process-for-manufacturing patent (’626). But Defendants sought approval to market vortioxetine for only one indication—proposing a label carve out—and the ’096 and ’910 patents did not cover that method of use. Plaintiffs nonetheless maintained that the ANDAs infringe the those patents.</span></p> <p style="margin-bottom: 12pt;"><span>After a bench trial, the district court determined that Defendants’ ANDAs did not infringe the method-of-use patents (’096 and ’910 patents) but that one ANDA product (Lupin’s) infringed the process-for-manufacturing patent (’626 patent). Plaintiffs (Lundbeck, Takeda) appealed. Lupin cross-appealed. The Federal Circuit affirmed the district court’s findings.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Defendants (except Lupin) Prevailed: </span></strong><span>Defendants proposed a label carve out and, thus, avoided infringing the method-of-use patents. On appeal, Plaintiffs argued that “the district court erred in not finding infringement of the ’096 and ’910 patents because section 271(e)(2)(A) creates a separate cause of action that does not require a showing of direct, induced, or contributory infringement by the ANDA filer.” Plaintiffs further argued that the labels do not prohibit prescribing vortioxetine for patented uses, even though Defendants suggest that they will not market the drug for those uses.</span></p> <p style="margin-bottom: 12pt;"><span>The Federal Circuit disagreed with Plaintiffs: consistent with <em>Warner-Lambert </em>and its progeny, even under 271(e)(2)(A), the <em>claimed</em> use must be the use for which applicant is seeking marketing approval. “[A]ctions for infringement of method of use patents under section 271(e)(2)(A) are limited to patents that claim an indication of the drug for which indication the applicant is seeking approval.”</span></p> <p style="margin-bottom: 12pt;"><span>Lupin, on its cross appeal, argued that the district court erred in its claim construction analysis and related finding that Lupin infringes the manufacturing patent. The Federal Circuit affirmed the district court’s plain and ordinary meaning construction, finding that nothing in the intrinsic record required Lupin’s narrower construction.</span></p>Thu, 07 Dec 2023 00:00:00 -0600{765151D2-021C-4C51-B6BC-BCA92EC16718}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2024/generically-speaking-q4/eisai-r-and-d-mgmt-co-v-dr-reddys-labs<i>Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.</em>, </span><span>No. 22-CV-5950, 2023 WL 7331272 (D.N.J. Nov. 7, 2023) (Chesler, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Halaven® (eribulin mesylate); U.S. Patents Nos. 6,214,865 (“the ’865 patent”) and RE46,965 (“the ’965 patent”) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>DRL’s ANDA contained two different certifications: a paragraph III certification to the </span><span>’</span><span>865 patent and a paragraph IV certification to the </span><span>’</span><span>965 patent. After offering DRL a covenant not to sue on the </span><span>’</span><span>965 patent, Eisai moved to dismiss all claims and counterclaims on the basis that the court lacked subject-matter jurisdiction. The court granted Eisai’s motion.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Eisai Prevailed: </span></strong><span>After DRL filed its ANDA, Eisai filed a complaint asserting infringement of the </span><span>’</span><span>965 patent. Shortly after, Eisai delivered DRL a covenant not to sue on the </span><span>’</span><span>965 patent. DRL’s opposition brief explained that Eisai tendered a limited and conditional covenant not to sue. Prior to oral argument, Eisai issued a revised covenant not to sue that contained no defects. The court acknowledged that Eisai had a “formidable burden” to demonstrate that it could not reasonably be expected to resume its enforcement efforts, but that the revised covenant extinguished an actual or real controversy between the parties as to Eisai’s claims against DRL.</span></p> <p style="margin-bottom: 12pt;"><span>The court next turned to Eisai’s motion to dismiss DRL’s counterclaims, explaining that there “is no bright-line rule for determining whether an action satisfies the case or controversy requirement.” DRL argued that a case and controversy existed because it is blocked from receiving final approval given the first ANDA applicant may have 180-day market exclusivity. More particularly, DRL argued that the first ANDA applicant may forfeit its 180-day market exclusivity if another ANDA applicant, such as DRL, secures a final court decision in its favor on the </span><span>’</span><span>965 patent. In response, Eisai argued that DRL’s allegation that the first-filer “may” have market exclusivity and that a judgment in favor of DRL “may” trigger such exclusivity was too speculative for subject-matter jurisdiction. The court found that the record supported an inference that the first filer had forfeited its 180 days of exclusivity because it failed to obtain approval within 30 months. For this reason, the court granted Eisai’s motion to dismiss DRL’s counterclaims.</span></p>Tue, 07 Nov 2023 00:00:00 -0600{F6EDF6BC-591E-4198-A835-DF46383523B2}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2024/generically-speaking-q4/actelion-pharms-v-mylan-pharms<i>Actelion Pharms. Ltd. v. Mylan Pharms. Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Actelion Pharms. Ltd. v. Mylan Pharms. Inc.</em>, </span><span>No. 2022-1889, 2023 WL 7289417 (Fed. Cir. Nov. 6, 2023) (Circuit Judges Reyna, Stoll, and Stark presiding; Opinion by Stoll, J.) (Appeal from N.D.W.V., Bailey, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Veletri® (epoprostenol); U.S. Patents Nos. 8,318,802 (“the ’802 patent”) and 8,598,227 (“the ’227 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> Epoprostenol is a naturally occurring substance useful for treating cardiovascular diseases that Plaintiffs sell under the tradename Veletri. The patents-in-suit claim improved epoprostenol formulations that “can be reconstituted with commercially available IV fluids and do not require refrigeration after reconstitution until use.” Mylan filed an ANDA seeking approval to make and sell a generic version of Veletri and Plaintiffs sued. The parties disputed the meaning of the claim term “a pH of 13 or higher.” Plaintiffs posited the definition, “a value of acidity that is given as an order of magnitude that is subject to rounding,” which would allow a pH of 12.5, rounding up to 13, to read on the claim limitation. Mylan argued that the proper construction cannot cover any pH values less than 13. Actelion took issue with Mylan’s proposed construction, relying, in part, on three textbooks. The textbooks explain how to calculate pH and identify significant figures for pH values.</span></p> <p style="margin-bottom: 12pt;"><span>The district court did not address this extrinsic evidence, adopting Plaintiffs’ construction based on the intrinsic record alone. The parties stipulated to final judgment of infringement in favor of Plaintiffs. Mylan appealed, and the Federal Circuit vacated and remanded.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Mylan Prevailed: </span></strong><span>The sole issue before the Federal Circuit is the meaning of “a pH of 13 or higher.” While the claim language appears to be a range with a specified lower limit, “there is no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding. This is especially true in this case where, though not expressly specified, there is in fact an upper limit in the claim because, as a matter of science, pH values are often said to range from 0 to 14.” Moreover, the absence of approximation language might suggest no approximation, but that the nature of measuring a pH value might nonetheless reasonably require a margin of error. The parties submitted extrinsic evidence on this issue that the District Court ignored.</span></p> <p style="margin-bottom: 12pt;"><span>The Federal Circuit next turned to the specification, which revealed that the inventor inconsistently described the level of specificity for a pH of 13. In one instance, the specification states, “[t]he pH of the bulk solution is preferably adjusted to about 12.5-13.5, most preferably 13.” Mylan argued that this shows that the inventor knew how to use approximation language when it wanted and chose not to for a pH of 13; distinguished a pH value of “12.5” from that of “13”; and distinguished a range from a definite value. Relying on the same disclosure, Plaintiffs argued that the inventor clearly shows that “13” should allow rounding or else a preferred embodiment of the invention, meaning a pH of about 12.5 to 13.5, would be excluded from the claim scope.</span></p> <p style="margin-bottom: 12pt;"><span>The Federal Circuit then found that the prosecution history also did not provide clarity. The inventor amended the claim language at issue several times, including: “a pH of greater than 11,” “a pH of greater than 12,” and “a pH of at least 12.” The prosecution history shows that the Examiner drew a distinction between the stability of a composition with a pH of 13 and that of 12. But that did not resolve the narrower issue before the court. </span></p> <p style="margin-bottom: 12pt;"><span>“We find that this case is one where the proper claim construction cannot be reached without the aid of extrinsic evidence, and that the district court should have considered, at minimum, the textbook excerpts offered and addressed by the parties. … It is not for this court to make those findings in the first instance.”</span></p>Mon, 06 Nov 2023 00:00:00 -0600{B5FB999C-51E1-4FD4-A833-FB35B1016918}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2024/generically-speaking-q4/norwich-pharms-v-becerra<i>Norwich Pharms., Inc. v. Becerra</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>Norwich Pharms., Inc. v. Becerra</span></em><span>, Civ. No. 23-1611 (RDM), 2023 WL 7174558 (D.D.C. Nov. 1, 2023) (Moss, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199 (“the ’199 patent”), 7,902,206 (“the ’206 patents”) (together, the ’199 and ’206 patents are referred to as the “Polymorph Patents”), 8,642,573 (“the ’573 patent”), 9,421,195 (“the ’195 patent”), 10,335,397 (“the ’397 patents”) (together, the ’573, ’195, and ’397 patents are referred to as the “HE Patents”), 8,309,569 (“the ’569 patent”), and 10,765,667 (“the ’667 patent”) (together, the ’569 and ’667 patents are referred to as the “IBS-D Patents”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Salix markets rifaximin for the treatment of irritable bowel syndrome with diarrhea (“IBS-D”) and the reduction of risk of hepatic encephalopathy (“HE”) recurrence in adults. Norwich wants to market a generic version of the drug, and is awaiting final approval from the FDA. The filing of Norwich’s original ANDA constituted an act of infringement of the Orange Book-listed patents that Salix listed to protect Xifaxan from generic competition. Salix sued Norwich, which lead to a district court decision that invalidated two drug substance patents and the two method-of-use patents covering the IBS-D indication. That court also found that Salix’s three HE method-of-use patents were valid and infringed. Based on that finding, the court entered an order directing “that the effective date of any final approval order of the [FDA] of Norwich’s ANDA ... is to be the date not earlier than the expiration of the” HE method-of-use patents—that is, October 2, 2029.</span></p> <p style="margin-bottom: 12pt;"><span>Given the district court’s decision, Norwich filed an amended ANDA with the FDA, omitting the HE indication from its proposed label. It then filed a motion under FRCP Rule 60(b) in the district court seeking to modify the judgment to permit the FDA to approve the amended ANDA without delay. The district court denied that motion. Norwich appealed that decision and the underlying merits decision. The FDA then tentatively approved Norwich’s ANDA, but it declined to grant final approval before October 2, 2029, in compliance with FDA’s reading of the district court’s final judgment.</span></p> <p style="margin-bottom: 12pt;"><span>Norwich filed this action challenging FDA’s decision to tentatively—not finally—approve Norwich’s amended ANDA. It sought injunctive and declaratory relief directing the FDA immediately to approve Norwich’s amended ANDA. The FDA and Salix opposed, cross-moving for summary judgment. The court denied Norwich’s motion and granted FDA and Salix’s cross motions for summary judgment.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why FDA and Salix Prevailed: </span></strong><span>Norwich argued that FDA’s determination that the Delaware District Court’s final judgment precluded it from granting final approval to Norwich’s amended ANDA prior to October 2, 2029, was “arbitrary, capricious, ... or otherwise not in accordance with law” and must therefore be set aside. The FDA’s interpretation of the final judgment was based on two documents: (i) a letter from FDA to Norwich, dated June 2, 2023, explaining that the FDA was “unable to grant final approval to [Norwich’s] ANDA at this time because” the final judgment “ordered that the effective date of any final approval by the FDA of Norwich’s ANDA No. 214369 is to be a date not earlier than the date of expiration of the last to expire of the ’573, ’195, and ’397 Patents (currently October 2, 2029), plus any regulatory exclusivity to which Plaintiffs are or become entitled;” and (ii) a second document from FDA explaining FDA’s decision to tentatively approve Norwich’s ANDA, which states, “Norwich’s ANDA is eligible for only a Tentative Approval based on the 271(e)(4)(A) judgment … we interpret the May 17 order refusing to modify the judgment to say that the prior … still stands and applies to Norwich’s post-amendment ANDA.” Thus, the court found that “in the end, all that matters for present purposes is how that [final judgment] order is best understood.”</span></p> <p style="margin-bottom: 12pt;"><span>The court found that the FDA’s determination tracks the most straightforward reading of the final judgment. Prior to issuing its judgment, the Delaware District Court directed the parties to meet and confer and file a joint proposed final judgment. Salix asked that the final judgment apply to Norwich’s ANDA in its entirety. Norwich, in contrast, argued that such an order would be overly “broad or speculative” and asked, instead, that the Delaware District Court “reject any proposed judgment that presupposes labeling excluding the HE indication would infringe the asserted HE patent claims, or precludes Norwich’s ability to seek a skinny label.” In a memorandum accompanying its final judgment, the District Court notes that the possibility that Norwich may seek to carve out the HE indication was immaterial to its analysis because such a label was not before the court. After amending its ANDA, the District Court denied Norwich’s motion—not because the proposed amendment was unnecessary, but because the court thought it “wrong ... that [Norwich] can litigate a case through trial and final judgment based on a particular ANDA, and then, after final judgment, change the ANDA to what it wishes it had started with, and win in a summary proceeding.” So it is clear what the Delaware District Court intended. The underlying merits of that decision are not before this court, but on appeal at the Federal Circuit. </span></p> <p style="margin-bottom: 12pt;"><span>“All that matters for present purposes is that Norwich has failed to show that the law is so clear that the FDA should have stretched to read the Delaware District Court’s final judgment and Rule 60(b) decision in a manner that ignores their plain terms. That proposition is unsustainable, as is Norwich’s ultimate contention that the FDA erred as a matter of reasoned-decision-making and law in reading those documents to leave the agency free to approve the company’s amended ANDA prior to October 2, 2029.”</span></p>Wed, 01 Nov 2023 00:00:00 -0500{2FF193A3-8786-46DD-8238-B80C44E61484}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2024/generically-speaking-q4/bausch-health-ireland-v-padagis-israel-pharms<i>Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.</span></em><span>, Civ. No. 22-4248 (SRC), 2023 WL 7131809 (D.N.J. Oct. 30, 2023) (Chesler, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Arazlo® (tazarotene); U.S. Patent Nos. 11,311,482 (“the ’482 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Bausch owns the ’482 patent, which covers its Arazlo product. Padagis filed an ANDA seeking approval from FDA to make and sell generic tazarotene lotion. Bausch filed suit alleging patent infringement. Padagis filed an amended answer asserting, among other things, an affirmative defense of inequitable conduct and a counterclaim seeking a declaration of unenforceability of the ’482 patent due to inequitable conduct. Bausch moved under Rule 12(c) for partial judgment on the pleadings on Padagis’s inequitable conduct affirmative defense and counterclaim. The court granted Bausch’s motion.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Bausch Prevailed: </span></strong><span>During the prosecution of the ’482 patent, the Examiner rejected the operative claims on the basis that the prior art Dow reference taught lotions containing halobetasol and tazarotene, wherein the tazarotene was present in concentrations of less than 0.5%. To overcome this rejection, Bausch amended its claims to make tazarotene .045% the sole active ingredient, which the Examiner credited in his notice of allowance. </span></p> <p style="margin-bottom: 12pt;"><span>Padagis’s inequitable conduct argument alleged that Bausch withheld certain spreadsheets that showed the use of tazarotene .05% to treat acne that occurred prior to the earliest effective filing date of the ’482 patent, and that but-for this failure to disclose, the claims of the ’482 patent would not have been allowed. In response, Bausch contended that it otherwise disclosed the prior art use of .05% tazarotene for the treatment of acne, and that the spreadsheets in question are merely cumulative of those other prior art disclosures. Specifically, Bausch argued that the spreadsheets were cumulative of two references that were before the Examiner, Shalita 1999 and Kircik 2009, both of which, according to Bausch, disclosed the use of .05% tazarotene to treat acne. Padagis responded that the spreadsheets were not cumulative because they document this use in “real-world clinical practice” rather than “experimental clinical studies.” </span></p> <p style="margin-bottom: 12pt;"><span>“The problem for [Padagis] is that this is a new argument unsupported by the factual allegations in the Amended Answer. The Third Counterclaim, as pled in the Amended Answer, says nothing about real-world clinical practice, nor about the distinction between use of a treatment in a study versus use in clinical practice. No facts have been pled which would make plausible the inference that, but for the withholding of the spreadsheets, the applicants would not have overcome the rejection for obviousness in view of Dow and Donello, and obtained allowance.”</span></p> <p style="margin-bottom: 12pt;"><span>Padagis’s counterclaim failed to plead sufficient facts to make plausible the inference of materiality. On the other hand, Bausch has clearly established that no material issue of fact remains to be resolved and that it is entitled to judgment as a matter of law. The court dismissed the counterclaim with prejudice because Padagis had not suggested that repleading might remedy the deficiency that has led to dismissal.</span></p>Mon, 30 Oct 2023 00:00:00 -0500{15A31DD6-A64A-4564-BD66-3FED67253DE9}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/anda-approvalsANDA Approvals<p>This ANDA Approvals chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.</p> <!--ANDA Approvals --> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table" style="text-align: center; font-family: 'Times New Roman';"> <tbody> <tr class="tableizer-firstrow"> <th width="129"><span style="color: #000000;">Approval Date</span></th> <th width="170"><span style="color: #000000;">Reference Listed Drug</span></th> <th width="140"><span style="color: #000000;">Generic Drug Name</span></th> <th width="129"><span style="color: #000000;">ANDA Holder</span></th> <th width="129"><span style="color: #000000;">ANDA Applicant</span></th> </tr> <tr> <td>07/03/2023</td> <td>Trileptal</td> <td>Oxcarbazepine  </td> <td>Novartis</td> <td>Zydus</td> </tr> <tr> <td>07/03/2023</td> <td>Pylera</td> <td>Bismuth Subcitrate Potassium / Metronidazole / Tetracycline HCl </td> <td>AbbVie</td> <td>Riconpharma</td> </tr> <tr> <td>07/05/2023</td> <td>Jevtana Kit</td> <td>Cabazitaxel  </td> <td>Sanofi</td> <td>Mylan</td> </tr> <tr> <td>07/05/2023</td> <td>Immodium A-D</td> <td>Loperamide HCl  </td> <td>Johnson & Johnson</td> <td>Jubilant Cadista</td> </tr> <tr> <td>07/06/2023</td> <td>Vivitrol</td> <td>Naltrexone  </td> <td>Alkermes</td> <td>Teva</td> </tr> <tr> <td>07/06/2023</td> <td>Antizol</td> <td>Fomepizole  </td> <td>Par</td> <td>Gland Pharma</td> </tr> <tr> <td>07/07/2023</td> <td>Viibryd</td> <td>Vilazodone HCl  </td> <td>AbbVie</td> <td>Apotex</td> </tr> <tr> <td>07/07/2023</td> <td>Hexadrol</td> <td>Dexamethasone Sodium Phosphate  </td> <td>Aspen Global</td> <td>Geneyork Pharms</td> </tr> <tr> <td>07/07/2023</td> <td>Nicardipine Hydrochloride  </td> <td>Nicardipine HCl  </td> <td>Hikma</td> <td>Micro Labs</td> </tr> <tr> <td>07/07/2023</td> <td>Pepsid</td> <td>Famotidine  </td> <td>Salix</td> <td>Carnegie</td> </tr> <tr> <td>07/10/2023</td> <td>Rozerem</td> <td>Ramelteon  </td> <td>Takeda</td> <td>Aurobindo</td> </tr> <tr> <td>07/10/2023</td> <td>Advil Dual Action with Acetaminophen</td> <td>Acetaminophen / Ibuprofen  </td> <td>Glaxo</td> <td>Marksans Pharma</td> </tr> <tr> <td>07/10/2023</td> <td>Leucovorin Calcium</td> <td>Leucovorin Calcium  </td> <td>Hospira</td> <td>Hainan Poly</td> </tr> <tr> <td>07/11/2023</td> <td>Benicar</td> <td>Olmesartan Medoxomil  </td> <td>Cosette</td> <td>Amneal</td> </tr> <tr> <td>07/11/2023</td> <td>Renagel</td> <td>Sevelamer HCl  </td> <td>Genzyme</td> <td>Aurobindo</td> </tr> <tr> <td>07/11/2023</td> <td>Macrobid</td> <td>Nitrofurantoin (Monohydrate / Macrocrystals)  </td> <td>Almatica</td> <td>Mankind</td> </tr> <tr> <td>07/11/2023</td> <td>Sterile water for Injection </td> <td>Sterile water for Injection  </td> <td>Hospira</td> <td>Nexus</td> </tr> <tr> <td>07/11/2023</td> <td>Xylocaine</td> <td>Lidocaine HCl  </td> <td>Fresenius Kabi</td> <td>Mankind</td> </tr> <tr> <td>07/11/2023</td> <td>Sodium Chloride</td> <td>Sodium Chloride 23.4%  </td> <td>Abraxis</td> <td>Fresenius Kabi</td> </tr> <tr> <td>07/12/2023</td> <td>Lyrica</td> <td>Pregabalin  </td> <td>Upjohn</td> <td>Cadila Pharms</td> </tr> <tr> <td>07/12/2023</td> <td>Potassium Chloride </td> <td>Potassium Chloride  </td> <td>Pharma Res Software</td> <td>Novitium Pharma</td> </tr> <tr> <td>07/12/2023</td> <td>Nexium 24 hour</td> <td>Esomeprazole Magnesium  </td> <td>AstraZeneca</td> <td>Aurobindo</td> </tr> <tr> <td>07/12/2023</td> <td>MetroGel-Vaginal</td> <td>Metronidazole  </td> <td>Bausch</td> <td>Cosette</td> </tr> <tr> <td>07/13/2023</td> <td>Chlorpromazine HCl</td> <td>Chlorpromazine HCl  </td> <td>Upsher-Smith</td> <td>Lupin</td> </tr> <tr> <td>07/13/2023</td> <td>Oxtellar XR</td> <td>Oxcarbazepine  </td> <td>Supernus</td> <td>Apotex</td> </tr> <tr> <td>07/13/2023</td> <td>Advil Dual Action with Acetaminophen</td> <td>Acetaminophen / Ibuprofen  </td> <td>Glaxo</td> <td>Granules</td> </tr> <tr> <td>07/13/2023</td> <td>Steglatro</td> <td>Ertugliflozin  </td> <td>Pfizer / Merck</td> <td>Aurobindo</td> </tr> <tr> <td>07/14/2023</td> <td>Otezla</td> <td>Apremilast  </td> <td>Amgen</td> <td>Dr Reddys Labs</td> </tr> <tr> <td>07/14/2023</td> <td>Iclusig</td> <td>Ponatinib HCl  </td> <td>Takeda</td> <td>Apotex</td> </tr> <tr> <td>07/14/2023</td> <td>Zebeta</td> <td>Bisoprolol Fumarate  </td> <td>Teva</td> <td>Prinston</td> </tr> <tr> <td>07/14/2023</td> <td>Sodium Phenylacetate / Sodium Benzoate</td> <td>Sodium Phenylacetate / Sodium Benzoate  </td> <td>Maia Pharms</td> <td>Navinta</td> </tr> <tr> <td>07/17/2023</td> <td>Cytoxan</td> <td>Cyclophosphamide  </td> <td>Baxter Healthcare</td> <td>Sagent Pharms</td> </tr> <tr> <td>07/17/2023</td> <td>Cortef</td> <td>Hydrocortisone  </td> <td>Pharmacia and Upjohn</td> <td>Aurobindo</td> </tr> <tr> <td>07/17/2023</td> <td>Cardine</td> <td>Nicardipine HCl  </td> <td>Chiesi</td> <td>Senores Pharms</td> </tr> <tr> <td>07/18/2023</td> <td>Chlorpromazine HCl</td> <td>Chlorpromazine HCl  </td> <td>Upsher-Smith Labs</td> <td>Alembic</td> </tr> <tr> <td>07/19/2023</td> <td>Otezla</td> <td>Apremilast  </td> <td>Amgen</td> <td>Aurobindo</td> </tr> <tr> <td>07/19/2023</td> <td>Leucovorin Calcium</td> <td>Leucovorin Calcium  </td> <td>Hospira</td> <td>Kindos</td> </tr> <tr> <td>07/19/2023</td> <td>Neurontin</td> <td>Gabapentin  </td> <td>Viatris</td> <td>Rising</td> </tr> <tr> <td>07/24/2023</td> <td>Mozobil</td> <td>Plerixafor  </td> <td>Genzyme</td> <td>Dr Reddys Labs</td> </tr> <tr> <td>07/24/2023</td> <td>Mozobil</td> <td>Plerixafor  </td> <td>Genzyme</td> <td>Teva</td> </tr> <tr> <td>07/24/2023</td> <td>Mozobil</td> <td>Plerixafor  </td> <td>Genzyme</td> <td>MSN</td> </tr> <tr> <td>07/24/2023</td> <td>Bumex</td> <td>Bumetanide  </td> <td>Validus Pharms</td> <td>Taro</td> </tr> <tr> <td>07/24/2023</td> <td>Mozobil</td> <td>Plerixafor  </td> <td>Genzyme</td> <td>Eugia Pharma</td> </tr> <tr> <td>07/24/2023</td> <td>Aggrastat</td> <td>Tirofiban HCl  </td> <td>Medicure</td> <td>Nexus</td> </tr> <tr> <td>07/24/2023</td> <td>Mozobil</td> <td>Plerixafor  </td> <td>Genzyme</td> <td>Amneal</td> </tr> <tr> <td>07/24/2023</td> <td>Mozobil</td> <td>Plerixafor  </td> <td>Genzyme</td> <td>Kindos</td> </tr> <tr> <td>07/25/2023</td> <td>Ranexa</td> <td>Ranolazine  </td> <td>Gilead</td> <td>Piramal</td> </tr> <tr> <td>07/25/2023</td> <td>Hemabate</td> <td>Carboprost Tromethamine  </td> <td>Pfizer</td> <td>Steriscience</td> </tr> <tr> <td>07/25/2023</td> <td>Chantrix</td> <td>Varenicline Tartrate  </td> <td>PF Prism</td> <td>Medley Pharms</td> </tr> <tr> <td>07/26/2023</td> <td>Mozobil</td> <td>Plerixafor  </td> <td>Genzyme</td> <td>Zydus</td> </tr> <tr> <td>07/26/2023</td> <td>Otezla</td> <td>Apremilast  </td> <td>Amgen</td> <td>Annora</td> </tr> <tr> <td>07/27/2023</td> <td>Inomax</td> <td>Ulspira - Nitric Oxide</td> <td>Mallinckrodt</td> <td>Airgas Therapeutics</td> </tr> <tr> <td>07/27/2023</td> <td>Zithromax</td> <td>Azithromycin  </td> <td>Pfizer</td> <td>Hainan Poly</td> </tr> <tr> <td>07/27/2023</td> <td>Tobi</td> <td>Tobramycin  </td> <td>Mylan</td> <td>Micro Labs</td> </tr> <tr> <td>07/28/2023</td> <td>Rocaltrol</td> <td>Calcitriol  </td> <td>Validus Pharms</td> <td>Patrin</td> </tr> <tr> <td>07/28/2023</td> <td>Claritin</td> <td>Loratadine  </td> <td>Bayer</td> <td>Hetero Lab</td> </tr> <tr> <td>07/28/2023</td> <td>Azopt</td> <td>Brinzolamide  </td> <td>Novartis</td> <td>Padagis</td> </tr> <tr> <td>07/28/2023</td> <td>Mephyton</td> <td>Phytonadione  </td> <td>Bausch Health</td> <td>Sciegen Pharms Inc</td> </tr> <tr> <td>07/28/2023</td> <td>Dexamethasone Sodium Phosphate</td> <td>Dexamethasone Sodium Phosphate  </td> <td>Fresenius Kabi</td> <td>Gene York Pharms</td> </tr> <tr> <td>07/31/2023</td> <td>LO/Ovral-28</td> <td>Turqoz  </td> <td>Wyeth</td> <td>Lupin</td> </tr> <tr> <td>07/31/2023</td> <td>Onglyza</td> <td>Saxagliptin HCl</td> <td>AstraZeneca</td> <td>Amneal</td> </tr> <tr> <td>07/31/2023</td> <td>Onglyza</td> <td>Saxagliptin HCl</td> <td>AstraZeneca</td> <td>Aurobindo</td> </tr> <tr> <td>07/31/2023</td> <td>Onglyza</td> <td>Saxagliptin HCl</td> <td>AstraZeneca</td> <td>Mylan</td> </tr> <tr> <td>07/31/2023</td> <td>Kombiglyze ER</td> <td>Saxagliptin / Metformin HCl  </td> <td>AstraZeneca</td> <td>Mylan</td> </tr> <tr> <td>07/31/2023</td> <td>Onglyza</td> <td>Saxagliptin HCl</td> <td>AstraZeneca</td> <td>Glenmark</td> </tr> <tr> <td>07/31/2023</td> <td>Onglyza</td> <td>Saxagliptin HCl</td> <td>AstraZeneca</td> <td>Sun</td> </tr> <tr> <td>07/31/2023</td> <td>Kombiglyze ER</td> <td>Saxagliptin / Metformin HCl  </td> <td>AstraZeneca</td> <td>Sun</td> </tr> <tr> <td>07/31/2023</td> <td>Derma Smooth/FS</td> <td>Fluocinolone Acetonide  </td> <td>Hill Dermac</td> <td>Novel Labs</td> </tr> <tr> <td>07/31/2023</td> <td>Argatroban</td> <td>Argatroban  </td> <td>Hikma</td> <td>Gland Pharma</td> </tr> <tr> <td>08/01/2023</td> <td>Permethrin</td> <td>Permethrin  </td> <td>Aurobindo</td> <td>Dr Reddys Labs</td> </tr> <tr> <td>08/01/2023</td> <td>Dexamethasone Sodium Phosphate</td> <td>Dexamethasone Sodium Phosphate  </td> <td>Fresenius Kabi</td> <td>Hikma</td> </tr> <tr> <td>08/01/2023</td> <td>Chantix</td> <td>Varenicline Tartrate  </td> <td>PF Prism</td> <td>Mankind Pharma</td> </tr> <tr> <td>08/01/2023</td> <td>Alphagan P</td> <td>Brimonidine Tartrate  </td> <td>AbbVie</td> <td>Alembic</td> </tr> <tr> <td>08/01/2023</td> <td>Advil Dual Action with Acetaminophen</td> <td>Acetaminophen / Ibuprofen  </td> <td>Glaxo</td> <td>Bionpharma</td> </tr> <tr> <td>08/01/2023</td> <td>Mucinex DM</td> <td>Guaifenesin / Dextromethorphan Hydrobromide  </td> <td>Reckitt Benckiser</td> <td>Dr Reddys Labs</td> </tr> <tr> <td>08/02/2023</td> <td>Indocin</td> <td>Indomethacin  </td> <td>Zyla Life Sciences</td> <td>Zydus</td> </tr> <tr> <td>08/03/2023</td> <td>Aptiom</td> <td>Eslicarbazepine Acetate  </td> <td>Sumitomo Pharma</td> <td>Hetero Labs</td> </tr> <tr> <td>08/03/2023</td> <td>Revlimid</td> <td>Lenalidomide  </td> <td>Celgene</td> <td>Torrent</td> </tr> <tr> <td>08/03/2023</td> <td>Zyloprim</td> <td>Allopurinol  </td> <td>Casper Pharma</td> <td>Hetero Lab</td> </tr> <tr> <td>08/04/2023</td> <td>Xiidra</td> <td>Lifitegrast  </td> <td>Novartis</td> <td>Micro Labs</td> </tr> <tr> <td>08/04/2023</td> <td>Diclegis</td> <td>Doxylamine Succinate / Pyridoxine HCl  </td> <td>Duchesnay</td> <td>Bionpharma</td> </tr> <tr> <td>08/04/2023</td> <td>Vancomycin HCl</td> <td>Vancomycin HCl  </td> <td>Mylan</td> <td>Eugia Pharma</td> </tr> <tr> <td>08/04/2023</td> <td>Bentyl</td> <td>Dicyclomine HCl  </td> <td>Allergan</td> <td>Bionpharma</td> </tr> <tr> <td>08/07/2023</td> <td>Derma-Smooth/FS</td> <td>Fluocinolone Acetonide  </td> <td>Hill Dermac</td> <td>Novel Labs</td> </tr> <tr> <td>08/07/2023</td> <td>Methotrexate Sodium</td> <td>Methotrexate Sodium  </td> <td>Strides</td> <td>Daito</td> </tr> <tr> <td>08/07/2023</td> <td>Toprol XL</td> <td>Metoprolol Succinate  </td> <td>Toprol</td> <td>Granules</td> </tr> <tr> <td>08/07/2023</td> <td>Denavir</td> <td>Penciclovir  </td> <td>Mylan</td> <td>Torrent</td> </tr> <tr> <td>08/07/2023</td> <td>Intuniv</td> <td>Guanfacine HCl  </td> <td>Takeda</td> <td>Alembic</td> </tr> <tr> <td>08/07/2023</td> <td>Hemabate</td> <td>Carboprost Tromethamine  </td> <td>Pfizer</td> <td>Gland Pharma</td> </tr> <tr> <td>08/08/2023</td> <td>Children's Motrin</td> <td>Ibuprofen  </td> <td>Johnson & Johnson</td> <td>Taro Pharms</td> </tr> <tr> <td>08/09/2023</td> <td>Kombiglyze XR</td> <td>Metformin HCl / Saxagliptin HCl  </td> <td>AstraZeneca</td> <td>Dr Reddys Labs</td> </tr> <tr> <td>08/09/2023</td> <td>Lotemax</td> <td>Loteprednol Etabonate  </td> <td>Bausch and Lomb </td> <td>Sun</td> </tr> <tr> <td>08/09/2023</td> <td>Paraflex</td> <td>Chlorzoxazone  </td> <td>Ortho McNeil</td> <td>Graviti Pharms</td> </tr> <tr> <td>08/10/2023</td> <td>Lioresal</td> <td>Baclofen  </td> <td>Amneal</td> <td>Acic Pharms</td> </tr> <tr> <td>08/11/2023</td> <td>Diovan HCT</td> <td>Valsartan / Hydrochlorothiazide  </td> <td>Novartis</td> <td>Amneal</td> </tr> <tr> <td>08/11/2023</td> <td>Doryx MPC</td> <td>Doxycycline Hyclate  </td> <td>Mayne Pharma</td> <td>Lupin</td> </tr> <tr> <td>08/11/2023</td> <td>Lexette</td> <td>Halobetasol Propionate  </td> <td>Mayne Pharma</td> <td>Padagis</td> </tr> <tr> <td>08/14/2023</td> <td>Firazyr</td> <td>Icatibant Acetate  </td> <td>Takeda</td> <td>Eugia Pharma</td> </tr> <tr> <td>08/14/2023</td> <td>Aloxi</td> <td>Palonosetron HCl  </td> <td>Helsinn Healthcare</td> <td>Nanjing King-Friend</td> </tr> <tr> <td>08/14/2023</td> <td>Cozaar</td> <td>Losartan Potassium  </td> <td>Organon</td> <td>MSN Labs</td> </tr> <tr> <td>08/14/2023</td> <td>Potassium Chloride for Injection Concentrate</td> <td>Potassium Chloride  </td> <td>Hospira</td> <td>Nexus Pharms</td> </tr> <tr> <td>08/14/2023</td> <td>Lithium Citrate Syrup</td> <td>Lithium Citrate  </td> <td>Hikma</td> <td>Rubicon</td> </tr> <tr> <td>08/15/2023</td> <td>Bromday</td> <td>Bromfenac Sodium  </td> <td>Bausch and Lomb</td> <td>Lupin</td> </tr> <tr> <td>08/15/2023</td> <td>Toprol XL</td> <td>Metoprolol Succinate  </td> <td>AstraZeneca</td> <td>Lupin</td> </tr> <tr> <td>08/15/2023</td> <td>Trokendi XR</td> <td>Topiramate  </td> <td>Supernus Pharms</td> <td>Ajanta</td> </tr> <tr> <td>08/15/2023</td> <td>Thiola EC</td> <td>Tiopronin  </td> <td>Mission Pharmacal</td> <td>Amneal</td> </tr> <tr> <td>08/15/2023</td> <td>Aventyl</td> <td>Nortriptyline HCl  </td> <td>Ranbaxy</td> <td>Rubicon</td> </tr> <tr> <td>08/16/2023</td> <td>Silenor</td> <td>Doxepin HCl  </td> <td>Currax</td> <td>Zydus</td> </tr> <tr> <td>08/16/2023</td> <td>Zonalon</td> <td>Doxepin HCl  </td> <td>Mylan</td> <td>Amneal</td> </tr> <tr> <td>08/16/2023</td> <td>Balcoltra</td> <td>Levonorgestrel / Ethinyl Estradiol / Ferrous Fumarate  </td> <td>Avion Pharms</td> <td>Xiromed</td> </tr> <tr> <td>08/17/2023</td> <td>Selzentry</td> <td>Maraviroc  </td> <td>ViiV Healthcare</td> <td>I 3 Pharms</td> </tr> <tr> <td>08/17/2023</td> <td>Pepcid</td> <td>Famotidine  </td> <td>Salix</td> <td>Annora</td> </tr> <tr> <td>08/17/2023</td> <td>Hydroxyzine HCl</td> <td>Hydroxyzine HCl  </td> <td>Pliva</td> <td>Graviti Pharms</td> </tr> <tr> <td>08/18/2023</td> <td>Ultane</td> <td>Sevoflurane  </td> <td>AbbVie</td> <td>Shandong</td> </tr> <tr> <td>08/18/2023</td> <td>D.H.E. 45</td> <td>Dihydroergotamine Mesylate  </td> <td>Bausch Health</td> <td>Gland Pharma</td> </tr> <tr> <td>08/18/2023</td> <td>Prolixin</td> <td>Fluphenazine HCl  </td> <td>Bristol-Myers Squibb</td> <td>Aurobindo</td> </tr> <tr> <td>08/21/2023</td> <td>Atacand</td> <td>Candesartan Cilexetil  </td> <td>ANI Pharms</td> <td>Prinston</td> </tr> <tr> <td>08/21/2023</td> <td>Morphine Sulfate</td> <td>Morphine Sulfate  </td> <td>Hikma</td> <td>SpecGx</td> </tr> <tr> <td>08/21/2023</td> <td>Calcium Gluconate</td> <td>Calcium Gluconate  </td> <td>Fresenius Kabi</td> <td>B Braun Medical</td> </tr> <tr> <td>08/21/2023</td> <td>Versed</td> <td>Midazolam HCl  </td> <td>HLR Technology</td> <td>Micro Labs</td> </tr> <tr> <td>08/21/2023</td> <td>Mucinex</td> <td>Guaifenesin  </td> <td>Reckitt Benckiser</td> <td>Marksans Pharma</td> </tr> <tr> <td>08/21/2023</td> <td>Sinequan</td> <td>Doxepin HCl  </td> <td>Pfizer </td> <td>Unique Pharm</td> </tr> <tr> <td>08/21/2023</td> <td>Sutent</td> <td>Sunitinib Malate  </td> <td>CPPI</td> <td>Novugen</td> </tr> <tr> <td>08/22/2023</td> <td>Retin-A Micro</td> <td>Tretinoin Microsphere  </td> <td>Valeant</td> <td>Encube</td> </tr> <tr> <td>08/22/2023</td> <td>Zinc Sulfate</td> <td>Zinc Sulfate  </td> <td>America Regent</td> <td>Zydus</td> </tr> <tr> <td>08/23/2023</td> <td>Esbriet</td> <td>Pirfenidone  </td> <td>Genentech</td> <td>Lupin</td> </tr> <tr> <td>08/23/2023</td> <td>Chantix</td> <td>Varenicline Tartrate  </td> <td>PF Prism CV</td> <td>Alkem</td> </tr> <tr> <td>08/23/2023</td> <td>Invega</td> <td>Paliperidone  </td> <td>Janssen</td> <td>Ascent Pharms</td> </tr> <tr> <td>08/23/2023</td> <td>Bacteriostic Sodium Chloride</td> <td>Sodium Chloride 0.9%  </td> <td>Hospira</td> <td>Nexus Pharms</td> </tr> <tr> <td>08/23/2023</td> <td>Dexamethasone</td> <td>Dexamethasone  </td> <td>Hikma</td> <td>Apotex</td> </tr> <tr> <td>08/24/2023</td> <td>Divigel</td> <td>Estradiol  </td> <td>Vertical Pharms</td> <td>Novitium</td> </tr> <tr> <td>08/24/2023</td> <td>Restoril</td> <td>Temazepam  </td> <td>SpecGx</td> <td>Alkem Labs</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Actavis Elizabeth</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Hikma</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Amneal</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Mylan</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>SpecGx</td> </tr> <tr> <td>08/25/2023</td> <td>Niaspan</td> <td>Niacin  </td> <td>AbbVie </td> <td>Eywa</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Sun</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Sun</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Norwich</td> </tr> <tr> <td>08/25/2023</td> <td>Combigan</td> <td>Brimonidine Tartrate / Timolol Maleate  </td> <td>AbbVie</td> <td>Alembic</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Rhodes</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Teva</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Lannett</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Prinston</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Apotex</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Ascent Pharms</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Alkem Labs</td> </tr> <tr> <td>08/25/2023</td> <td>Concerta</td> <td>Methylphenidate HCl  </td> <td>Johnson & Johnson</td> <td>Sun</td> </tr> <tr> <td>08/25/2023</td> <td>Xelganz</td> <td>Tofacitinib  </td> <td>PF Prism</td> <td>Sun</td> </tr> <tr> <td>08/25/2023</td> <td>Vyvanse</td> <td>Lisdexamfetamine Dimesylate  </td> <td>Takeda</td> <td>Ascent Pharms</td> </tr> <tr> <td>08/28/2023</td> <td>Esbriet</td> <td>Pirfenidone  </td> <td>Genentech </td> <td>Lupin</td> </tr> <tr> <td>08/28/2023</td> <td>Effient</td> <td>Prasugrel HCl  </td> <td>Cosette</td> <td>Unichem</td> </tr> <tr> <td>08/28/2023</td> <td>Ibrance</td> <td>Palbociclib  </td> <td>Pfizer</td> <td>Synthon</td> </tr> <tr> <td>08/28/2023</td> <td>Noxafil</td> <td>Posaconazole  </td> <td>Merck Sharp Dohme</td> <td>I 3 Pharms</td> </tr> <tr> <td>08/29/2023</td> <td>Accutane</td> <td>Isotretinoin  </td> <td>Takeda</td> <td>Zydus</td> </tr> <tr> <td>08/29/2023</td> <td>CellCept</td> <td>Mycophenolate Mofetil  </td> <td>Roche</td> <td>Strides</td> </tr> <tr> <td>08/29/2023</td> <td>Viagra</td> <td>Sildenafil Citrate  </td> <td>Viatris</td> <td>Novitium</td> </tr> <tr> <td>08/29/2023</td> <td>Sterile water for Injection </td> <td>Sterile water for Injection  </td> <td>Hospira</td> <td>American Regent</td> </tr> <tr> <td>08/30/2023</td> <td>Bentyl</td> <td>Dicyclomine Hydrochloride  </td> <td>Allergan</td> <td>Prinston</td> </tr> <tr> <td>08/31/2023</td> <td>Mydayis</td> <td>Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate</td> <td>Takeda</td> <td>Specgx</td> </tr> <tr> <td>08/31/2023</td> <td>Entereg</td> <td>Alvimopan</td> <td>Cubist</td> <td>Hikma</td> </tr> <tr> <td>09/08/2023</td> <td>Gadavist</td> <td>Gadobutrol</td> <td>Bayer</td> <td>Jiangsu Hengrui</td> </tr> <tr> <td>09/11/2023</td> <td>Diamox</td> <td>Acetazolamide</td> <td>Teva</td> <td>Ajanta Pharma</td> </tr> <tr> <td>09/11/2023</td> <td>CellCept</td> <td>Mycophenolate Mofetil</td> <td>Roche</td> <td>Airis Pharma</td> </tr> <tr> <td>09/11/2023</td> <td>Prolixin</td> <td>Fluphenazine HCl</td> <td>Bristol-Myers Squibb</td> <td>MSN Labs</td> </tr> <tr> <td>09/12/2023</td> <td>Lipitor</td> <td>Atorvastatin Calcium</td> <td>Upjohn</td> <td>Hetero Labs</td> </tr> <tr> <td>09/13/2023</td> <td>Augmentin</td> <td>Amoxicillin / Clavulanate Potassium</td> <td>US Antibiotics</td> <td>Deva Holding</td> </tr> <tr> <td>09/14/2023</td> <td>Prezista</td> <td>Darunavir</td> <td>Janssen</td> <td>Hetero Labs</td> </tr> <tr> <td>09/14/2023</td> <td>Ortho Evra</td> <td>Ethinyl Estradiol / Norelgestromin</td> <td>Janssen</td> <td>Zydus</td> </tr> <tr> <td>09/14/2023</td> <td>Advil Liqui-Gels</td> <td>Ibuprofen</td> <td>Glaxo</td> <td>Aurobindo</td> </tr> <tr> <td>09/14/2023</td> <td>Librax</td> <td>Chlordiazepoxide HCl / Clidinium Bromide</td> <td>Bausch Health</td> <td>Aurobindo</td> </tr> <tr> <td>09/14/2023</td> <td>Famotidine</td> <td>Famotidine</td> <td>Novitium Pharma</td> <td>Micro Labs</td> </tr> <tr> <td>09/15/2023</td> <td>Augmentin</td> <td>Amoxicillin / Clavulanate Potassium</td> <td>US Antibiotics</td> <td>Deva Holding</td> </tr> <tr> <td>09/15/2023</td> <td>Librax</td> <td>Chlordiazepoxide HCl / Clidinium Bromide</td> <td>Bausch Health</td> <td>Alembic</td> </tr> <tr> <td>09/15/2023</td> <td>Levophed</td> <td>Norepinephrine Bitartrate</td> <td>Hospira</td> <td>Caplin Steriles</td> </tr> <tr> <td>09/18/2023</td> <td>Pepcid </td> <td>Famotidine</td> <td>Salix</td> <td>Ajanta</td> </tr> <tr> <td>09/19/2023</td> <td>Cleosin T</td> <td>Clindamycin Phosphate</td> <td>Pfizer</td> <td>Cadila Healthcare</td> </tr> <tr> <td>09/21/2023</td> <td>Diflucan</td> <td>Fluconazole</td> <td>Pfizer </td> <td>Hainan Poly</td> </tr> <tr> <td>09/21/2023</td> <td>Mestinon</td> <td>Pyridostigmine Bromide</td> <td>Bausch Health</td> <td>MSN Labs</td> </tr> <tr> <td>09/22/2023</td> <td>Tegretol -;XR</td> <td>Carbamazepine</td> <td>Novartis</td> <td>Amneal</td> </tr> <tr> <td>09/22/2023</td> <td>Vascepa</td> <td>Icosapent Ethyl</td> <td>Amarin</td> <td>Strides</td> </tr> <tr> <td>09/25/2023</td> <td>AK-Fluor</td> <td>Fluorescein Sodium</td> <td>Long Grove Pharms</td> <td>Nexus Pharms</td> </tr> <tr> <td>09/25/2023</td> <td>Xeljanz</td> <td>Tofacitinib Citrate</td> <td>Pfizer</td> <td>Slayback</td> </tr> <tr> <td>09/25/2023</td> <td>Tapazole</td> <td>Methimazole</td> <td>King Pharms</td> <td>Bionpharma</td> </tr> <tr> <td>09/26/2023</td> <td>Depakote ER</td> <td>Divalproex Sodium</td> <td>AbbVie</td> <td>Annora Pharma</td> </tr> <tr> <td>09/26/2023</td> <td>Velcade</td> <td>Bortezomib</td> <td>Takeda</td> <td>Scinopharm</td> </tr> <tr> <td>09/27/2023</td> <td>Ranexa</td> <td>Ranolazine</td> <td>Gilead</td> <td>Novast Labs</td> </tr> <tr> <td>09/27/2023</td> <td>Topamax</td> <td>Topiramate</td> <td>Janssen</td> <td>Aurobindo</td> </tr> <tr> <td>09/27/2023</td> <td>Mydayis</td> <td>Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate</td> <td>Takeda</td> <td>Sun</td> </tr> <tr> <td>09/28/2023</td> <td>Uloric</td> <td>Febuxostat</td> <td>Takeda</td> <td>Macleods</td> </tr> <tr> <td>09/28/2023</td> <td>Aubagio</td> <td>Teriflunomide</td> <td>Sanofi</td> <td>Sola Pharms</td> </tr> <tr> <td>09/29/2023</td> <td>Nexium 24 hour</td> <td>Esomeprazole Magnesium</td> <td>AstraZeneca</td> <td>Marksans Pharma</td> </tr> <tr> <td>09/29/2023</td> <td>Hyzaar</td> <td>Losartan Potassium / Hydrochlorothiazide</td> <td>Organon</td> <td>Granules</td> </tr> <tr> <td>09/29/2023</td> <td>Vasopressin in Sodium Chloride Injection</td> <td>Vasopressin in Sodium Chloride Injection</td> <td>Endo / Par</td> <td>Baxter Healthcare</td> </tr> </tbody> </table>Tue, 10 Oct 2023 00:00:00 -0500{5618F470-E6FB-48E7-9674-33C12CF7F994}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/anda-litigation-settlementsANDA Litigation Settlements<p>This ANDA Litigation Settlements chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act.</p> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table"> <tbody> <tr class="tableizer-firstrow"> <th width="129"><span style="color: #000000;">Case Name</span></th> <th width="173"><span style="color: #000000;">Drug</span></th> <th width="111"><span style="color: #000000;">Patent No(s).</span></th> <th width="414"><span style="color: #000000;">Publicly Available Terms</span></th> </tr> <tr> <td style="text-align: center;">Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-0383 (D. Del.)</td> <td style="text-align: center;">Uptravi® (selexipag tablets)</td> <td style="text-align: center;">7,205,302</td> <td style="text-align: center;">The patent-in-suit is valid and enforceable. Unless otherwise authorized by Plaintiffs, Alembic is enjoined from infringing the patents-in-suit through and until after the later of (a) October 31, 2026, or (b) the last day of any period of pediatric exclusivity that is or may become associated with the ’302 patent. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.</td> </tr> <tr> <td style="text-align: center;">Fresenius Kabi USA, LLC v. Steriscience PTE Ltd., 22-1810 (D.N.J.)</td> <td style="text-align: center;">Levothyroxine sodium powder for injection</td> <td style="text-align: center;">9,006,289 9,168,238 9,168,239</td> <td style="text-align: center;">All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.</td> </tr> <tr> <td style="text-align: center;">Astellas Pharma Inc. v. Humanwell Puracap Pharms. (Wuhan) Co., Ltd., 23-1020 (D.N.J.)</td> <td style="text-align: center;">Xtandi® (enzalutamide capsules)</td> <td style="text-align: center;">7,709,517 8,183,274</td> <td style="text-align: center;">Each of plaintiffs’ claims against Defendants with respect to the patents-in-suit is dismissed with prejudice. The parties shall each bear their own costs.</td> </tr> <tr> <td style="text-align: center;">Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 19-2021, 21-1330 (D. Del.)</td> <td style="text-align: center;">Entresto® (sacubitril / valsartan tablets)</td> <td style="text-align: center;">8,101,659 8,796,331 8,877,938 9,388,134 11,096,918</td> <td style="text-align: center;">Consent Judgement and Order of Injunction between Plaintiff and Defendants Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. sealed.</td> </tr> <tr> <td style="text-align: center;">Servier Pharms. LLC v. Alembic Pharms. Ltd., 22-1420 (D. Del.)</td> <td style="text-align: center;">Tibsovo® (ivosidenib tablets)</td> <td style="text-align: center;">9,968,595 10,449,184 10,799,490 10,980,788</td> <td style="text-align: center;">Case stayed. Order sealed.</td> </tr> <tr> <td style="text-align: center;">Anacor Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 21-1349 (D. Del.)</td> <td style="text-align: center;">Eucrisa® (crisaborole ointment)</td> <td style="text-align: center;">8,039,451 8,168,614 8,501,712 9,682,092</td> <td style="text-align: center;">All claims and counterclaim are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. DRL will not infringe the patents-in-suit, except as provided for in the parties’ settlement and license agreement.</td> </tr> <tr> <td style="text-align: center;">Abraxis Bioscience, LLC v. Mylan Pharms. Inc., 23-0033 (N.D.W.V.)</td> <td style="text-align: center;">Abraxane® (paclitaxel protein-bound particles for injectable suspension)</td> <td style="text-align: center;">7,820,788</td> <td style="text-align: center;">Until expiration of the ’788 patent, Mylan is enjoined from infringing the ’788 patent. All claims, counterclaims, affirmative defenses, and demands are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Mylan from maintaining a “Paragraph IV Certification” with respect to the ’788 patent. Nothing restricts FDA approving Mylan’s ANDA.</td> </tr> <tr> <td style="text-align: center;">Novartis Pharms. Corp. v. Ingenus Pharms., LLC, 22-1045 (D. Del.)</td> <td style="text-align: center;">Xiidra® (lifitegrast ophthalmic solution)</td> <td style="text-align: center;">8,084,047 8,168,655 8,367,701 8,592,450 8,927,574 9,085,553 9,353,088 9,447,077 9,890,141 11,058,677</td> <td style="text-align: center;">All claims and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Takeda Pharms. U.S.A., Inc. v. Sun Pharm. Indus. Ltd., 22-0911 (D. Del.)</td> <td style="text-align: center;">Mydayis® (mixed salts of a single-entity amphetamine product extended-release capsules)</td> <td style="text-align: center;">8,846,100 9,173,857</td> <td style="text-align: center;">The patents-in-suit are valid and enforceable solely with respect to the Sun ANDA product. All affirmative defenses, claims, and counterclaims, which have been or could have been raised with respect to the validity or enforceability are dismissed with prejudice. Sun admits that in the absence of a license, its ANDA product infringes infringe each of the patents-in-suit. Except as authorized by Plaintiffs, Sun is enjoined during the term of the patents-in-suit from infringing the patents-in-suit or from challenging the validity or enforceability of the patents-in-suit. Any Protective Order entered by the Court shall remain in full force notwithstanding the conclusion of this action. The parties waive all right to appeal. Each party shall bear its own costs, expenses, and attorneys’ fees. Nothing shall prohibit (i) Sun from maintaining or filing Paragraph IV certifications and (ii) FDA from reviewing or approving Sun’s ANDA.</td> </tr> <tr> <td style="text-align: center;">Bayer Intellectual Property GmbH v. Biocon Pharma Ltd., 23-0334 (D. Del.)</td> <td style="text-align: center;">Xarelto® (rivaroxaban tablets)</td> <td style="text-align: center;">9,539,218 10,828,310</td> <td style="text-align: center;">All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Aragon Pharms., Inc. v. Sandoz Inc., 22-0678 (D. Del.)</td> <td style="text-align: center;">Erleada® (apalutamide tablets)</td> <td style="text-align: center;">8,445,507 8,802,689 9,388,159 9,481,663 9,987,261</td> <td style="text-align: center;">Plaintiffs dismiss the action without prejudice.</td> </tr> <tr> <td style="text-align: center;">Merck Sharp & Dohme LLC v. Biocon Pharma Ltd., 23-0683 (D. Del.)</td> <td style="text-align: center;">Januvia® (sitagliptin phosphate tablets)</td> <td style="text-align: center;">7,326,708</td> <td style="text-align: center;">Unless otherwise authorized pursuant to the settlement agreement, Biocon is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Newron Pharms. S.p.A. v. Aurobindo Pharma Ltd., 21-0843 (D. Del.)</td> <td style="text-align: center;">Xadago® (safinamide tablets)</td> <td style="text-align: center;">8,076,515 8,278,485 8,283,380</td> <td style="text-align: center;">The parties have entered into a confidential settlement agreement resolving this action. All affirmative defenses, claims, and counterclaims, which have been or could have been raised by Plaintiffs against Prinston, or by Prinston against Plaintiffs, are dismissed without prejudice. The Parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Supernus Pharms., Inc. v. Riconpharma LLC, 21-12133 (D.N.J.)</td> <td style="text-align: center;">Oxtellar XR® (oxcarbazepine extended-release tablets)</td> <td style="text-align: center;">7,722,898 7,910,131 8,617,600 8,821,930 9,119,791 9,351,975 9,370,525 9,855,278 10,220,042</td> <td style="text-align: center;">All claims, counter-claims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Anacor Pharms., Inc. v. Macleods Pharms. Ltd., 21-1350 (D. Del.)</td> <td style="text-align: center;">Eucrisa® (crisaborole ointment)</td> <td style="text-align: center;">8,039,451 8,168,614 8,501,712 9,682,092</td> <td style="text-align: center;">All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. The parties have entered into a settlement and license agreement, and Macleods will not infringe the patents-in-suit with its ANDA product, except as provided by the settlement agreement.</td> </tr> <tr> <td style="text-align: center;">Gilead Sciences, Inc. v. Natco Pharma Ltd., 22-0852, 22-1259 (D. Del.)</td> <td style="text-align: center;">Zydelig® (idelalisib tablets)</td> <td style="text-align: center;">RE44,599 RE44,638 8,865,730 9,469,643 9,492,449 10,730,879</td> <td style="text-align: center;">All affirmative defenses, claims, and counterclaims are dismissed without prejudice. Except as provided by the parties’ agreement, Natco is enjoined from infringing the patents-in-suit. The parties waive all right to appeal. Each party shall bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Pfizer Inc. v. Sun Pharm. Indus. Ltd., 23-0718 (D. Del.)</td> <td style="text-align: center;">Xeljanz® XR (tofacitinib citrate extended-release tablets)</td> <td style="text-align: center;">RE41,783</td> <td style="text-align: center;">Plaintiffs dismiss all claims without prejudice.</td> </tr> <tr> <td style="text-align: center;">Pfizer Inc. v. Annora Pharma Private Ltd., 23-0634 (D. Del.)</td> <td style="text-align: center;">Xeljanz® (tofacitinib oral solution)</td> <td style="text-align: center;">RE41,783</td> <td style="text-align: center;">Plaintiffs dismiss all claims without prejudice.</td> </tr> <tr> <td style="text-align: center;">Apotex Inc. v. Boehringer Ingelheim Pharms., Inc., 23-0704 (D. Del.)</td> <td style="text-align: center;">Tradjenta® (linagliptin tablets)</td> <td style="text-align: center;">8,673,927 8,846,695 8,883,805</td> <td style="text-align: center;">The Court grants final judgment that the claims of the ’927 patent are invalid for obviousness and obviousness-type double patenting. Final judgment of invalidity of the ’927 patent is therefore entered in favor of Apotex. The Court grants final judgment that the claims of the ‘695 patent are not enforceable since all claims have been disclaimed by the patentee. Final judgment of unenforceability of the ‘695 patent is therefore entered in favor of Apotex. The Court grants final judgment that Apotex’s ANDA and product do not infringe any claim of the ‘805 patent. Final judgment of non-infringement of the ‘805 patent is therefore entered in favor of Apotex. This final judgment shall not have any preclusive effect in any cause of action, litigation, or proceeding with respect to any other product other than the Apotex ANDA product. Each party shall bear its own fees and costs.</td> </tr> <tr> <td style="text-align: center;">Takeda Pharms. America, Inc. v. Teva Pharms., Inc., 22-7454 (D.N.J.)</td> <td style="text-align: center;">Iclusig® (ponatinib HCl tablets)</td> <td style="text-align: center;">9,493,470 11,192,895 11,192,897 11,384,086</td> <td style="text-align: center;">Until expiration of the patents-in-suit, Teva is enjoined from infringing the patents-in-suit, except as specifically authorized by Takeda. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Teva from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Teva’s ANDA.</td> </tr> <tr> <td style="text-align: center;">Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-847, 23-0848, 23-849 (D. Del.)</td> <td style="text-align: center;">Jardiance® (empagliflozin tablets)</td> <td style="text-align: center;">9,949,998 10,258,637 11,090,323</td> <td style="text-align: center;">The patents-in-suit are valid and enforceable with respect to the Ajanta ANDA products.  Making and selling Ajanta’s ANDA products would infringe the patents-in-suit. Unless authorized by BI, Ajanta is enjoined from infringing the patents-in-suit until their expiration. Neither this judgment nor the entry of this consent judgment may be asserted by BI against Ajanta, and there shall be no preclusive effect in any proceeding with respect to any product other than the Ajanta ANDA products with respect to the patents-in-suit. The parties shall bear their own fees and costs. The complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Alkermes, Inc. v. Teva Pharm. Indus. Ltd., 20-12470 (D.N.J.)</td> <td style="text-align: center;">Vivitrol® (extended-release naltrexone for injection)</td> <td style="text-align: center;">7,919,499</td> <td style="text-align: center;">Terms not public.</td> </tr> <tr> <td style="text-align: center;">Galderma Labs., L.P. v. Dr. Reddy’s Labs., Ltd., 23-0711 (D. Del.)</td> <td style="text-align: center;">Oracea® (doxycycline capsules</td> <td style="text-align: center;">7,749,532 8,206,740</td> <td style="text-align: center;">All claims, counterclaims, and affnmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Boehringer Ingelheim Pharms. Inc. v. Cipla Ltd., 18-1789, 19-1494 (D. Del.)</td> <td style="text-align: center;">Jardiance® (empagliflozin tablets) Synjardy XR® (empagliflozin / metformin HCl extended-release tablets)</td> <td style="text-align: center;">9,949,998 10,258,637</td> <td style="text-align: center;">The patents-in-suit are valid and enforceable. Unless specifically authorized, Cipla is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit. The parties shall bear their own costs and fees, including attorneys’ fees. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice.</td> </tr> <tr> <td style="text-align: center;">Bristol-Myers Squibb Co. v. Xspray Pharma AB, 22-0964 (D.N.J.)</td> <td style="text-align: center;">Sprycel® (dasatinib tablets)</td> <td style="text-align: center;">7,491,725 8,680,103</td> <td style="text-align: center;">All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Evofem Biosciences, Inc. v. Padagis Israel Pharms. Ltd., 23-3003 (D.N.J.)</td> <td style="text-align: center;">Phexxi® (lactic acid / citric acid / potassium bitartrate vaginal gel)</td> <td style="text-align: center;">10,568,855 11,337,989 11,439,610</td> <td style="text-align: center;">Padagis has amended its PIV certifications to the patents-in-suit to PIII certifications. All claims, counterclaims, and defenses are voluntarily dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Azurity Pharms., Inc. v. Alkem Labs Ltd., 23-0079 (D.N.J.)</td> <td style="text-align: center;">Eprontia® (topiramate oral solution)</td> <td style="text-align: center;">11,433,046</td> <td style="text-align: center;">All claims and counterclaims are dismissed without prejudice. The parties shall bear their own fees and costs.</td> </tr> <tr> <td style="text-align: center;">Astellas Pharma Inc. v. Qilu Pharma, Inc., 23-0022 (D. Del.)</td> <td style="text-align: center;">Myrbetriq® (mirabegron extended-release tablets)</td> <td style="text-align: center;">10,842,780</td> <td style="text-align: center;">All claims asserted against Qilu are dismissed without prejudice, and  all defenses to such claims and counterclaims are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Otsuka Pharm. Co., Ltd. v. Apotex Inc., 23-0710 (D. Del.)</td> <td style="text-align: center;">Jynarque® (tolvaptan tablets)</td> <td style="text-align: center;">8,501,730 8,273,735</td> <td style="text-align: center;">With respect to Apotex’s ANDA and ANDA products, the patents-in-suit are valid and enforceable. Apotex stipulates that the patents-in-suit would be infringed by its ANDA products. Apotex, except as licensed by Plaintiff, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Each party will bear its own attorneys’ fees and costs.</td> </tr> <tr> <td style="text-align: center;">Par Pharm., Inc. v. Cipla Ltd., 23-1150 (D.N.J.)</td> <td style="text-align: center;">Vasostrict® (vasopressin injection)</td> <td style="text-align: center;">9,919,026 9,925,233 9,962,422 9,968,649 9,974,827 9,981,006 10,010,575 9,925,234</td> <td style="text-align: center;">All claims, counterclaims, causes of action, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Actelion Pharms. Ltd. v. Apotex Inc., 23-0734 (D. Del.)</td> <td style="text-align: center;">Opsumit® (macitentan tablets)</td> <td style="text-align: center;">7,094,781</td> <td style="text-align: center;">Apotex admits the ’781 patent is valid and enforceable and that its claims would be infringed by the ANDA product. Unless otherwise authorized by plaintiff, Apotex is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-1902 (D.N.J.)</td> <td style="text-align: center;">Opsumit® (macitentan tablets)</td> <td style="text-align: center;">7,094,781</td> <td style="text-align: center;">Alembic admits the ’781 patent is valid and enforceable and that its claims would be infringed by the ANDA product. Unless otherwise authorized by plaintiff, Alembic is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> </tbody> </table>Tue, 10 Oct 2023 00:00:00 -0500{6DCA6535-D6B5-42E7-AC06-FAE25BEC2157}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/generic-launchesGeneric Launches<p>This Generic Launches chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.</p> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table"> <tbody> <tr class="tableizer-firstrow"> <th width="119"><span style="color: #000000;">Reference Listed Drug</span></th> <th width="115"><span style="color: #000000;">ANDA Holder</span></th> <th width="185"><span style="color: #000000;">Generic Drug Name</span></th> <th width="134"><span style="color: #000000;">ANDA<br /> Applicant(s)</span></th> <th width="863"><span style="color: #000000;">Indication</span></th> <th width="113"><span style="color: #000000;">Launch Date</span></th> </tr> <tr> <td style="text-align: center;">Xyrem</td> <td style="text-align: center;">Jazz</td> <td style="text-align: center;">sodium oxybate</td> <td style="text-align: center;">Amneal</td> <td style="text-align: center;"> Used to treat cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy</td> <td style="text-align: center;">7/3/2023</td> </tr> <tr> <td style="text-align: center;">Ganirelix</td> <td style="text-align: center;">Organon</td> <td style="text-align: center;">ganirelix acetate</td> <td style="text-align: center;">Fresenius Kabi</td> <td style="text-align: center;">Used to inhibit premature surges in luteinizing hormone, or LH, a chemical in the body that triggers reproductive processes such as ovulation; used to treat women who are undergoing controlled ovarian hyperstimulation</td> <td style="text-align: center;">7/10/2023</td> </tr> <tr> <td style="text-align: center;">Aczone</td> <td style="text-align: center;">AbbVie</td> <td style="text-align: center;">dapsone</td> <td style="text-align: center;">Cosette</td> <td style="text-align: center;">Used for the topical treatment of acne vulgaris</td> <td style="text-align: center;">7/13/2023</td> </tr> <tr> <td style="text-align: center;">Cubicin</td> <td style="text-align: center;">Cubist</td> <td style="text-align: center;">daptomycin</td> <td style="text-align: center;">Camber</td> <td style="text-align: center;">Used to treat complicated skin and skin structure infections (cSSSI) in adult patients and pediatric patients (1 to 17 years of age)</td> <td style="text-align: center;">7/27/2023</td> </tr> <tr> <td style="text-align: center;">Symbicort</td> <td style="text-align: center;">AstraZeneca</td> <td style="text-align: center;">budesonide / formoterol fumarate dihydrate</td> <td style="text-align: center;">Viatris</td> <td style="text-align: center;">Used in certain patients to treat asthma or chronic obstructive pulmonary disease (COPD) </td> <td style="text-align: center;">7/31/2023</td> </tr> <tr> <td style="text-align: center;">Duexis</td> <td style="text-align: center;">Horizon</td> <td style="text-align: center;">ibuprophen / famotidine</td> <td style="text-align: center;">Camber</td> <td style="text-align: center;">Used  to (1) relieve signs and symptoms of rheumatoid arthritis and osteoarthritis and (2) decrease the risk of developing upper gastrointestinal ulcers, in patients who are taking ibuprofen for those indications</td> <td style="text-align: center;">8/1/2023</td> </tr> <tr> <td style="text-align: center;">Sabril</td> <td style="text-align: center;">Lundbeck</td> <td style="text-align: center;">vigabatrin</td> <td style="text-align: center;">Upsher-Smith</td> <td style="text-align: center;">Used for infantile spasms in patients 1 month to 2 years of age and Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS)</td> <td style="text-align: center;">8/1/2023</td> </tr> <tr> <td style="text-align: center;">Gadavist</td> <td style="text-align: center;">Bayer</td> <td style="text-align: center;">gadobutrol</td> <td style="text-align: center;">Fresenius Kabi</td> <td style="text-align: center;">Used as a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI)</td> <td style="text-align: center;">8/8/2023</td> </tr> <tr> <td style="text-align: center;">Luxiq</td> <td style="text-align: center;">Mylan</td> <td style="text-align: center;">betamethasone</td> <td style="text-align: center;">Xiromed</td> <td style="text-align: center;">Used to relieve inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp</td> <td style="text-align: center;">8/2/2023</td> </tr> <tr> <td style="text-align: center;">Cardura</td> <td style="text-align: center;">Viatris</td> <td style="text-align: center;">doxazosin mesylate</td> <td style="text-align: center;">Apotex</td> <td style="text-align: center;">Used to treat high blood pressure (hypertension) and symptoms of an enlarged prostate (benign prostatic enlargement)</td> <td style="text-align: center;"> </td> </tr> <tr> <td style="text-align: center;">Toradol</td> <td style="text-align: center;">Roche</td> <td style="text-align: center;">ketorolac tromethamine</td> <td style="text-align: center;">Camber</td> <td style="text-align: center;">Used for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting</td> <td style="text-align: center;">8/7/2023</td> </tr> <tr> <td style="text-align: center;">Mozobil</td> <td style="text-align: center;">Genzyme</td> <td style="text-align: center;">plerixafor</td> <td style="text-align: center;">Fresenius Kabi</td> <td style="text-align: center;">Used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma</td> <td style="text-align: center;">8/9/2023</td> </tr> <tr> <td style="text-align: center;">Jadenu Sprinkle</td> <td style="text-align: center;">Novartis</td> <td style="text-align: center;">deferasirox</td> <td style="text-align: center;">Camber</td> <td style="text-align: center;">Used to treat chronic iron overload (1) due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older, and (2) in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes exhibiting elevated liver and serum iron concentrations</td> <td style="text-align: center;">8/8/2023</td> </tr> <tr> <td style="text-align: center;">Spiriva HandiHaler</td> <td style="text-align: center;">Boehringer Ingelheim</td> <td style="text-align: center;">tiotropium bromide</td> <td style="text-align: center;">Lupin</td> <td style="text-align: center;">Used to treat chronic obstructive pulmonary disease (COPD)</td> <td style="text-align: center;">8/16/2023</td> </tr> <tr> <td style="text-align: center;">Pepcid</td> <td style="text-align: center;">Johnson & Johnson</td> <td style="text-align: center;">famotidine</td> <td style="text-align: center;">Upsher-Smith</td> <td style="text-align: center;">Used to treat active duodenal ulcer, active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD, diagnosed by biopsy</td> <td style="text-align: center;">8/15/2023</td> </tr> <tr> <td style="text-align: center;">Balcoltra</td> <td style="text-align: center;">Avion</td> <td style="text-align: center;"> levonorgestrel / ethinyl estradiol</td> <td style="text-align: center;">Xiromed</td> <td style="text-align: center;">Used as an oral contraceptive</td> <td style="text-align: center;">8/17/2023</td> </tr> <tr> <td style="text-align: center;">Apriso</td> <td style="text-align: center;">Valeant </td> <td style="text-align: center;">mesalamine</td> <td style="text-align: center;">Upsher-Smith</td> <td style="text-align: center;">Used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease)</td> <td style="text-align: center;">8/21/2023</td> </tr> <tr> <td style="text-align: center;">Zetia</td> <td style="text-align: center;">Organon</td> <td style="text-align: center;">ezetimibe</td> <td style="text-align: center;">Hetero</td> <td style="text-align: center;">Used to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin);<br /> reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate;<br /> reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin; reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia)</td> <td style="text-align: center;">8/24/2023</td> </tr> <tr> <td style="text-align: center;">Alphagan</td> <td style="text-align: center;">AbbVie</td> <td style="text-align: center;">brimonidine tartrate</td> <td style="text-align: center;">Apotex</td> <td style="text-align: center;">Used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension</td> <td style="text-align: center;">9/2/2023</td> </tr> <tr> <td style="text-align: center;">Aubagio</td> <td style="text-align: center;">Sanofi</td> <td style="text-align: center;">teriflunomide</td> <td style="text-align: center;">Apotex</td> <td style="text-align: center;">Used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease</td> <td style="text-align: center;">9/6/2023</td> </tr> <tr> <td style="text-align: center;">Zyprexa</td> <td style="text-align: center;">Eli Lilly</td> <td style="text-align: center;">olanzapine</td> <td style="text-align: center;">Camber</td> <td style="text-align: center;">Used to treat acute agitation associated with schizophrenia and bipolar I mania</td> <td style="text-align: center;">9/25/2023</td> </tr> <tr> <td style="text-align: center;">Rozerem</td> <td style="text-align: center;">Takeda</td> <td style="text-align: center;">ramelteon</td> <td style="text-align: center;">Ziromed</td> <td style="text-align: center;">Used to treat insomnia characterized by difficulty with sleep onset</td> <td style="text-align: center;">9/29/2023</td> </tr> </tbody> </table>Tue, 10 Oct 2023 00:00:00 -0500{21C0EDB6-C5EA-4E58-9FA1-37D34B82D571}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/new-anda-casesNew ANDA Cases<p>This New ANDA Cases chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.</p> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table" style="text-align: center;"> <tbody> <tr class="tableizer-firstrow"> <th width="488" height="26"><span style="color: #000000;">Case Name</span></th> <th width="88"><span style="color: #000000;">Date Filed</span></th> <th width="167"><span style="color: #000000;">Judge</span></th> <th width="506"><span style="color: #000000;">Drug</span></th> <th width="284"><span style="color: #000000;">Patent No(s).</span></th> </tr> <tr> <td>Actelion Pharms. US, Inc. v. MSN Labs. Private Ltd., 23-0731 (D. Del.)</td> <td>6-Jul-23</td> <td>Hon. Gregory B. Williams</td> <td>Uptravi® (selexipag for injection)</td> <td>8,791,122<br /> 9,284,280</td> </tr> <tr> <td>Biogen Inc. v. Zydus Worldwide DMCC, 23-0732 (D. Del.)</td> <td>6-Jul-23</td> <td>Hon. Gregory B. Williams</td> <td>Vumerity® (diroximel fumarate delayed-release capsules)</td> <td>8,669,281<br /> 9,090,558<br /> 10,080,733</td> </tr> <tr> <td>Actelion Pharms. Ltd. v. Apotex Inc., 23-0734 (D. Del.)</td> <td>6-Jul-23</td> <td>Hon. Colm F. Connolly</td> <td>Opsumit® (macitentan tablets)</td> <td>7,094,781</td> </tr> <tr> <td>CMP Development, LLC v. Hetero USA, Inc., 23-0747 (D. Del.)</td> <td>10-Jul-23</td> <td>Hon. Maryellen Noreika</td> <td>CaroSpir® (spironolactone oral suspension)</td> <td>9,757,394<br /> 10,493,083<br /> 10,624,906<br /> 10,660,907<br /> 10,888,570<br /> 11,389,461<br /> 11,395,828<br /> 11,491,166</td> </tr> <tr> <td>AbbVie Inc. v. Lupin Ltd., 23-0750 (D. Del.)</td> <td>10-Jul-23</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>11,542,239</td> </tr> <tr> <td>Mitsubishi Tanabe Pharma Corp. v. Cipla USA Inc., 23-0759 (D. Del.)</td> <td>12-Jul-23</td> <td>Hon. Colm F. Connolly</td> <td>Radicava Ors® (edaravone oral suspension)</td> <td>10,987,341<br /> 11,241,416<br /> 11,478,450</td> </tr> <tr> <td>Gilead Sciences, Inc. v. Apotex Inc., 23-0774 (D. Del.)</td> <td>14-Jul-23</td> <td>Hon. Maryellen Noreika</td> <td>Genvoya® (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide tablets)</td> <td>10,039,718</td> </tr> <tr> <td>Gilead Sciences, Inc. v. Apotex Inc., 23-0775 (D. Del.)</td> <td>14-Jul-23</td> <td>Hon. Maryellen Noreika</td> <td>Genvoya® (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide tablets)</td> <td>8,754,065<br /> 9,296,769</td> </tr> <tr> <td>Alkermes Pharma Ireland Ltd. v. Slayback Pharma LLC, 23-3794 (D.N.J.)</td> <td>14-Jul-23</td> <td>Hon. Georgette Castner</td> <td>Anjeso® (meloxicam injection)</td> <td>10,463,673<br /> 10,471,067<br /> 10,709,713<br /> 10,881,663<br /> 11,458,145</td> </tr> <tr> <td>Azurity Pharms., Inc. v. Cosette Pharms., Inc., 23-3830 (D.N.J.)</td> <td>18-Jul-23</td> <td>Hon. Evelyn Padin</td> <td>Firvanq® (vancomycin HCl oral solution)</td> <td>11,638,692</td> </tr> <tr> <td>Oyster Point Pharma, Inc. v. Apotex, Inc., 23-3860 (D.N.J.)</td> <td>19-Jul-23</td> <td>Hon. Julien Xavier Neals</td> <td>Tyrvaya® (varenicline solution)</td> <td>9,504,644<br /> 9,504,645<br /> 9,532,944<br /> 9,597,284<br /> 10,456,396<br /> 11,224,598</td> </tr> <tr> <td>Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., 23-0794 (D. Del.)</td> <td>21-Jul-23</td> <td>Hon. Richard G. Andrews</td> <td>Viberzi® (eluxadoline tablets)</td> <td>11,484,527</td> </tr> <tr> <td>Allergan Holdings Unlimited Co. v. Sun Pharm. Indus. Ltd., 23-0795 (D. Del.)</td> <td>21-Jul-23</td> <td>Hon. Richard G. Andrews</td> <td>Viberzi® (eluxadoline tablets)</td> <td>11,484,527</td> </tr> <tr> <td>Boehringer Ingelheim Pharms., Inc. v. Alvogen, Inc., 23-3911 (D.N.J.)</td> <td>21-Jul-23</td> <td>Hon. Kevin McNulty</td> <td>Spiriva® HandiHaler® (tiotropium bromide inhalation powder)</td> <td>9,010,323</td> </tr> <tr> <td>GW Research Ltd. v. Teva Pharms., Inc., 23-3914 (D.N.J.)</td> <td>21-Jul-23</td> <td>Hon. Michael Farbiarz</td> <td>Epidiolex® (cannabidiol oral solution)</td> <td>11,633,369</td> </tr> <tr> <td>Currax Pharms. LLC v. Ajanta Pharma Ltd., 23-3937 (D.N.J.)</td> <td>24-Jul-23</td> <td>Hon. Christine P. O’Hearn</td> <td>Silenor® (doxepin HCl tablets)</td> <td>7,915,307<br /> 8,513,299<br /> 9,107,898<br /> 9,486,43<br /> 9,572,814<br /> 9,861,607<br /> 10,238,620<br /> 10,653,660<br /> 10,653,662<br /> 11,110,074</td> </tr> <tr> <td>Janssen Pharmaceutica NV v. Natco Pharma Ltd., 23-3959 (D.N.J.)</td> <td>25-Jul-23</td> <td>Hon. Brian R. Martinotti</td> <td>Balversa® (erdafitinib tablets)</td> <td>9,902,714<br /> 11,077,106</td> </tr> <tr> <td>Supernus Pharms., Inc. v. Ascent Pharms. Inc., 23-4015 (D.N.J.)</td> <td>26-Jul-23</td> <td>Hon. Georgette Castner</td> <td>Trokendi XR® (topiramate extended-release capsules)</td> <td>8,298,576<br /> 8,298,580<br /> 8,663,683<br /> 8,877,248<br /> 8,889,191<br /> 8,992,989<br /> 9,549,940<br /> 9,555,004<br /> 9,622,983<br /> 10,314,790</td> </tr> <tr> <td>Novo Nordisk Inc. v. Lupin Ltd., 23-4027 (D.N.J.)</td> <td>27-Jul-23</td> <td>Hon. Georgette Castner</td> <td>Victoza® (liraglutide recombinant solution injection)</td> <td>8,114,833<br /> 9,265,893</td> </tr> <tr> <td>Novo Nordisk Inc. v. Lupin Ltd., 23-4031 (D.N.J.)</td> <td>27-Jul-23</td> <td>Hon. Susan D. Wigenton</td> <td>Saxenda® (liraglutide recombinant solution injection)</td> <td>8,114,833<br /> 8,684,969<br /> 8,920,383<br /> 9,108,002<br /> 9,132,239<br /> 9,457,154<br /> 9,616,180<br /> 9,687,611<br /> 9,775,953<br /> 9,861,757<br /> 10,220,155<br /> 10,357,616<br /> 10,376,652<br /> 11,097,063<br /> 11,311,679<br /> RE46,363</td> </tr> <tr> <td>Astellas Pharma Inc. v. Lupin Ltd., 23-0819 (D. Del.)</td> <td>28-Jul-23</td> <td>Hon. Gregory B. Williams</td> <td>Myrbetriq® (mirabegron extended-release tablets)</td> <td>11,707,451</td> </tr> <tr> <td>Supernus Pharms., Inc. v. Ascent Pharms. Inc., 23-5720 (E.D.N.Y.)</td> <td>28-Jul-23</td> <td>Hon. Gary R. Brown</td> <td>Trokendi XR® (topiramate extended-release capsules)</td> <td>8,298,576<br /> 8,298,580<br /> 8,663,683<br /> 8,877,248<br /> 8,889,191<br /> 8,992,989<br /> 9,549,940<br /> 9,555,004<br /> 9,622,983<br /> 10,314,790</td> </tr> <tr> <td>Genentech, Inc. v. Sandoz, Inc., 23-4085 (D.N.J.)</td> <td>31-Jul-23</td> <td>Hon. Julien Xavier Neals</td> <td>Esbriet® (pirfenidone tablets)</td> <td>10,188,637</td> </tr> <tr> <td>Azurity Pharms., Inc. v. Zydus Worldwide DMCC, 23-0833 (D. Del.)</td> <td>Aug. 2, 2023</td> <td>Hon. Maryellen Noreika</td> <td>Edarbi® (azilsartan medoxomil tablets) Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets)</td> <td>9,066,936<br /> 9,169,238<br /> 9,387,249</td> </tr> <tr> <td>Azurity Pharms., Inc. v. Zydus Worldwide DMCC, 23-4152 (D.N.J.)</td> <td>Aug. 3, 2023</td> <td>Hon. Robert Kirsch</td> <td>Edarbi® (azilsartan medoxomil tablets) Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets)</td> <td>9,066,936<br /> 9,169,238<br /> 9,387,249</td> </tr> <tr> <td>Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0847 (D. Del.)</td> <td>Aug. 4, 2023</td> <td>Hon. Colm F. Connolly</td> <td>Glyxambi® (empagliflozin / linagliptin tablets)</td> <td>8,551,957<br /> 9,949,998<br /> 10,258,637<br /> 11,090,323</td> </tr> <tr> <td>Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0848 (D. Del.)</td> <td>Aug. 4, 2023</td> <td>Hon. Colm F. Connolly</td> <td>Jardiance® (empagliflozin tablets)</td> <td>9,949,998<br /> 10,258,637<br /> 11,090,323</td> </tr> <tr> <td>Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0849 (D. Del.)</td> <td>Aug. 4, 2023</td> <td>Hon. Colm F. Connolly</td> <td>Synjardy® (empagliflozin / metformin HCl tablets)</td> <td>10,258,637<br /> 11,090,323</td> </tr> <tr> <td>Par Pharm., Inc. v. Zydus Pharms. (USA) Inc., 23-0866 (D. Del.)</td> <td>Aug. 8, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Chantix® (varenicline tartrate tablets)</td> <td>11,717,524</td> </tr> <tr> <td>Vifor Fresenius Medical Care Renal Pharma Ltd. v. Aurobindo Pharma Ltd., 23-0877 (D. Del.)</td> <td>Aug. 10, 2023</td> <td>Hon. Maryellen Noreika</td> <td>Velphoro® (sucroferric oxyhydroxide tablets)</td> <td>9,561,251<br /> 10,624,855<br /> 10,682,376<br /> 10,695,367<br /> 10,925,896<br /> 10,925,897<br /> 10,933,090<br /> 11,013,761<br /> 11,013,762<br /> 11,234,938<br /> 11,446,252</td> </tr> <tr> <td>Pfizer Inc. v. Dexcel Pharma Technologies Ltd., 23-0879 (D. Del.)</td> <td>Aug. 10, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Vyndamax® (tafamidis capsules)</td> <td>7,214,695<br /> 7,214,696<br /> 9,770,441</td> </tr> <tr> <td>AbbVie Inc. v. Alkem Labs. Ltd., 23-0881 (D. Del.)</td> <td>Aug. 10, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>11,542,239</td> </tr> <tr> <td>AbbVie Inc. v. Zenara Pharma Private Ltd., 23-0892 (D. Del.)</td> <td>Aug. 11, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>11,542,239</td> </tr> <tr> <td>Fresenius Kabi USA, LLC v. Amneal Pharms. LLC, 23-4343 (D.N.J.)</td> <td>Aug. 11, 2023</td> <td>Hon. Claire C. Cecchi</td> <td>Diprivan® (propofol injection)</td> <td>8,476,010</td> </tr> <tr> <td>Allergan, Inc. v. Amneal Pharms. of New York, LLC, 23-6208 (E.D.N.Y.)</td> <td>Aug. 17, 2023</td> <td>Hon. Gary R. Brown</td> <td>Lumigan® (bimatoprost ophthalmic solution)</td> <td>7,851,504<br /> 8,278,353<br /> 8,299,118<br /> 8,309,605<br /> 8,338,479<br /> 8,524,777<br /> 8,586,630<br /> 8,772,338<br /> 8,933,120<br /> 8,933,127<br /> 9,155,716<br /> 9,241,918</td> </tr> <tr> <td>Pfizer Inc. v. Cipla Ltd., 23-0909 (D. Del.)</td> <td>Aug. 18, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Vyndamax® (tafamidis capsules)</td> <td>9,770,441</td> </tr> <tr> <td>Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-6667 (D.N.J.)</td> <td>Aug. 21, 2023</td> <td>Hon. Karen M. Williams</td> <td>Yupelri® (revefenacin inhalation solution)</td> <td>11,691,948</td> </tr> <tr> <td>Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0923 (D. Del.)</td> <td>Aug. 23, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Vyndaqel® (tafamidis meglumine capsules)</td> <td>7,214,695</td> </tr> <tr> <td>Pfizer Inc. v. Zenara Pharma Private Ltd., 23-0924 (D. Del.)</td> <td>Aug. 23, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Vyndamax® (tafamidis capsules)</td> <td>9,770,441</td> </tr> <tr> <td>Alkermes Pharma Ireland Ltd. v. Nanjing Delova Biotech Co., Ltd., 23-9763 (D.N.J.)</td> <td>Aug. 24, 2023</td> <td>Hon. Georgette Castner</td> <td>Anjeso® (meloxicam injection)</td> <td>9,974,746<br /> 10,709,713<br /> 10,881,663<br /> 11,458,145</td> </tr> <tr> <td>Endo Par Innovation Co., LLC v. BPI Labs, LLC, 23-1953 (M.D. Fl.)</td> <td>Aug. 29, 2023</td> <td>Hon. William F. Jung</td> <td>Adrenalin® (epinephrine injection)</td> <td>9,119,876 <br /> 9,295,657</td> </tr> <tr> <td>Curia IP Holdings, LLC v. Salix Pharms., Ltd., 23-13764 (D.N.J.)</td> <td>Aug. 31, 2023</td> <td>Hon. Karen M. Williams</td> <td>Xifaxan® (rifaximin tablets)</td> <td>11,739,099</td> </tr> <tr> <td>Amicus Therapeutics US, LLC v. Lupin Ltd., 23-0964 (D. Del.)</td> <td>Sept. 1, 2023</td> <td>Hon. Christopher J. Burke</td> <td>Galafold® (migalastat capsules)</td> <td>9,000,011<br /> 9,987,263<br /> 10,383,864<br /> 10,406,143<br /> 10,925,866<br /> 10,813,921<br /> RE48,608</td> </tr> <tr> <td>Par Pharm., Inc. v. Mankind Pharma Ltd., 23-0399 (E.D. Tex.)</td> <td>Sept. 1, 2023</td> <td>Hon. Rodney Gilstrap</td> <td>Varenicline Tartrate</td> <td>11,717,524</td> </tr> <tr> <td>Par Pharm., Inc. v. Alkem Labs. Ltd., 23-0400 (E.D. Tex.)</td> <td>Sept. 1, 2023</td> <td>Hon. Rodney Gilstrap</td> <td>Varenicline Tartrate</td> <td>11,717,524</td> </tr> <tr> <td>United Therapeutics Corp. v. Liquidia Technologies, Inc., 23-0975 (D. Del.)</td> <td>Sept. 5, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Tyvaso® (treprostinil inhalation solution) Tyvaso DPI® (treprostinil inhalation powder) Yutrepia® (treprostinil inhalation powder)</td> <td>10,716,793</td> </tr> <tr> <td>Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 23-18420 (D.N.J.)</td> <td>Sept. 7, 2023</td> <td>Hon. Christine P. O’Hearn</td> <td>Qbrelis® (lisinopril oral solution)</td> <td>9,463,183<br /> 9,616,096<br /> 9,814,751<br /> 10,039,800<br /> 10,265,370<br /> 10,406,199<br /> 10,940,177<br /> 11,179,434</td> </tr> <tr> <td>Celgene Corp. v. Teva Pharms., Inc., 23-1008 (D. Del.)</td> <td>Sept. 13, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Onureg® (azacitidine tablets)</td> <td>8,846,628<br /> 11,571,436</td> </tr> <tr> <td>Axsome Malta Ltd. v. Alkem Labs Ltd., 23-20354 (D.N.J.)</td> <td>Sept. 13, 2023</td> <td>Hon. Madeline Cox Arleo</td> <td>Sunosi® (solriamfetol tablets)</td> <td>8,440,715<br /> 8,877,806<br /> 9,604,917<br /> 10,351,517<br /> 10,195,151<br /> 10,512,609<br /> 11,439,597<br /> 10,912,754<br /> 10,959,976<br /> 11,160,779<br /> 10,940,133<br /> 11,560,354<br /> 11,648,232</td> </tr> <tr> <td>Heron Therapeutics, Inc. v. Mylan Pharms. Inc., 23-1015 (D. Del.)</td> <td>Sept. 15, 2023</td> <td>Hon. William C. Bryson</td> <td>Civanti® (aprepitant injection)</td> <td>9,561,229<br /> 9,808,465<br /> 9,974,742<br /> 9,974,793<br /> 9,974,794<br /> 10,500,208<br /> 10,624,850<br /> 10,953,018<br /> 11,173,118</td> </tr> <tr> <td>Celgene Corp. v. Natco Pharma Ltd., 23-1019 (D. Del.)</td> <td>Sept. 18, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Onureg® (azacitidine tablets)</td> <td>8,846,628<br /> 11,571,436</td> </tr> <tr> <td>Fresenius Kabi USA, LLC v. Meitheal Pharms., Inc., 23-1050 (D. Del.)</td> <td>Sept. 26, 2023</td> <td>Hon. Colm F. Connolly</td> <td>Diprivan® (propofol injectable emulsion)</td> <td>8,476,010</td> </tr> <tr> <td>Orphalan SA v. Novitium Pharma LLC, 23-1079 (D. Del.)</td> <td>Sept. 29, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Cuvrior® (triethylenetetramine tetrachloride tablets)</td> <td>10,988,436<br /> 11,072,577</td> </tr> <tr> <td>Azurity Pharms., Inc. v. Teva Pharms., Inc., 23-1080 (D. Del.)</td> <td>Sept. 29, 2023</td> <td>Hon. Maryellen Noreika</td> <td>Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets)</td> <td>9,066,936<br /> 9,169,238<br /> 9,387,249</td> </tr> </tbody> </table>Tue, 10 Oct 2023 00:00:00 -0500{C2A4B7F8-5FD4-4F3D-992E-9B60C53B72B3}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/cmp-development-v-amneal-pharms<i>CMP Development, LLC v. Amneal Pharms. LLC</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>CMP Development, LLC v. Amneal Pharms. LLC</em>, Civ No. 21-549 (MN), 2023 WL 6387792 (D. Del. Sept. 29, 2023)</span><span> (Noreika, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> CaroSpir® (spironolactone); U.S. Patents Nos. 10,624,906 (“the </span><span>’</span><span>906 patent”), 10,660,907 (“the </span><span>’</span><span>907 patent”), and 10,888,570 (“the </span><span>’</span><span>570 patent”) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>CaroSpir is indicated for the treatment of heart failure, hypertension, and edema caused by cirrhosis. The patents-in-suit claim about 0.18% w/v to about 0.36% w/v of xanthan gum. Amneal argued that it did not infringe because it used tragacanth powder—not xanthan gum—as its suspending agent. After a two-day bench trial, the court found that CMP had not met its burden of proving infringement.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Amneal prevailed:</span></strong><span> The parties agreed that Amneal did not literally infringe, as Amneal’s product did not use xanthan gum. Rather, CMP argued that Amneal’s suspending agent—tragacanth powder—infringed the xanthan gum weight percent limitation under the doctrine of equivalents. Amneal did not contest that tragacanth powder performs substantially the same function to obtain substantially the same result as the recited xanthan gum. Instead, Amneal disputed that tragacanth powder worked in substantially the same way as xanthan gum.</span></p> <p style="margin-bottom: 12pt;"><span>CMP argued that tragacanth powder and xanthan gum work in substantially the same way because Amneal’s ANDA described a study examining four suspending agents and only tragacanth powder and xanthan gum prevented visually observable sedimentation. Other than this observation, CMP conducted no other scientific experiments to support its argument that each of the excipients work in substantially the same way. More particularly, the Court explained that “apart from his say-so and expertise as a polymer scientist, [CMP’s expert] offered no scientific support for the connection he made between … [the way] the two suspending agents work.” Conversely, Amneal argued that the suspending agents do not increase viscosity in substantially the same way. In particular, because of the presence of bassorin, tragacanth powder increases viscosity by a combination of swelling and polymer chain entanglement. It was undisputed that xanthan gum increases viscosity only by entanglement of dissolved polymer chains. Further, the amount of tragacanth powder in the ANDA product was 0.65% w/v, which was almost double the amount of xanthan gum recited in the patents-in-suit. CMP argued that due to the presence of bassorin, only 30-40% of the tragacanth powder will in fact be tragacanthin, and thus Amneal’s product infringed under the doctrine of equivalents. But the court found that there was no expert testimony or evidence to support this theory. In sum, there was no evidence that the amount of tragacanth powder in Amneal’s ANDA product is equivalent to the amount of xanthan gum in the patents-in-suit.</span></p>Fri, 29 Sep 2023 00:00:00 -0500{2FB2FB08-D80F-4EF7-A0D5-6340121956C6}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/novartis-pharms-v-alembic-pharms<i>Novartis Pharms. Corp. v. Alembic Pharms. Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>Novartis Pharms. Corp. v. Alembic Pharms. Ltd.</span></em><span>, Civ. No. 22-1395-RGA, 2023 WL 6387975 (D. Del. Sept. 29, 2023) (Andrews, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Entresto® (sacubitril/valsartan); U.S. Patent No. 11,096,918 (“the ’918 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Previously, Novartis sued Noratech, MSN, and other defendants, alleging that each defendant’s ANDA products infringed various patents. As part of that previous litigation, Noratech and MSN provided to Novartis their ANDAs, product samples, and other confidential information subject to the protective order entered in that case. Novartis ultimately dismissed its infringement claims.</span></p> <p style="margin-bottom: 12pt;"><span>Novartis then filed this case asserting, “on information and belief,” that Noratech’s and MSN’s ANDA products (the same ANDA products accused in the previous case) infringe the ’918 patent. Noratech filed a motion to dismiss for failure to state a claim, and the MSN defendants filed a motion for judgment on the pleadings. Defendants argued that Novartis’s “on information and belief” allegations were insufficient, and that Novartis should have to plead infringement with greater specificity based on ANDAs, testing data, and other documents it obtained during the previous litigation. The court denied both motions.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Novartis Prevailed: </span></strong><span>The court had previously interpreted the protective order governing Defendants’ disclosures in the previous litigation as preventing use of that information to initiate other litigation. Thus, Novartis <em>could not</em> plead infringement with the additional detail that Defendants demanded. Moreover, the court reaffirmed application of the more “relaxed” <em>Belcher</em> pleading standard in ANDA infringement cases, including those asserting only non-OB-listed patents, like this one—ANDA infringement plaintiffs are held to a lower level of specificity than plaintiffs in other patent infringement cases.</span></p> <p style="margin-bottom: 12pt;"><span>MSN also moved for judgment of non-infringement, arguing that the ’918 patent claims an <em>amorphous</em> form of the claimed compound and its ANDA product requires a <em>crystalline</em> form. Consistent with recent trends, the court determined that it could not adjudicate infringement at this early stage—in particular, without expert testimony—and pleading that the ANDA product infringes was sufficient. The court went so far as to state that “an ANDA does not provide a complete answer to infringement.”</span></p>Fri, 29 Sep 2023 00:00:00 -0500{11A86D05-5627-4DAA-A867-9A5069848FED}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/allergan-usa-v-msn-labs<i>Allergan USA, Inc. v. MSN Labs. Private Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Allergan USA, Inc. v. MSN Labs. Private Ltd.</em>, C.A. </span><span>Nos. 19-1727-RGA, 20-1479-RGA, 2023 WL 6295496 (D. Del. Sept. 27, 2023) (Andrews, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Viberzi® (eluxadoline); U.S. Patents Nos. 11,007,179 (“the ’179 patent”), 11,090,291 (“the ’291 patent”), 11,160,792 (“the ’792 patent”), 11,311,516 (“the ’516 patent”), 7,741,356 (“the ’356 patent”), and 11,229,627 (“the ’627 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Allergan holds the NDA for Viberzi, which is FDA approved for treating irritable bowel syndrome with diarrhea (“IBS-D”) in adults. Defendants submitted ANDAs seeking FDA approval to make and sell generic versions of that drug. Allergan filed complaints against MSN and Sun alleging infringement of earlier issued Orange Book-listed patents. As the cases progressed, the patents-in-suit issued and were also asserted against Defendants. Allergan and Sun stipulated that Sun would infringe the asserted claims of the ’179, ’291, ’792, ’516, and ’356 patents if the claims were found valid. At trial, the only issues between Allergan and Sun were whether the asserted claims of the ’179, ’291, ’792, ’516, and ’356 patents are invalid. Sun argued the asserted claims of the ’179, ’291, ’792, and ’516 patents were invalid for lack of written description. If the court found that those asserted claims were sufficiently described, then Sun argued those claims would be invalid as obvious. Sun also argued that the asserted claim of the ’356 patent was invalid for obviousness-type double patenting. At trial, the only issues between Allergan and MSN were whether the asserted claims of the ’627 and ’291 patents were invalid for lack of written description and non-enabled. If the court found adequate written description and enablement, then, according to MSN, the claims would be invalid as obvious. After a three-day bench trial, the court found the asserted claims of the ’627, ’291, ’179, ’792, and ’516 patents invalid for lack of written description and the asserted claim of the ’356 patent invalid for obviousness-type double patenting (“ODP”).</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Defendants Prevailed</span></strong><span>: <em>Sun’s written description defense</em>. A glidant is an agent that is used to improve the flow characteristics of a powder mixture. Sun argued that the shared specification does not adequately describe a pharmaceutical formulation that does not require a glidant. Put another way, Sun contended that because the specification only discloses formulations that contain a glidant and “nothing in the specification describes, or even suggests, that the inventors possessed a formulation without a glidant,” the claims are invalid for lack of written description. The court agreed. “For all the formulations disclosed in the patent specification, a glidant is used without any indication that it was not required to practice the invention. For example, there is nothing to signal to a POSA that without a glidant the formulations would have sufficient flow characteristics. Of course, patents are not limited to the specific embodiments disclosed in the specification. But the specification here fails to show that the patentee was in possession of a formulation in which the inclusion of the glidant was optional.”</span></p> <p style="margin-bottom: 12pt;"><em><span>MSN’s written description defense</span></em><span>. The shared specification of the patents-in-suit incorporates by reference a prior art reference, Breslin, and the parties dispute the scope of incorporation. MSN argued that, based on the context in which Breslin is cited in the specification, a POSA would understand Breslin to be incorporated only for its discussion about how eluxadoline can be used to treat gastrointestinal disorders along with the identification of the eluxadoline molecule and its mechanism of action. Allergan argued that the excerpted portion of Breslin is incorporated into the patent specification because the specification states that Breslin is incorporated in its entirety, and the court agreed. </span></p> <p style="margin-bottom: 12pt;"><span>The asserted claims against MSN cover formulations of eluxadoline that use any “filler” and any “disintegrant” at specific amounts or weight percentages. The specification only disclosed formulations made with the same disintegrant (crospovidone) and fillers (mannitol and SMCC). “The specification is explicit about using these specific excipients, not functional groups, as it repeatedly recites using SMCC and crospovidone.” When referring to glidants, the patentee referred to the common functional category, “glidant,” and then provided colloidal silica as a preferred embodiment. “In contrast to glidant, the patentee did not use a similar descriptive framework for filler and disintegrant (e.g., listing ‘disintegrant’ and then providing crospovidone as a preferred embodiment).” Therefore, a POSA would read the specification to only disclose a formulation with SMCC and crospovidone, not a formulation using any filler and any disintegrant. Allergan’s argument that Breslin gives examples of fillers and disintegrants, while true, is misplaced. “That Breslin gives multiple examples of fillers and disintegrants, however, does not mean it gives multiple examples of the claimed species (i.e., the combinations of fillers and disintegrants that can be used to make formulations of eluxadoline).”</span></p> <p style="margin-bottom: 12pt;"><em><span>Sun’s ’356 patent ODP defense</span></em><span>. The issue here was whether the fact the ’356 patent expires after the ’011 and ’709 patents makes it invalid for obviousness-type double patenting over those two patents. Claim 40 of the ’356 patent is not patentably distinct from the asserted claims of the ’011 and ’709 patents. The expiration date of the ’356 patent, after addition of PTA, falls after the expiration dates of the ’011 and ’709 patents. ODP therefore invalidates the challenged claim.</span></p>Wed, 27 Sep 2023 00:00:00 -0500{E7C46624-1E60-4FA4-AEEB-FC78FDEC2A70}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/takeda-pharms-usa-v-mylan-pharms<i>Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc.</span></em><span>, Civ. No. 19-2216-RGA, 2023 WL 6295453 (D. Del. Sept. 27, 2023) (Andrews, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Colcrys® (colchicine); technically, 22 patents, though the court did not reach Takeda’s patent claims.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> Takeda has 17 Orange Book-listed patents for Colcrys and previously sued a number of generic manufacturers, including Mylan, that submitted ANDAs relying on that drug product. The parties settled that lawsuit in 2017. As part of that settlement, the parties executed a license agreement, which allowed Mylan to sell generic colchicine after a certain date. The license, as is typical, identified certain events that would trigger an earlier launch, including “[t]he date that is [a specified time period] after the date of a Final Court Decision (as defined in Exhibit A) holding that all unexpired claims of the Licensed Patents that were asserted and adjudicated against a Third Party are either (i) not infringed, or (ii) any combination of not infringed and invalid or unenforceable.”</span></p> <p style="margin-bottom: 12pt;"><span>Mylan believed that a separate case, in which Takeda asserted eight of its Orange Book-listed patents against West-Ward, triggered an early launch. In particular, in the purportedly triggering case, Takeda stipulated to dismiss five of the asserted patents with prejudice, and the court ordered the dismissal. The court then adjudicated the remaining claims, finding non-infringement. As a result, Mylan told Takeda that it intended to launch, and Takeda sued for infringement and breach of contract. Takeda moved for a preliminary injunction, which the court denied after finding that Takeda “failed to show that it is likely to succeed on the merits or that it will suffer irreparable harm.” The Federal Circuit affirmed that finding.</span></p> <p style="margin-bottom: 12pt;"><span>Then the court bifurcated Takeda’s claims, electing to resolve the breach of contract claim first. After completing discovery, Mylan moved for summary judgment, arguing that the license agreement is unambiguous and permits Mylan to launch. The court agreed and granted summary judgment in favor of Mylan.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Mylan Prevailed: </span></strong><span>The parties’ dispute turned on the phrase “asserted and adjudicated.” Mylan read the terms together, arguing that the clause requires a Final Court Decision only for a claim asserted <em>and</em> adjudicated. Thus, when Takeda dismissed certain patents, they were no longer asserted and need not be adjudicated to trigger Mylan’s launch. The dismissed patents were, in short, not relevant. Takeda, for its part, argued that <em>all</em> asserted claims were asserted but not all claims (i.e., the dismissed claims) were subject to a non-infringement holding.</span></p> <p style="margin-bottom: 12pt;"><span>The court agreed with Mylan, separating the license term from preclusion issues and finding that “the plain meaning of the term [adjudicated] makes clear that judicial analysis and a resolution is required for a claim to be ‘adjudicated.’” Thus, voluntary dismissal does not constitute “adjudication.” And “asserted” and “adjudicated” work together in the clause in question. Indeed, to read the clause as Takeda argued “would give Takeda 100% control to make sure that [the launch clause] never applies.” And “[t]he provision in the Agreement is to protect Mylan so that it is not outpaced by competitors, not the other way around.”</span></p>Wed, 27 Sep 2023 00:00:00 -0500{35E0B758-0392-4569-AB8E-6DD91A98A3D5}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-september-2023/evenstad-family-trial-aftermathEvenstad Family Trial Aftermath: Rule 408 May Not Be Used as a Sword and Shield<p> It’s unlikely the extended Evenstad family, former owners and heirs of the Upsher-Smith company, will be celebrating Thanksgiving together this year. After all, the last time the family got together was likely for the 16-day bench trial in Minnesota state court before Judge Edward T. Wahl,<span style="font-size: 8px;"><sup>1</sup></span> who considered Serene Warren’s (née Evenstad) various fiduciary-duty and shareholder-oppression claims against her family’s company (ACOVA), her family members (including her parents and brother), and a trustee. In a 354-page opinion in <em>Warren v. ACOVA</em>, issued on March 27, 2023, Judge Wahl ruled against Serene Warren and denied her request for a buyout. He instead ordered that ACOVA must continue to wind down operations and liquidate now that it has sold its primary asset, the Upsher-Smith pharmaceutical company.</p> <p> One of the many issues that Judge Wahl addressed in the lengthy opinion was the following: What are the confines of Rule of Evidence 408 and when can settlement and mediation discussions be admissible at trial? During trial, the court admitted evidence of discussions at two mediations — one in 2017 and one in 2019 — “as well as communications between the parties’ attorneys in the aftermath of those mediations[.]” While the court had explained on the record its reasoning, it further elaborated on the ruling in the opinion.</p> <p> Many legal practitioners have a knee-jerk reaction to an opposing party making any reference to settlement discussions or statements made during mediations. That may have something to do with the fact that many mediators’ agreements contain language that creates a contractual agreement between the parties. \</p> <p> But Minn. R. Evid. 408 (and its analogous but not-identical federal counterpart, Fed. R. Evid. 408) is more nuanced than just prohibiting the admission of any reference to mediation or settlement. Minn. R. Evid. 408 states: </p> <p> <strong>Rule 408. Compromise and Offers to Compromise</strong></p> <p style="margin-left: 40px;">Evidence of (1) furnishing or offering or promising to furnish, or (2) accepting or offering or promising to accept, a valuable consideration in compromising or attempting to compromise a claim which was disputed as to either validity or amount, is not admissible to prove liability for or invalidity of the claim or its amount. Evidence of conduct or statements made in compromise negotiations is likewise not admissible. This rule does not require the exclusion of any evidence otherwise discoverable merely because it is presented in the course of compromise negotiations. This rule also does not require exclusion when the evidence is offered for another purpose, such as proving bias or prejudice of a witness, negativing a contention of undue delay, or proving an effort to obstruct a criminal investigation or prosecution.</p> <p style="margin-left: 40px;"> The court provided several reasons why admitting the settlement evidence was appropriate.</p> <p> First, noting that the evidence was not being admitted to prove either liability or invalidity of Serene’s claims or the amount of those claims, the court found that Serene Warren herself opened the door to admitting the evidence by seeking a buyout under Minn. Stat. § 302A.751 and § 302A.467. In considering this equitable claim, the court “is obliged to consider ‘all circumstances of the case’ to assess if” the defendants acted in a way that was “unfairly prejudicial to Serene that frustrated her reasonable expectations of financial separation,” and the mediation negotiations were necessary to consider a “complete picture of the parties’ dealings[.]” <em>Warren v. </em><em>ACOVA, </em> <em>Inc.</em>, No. 27-CV-18-3944 2023 WL 2663230 (Minn. Dist. Ct. Mar. 27, 2023). </p> <p> Thus, the court found that, in seeking to exclude the settlement evidence, “Serene sought to use Rule 408 as a sword and a shield.” <em>Id. </em>at 312. Serene pled “her claims as if these communications never occurred, turning a blind eye to the continual — and in the Courts view, good faith — efforts by ACOVA and the Evenstad defendants seeking to reach agreement with Serene for ACOVA to buy out her ACOVA stock.” <em>Id. </em>But “[s]he cannot have it both ways: she cannot offer her side of the mediation evidence while simultaneously seeking to preclude Defendants from offering other contextual evidence relating to the mediations.” <em>Id</em>. at 313. The court had proposed solving the sword-shield problem by “broadly exclud[ing] any settlement evidence that either Serene or any of the Defendants sought to offer,” but Serene declined the court’s proposal. <em>Id.</em></p> <p> Second, the court also made clear that the 2017 and 2019 mediation evidence was offered “to disprove Serene’s claim, pled for the first time after the 2019 post-mediation negotiations ended, that they had acted in ways that were unfairly prejudicial to and deprived her of her reasonable expectations of receiving fair value for her ACOVA shares.” <em>Id</em>. at 315. Thus, the mediations were addressing different disputes than Serene’s later-asserted “reasonable expectation” or “fair separation” claim. Because “[t]he scope of Rule 408 is limited to the particular claim discussed during the compromise discussion,” the court held that the rule did not preclude offering evidence to disprove a <em>different</em> claim that had not yet been asserted at the time of the mediations. <em>Id</em>. 314.</p> <p> The court was careful to caution that its “ruling on this issue does not mean settlement evidence should always be admitted in all lawsuits involving section 302A.751 buyout claims.” <em>Id.</em> at 313. Rather, the unique nature of the “two-track process by which the mature, readily marketable generic drug business would be sold first, followed by efforts to wind down the company selling off all remaining assets to fund distributions to all shareholders” made it impossible to separate the continuing negotiations from the mediations. <em>Id</em>. at 313-14.</p> <p> Nevertheless, practitioners will likely try to apply this holding to other shareholder-oppression claims and expand it to other scenarios as well. Therefore, attorneys — and their clients — should be mindful of how their demands, offers, and conduct during the course of a mediation could be used against them to show the reasonableness of conduct if that is relevant to an equitable determination. </p>Fri, 22 Sep 2023 00:00:00 -0500{722BDFC0-5750-4CFE-90D7-A6A5F14E3F09}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-september-2023/meet-our-keynote-speaker-journalist-and-new-york-times-contributor-katie-engelhartMeet Our Keynote Speaker: Journalist and New York Times Contributor Katie Engelhart<p>In anticipation of our upcoming annual CLE, entitled <a href="https://www.robinskaplan.com/resources/events/2023/11/wealth-disputes-seminar-2023">“Inconceivable: Fiduciary Circumstances That You Never Imagined (But Maybe Should),” </a> we are excited to feature this profile of our keynote speaker, Katie Engelhart, and some of her reporting. Katie is a journalist, documentary producer, and contributing writer at the New York Times Magazine. Based in New York and Toronto, she is a Fellow at New America.</p> <p>Earlier this year Katie’s reporting came to our attention with her New York Times Magazine feature article “The Mother Who Changed: A Story of Dementia,” which told the story of a mother suffering from Alzheimer’s disease, the man she had a romantic relationship with after the death of her husband, and her two daughters. </p> <p> Katie’s reporting focuses on ethics and medicine, and <a href="https://www.nytimes.com/2023/05/09/magazine/dementia-mother.html">“The Mother Who Changed: A Story of Dementia”</a> was not her first foray into the topic of elder issues. Her story <a href="https://story.californiasunday.com/covid-life-care-center-kirkland-washington/">“What Happened in Room 10?”</a> for the California Sunday Magazine won a George Polk Award for Magazine Reporting in 2021. The article was the product of Katie’s months-long investigation into the first COVID outbreak in an American nursing home — and, more broadly, the rise of the for-profit nursing home industry in America. The article also won the John Bartlow Martin Award for Public Interest Journalism and the MOLLY Prize for Investigative Journalism, and it was a finalist for the National Magazine Award in Feature Writing.</p> <p> More recently, she penned an opinion piece for the New York Times Sunday edition about dementia in the prison population, entitled: <a href="https://www.nytimes.com/2023/08/11/opinion/dementia-prisons.html">“I’ve Reported on Dementia for Years, and One Image of a Prisoner Keeps Haunting Me.”</a> That image is “that of a prisoner who, as a result of cognitive impairment, no longer remembers his crimes — but is still being punished for them.” She visits a “Memory Disorder Unit” in Massachusetts, “the federal prison system’s first purpose-built facility for incarcerated people with Alzheimer’s disease and other forms of dementia.” And as is the case with all her writing, she grapples with challenging questions with no easy answers. One of the clinical directors she speaks to states: “In this country, we incarcerate way too many people for way too long. We give people life sentences. And then they turn 90, they’re in diapers, they get demented. We have to ask ourselves, what are we accomplishing?”</p> <p> In “The Mother Who Changed,” Katie poses the question: “When cognitive decline changes people, should we respect their new desires?” This was the key question in a lawsuit brought by the mother’s two daughters. The mother, Diane Norelius, found herself alone for the first time in 2011 after the death of her husband of 53 years. She later started a relationship with Denzil Nelson, a caretaker on the Norelius farm. According to her daughters, Diane had always complained about Denzil — that he smelled bad or would stop by for coffee when she wished he wouldn’t. Then, suddenly, Denzil moved in with Diane and she referred to him as “the love of my life.” The daughters later learned that Diane had been diagnosed with dementia. Shortly after her diagnosis, Diane gave Denzil her financial power of attorney and granted him the right to live in her house when she died. She also dissolved her financial trust that held all her assets and investments of which one of the daughters was trustee. The daughters filed an elder-abuse claim against Denzil and a motion for immediate temporary (and later, permanent) guardianship and conservatorship of their mother, requesting control of Diane’s finances. Sadly, the story was familiar to those of us who handle trust and estate and conservatorship/guardianship matters.</p> <p> Katie’s stories, while focused on medicine and ethics, also touch upon tough legal issues. Indeed, much of her reporting in “The Mother Who Changed,” came from transcripts from the various legal proceedings that arose as a result of Diane’s dementia and relationship with Denzil. And the legal issues were many: What does it mean to have legal capacity, and how should that be decided? How does the law answer the philosophical question of whether the decision making of the “then-self: before the disease” or the “now-self,” should prevail? If Diane and Denzil were having sex, was she competent enough to consent to it, or was it rape? How could Diane and Denzil share the same legal counsel when he was alleged to be her abuser? Should Diane’s stated preferences be dispositive, or, as suggested by an expert, are they analogous to the expert’s six-year-old grandson stating his preferences — very few of which are allowed?</p> <p>Unlike lawyers, who have a duty to zealously represent their clients and focus on telling their client’s story as persuasively as possible, as a journalist, Katie is able to tell a more comprehensive story that seeks to include a wide variety of perspectives— the daughters, Denzil, the lawyers, medical professionals, guardians/conservators, and the judge. But that doesn’t necessarily mean she can provide any clear answers to the questions she raises.</p> <p> We look forward to talking to Katie in greater depth about her reporting on these important issues and challenges that will no doubt continue and likely increase.</p>Fri, 22 Sep 2023 00:00:00 -0500{950DF142-E9FF-4BB7-A839-E2D7233D3949}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-september-2023/walking-the-razors-edgeWalking the Razor’s Edge: Client Capacity and the Attorney-Client Relationship<p style="text-align: center;"><em>“Representing a client with diminished capacity is like walking on the edge of a razor – only more precarious and potentially more painful if the attorney missteps.”</em><br /> -Professor Thomas E. Simmons, South Dakota School of Law<sup><span style="font-size: 4px;">1</span></sup></p> <p>Special problems arise for attorneys representing individuals with diminished mental capacity. Indeed, there are few ethical dilemmas more difficult. Diminished capacity can call into question the attorney’s authority to act on the client’s behalf at all. And it can cause direct conflict between the attorney’s duties of loyalty and confidentiality. </p> <p> Under the common law, the incapacity of a principal wholly terminates an agency relationship. Restatement (Second) of Agency § 122(1). If the common law were strictly applied to the attorney-client relationship, a client’s diminished capacity could be viewed as ending the relationship altogether. But many jurisdictions have adopted a more nuanced approach. As the Restatement observes, even those with diminished capacity “continue to have rights requiring protection,” and are often “able to participate to some extent in the representation.” Restatement (Third) Law Governing Lawyers § 31, cmt. e. For example, even a client with diminished capacity should have the right to retain counsel to resist an application for an appointment of a guardian ad litem. <em>Graham v. Graham</em>, 240 P.2d 564 (Wash. 1950). </p> <p> Ultimately, most states have recognized that determining whether the attorney’s authority persists during diminished capacity calls for legal judgment informed by the attorney’s duties of loyalty and confidentiality and other fiduciary obligations. For example, the duty of loyalty requires the attorney to act in the client’s best interests. But what if the attorney concludes that the client’s best interest is that the client lose the right of self-determination, such as by appointment of a conservator? States that have adopted ABA Model Rule 1.14(b), like Minnesota, hold that a lawyer has implied consent to speak with relatives or other third parties who can help the client, and even reveal information relating to the client’s apparent lack of capacity, when necessary to protect the client from financial harm. Other states, like California, view that approach as an unacceptable breach of the attorney’s duty of confidentiality, unless the client expressly consents to such a disclosure. <em>See </em>State Bar of California, Formal Opinion No. 2021-207. Under the California approach, when confronted with an impossible choice, the lawyer may have to simply decline from carrying out the client’s wishes and even terminate the representation. <em>Id.</em></p> <p> Neither approach is without shortcomings. For example, assume an attorney believes his client is suffering from diminished capacity. The client contacts the lawyer, asking for help transferring real property to the client’s nephew to the exclusion of the client’s children. The lawyer, suspecting undue influence, retains a consultant with the client’s permission to evaluate the client’s capacity. After the consultant reports back that the client has indeed lost the capacity to understand the transaction, the nephew reveals he now has power of attorney over the client’s estate and instructs the lawyer to proceed with the transaction. When the lawyer tries to contact the client, the nephew isolates the client and prevents the communication. What can the ethical attorney do? In states like Minnesota, the attorney is empowered by Rule 1.14(b) to seek help for the client, including by disclosing facts related to the diminished capacity. But doing so may lead to the client permanently losing the right to make independent financial decisions. In contrast, in California, the lawyer’s only option is to try to re-establish contact with the client or simply withdraw from the representation, leaving the client defenseless against the unscrupulous nephew.</p> <p> Of course, in real life, the circumstances faced by attorneys are far messier than the hypothetical above. Regardless of the situation, attorneys have an obligation to maintain, as far as reasonably practicable, a normal attorney-client relationship. This means keeping the client informed, providing competent advice, and taking direction from the client to the extent possible. Even among clients with unquestionable capacity, each client’s ability to understand legal strategy and participate in the representation will vary. In each case, an attorney must be diligent in ensuring effective communication and respecting the client’s objectives. When disabilities or other capacity issues come into play, these obligations do not simply go away. To the contrary, even greater care must be exercised in ensuring they are fulfilled.</p> <p> Attorneys must also avoid paternalism, being “careful not to construe as proof of disability a client’s insistence on a view of the client’s welfare that a lawyer considers unwise or otherwise at variance with the lawyer’s own views.” Restatement (Third) Law Governing Lawyers § 24 cmt. c. An attorney must stay mindful that their primary responsibility is to effect the wishes of the client after the client has understood the available options and legal and practical implications of the course ultimately chosen. <em>Moore v. Anderson, Zeigler, Disharoon, Gallagher & Gray, PC</em>, 135 Cal. Rptr. 2d 888 (Cal. App. 2003). In evaluating a client’s objectives, attorneys should be mindful to listen not just to their client’s stated goals, but also to their ability to explain their reasoning and to appreciate the likely consequences of their actions. </p> <p> And finally, attorneys should recognize that the clients themselves should be involved in any concerns about capacity issues. Some clients may benefit from including a trusted family member into the decision-making. Attorneys should be encouraged to raise any concerns they have with the client and allow the client, to the greatest extent possible, an opportunity to participate in deciding how to address concerns about their own capacity.</p>Fri, 22 Sep 2023 00:00:00 -0500{06ADCF1D-36BF-43A0-8F80-DF512D38FF01}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/purdue-pharma-v-accord-healthcare<i>Purdue Pharma L.P. v. Accord Healthcare Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Purdue Pharma L.P. v. Accord Healthcare Inc.</em>, C.A. </span><span>No. 22-913-WCB, 2023 WL 5835811 (D. Del. Sept. 8, 2023) (Bryson, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> OxyContin® (oxycodone HCl); U.S. Patents Nos. 11,304,908 (“the ’908 patent”) and 11,304,909 (“the ’909 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>The patents-in-suit claim tablet formulations that are “tamper resistant.” Specifically, they claim technology that makes oxycodone HCl tablets that are “hard enough to resist crushing by abusers and viscous enough to deter intravenous abuse by abusers who manage to crush the tablets into particles and mix with water for injection.” In a prior action, <em>Accord I</em>, three patents in the same family as the patents-in-suit were held invalid as obvious. Accord moved for judgment on the pleadings, arguing that Purdue is barred from asserting the claims of the patents-in-suit because those claims are invalid for obviousness due to collateral estoppel from court’s findings in <em>Accord I</em> action. Accord’s motion was denied. </span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Defendants Prevailed</span></strong><span>: Purdue’s principal arguments were that: (i) Accord’s motion impermissibly asks the court to take judicial notice of the <em>Accord I</em> trial record; and (ii) Accord failed to demonstrate that collateral estoppel applied to the claims in this case. The court disagreed with the former and agreed with the latter.</span></p> <p style="margin-bottom: 12pt;"><span>Regarding the judicial notice argument, Purdue does not dispute that a court may take judicial notice of a prior proceeding, but argued that at the pleading stage the court may take notice of only the existence of the opinion, not for the truth of the facts asserted in the opinion. The court disagreed, citing extensive case law standing for the proposition that “[i]n the context of deciding a Rule 12(b)(6) motion that raises issue preclusion concerns ... it is axiomatic that a court must still consider the prior adjudication in order to determine whether issue preclusion bars that plaintiff’s claims.” In deciding that the court may take judicial notice of the earlier trial record, it noted that judicial notice did not extend to the evidence presented to the court at trial or transcripts of the proceedings that took place during the action.</span></p> <p style="margin-bottom: 12pt;"><span>Regarding the collateral estoppel argument, each of the independent claims in the patents-in-suit required “a plurality of convection heated particles of PEO [polyethylene oxide]” that “adhere to or fuse with each other within the matrix.” That limitation was not expressly recited in the claims in <em>Accord I</em>, and Judge Andrews did not discuss or decide whether the prior art asserted in that case disclosed that limitation. In response, Accord argued that those limitations were the inherent result of heating the PEO matrix as described in the prior art asserted in <em>Accord I</em>. But as noted, testimony offered during a prior proceeding cannot be the subject of judicial notice for purposes of finding facts. Moreover, finding inherency is a high standard. The statements in the shared specification of the patents-in-suit and those found invalid in <em>Accord I</em> related to curing and heating PEO are suggestive at best, which is insufficient to establish inherency. “As the specification demonstrates, a number of variables exist in the manufacturing process, such as the use of direct compression, the order and sequencing of compression and curing, the percentage of PEO that melts, the curing temperature and time, the use of a cooling step, and the equipment used in manufacturing.” Because the specification did not state or even imply that adherence and/or fusion is an inherent result of every combination of variables that involve curing PEO at a temperature above its softening temperature, and Judge Andrews did not decide any such questions in his <em>Accord I</em> opinion, those are factual matters that should be reserved for trial in the instant case.</span></p>Fri, 08 Sep 2023 00:00:00 -0500{FDE2A019-C4B0-4166-A91D-282E0D9B976C}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/zogenix-v-apotex<i>Zogenix, Inc. v. Apotex Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Zogenix, Inc. v. Apotex Inc.</em>, Civ. </span><span>No. 21-1252-RGA, 2023 WL 5835828 (D. Del. Sept. 8, 2023) (Andrews, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Fintepla® (fenfluramine HCl); U.S. Patents Nos. 10,478,441 (“the </span><span>’</span><span>441 patent”), 10,478,442 (“the </span><span>’</span><span>442 patent”), and 11,406,606 (“the </span><span>’</span><span>606 patent”) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Fintepla is indicated for the treatment of seizures associated with Dravet syndrome. Defendants submitted section viii carve-out certifications to the </span><span>’</span><span>411 patent and the </span><span>’</span><span>442 patent. The </span><span>’</span><span>606 patent recites methods of treating patients with Dravet syndrome by administering a combination of stiripentol and reduced dosages of fenfluramine. Apotex filed a motion to dismiss the complaint for lack of subject matter jurisdiction and failure to state a claim under Rule 12(b)(1) and 12(b)(6). The Magistrate Judge recommended granting that motion. Plaintiffs objected to that Report and Recommendation, and the court adopted it.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Apotex Prevailed:</span></strong><span> Zogenix argued that the Magistrate Judge incorrectly interpreted Apotex’s label and ignored its allegations about how a physician would read the label. In particular, Zogenix argued that Apotex’s label encouraged infringing uses—namely, the co-administration of fenfluramine and stiripentol. First, Zogenix stated that § 12.1of Apotex’s label—which warns of an association between drugs like fenfluramine and certain cardiac side-effects—encouraged lower doses of fenfluramine. Second, Zogenix averred that the dosing instructions in §§ 2.3, 2.4, 7.1, and 8.6 instruct that administering stiripentol with fenfluramine enables lower dosages of fenfluramine. Third, Zogenix argued that the label instructs that administering fenfluramine with other AEDs—specifically, stiripentol—is safe and effective for treating seizures associated with Dravet syndrome. </span></p> <p style="margin-bottom: 12pt;"><span>The court was not persuaded. As to § 12.1, the court found Zogenix’s arguments were without merit because “warnings are not an instruction.” Specifically, § 12.1 did not instruct physicians to administer lower doses of fenfluramine, meaning that although some users might infringe, the proposed label nevertheless did not instruct users to perform the patented method. Further, the court explained that Zogenix’s argument that the phrase “another AED” means stiripentol to the exclusion of other AEDs did not align with the plain language of the label. Finally, the court agreed with the Magistrate Judge that even if the reference to AEDs somehow encompassed an infringing use of fenfluramine in combination with stiripentol, the label’s inclusion of both infringing and non-infringing uses was not sufficient to plead encouragement of the patented use.</span></p>Fri, 08 Sep 2023 00:00:00 -0500{CF5C68A0-5AA6-4720-84AC-3ED302B878F1}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/ucb-v-annora-pharma-priv<i>UCB, Inc. v. Annora Pharma Priv. Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>UCB, Inc. v. Annora Pharma Priv. Ltd.</span></em><span>, Civ. No. 20-987-CFC, 2023 WL 5274566 (D. Del. Aug. 16, 2023) (Connolly, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Briviact® (brivaracetam); U.S. Patent No. 6,911,461 (“the ’461 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> UCB sued Annora, Apotex, and MSN, alleging that their ANDAs infringe one claim of one patent. The asserted claim described the compound brivaracetam, used to treat partial-onset seizures in epilepsy patients. Defendants did not dispute that they infringe the asserted claim; they mounted a lone obviousness defense.</span> <span>After a bench trial, the court issued findings of facts and conclusions of law finding the asserted claim infringed and not invalid.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why UCB Prevailed: </span></strong><span>The court’s analysis began with a simple premise: “[i]t is undisputed that brivaracetam is an analogue of the compound levetiracetam, a predecessor compound patented by UCB in 1987 and approved by the FDA in 1999 for the treatment of epilepsy-related seizures.” The compounds share the same chemical formula in all but one respect: brivaracetam has a propyl group at the 4-position of the pyrrolidine ring. So went Defendants’ obviousness argument: it would have been obvious to a skilled artisan to select levetiracetam as a lead compound from which to develop new anti-seizure drugs and to modify levetiracetam by increasing its lipophilicity with the addition of a propyl group to the 4-position of its pyrrolidine ring.</span></p> <p style="margin-bottom: 12pt;"><span>At trial, UCB argued that a skilled artisan would not have started with levetiracetam when looking to develop a new anti-seizure drug. But despite its trial argument, post-trial, UCB stipulated that it would not challenge Defendants’ assertion that a skilled aritsan would have chosen levetiracetam as a lead compound “for further development efforts.” (The court seemed puzzled by the concession.) As a result of UCB’s concession, the court decided only one issue: whether it would have been obvious to modify levetiracetam by increasing its lipophilicity with the addition of a propyl group to the 4‑position of its pyrrolidine ring.</span></p> <p style="margin-bottom: 12pt;"><span>Ultimately, the court determined that Defendants did not carry their burden in proving a reasonable expectation of success in modifying a compound to increase lipophilicity to increase antiepileptic activity. As part of that conclusion, the court found that a skilled artisan would not have been motivated to improve levetiracetam’s brain uptake, because levetiracetam was already a successful central nervous system drug and increasing brain uptake would risk increasing its side effects. Further, a skilled artisan would not have thought to increase levetiracetam’s lipophilicity. And even if a skilled artisan were motivated to focus on lipophilicity, in view of the prior art, Defendants could not show that a skilled artisan would have been motivated to modify levetiracetam at the 4-position of the pyrrolidine ring.</span></p>Wed, 16 Aug 2023 00:00:00 -0500{EAFB0268-D3E0-4B37-B8EB-BDA1CE2F1A51}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/taiho-pharm-v-eugia-pharma<i>Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialties Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialties Ltd.</em>,</span><span> Civil Nos. 19-2309-CFC, 19-2321-CFC, 19-2342-CFC-JLH, 19-2368-JLH, 2023 WL 5218125 (D. Del. Aug. 15, 2023) (Connolly, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Lonsurf® (trifluorothymidine / tipiracil); U.S. Patent No. RE46,284 (“the ’284 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Lonsurf is an oral combination therapy indicated to treat metastatic colorectal cancer in adults that have failed on previous treatments.</span><span> </span><span>Lonsurf contains two active ingredients: trifluorothymidine (FTD) and</span><span> </span><span>tipiracil. Plaintiff asserted claim 13 of the </span><span>’</span><span>284 patent, which recited</span><span> a </span><span>method of treating patients with colorectal cancer by orally administering a specific dosage and molar ratio of FTD and tipiracil in two divided portions per day for a period of five days followed by two days without treatment. Defendants did not dispute infringement, but instead argued that the </span><span>’</span><span>284 patent was invalid for obviousness and lack of written description. Following a two-day bench trial, the court found that Defendants have not proven claim 13 invalid.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Plaintiffs prevailed:</span></strong><span> Regarding the issue of obviousness, the parties agreed that every element of the asserted claim was in the prior art, except for the twice-daily dosing limitation. The court concluded that a skilled artisan would have been motived to administer the combination therapy in divided doses, but that a skilled artisan would not have been motivated to administer in twice-daily doses. In particular, the closest prior art examined three-times daily dosing compared to once-daily dosing, and, as such, a skilled artisan would not have been motivated to administer twice-daily doses.</span></p> <p style="margin-bottom: 12pt;"><span>The court also addressed secondary indicia of non-obviousness. As to unexpected results, the court found that the inventor’s testimony “sounded mystical” and that he “had a really hard time accepting that … was a scientific approach” to twice-a-day dosing. As to long-felt need, the court agreed that a need existed for treatment options that would extend the length and quality of life of patients with advanced colorectal cancer, but found that because of its complicated dosing schedule, Lonsurf failed to satisfy this need. With respect to industry praise, the court agreed that the industry praised Lonsurf as a product, but found that there was no record evidence that the industry praised the dosing schedule in claim 13 of the </span><span>’</span><span>284 patent. Finally, as to commercial success, the court agreed that Lonsurf was a financial success, but did not find that this factor weighed in favor of non-obviousness because Taiho’s other patents barred others from commercially testing the features of the asserted claim. Despite concluding that no secondary indicia of non-obviousness were present, the court still found that the patent was not invalid as obvious.</span></p> <p style="margin-bottom: 12pt;"><span>Regarding inadequate written description, Defendants argued that the </span><span>’</span><span>284 patent specification did not adequately describe a study in which colorectal or digestive cancer patients were orally administered the recited combination therapy in twice-daily doses for a period of five days followed by two days of rest. The examples in the patent did, though, describe clinical trials where breast cancer patients received the combination therapy</span><span> </span><span>by oral administration twice-daily. Defendants argued that the studies in the specification were run on different diseases—breast cancer—and that any conclusions would not apply equally to colorectal cancer. The court disagreed, finding that both breast and colorectal cancer are solid tumors that commonly respond to cytotoxic agents.</span></p>Tue, 15 Aug 2023 00:00:00 -0500{F9CEDCC6-D9D3-4A3B-8DF0-CCBDE5780CAC}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-quarterly-business-litigation-update/2023/rk-quarterly-q3/minnesota-bans-non-competesMinnesota Bans Non-Competes Formed on or After July 1, 2023: Assessing Remaining Strategies to Protect Confidential Information and Trade Secrets<p><span>On May 24, 2023, Minnesota Governor Walz signed into law a bill banning non-competition agreements formed on or after July 1, 2023. The new law applies to non-compete agreements formed with employees or independent contractors primarily residing and working in Minnesota. It provides limited exceptions, only permitting non-competes formed during the sale or dissolution of a business. The law also prohibits the use of choice of law or venue provisions to circumvent the non-compete ban.</span></p> <p><span>Before this legislation, non-compete agreements had been one of several tools that Minnesota businesses commonly used to prevent the unauthorized dissemination of confidential and trade secret information to competitors. Agreements preventing insiders with knowledge of company confidential information from working for competitors often provided a clear, objective means to limit the risk of trade secret misappropriation and misuse of confidential information.  Breaches of non-compete agreements are in many cases easier to assess and prove than other more targeted agreements protecting trade secret and confidential information.  </span></p> <p><span>Despite these benefits, the Minnesota legislature was moved by concerns about the misuse of non-compete agreements, especially the widespread use of such agreements to employees with only limited access to truly confidential information.   The resulting new law provides businesses an opportunity to assess their protection strategies employed for company trade secret and confidential information in Minnesota. </span></p> <p><span>Legal strategies employing trade secret law (via the federal Defend Trade Secrets Act or the Minnesota Uniform Trade Secrets Act) to protect proprietary information are presumably unaffected by the new law. To claim information as a trade secret, companies must, among other things, take “reasonable measures under the circumstances[.]” Thus, with the loss of non-compete agreements as a tool to facilitate protection, companies should assess whether remaining measures adequately cover the information that the company desires to protect. Companies should consider, for each type of information, whether there are overlapping protection measures that protect the information in different ways. If not, a company should consider augmenting its protection plan. Such alternative protection measures may be necessary to demonstrate that a trade secret holder took reasonable measures to protect information. Such a finding could result in a misappropriating employee—and their new employer—escaping with no liability at all.</span></p> <p><span>The new Minnesota law leaves untouched several other contractual protections that businesses may leverage to protect their information. The new Minnesota law expressly carves out, and thus permits, non-disclosure agreements and non-solicitation agreements. The new law also provides that an unenforceable non-compete covenant does not render void or unenforceable other provisions in the agreement. Companies should beware, however, that certain provisions designated as non-disclosure or non-solicitation agreements may still be considered unenforceable noncompete agreements under Minnesota law. Non-disclosure or non-solicitation agreements that are unusually broad in scope may function as <em>de facto</em> non-compete agreements, falling within the scope of the new law and making it unenforceable.</span></p> <p><span>More specifically, companies should consider evaluating and revising (as needed) the language of existing and proposed non-disclosure, non-solicitation, or no-business agreements so these agreements more clearly instruct employees on what is expected of them. For example, companies should avoid overly broad definitions of confidential information and trade secrets, as well as overly broad restrictions on potential post-employment conduct. A narrowly drafted restrictive covenant that addresses a legitimate business interest may be more defensible than one aimed at restricting the conduct or rights of a former employee. In addition, when crafting a restrictive covenant, companies should consider developing a credible and straightforward explanation for it, such as identifying the specific business interest it protects. </span></p> <p><span>Minnesota’s ban on non-compete agreements may affect some companies’ efforts to protect confidential or trade secret information. To mitigate any risk of loss, companies should reevaluate their employment agreements to ensure they focus on protection that addresses the information itself and not the individuals that use the information.</span></p>Thu, 10 Aug 2023 00:00:00 -0500{03F616CA-D908-45EA-A5DE-4811D5776E5C}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-quarterly-business-litigation-update/2023/rk-quarterly-q3/minnesota-passes-survivorship-billMinnesota Passes Survivorship Bill, Expanding Justice for Victims of Medical Malpractice and Wrongful Death<p>On May 20, 2023, Minnesota became the last state to pass a Survivorship Bill, expanding the damages that families can pursue after losing a loved one. </p> <p> Liz Fors, co-chair of the Legislative Committee for Minnesota Association for Justice (MAJ) and partner at Robins Kaplan LLP, said MAJ has been working on behalf of consumers for over a decade to get this bill passed. </p> <p>“We have been lobbying and educating our representatives and senators about the need for this bill for years,” Fors said. “One of our top priorities for 2023 was to get this law passed.”</p> <p> There are two primary scenarios in which the Minnesota Survivorship Statute is pertinent, she explained. The first is when someone is the victim of medical malpractice but dies from an unrelated cause. Prior to the law being passed, the case could not be carried on after the person’s death. Unfortunately, this situation was not uncommon when the person was very old or sick, and defense attorneys have been known to drag their feet in those cases.</p> <p> In one instance, a wife lobbying for the Minnesota Survivorship Bill testified about a situation with her husband, who was suffering from stage 4 colon cancer. During one of the surgeries required to treat his cancer, a 12-inch sponge was left inside his abdomen. It was discovered two weeks later. He was hospitalized for nearly two months after it was removed, losing nearly 50 pounds and undergoing surgery after surgery to insert drains in all the infected abscesses the sponge left behind.  </p> <p> The couple hired a lawyer and offered to negotiate a fair settlement, but the hospital did not respond. After moving forward with a lawsuit, the hospital denied any negligence and requested a jury trial, which is now set after Thanksgiving.  </p> <p>“In my mind, there can be only one reason for the hospital to refuse to negotiate and to include ridiculous defenses and to ask for a jury trial—and that is they are hoping he will die from cancer before they can be held accountable for their negligence,” the wife said.</p> <p> Fors recalls another case involving victims of alleged abuse in Minnesota nursing homes.</p> <p>“Years ago in Southern Minnesota, there were numerous investigations at nursing homes where residents were sexually and physically abused,” Fors said. “Many of the victims died from unrelated causes before the lawsuit was resolved and their families could never hold the wrongdoers accountable.”</p> <p> The second scenario involves claims for the deceased’s pain and suffering, and emotional distress. The previous law only allowed families to bring a claim for wrongful death when a loved one died from medical malpractice. The deceased’s economic damages, such as lost wages, were assessed. The families could only claim the loss of the relationship with their loved one, not the deceased’s pain and suffering.  </p> <p>“Now we can get justice for these families,” Fors said. “We don’t have to ignore the horrible things that their loved ones went through.”</p> <p> With the passage of the bill, Fors and other members of the firm’s Personal Injury and Medical Malpractice Group are seeking to amend complaints to add these damages for a number of clients. They look forward to helping their clients finally get the justice they deserve and hold the wrongdoers accountable.</p>Thu, 10 Aug 2023 00:00:00 -0500{F4554D1A-F670-4E82-A376-A4537CFE3E96}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/united-therapeutics-v-liquidia-technologies<i>United Therapeutics Corp. v. Liquidia Technologies, Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>United Therapeutics Corp. v. Liquidia Technologies, Inc.</em>, </span><span>Nos. 2022-2217, 2023-1021, 2023 WL 4695903 (Fed. Cir. July 24, 2023) (Circuit Judges Lourie, Dyk, and Stoll presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Tyvaso® (treprostinil); U.S. Patents Nos. 10,716,793 (“the ’793 patent”) and 9,593,066 (“the ’066 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> UTC holds and NDA for Tyvaso, an inhaled solution formulation of treprostinil approved for the treatment of pulmonary hypertension (“PH”). There are five subgroups of PH: Group 1, pulmonary arterial hypertension (“PAH”); Group 2, pulmonary venous hypertension, i.e., pulmonary hypertension related to left-heart disease; Group 3, pulmonary hypertension associated with disorders damaging the lungs; Group 4, pulmonary hypertension caused by chronic thrombotic or embolic disease, including chronic blood clots in the lungs; and Group 5, a miscellaneous category for conditions that do not fit well into the other four subgroups. Each group may require group-specific treatment. The patents-in-suit claim methods of treating PH and pharmaceutical compositions comprising treprostinil. Liquidia filed a 505(b)(2) application for Yutrepia™, a dry powder inhalation formulation of treprostinil, referencing UTC’s NDA. UTC sued Liquidia in district court. The district court found held the ’793 patent claims valid and infringed and the ’066 patent claims invalid. The parties cross appealed and the Federal Circuit affirmed.</span></p> <p style="margin-bottom: 12pt;"><span>In parallel, Liquidia filed a petition for IPR of the ’793 patent, alleging that all claims would have been unpatentable as obvious. On July 19, 2022, the PTAB issued a Final Written Decision finding all claims of the ’793 patent unpatentable as obvious. UTC’s appeal of that decision is currently pending and not the subject of this opinion.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why UTC Prevailed: </span></strong><span>Liquidia raised five issues on appeal: the district court erred (i) in construing the claim limitation “treating pulmonary hypertension” in claim 1 of the ’793 patent not to include safety and efficacy; (ii) in finding the asserted claims of the ’793 patent enabled; (iii) in finding the asserted claims of the ’793 patent supported by written description; (iv) in  finding Liquidia liable for induced infringement of claims 1, 4, and 6–8 of the ’793 patent; and (v) in finding claims 1–3 of the ’066 patent to be infringed. UTC raised two issues on appeal: the district court erred (i) in finding that Liquidia did not infringe claims 6 and 8 of the ’066 patent; and (ii) in finding that claims 1–3, 6, and 9 of the ’066 patent were invalid as anticipated by Moriarty.</span></p> <p style="margin-bottom: 12pt;"><em><span>The ’793 patent</span></em><span>. The Federal Circuit agreed with the district court that “treating PH” included treating all five groups of PH patients. “Questions of safety and efficacy in patent law have long fallen under the purview of the FDA” and therefore the Federal Circuit declined to insert the FDA’s responsibilities into claims by importing requirements where they do not recite such limitations. </span></p> <p style="margin-bottom: 12pt;"><span>Next, Liquidia argued that the ’793 patent specification provided no guidance or examples of treating Group 2 PH patients, and thus a skilled artisan would have had to engage in undue experimentation to practice the full scope of the claimed invention. Liquidia further argued that the ’793 patent never described treating Group 2 PH patients with inhaled treprostinil, but only Group 1, 3, and 4 patients, all of whom have precapillary PH. Thus, a skilled artisan would have understood that the inventors did not invent or possess a method of treating Group 2 PH patients. The Federal Circuit disagreed. While the record showed that a physician may have safety concerns in treating Group 2 PH patients with treprostinil and other vasodilators, the district court properly relied on the record evidence showing that the claimed administration of treprostinil vasodilates the pulmonary vasculature and reduces pulmonary blood pressure even in Group 2 PH patients. </span></p> <p style="margin-bottom: 12pt;"><span>Turning to the induced infringement argument, Liquidia contended that it could not be held liable for induced infringement because the ’793 patent was found to be unpatentable in an IPR, and an unpatentable or invalid patent cannot be infringed. The Federal Circuit agreed with the district court that a pending, non-final litigation does not negate an intent to infringe that is otherwise supported by evidence. An IPR decision does not have collateral estoppel effect until that decision is affirmed or the parties waive their appeal rights.</span></p> <p style="margin-bottom: 12pt;"><em><span>The ’066 patent</span></em><span>. UTC argued that Moriarty did not anticipate the ’066 patent because Moriarty did not teach the purification of treprostinil through salt formation and did not disclose any information on specific alkylation and hydrolysis impurities. Those limitations were added to overcome validity challenges and the district court failed to recognize the structural features that are imparted by the claimed salt-formation purification. The asserted claims are product-by-process claims. “But a product-by-process claim is a product claim, even if claimed by a process by which it can be made.” The specification of the ’066 patent discloses an impurity level of 99.7%-99.9%, and Moriarty similarly discloses the synthesis of impure Treprostinil having 99.7% purity. </span></p> <p style="margin-bottom: 12pt;"><span>Next, claims 6 and 8 require that the treprostinil salt be stored at ambient temperature. UTC argued that Liquidia’s promise not to make its product with batches of treprostinil salt that were stored at ambient temperature is insufficient to avoid a finding of infringement. But the district court properly credited Liquidia’s representations to the FDA that it would store Treprostinil sodium between 2°C and 8°C. There was no evidence showing that Liquidia used ambient-temperature-stored batches of treprostinil in its manufacturing process in making a pharmaceutical composition as required by claim 6 or claim 8.</span></p>Mon, 24 Jul 2023 00:00:00 -0500{AEDA8999-4417-4406-A747-1601FCFD2A73}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/anda-approvalsANDA Approvals<p>This ANDA Approvals chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.</p> <!--ANDA Approvals --> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table" style="text-align: center; font-family: 'Times New Roman';"> <tbody> <tr class="tableizer-firstrow"> <th width="129"><span style="color: #000000;">Approval Date</span></th> <th width="170"><span style="color: #000000;">Reference Listed Drug</span></th> <th width="140"><span style="color: #000000;">Generic Drug Name</span></th> <th width="129"><span style="color: #000000;">ANDA Holder</span></th> <th width="129"><span style="color: #000000;">ANDA Applicant</span></th> </tr> <tr> <td>04/03/2023</td> <td>Silenor</td> <td>Doxepin HCl  </td> <td>Currax</td> <td>MSN</td> </tr> <tr> <td>04/04/2023</td> <td>Effexor XR</td> <td>Venlafaxine HCl  </td> <td>Upjohn</td> <td>Nostrum </td> </tr> <tr> <td>04/04/2023</td> <td>Diamox</td> <td>Acetazolamide  </td> <td>Teva</td> <td>Zydus</td> </tr> <tr> <td>04/04/2023</td> <td>Lexiscan</td> <td>Regadenoson  </td> <td>Astellas</td> <td>Mylan</td> </tr> <tr> <td>04/04/2023</td> <td>Sinemet</td> <td>Carbidopa / Levodopa  </td> <td>Organon</td> <td>Zydus</td> </tr> <tr> <td>04/04/2023</td> <td>Arranon</td> <td>Nelarabine  </td> <td>Novartis</td> <td>Amneal</td> </tr> <tr> <td>04/04/2023</td> <td>Compazine</td> <td>Prochlorperazine Maleate  </td> <td>GlaxoSmithKline</td> <td>Bionpharma</td> </tr> <tr> <td>04/04/2023</td> <td>Daliresp</td> <td>Roflumilast  </td> <td>AstraZeneca</td> <td>Camber / Hetero</td> </tr> <tr> <td>04/05/2023</td> <td>Bepreve</td> <td>Bepotastine Besilate  </td> <td>Bausch and Lomb</td> <td>Alembic</td> </tr> <tr> <td>04/05/2023</td> <td>Clindamycin Phosphate in Dextrose 5%</td> <td>Clindamycin Phosphate in Dextrose 5%  </td> <td>Abraxix</td> <td>Hikma</td> </tr> <tr> <td>04/05/2023</td> <td>Bepreve</td> <td>Bepotastine Besilate  </td> <td>Bausch and Lomb</td> <td>Alembic</td> </tr> <tr> <td>04/06/2023</td> <td>Cardizem LA</td> <td>Diltiazem HCl  </td> <td>Bausch</td> <td>Sciegen Pharms</td> </tr> <tr> <td>04/06/2023</td> <td>Evoxac</td> <td>Cevimeline HCl  </td> <td>Cosette</td> <td>Rubicon</td> </tr> <tr> <td>04/07/2023</td> <td>Otezla</td> <td>Apremilast  </td> <td>Amgen</td> <td>Shilpa</td> </tr> <tr> <td>04/07/2023</td> <td>Zithromax</td> <td>Azithromycin  </td> <td>Pfizer</td> <td>Zydus</td> </tr> <tr> <td>04/10/2023</td> <td>Kerydin</td> <td>Tavaborole  </td> <td>Anacor </td> <td>Zydus</td> </tr> <tr> <td>04/10/2023</td> <td>Celebrex</td> <td>Celecoxib  </td> <td>Upjohn </td> <td>Yabao Pharm</td> </tr> <tr> <td>04/10/2023</td> <td>Paraflex</td> <td>Chlorzoxazone  </td> <td>Ortho McNeil </td> <td>Corepharma</td> </tr> <tr> <td>04/10/2023</td> <td>Sular</td> <td>Nisoldipine  </td> <td>Covis</td> <td>Amta</td> </tr> <tr> <td>04/11/2023</td> <td>Valcyte</td> <td>Valganciclovir HCl  </td> <td>Cheplapharm</td> <td>APPCO</td> </tr> <tr> <td>04/11/2023</td> <td>Zithromax</td> <td>Azithromycin  </td> <td>Pfizer</td> <td>Zydus</td> </tr> <tr> <td>04/11/2023</td> <td>Valcyte</td> <td>Valganciclovir HCl  </td> <td>Cheplapharm</td> <td>Appco</td> </tr> <tr> <td>04/12/2023</td> <td>Venlafaxine HCl  </td> <td>Venlafaxine HCl  </td> <td>Osmotica</td> <td>Ajanta Pharma</td> </tr> <tr> <td>04/12/2023</td> <td>Uceris</td> <td>Budesonide  </td> <td>Bausch</td> <td>Padagis</td> </tr> <tr> <td>04/12/2023</td> <td>Doryx</td> <td>Doxycycline Hyclate  </td> <td>Fresenius Kabi</td> <td>Gland Pharma</td> </tr> <tr> <td>04/12/2023</td> <td>Alrex</td> <td>Loteprednol Etabonate  </td> <td>Bausch and Lomb</td> <td>Akorn</td> </tr> <tr> <td>04/12/2023</td> <td>Nexavar</td> <td>Sorafenib Tosylate  </td> <td>Bayer</td> <td>Torrent</td> </tr> <tr> <td>04/13/2023</td> <td>Depo-Medrol</td> <td>Methylprednisolone Acetate  </td> <td>Pfizer</td> <td>Eugia Pharma</td> </tr> <tr> <td>04/13/2023</td> <td>Depo-Testosterone</td> <td>Testosterone Cypionate  </td> <td>Pfizer</td> <td>Xiromed</td> </tr> <tr> <td>04/14/2023</td> <td>Isuprel</td> <td>Isoproterenol HCl  </td> <td>Bausch</td> <td>Zydus</td> </tr> <tr> <td>04/14/2023</td> <td>Furadantin</td> <td>Nitrofurantoin  </td> <td>Casper Pharma</td> <td>Novitium Pharma</td> </tr> <tr> <td>04/14/2023</td> <td>Piperacillin / Tazobactam</td> <td>Piperacillin / Tazobactam  </td> <td>Wockhardt Bio</td> <td>Shandong</td> </tr> <tr> <td>04/14/2023</td> <td>RizaFilm</td> <td>Rizatriptan Benzoate</td> <td>IntelGenx</td> <td>IntelGenx</td> </tr> <tr> <td>04/17/2023</td> <td>Menostar</td> <td>Estradiol  </td> <td>Bayer Healthcare</td> <td>Zydus</td> </tr> <tr> <td>04/17/2023</td> <td>Prograf</td> <td>Tacrolimus  </td> <td>Astellas</td> <td>Hangzhou Zhongmei</td> </tr> <tr> <td>04/17/2023</td> <td>Daliresp</td> <td>Roflumilast  </td> <td>AstraZeneca</td> <td>Aurobindo</td> </tr> <tr> <td>04/17/2023</td> <td>Midazolam</td> <td>Midazolam  </td> <td>InfoRLife</td> <td>Hikma</td> </tr> <tr> <td>04/17/2023</td> <td>Compazine</td> <td>Prochlorperazine Maleate  </td> <td>GlaxoSmithKline</td> <td>Amneal</td> </tr> <tr> <td>04/18/2023</td> <td>Acetaminophen</td> <td>Acetaminophen  </td> <td>B Braun Medical</td> <td>Wockhardt Bio</td> </tr> <tr> <td>04/18/2023</td> <td>Daliresp</td> <td>Roflumilast  </td> <td>AstraZeneca</td> <td>Zydus</td> </tr> <tr> <td>04/18/2023</td> <td>Luxiq</td> <td>Betamethasone Valerate  </td> <td>Mylan</td> <td>Xiromed</td> </tr> <tr> <td>04/18/2023</td> <td>Daliresp</td> <td>Roflumilast  </td> <td>AstraZeneca</td> <td>Alkem</td> </tr> <tr> <td>04/18/2023</td> <td>Evoxac</td> <td>Cevimeline HCl  </td> <td>Cosette</td> <td>Aurobindo</td> </tr> <tr> <td>04/19/2023</td> <td>Viagra</td> <td>Sildenafil Citrate  </td> <td>Vaitris</td> <td>Macleods</td> </tr> <tr> <td>04/19/2023</td> <td>Nimbex</td> <td>Cisatracurium Besylate  </td> <td>AbbVie</td> <td>Hikma</td> </tr> <tr> <td>04/19/2023</td> <td>Renvela</td> <td>Sevelamer Carbonate  </td> <td>Sanofi</td> <td>Macleods</td> </tr> <tr> <td>04/19/2023</td> <td>Lopressor</td> <td>Metoprolol Tartrate  </td> <td>Validus</td> <td>Zydus</td> </tr> <tr> <td>04/19/2023</td> <td> Dexamethasone</td> <td>Dexamethasone  </td> <td>Hikma</td> <td>Bionpharma</td> </tr> <tr> <td>04/19/2023</td> <td>Acetadote</td> <td>Acetylcysteine  </td> <td>Cumberland Pharms</td> <td>Steriscience</td> </tr> <tr> <td>04/20/2023</td> <td>Trisenox</td> <td>Arsenic Trioxide  </td> <td>Cephalon</td> <td>Orbicular</td> </tr> <tr> <td>04/20/2023</td> <td>Vascepa</td> <td>Icosapent Ethyl  </td> <td>Amarin Pharms</td> <td>Zydus</td> </tr> <tr> <td>04/21/2023</td> <td>Brilinta</td> <td>Ticagrelor  </td> <td>AstraZeneca</td> <td>Alkem</td> </tr> <tr> <td>04/21/2023</td> <td>Metrocream</td> <td>Metronidazole  </td> <td>Galderma Labs</td> <td>Zydus</td> </tr> <tr> <td>04/24/2023</td> <td>Pepcid AC</td> <td>Famotidine  </td> <td>Johnson & Johnson / McNeil</td> <td>Alkem Labs</td> </tr> <tr> <td>04/25/2023</td> <td>Tazorac</td> <td>Tazarotene  </td> <td>Allergan</td> <td>Padagis</td> </tr> <tr> <td>04/26/2023</td> <td>Iressa</td> <td>Gefitinib  </td> <td>AstraZeneca</td> <td>Actavis</td> </tr> <tr> <td>04/26/2023</td> <td>Isuprel</td> <td>Isoproterenol HCl  </td> <td>Bausch</td> <td>Hikma</td> </tr> <tr> <td>04/26/2023</td> <td>Lyrica </td> <td>Pregabalin  </td> <td>Upjohn </td> <td>ACI</td> </tr> <tr> <td>04/26/2023</td> <td>Dexamethasone</td> <td>Dexamethasone  </td> <td>Hikma</td> <td>Bionpharma</td> </tr> <tr> <td>04/27/2023</td> <td>Thalomid</td> <td>Thalidomide  </td> <td> Celgene</td> <td>Natco</td> </tr> <tr> <td>04/27/2023</td> <td>Parafon Forte</td> <td>Chlorzoxazone  </td> <td>Janssen </td> <td>Acme Labs</td> </tr> <tr> <td>04/27/2023</td> <td>Intuniv</td> <td>Guanfacine HCl  </td> <td>Takeda</td> <td>Ajanta</td> </tr> <tr> <td>04/28/2023</td> <td>Treanda</td> <td>Bendamustine HCl  </td> <td>Cephalon</td> <td>Mylan</td> </tr> <tr> <td>04/28/2023</td> <td>Sabril</td> <td>Vigabatrin  </td> <td>Lundbeck</td> <td>Propel Pharma</td> </tr> <tr> <td>04/28/2023</td> <td>Delestrogen</td> <td>Estradiol Valerate  </td> <td>Par Sterile</td> <td>Xiromed</td> </tr> <tr> <td>05/01/2023</td> <td>Amitriptyline HCl  </td> <td>Amitriptyline HCl  </td> <td>Sandoz</td> <td>Rubicon</td> </tr> <tr> <td>05/01/2023</td> <td>Aggrastat</td> <td>Tirofiban HCl  </td> <td>Medicure</td> <td>Eugia Pharma</td> </tr> <tr> <td>05/01/2023</td> <td>Celontin</td> <td>Methsuximide  </td> <td>Parke Davis</td> <td>Novitium Pharma</td> </tr> <tr> <td>05/01/2023</td> <td>Cosopt PF</td> <td>Dorzolamide HCl / Timolol Maleate  </td> <td>Thea Pharma</td> <td>Ingenus Pharms</td> </tr> <tr> <td>05/02/2023</td> <td>Ivanz</td> <td>Ertapenem Sodium  </td> <td>Merck</td> <td>Sun Pharm</td> </tr> <tr> <td>05/02/2023</td> <td>Cerdelga</td> <td>Eliglustat Tartrate  </td> <td>Genzyme </td> <td>Zenara</td> </tr> <tr> <td>05/03/2023</td> <td>Ofirmev</td> <td>Acetaminophen  </td> <td>Mallinckrodt</td> <td>HQ Specialty Pharma</td> </tr> <tr> <td>05/03/2023</td> <td>Carafate</td> <td>Sucralfate  </td> <td>AbbVie</td> <td>Zydus</td> </tr> <tr> <td>05/03/2023</td> <td>Edetate</td> <td>Calcium Disodium Versenate  </td> <td>Bausch Health</td> <td>Casper Pharma</td> </tr> <tr> <td>05/03/2023</td> <td>Cardene</td> <td>Nicardipine HCl  </td> <td>Chiesi USA</td> <td>Square Pharms</td> </tr> <tr> <td>05/04/2023</td> <td>Motpoly XR</td> <td>Lacosamide</td> <td>Aucta</td> <td>Aucta</td> </tr> <tr> <td>05/04/2023</td> <td>Trokendi XR</td> <td>Topiramate  </td> <td>Supernus</td> <td>Par</td> </tr> <tr> <td>05/08/2023</td> <td>Zemuron</td> <td>Rocuronium Bromide  </td> <td>Organon USA</td> <td>Hong Kong</td> </tr> <tr> <td>05/08.2023</td> <td>Dibenzyline</td> <td>Phenoxybenzamine HCl  </td> <td>Concordia</td> <td>Aurobindo</td> </tr> <tr> <td>05/08/2023</td> <td>Timoptic in Ocudose</td> <td>Timolol Maleate  </td> <td>Bausch and Lomb</td> <td>Sentiss Pharma</td> </tr> <tr> <td>05/09/2023</td> <td>Ambien</td> <td>Zolpidem Tartrate</td> <td>Sanofi</td> <td>Almatica</td> </tr> <tr> <td>05/09/2023</td> <td>Diamox</td> <td>Acetazolamide  </td> <td>Teva</td> <td>Aarksih Pharms</td> </tr> <tr> <td>05/09/2023</td> <td> Dexamethasone</td> <td>Dexamethasone  </td> <td>Hikma</td> <td>Novitium Pharma</td> </tr> <tr> <td>05/10/2023</td> <td>Propylthiouracil  </td> <td>Propylthiouracil  </td> <td>Dava Pharms</td> <td>Macleods</td> </tr> <tr> <td>05/10/2023</td> <td>Toradol</td> <td>Ketorolac Tromethamine  </td> <td>Roche Palo Alto</td> <td>Caplin</td> </tr> <tr> <td>05/11/2023</td> <td>Abraxane</td> <td>Paclitaxel</td> <td>Abraxis</td> <td>Teva</td> </tr> <tr> <td>05/11/2023</td> <td>Docetaxel</td> <td>Docetaxel  </td> <td>Accord Healthcare</td> <td>Mylan</td> </tr> <tr> <td>05/11/2023</td> <td>Revlimid</td> <td>Lenalidomide  </td> <td>Celgene</td> <td>Hetero Labs</td> </tr> <tr> <td>05/11/2023</td> <td>Furadantin</td> <td>Nitrofurantoin  </td> <td>Casper Pharma</td> <td>Aurobindo</td> </tr> <tr> <td>05/11/2023</td> <td>Theophylline</td> <td>Theophylline  </td> <td>Bausch</td> <td>Rhodes </td> </tr> <tr> <td>05/11/2023</td> <td>Fosamax</td> <td>Alendronate Sodium  </td> <td>Merck</td> <td>Novitium Pharma</td> </tr> <tr> <td>05/11/2023</td> <td>Bicnu</td> <td>Carmustine  </td> <td>Avet Lifesciences</td> <td>MSN</td> </tr> <tr> <td>05/11/2023</td> <td>Voltaren</td> <td>Diclofenac Sodium  </td> <td>Novartis</td> <td>Rubicon</td> </tr> <tr> <td>05/12/2023</td> <td>Lialda</td> <td>Mesalamine  </td> <td>Takeda </td> <td>Sinotherapeutics</td> </tr> <tr> <td>05/12/2023</td> <td>Neurontin</td> <td>Gabapentin  </td> <td>Viatris</td> <td>Laurus</td> </tr> <tr> <td>05/15/2023</td> <td>Aubagio</td> <td>Teriflunomide  </td> <td>Sanofi</td> <td>Natco</td> </tr> <tr> <td>05/15/2023</td> <td>Pepcid </td> <td>Famotidine  </td> <td>Johnson & Johnson</td> <td>Alkem</td> </tr> <tr> <td>05/15/2023</td> <td>Precedex </td> <td>Dexmedetomidine HCl  </td> <td>Hospira</td> <td>Amneal</td> </tr> <tr> <td>05/15/2023</td> <td>Banzel</td> <td>Rufinamide  </td> <td>Esai</td> <td>Micro Labs</td> </tr> <tr> <td>05/16/2023</td> <td>Emend</td> <td>Fosaprepitant Dimeglumine  </td> <td>Merck</td> <td>Piramal Critical</td> </tr> <tr> <td>05/16/2023</td> <td>Nalfon</td> <td>Fenoprofen Calcium  </td> <td>Xspire Pharma</td> <td>Misemer</td> </tr> <tr> <td>05/16/2023</td> <td>Akovaz</td> <td>Ephedrine Sulfate  </td> <td>Exela Pharma</td> <td>Zydus</td> </tr> <tr> <td>05/17/2023</td> <td>Lymphazurin</td> <td>Isosulfan Blue  </td> <td>Covidien</td> <td>AM Regent</td> </tr> <tr> <td>05/18/2023</td> <td>Effexor XR</td> <td>Venlafaxine HCl  </td> <td>Upjohn</td> <td>Granules</td> </tr> <tr> <td>05/19/2023</td> <td>Hemabate</td> <td>Carboprost Tromethamine  </td> <td>Pfizer</td> <td>Welding</td> </tr> <tr> <td>05/19/2023</td> <td>Amitriptyline HCl</td> <td>Amitriptyline HCl  </td> <td>Sandoz</td> <td>Graviti Pharms</td> </tr> <tr> <td>05/22/2023</td> <td>Alimta</td> <td>Pemetrexed</td> <td>Eli Lilly</td> <td>Shilpa</td> </tr> <tr> <td>05/22/2023</td> <td>Fusilev</td> <td>Levoleucovorin Calcium  </td> <td>Spectrum</td> <td>Hainan Poly Pharm</td> </tr> <tr> <td>05/23/2023</td> <td>Brixadi</td> <td>Bupremorphine</td> <td>Braeburn</td> <td>Braeburn</td> </tr> <tr> <td>05/23/2023</td> <td>Allegra</td> <td>Fexofenadine HCl  </td> <td>Chattem Sanofi</td> <td>Aurobindo</td> </tr> <tr> <td>05/23/2023</td> <td>Concerta</td> <td>Methylphenidate HCl  </td> <td>Janssen</td> <td>Alkem</td> </tr> <tr> <td>05/23/2023</td> <td>Haldol</td> <td>Haloperidol Decanoate  </td> <td>Janssen</td> <td>Mankind Pharma</td> </tr> <tr> <td>05/23/2023</td> <td>Lexiscan</td> <td>Regadenoson  </td> <td>Astellas</td> <td>Baxter</td> </tr> <tr> <td>05/24/2023</td> <td>Tapazole</td> <td>Methimazole</td> <td>King Pharms</td> <td>Macleods</td> </tr> <tr> <td>05/24/2023</td> <td>Gilenya</td> <td>Fingolimod HCl  </td> <td>Novartis</td> <td>Bionpharma</td> </tr> <tr> <td>05/24/2023</td> <td>Zemuron</td> <td>Rocuronium Bromide  </td> <td>Organon</td> <td>Hikma</td> </tr> <tr> <td>05/24/2023</td> <td>Metronidazole</td> <td>Metronidazole </td> <td>Hospira</td> <td>Amneal</td> </tr> <tr> <td>05/25/2023</td> <td>Orfadin</td> <td>Nitisinone  </td> <td>Swedish Orphan</td> <td>Zenara</td> </tr> <tr> <td>05/25/2023</td> <td>Hemabate</td> <td>Carboprost Tromethamine  </td> <td>Pfizer</td> <td>Eugia Pharma</td> </tr> <tr> <td>05/26/2023</td> <td>Renagel</td> <td>Sevelamer HCl  </td> <td>Genzyme</td> <td>Macleods Pharms</td> </tr> <tr> <td>05/26/2023</td> <td>Eliquis</td> <td>Apixaban  </td> <td>Bristol-Myers Squibb</td> <td>Aurobindo</td> </tr> <tr> <td>05/26/2023</td> <td>Vasostrict</td> <td>Vasopressin  </td> <td>Endo / Par</td> <td>Fresenius Kabi</td> </tr> <tr> <td>05/26/2023</td> <td>Timoptic</td> <td>Timolol Maleate  </td> <td>Bausch and Lomb</td> <td>Micro Labs</td> </tr> <tr> <td>05/30/2023</td> <td>Diastat Acudial</td> <td>Diazepam  </td> <td>Bausch </td> <td>Novel Labs</td> </tr> <tr> <td>05/30/2023</td> <td>Ocalvia</td> <td>Obeticholic Acid  </td> <td>Intercept </td> <td>Apotex</td> </tr> <tr> <td>05/30/2023</td> <td>Ocaliva</td> <td>Obeticholic Acid  </td> <td>Intercept </td> <td>Lupin</td> </tr> <tr> <td>05/30/2023</td> <td>Ocaliva</td> <td>Obeticholic Acid  </td> <td>Intercept </td> <td>MSN</td> </tr> <tr> <td>05/30/2023</td> <td>Rowasa</td> <td>Mesalamine  </td> <td>Mylan Speciality</td> <td>Encube</td> </tr> <tr> <td>05/31/2023</td> <td>Aczone</td> <td>Dapsone  </td> <td>Almirall</td> <td>Amneal</td> </tr> <tr> <td>05/31/2023</td> <td>Esbriet</td> <td>Pirfenidone  </td> <td>Genentech</td> <td>Apotex</td> </tr> <tr> <td>05/31/2023</td> <td>Iressa</td> <td>Gefitinib  </td> <td>AstraZeneca</td> <td>Natco</td> </tr> <tr> <td>05/31/2023</td> <td>Wellbutrin</td> <td>Bupropion HCl  </td> <td>GlaxoSmithKline</td> <td>Annora Pharma</td> </tr> <tr> <td>05/31/2023</td> <td>EC-Naprosyn</td> <td>Naproxen  </td> <td>Atnahs Pharma</td> <td>Tulex Pharms</td> </tr> <tr> <td>06/01/2023</td> <td>Benicar HCT</td> <td>Olmesartan Medoxomil / Hydrochlorothiazide</td> <td>Cosette</td> <td>Macleods</td> </tr> <tr> <td>06/01/2023</td> <td>Cellcept</td> <td>Mycophenolate Mofetil HCl  </td> <td>Roche </td> <td>Bpi Labs</td> </tr> <tr> <td>06/01/2023</td> <td>Lyrica CR</td> <td>Pregabalin</td> <td>Upjohn</td> <td>Sinotherapeutics</td> </tr> <tr> <td>06/01/2023</td> <td>Bentyl</td> <td>Dicyclomine HCl  </td> <td>Allergan</td> <td>Twi</td> </tr> <tr> <td>06/02/2023</td> <td>Corgard</td> <td>Nadolol</td> <td>USWM</td> <td>Alembic</td> </tr> <tr> <td>06/02/2023</td> <td>Inspira</td> <td>Eplerenone</td> <td>Upjohn</td> <td>Annora Pharma</td> </tr> <tr> <td>06/02/2023</td> <td>Arranon</td> <td>Nelarabine</td> <td>Sandoz</td> <td>Nexus Pharms</td> </tr> <tr> <td>06/05/2023</td> <td>Treanda</td> <td>Bendamustine HCl </td> <td>Cephalon</td> <td>Apotex</td> </tr> <tr> <td>06/05/2023</td> <td>Treanda</td> <td>Bendamustine HCl </td> <td>Cephalon</td> <td>Kindos</td> </tr> <tr> <td>06/05/2023</td> <td>Reclast </td> <td>Zoledronic Acid  </td> <td>Sandoz</td> <td>Hong Kong</td> </tr> <tr> <td>06/05/2023</td> <td>Foscavir</td> <td>Foscarnet Sodium  </td> <td>Clinigen Healthcare</td> <td>Avet Lifesciences</td> </tr> <tr> <td>06/05/2023</td> <td>Treanda</td> <td>Bendamustine HCl  </td> <td>Cephalon</td> <td>Eugia Pharma</td> </tr> <tr> <td>06/06/2023</td> <td>Vesicare</td> <td>Solifenacin Succinate</td> <td>Astellas</td> <td>Lannett</td> </tr> <tr> <td>06/06/2023</td> <td>Adcirca</td> <td>Tadalafil</td> <td>Eli Lilly</td> <td>Zydus</td> </tr> <tr> <td>06/06/2023</td> <td>Aczone</td> <td>Dapsone</td> <td>Almirall (Allergan)</td> <td>Acrux Dds</td> </tr> <tr> <td>06/06/2023</td> <td>Lovenox</td> <td>Enoxaparin Sodium</td> <td>Sanofi Aventis</td> <td>Be Pharms</td> </tr> <tr> <td>06/06/2023</td> <td>Apriso</td> <td>Mesalamine</td> <td>Valeant Pharms</td> <td>Amta</td> </tr> <tr> <td>06/07/2023</td> <td>Nexium </td> <td>Esomeprazole Magnesium</td> <td>AstraZeneca</td> <td>Zydus</td> </tr> <tr> <td>06/07/2023</td> <td>Treanda</td> <td>Bendamustine HCl  </td> <td>Cephalon</td> <td>Nang Kuang Pharm</td> </tr> <tr> <td>06/07/2023</td> <td>Depo-Provera</td> <td>Medroxyprogesterone Acetate</td> <td>Pfizer</td> <td>Amneal</td> </tr> <tr> <td>06/07/2023</td> <td>Precedex </td> <td>Dexmedetomidine HCl </td> <td>Hospira</td> <td>Milla Pharms</td> </tr> <tr> <td>06/07/2023</td> <td>Mobic</td> <td>Meloxicam</td> <td>Boehringer Ingelheim</td> <td>Ascent Pharms</td> </tr> <tr> <td>06/08/2023</td> <td>Fleqsuvy</td> <td>Baclofen</td> <td>Azurity</td> <td>Slayback Pharma</td> </tr> <tr> <td>06/08/2023</td> <td>Colazel</td> <td>Balsalazide Disodium</td> <td>Valeant Pharms</td> <td>Zydus</td> </tr> <tr> <td>06/09/2023</td> <td>Latuda</td> <td>Lurasidone HCl </td> <td>Sunovion</td> <td>Macleods</td> </tr> <tr> <td>06/09/2023</td> <td>Esbriet</td> <td>Pirfenidone </td> <td>Genentech</td> <td>Apotex</td> </tr> <tr> <td>06/09/2023</td> <td>Bridion</td> <td>Sugammadex Sodium</td> <td>Merck</td> <td>Aspiro</td> </tr> <tr> <td>06/09/2023</td> <td>Ciprodex</td> <td>Ciprofloxacin / Dexamethasone  </td> <td>Novartis</td> <td>Akorn</td> </tr> <tr> <td>06/09/2023</td> <td>Nimbex</td> <td>Cisatracurium Besylate  </td> <td>Abbvie</td> <td>Caplin</td> </tr> <tr> <td>06/12/2023</td> <td>Athrotec</td> <td>Diclofenac Sodium / Misoprostol </td> <td>Pfizer</td> <td>Zydus</td> </tr> <tr> <td>06/12/2023</td> <td>Chantix</td> <td>Varenicline Tartrate</td> <td>Pfizer</td> <td>Zydus</td> </tr> <tr> <td>06/12/2023</td> <td>Toprol-XL</td> <td>Metoprolol Succinate  </td> <td>Toprol</td> <td>Granules</td> </tr> <tr> <td>06/13/2023</td> <td>Lonsurf</td> <td>Tipiracil HCl / Trifluridine  </td> <td>Taiho Oncology</td> <td>Natco</td> </tr> <tr> <td>06/13/2023</td> <td>Katerzia</td> <td>Amlodipine Benzoate  </td> <td>Azurity</td> <td>Amneal</td> </tr> <tr> <td>06/13/2023</td> <td>Sandostatin</td> <td>Octreotide Acetate  </td> <td>Novartis</td> <td>Gland Pharma</td> </tr> <tr> <td>06/13/2023</td> <td>Keppra</td> <td>Levetiracetam  </td> <td>UCB</td> <td>Granules</td> </tr> <tr> <td>06/14/2023</td> <td>Xadago</td> <td>Safinamide Mesylate  </td> <td>MDD US</td> <td>Aurobindo</td> </tr> <tr> <td>06/14/2023</td> <td>Nasonex 24 Hr Allegy</td> <td>Mometasone Furoate  </td> <td>Perrigo</td> <td>Amneal</td> </tr> <tr> <td>06/15/2023</td> <td>Bridion</td> <td>Sugammadex Sodium  </td> <td>Merck</td> <td>Mylan</td> </tr> <tr> <td>06/15/2023</td> <td>Hectorol</td> <td>Doxercalciferol  </td> <td>Sanofi</td> <td>Alembic</td> </tr> <tr> <td>06/15/2023</td> <td>Sodium Bicarbonate</td> <td>Sodium Bicarbonate  </td> <td>Abbott Labs</td> <td>Omnivium Pharms</td> </tr> <tr> <td>06/15/2023</td> <td>Hemabate</td> <td>Carboprost Tromethamine  </td> <td>Pfizer</td> <td>Alembic</td> </tr> <tr> <td>06/16/2023</td> <td>Solodyn</td> <td>Minocycline HCl  </td> <td>Bausch</td> <td>Zydus</td> </tr> <tr> <td>06/16/2023</td> <td>MetroGel-Vaginal</td> <td>Metronidazole  </td> <td>Bausch</td> <td>Encube</td> </tr> <tr> <td>06/16/2023</td> <td>Protonix</td> <td>Pantoprazole Sodium  </td> <td>Wyeth </td> <td>Dexcel</td> </tr> <tr> <td>06/16/2023</td> <td>Klor-Con</td> <td>Potassium Chloride  </td> <td>Upsher-Smith</td> <td>Rubicon</td> </tr> <tr> <td>06/16/2023</td> <td>Banzel</td> <td>Rufinamide </td> <td>Eisai</td> <td>Aurobindo</td> </tr> <tr> <td>06/16/2023</td> <td>Pepcid </td> <td>Famotidine</td> <td>Johnson & Johnson</td> <td>Appco</td> </tr> <tr> <td>06/16/2023</td> <td>Xylocaine</td> <td>Lidocaine HCl </td> <td>Fresenius Kabi</td> <td>Mankind Pharma</td> </tr> <tr> <td>06/16/2023</td> <td>Lodoco</td> <td>Colchicine</td> <td>Agepha Pharma</td> <td>Agepha Pharma</td> </tr> <tr> <td>06/20/2023</td> <td>Dibenzyline</td> <td>Phenoxybenzamine HCl  </td> <td>Concordia</td> <td>Rising</td> </tr> <tr> <td>06/20/2023</td> <td>Spiriva HandiHaler</td> <td>Tiotropium Bromide </td> <td>Boehringer Ingelheim</td> <td>Lupin</td> </tr> <tr> <td>06/20/2023</td> <td>Glumetza</td> <td>Metformin HCl  </td> <td>Santarus</td> <td>Vgyaan</td> </tr> <tr> <td>06/20/2023</td> <td>Noxafil</td> <td>Posaconazole </td> <td>Merck</td> <td>Welding</td> </tr> <tr> <td>06/20/2023</td> <td>Toradol</td> <td>Ketorolac Tromethamine  </td> <td>Roche</td> <td>Aspiro</td> </tr> <tr> <td>06/20/2023</td> <td>Trokendi XR</td> <td>Topiramate</td> <td>Supernus</td> <td>Alkem Labs</td> </tr> <tr> <td>06/21/2023</td> <td>Samsca</td> <td>Tolvaptana </td> <td>Otsuka </td> <td>MSN</td> </tr> <tr> <td>06/21/2023</td> <td>Nebcin</td> <td>Tobramycin Sulfate  </td> <td>Eli Lilly</td> <td>Eugia Pharma</td> </tr> <tr> <td>06/22/2023</td> <td>Adzenys SR-ODT</td> <td>Amphetamine </td> <td>Neos Theraps</td> <td>Actavis</td> </tr> <tr> <td>06/22/2023</td> <td>Sandostatin</td> <td>Octreotide Acetate  </td> <td>Novartis </td> <td>Gland Pharma</td> </tr> <tr> <td>06/22/2023</td> <td>Migranal</td> <td>Dihydroergotamine Mesylate</td> <td>Bausch</td> <td>Rubicon</td> </tr> <tr> <td>06/23/2023</td> <td>Lastacaft</td> <td>Alcaftadine </td> <td>AbbVie</td> <td>Eugia Pharma</td> </tr> <tr> <td>06/23/2023</td> <td>Bridion</td> <td>Sugammadex Sodium</td> <td>Merck</td> <td>Sandoz</td> </tr> <tr> <td>06/23/2023</td> <td>Sensorcaine</td> <td>Bupivacaine Hydrochloride  </td> <td>Fresenius Kabi</td> <td>Kindos</td> </tr> <tr> <td>06/26/2023</td> <td>Phenylphrine HCl</td> <td>Phenoxybenzamine HCl  </td> <td>Hikma</td> <td>Be Pharms</td> </tr> <tr> <td>06/27/2023</td> <td>Sinequan</td> <td>Doxepin HCl  </td> <td>Pfizer</td> <td>Micro Labs</td> </tr> <tr> <td>06/28/2023</td> <td>Vidaza</td> <td>Azacitidine</td> <td>Bristol-Myers Squibb</td> <td>Jiangsu Hansoh </td> </tr> <tr> <td>06/29/2023</td> <td>Nuvaring</td> <td>Etonogestrel / Ethinyl Estradiol</td> <td>Merck </td> <td>Xiromed</td> </tr> <tr> <td>06/29/2023</td> <td>Sabril</td> <td>Vigabatrin  </td> <td>Lundbeck</td> <td>Zenara</td> </tr> <tr> <td>06/29/2023</td> <td>Vancomycin HCl</td> <td>Vancomycin HCl </td> <td>Mylan</td> <td>Hikma</td> </tr> <tr> <td>06/30/2023</td> <td>Nascobal</td> <td>Cyanocobalamin</td> <td>Endo</td> <td>Lupin</td> </tr> <tr> <td>06/30/2023</td> <td>Activella</td> <td>Estradiol / Norethindrone Acetate</td> <td>Amneal</td> <td>Aurobindo</td> </tr> <tr> <td>06/30/2023</td> <td>Faslodex</td> <td>Fulvestrant</td> <td>AstraZeneca</td> <td>Eugia Pharma</td> </tr> </tbody> </table>Fri, 14 Jul 2023 00:00:00 -0500{CC920C69-31A0-4B8B-B75A-3AE49682A388}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/anda-litigation-settlementsANDA Litigation Settlements<p>This ANDA Litigation Settlements chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act.</p> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table"> <tbody> <tr class="tableizer-firstrow"> <th width="129"><span style="color: #000000;">Case Name</span></th> <th width="173"><span style="color: #000000;">Drug</span></th> <th width="111"><span style="color: #000000;">Patent No(s).</span></th> <th width="414"><span style="color: #000000;">Publicly Available Terms</span></th> </tr> <tr> <td style="text-align: center;">Alcon Inc. v. Alembic Pharms. Ltd., 23-0194 (D. Del.)</td> <td style="text-align: center;">Pataday® (olopatadine HCl ophthalmic solution)</td> <td style="text-align: center;">8,791,154<br /> 9,533,053</td> <td style="text-align: center;">Plaintiffs dismissed the action with prejudice.</td> </tr> <tr> <td style="text-align: center;">Cosette Pharms., Inc. v. Azurity Pharms., Inc., 23-0018 (D. Del.)</td> <td style="text-align: center;">Firvanq® Kit (vancomycin HCl oral solution)</td> <td style="text-align: center;">10,493,028<br /> 10,688,046<br /> 10,959,946<br /> 10,959,947<br /> 10,959,948<br /> 10,959,949</td> <td style="text-align: center;"><br /> The court grants final judgment and finds that Cosette’s ANDA product will not infringe the patents-in-suit. <br /> <br /> Final judgment of noninfringement of the patents-in-suit is hereby entered in favor of Cosette as to Cosette’s ANDA product.<br /> <br /> Cosette shall pro</td> </tr> <tr> <td style="text-align: center;">Teva Pharms. Int’l GmbH v. Dr. Reddy’s Labs., Ltd., 21-0695 (D. Del.)</td> <td style="text-align: center;">Bendeka® (bendamustine HCl for injection)</td> <td style="text-align: center;">8,609,707<br /> 9,265,831<br /> 9,572,796<br /> 9,572,797<br /> 9,034,908<br /> 9,144,568<br /> 9,572,887<br /> 9,597,397<br /> 9,597,398<br /> 9,597,399<br /> 9,000,021<br /> 9,579,384<br /> 10,010,533<br /> 10,052,385</td> <td style="text-align: center;">All claims and defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 19-2053, 21-1330, 22-0498 (D. Del.)</td> <td style="text-align: center;">Entresto® (sacubitril / valsartan tablets)</td> <td style="text-align: center;">8,101,659<br /> 8,796,331<br /> 8,877,938<br /> 9,388,134</td> <td style="text-align: center;">Final approval of DRL’s ANDA may be granted on or after the date of the consent judgment.<br /> <br /> Under the settlement agreement, all other Novartis claims are dismissed without prejudice and all of DRL’s defenses, demands, and counterclaims are dismissed withou</td> </tr> <tr> <td style="text-align: center;">Acadia Pharms. Inc. v. Zydus Pharms. (USA) Inc., 22-1386 (D. Del.)</td> <td style="text-align: center;">Nuplazid® (pimavanserin tartrate capsules)</td> <td style="text-align: center;">11,452,721</td> <td style="text-align: center;">The parties stipulate to dismiss all claims and counterclaims without prejudice.</td> </tr> <tr> <td style="text-align: center;">Novartis Pharms. Corp. v. Aurobindo Pharma USA Inc., 19-1979, 21-1330, 21-1407 (D. Del.)</td> <td style="text-align: center;">Entresto® (sacubitril / valsartan tablets)</td> <td style="text-align: center;">8,101,659<br /> 8,796,331<br /> 11,096,918<br /> 11,058,667</td> <td style="text-align: center;"><br /> The asserted claims are valid and enforceable.<br /> <br /> The filing of Aurobindo’s ANDA infringed the asserted claims, and Aurobindo’s ANDA product would infringe the asserted claims.<br /> <br /> The Consent Judgment constitutes a “consent decree” such that Final Approval o</td> </tr> <tr> <td style="text-align: center;">Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 22-4499 (D.N.J.)</td> <td style="text-align: center;">Xtandi® (enzalutamide tablets)</td> <td style="text-align: center;">7,709,517</td> <td style="text-align: center;">All claims and defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Novartis Pharms. Corp. v. Sun Pharm. Indus. Ltd., 21-1656 (D. Del.)</td> <td style="text-align: center;">Xiidra® (lifitegrast ophthalmic solution)</td> <td style="text-align: center;">11,058,677<br /> 8,927,574<br /> 9,353,088<br /> 9,890,141<br /> 9,085,553</td> <td style="text-align: center;">All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Bristol-Myers Squibb Co. v. ScieGen Pharms., Inc., 23-0393 (D. Del.)</td> <td style="text-align: center;">Eliquis® (apixaban tablets)</td> <td style="text-align: center;">9,326,945</td> <td style="text-align: center;">All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice.<br /> <br /> Each party shall bear its own costs and attorneys’ fees.<br /> <br /> The parties waive any right to appeal.</td> </tr> <tr> <td style="text-align: center;">Horizon Medicines LLC v. Apotex Inc., 22-0640 (D. Del.)</td> <td style="text-align: center;">Pennsaid® (diclofenac sodium topical solution)</td> <td style="text-align: center;">9,066,913</td> <td style="text-align: center;">The parties stipulate that the action be dismissed with prejudice, including all claims, counterclaims, defenses, and demands, with each to bear its own attorneys’ fees and costs.<br /> <br /> The parties request that the court grant the release, to Plaintiffs, of th</td> </tr> <tr> <td style="text-align: center;">Astellas US LLC v. Baxter Healthcare Corp., 22-1390 (D. Del.)</td> <td style="text-align: center;">Lexiscan® (regadenoson intravenous solution)</td> <td style="text-align: center;">8,106,183<br /> RE 47,301<br /> 8,524,883</td> <td style="text-align: center;">All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice.<br /> <br /> Each party shall bear its own costs and attorneys’ fees.<br /> <br /> The parties waive any right to appeal.</td> </tr> <tr> <td style="text-align: center;">Astellas US LLC v. Curia Missouri, Inc., 22-0199 (D. Del.)</td> <td style="text-align: center;">Lexiscan® (regadenoson for injection)</td> <td style="text-align: center;">6,403,567</td> <td style="text-align: center;">Plaintiffs dismiss all claims against Curia.</td> </tr> <tr> <td style="text-align: center;">Abraxis Bioscience, LLC v. Hainan Shuangcheng Pharms. Co., Ltd., 23-0750 (D.N.J.)</td> <td style="text-align: center;">Abraxane® (paclitaxel injection)</td> <td style="text-align: center;">7,820,788<br /> 7,923,536<br /> 8,138,229</td> <td style="text-align: center;">Until expiration, HNSP is enjoined from infringing the patents-in-suit, unless specifically authorized by Abraxis.<br /> <br /> All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ f</td> </tr> <tr> <td style="text-align: center;">Bayer Intellectual Property GmbH v. Sciegen Pharms., Inc., 23-0335 (D. Del.)</td> <td style="text-align: center;">Xarelto® (rivaroxaban tablets)</td> <td style="text-align: center;">9,539,218<br /> 10,828,310</td> <td style="text-align: center;">All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Anacor Pharms., Inc. v. Padagis Israel Pharms. Ltd., 21-1351 (D. Del.)</td> <td style="text-align: center;">Eucrisa® (crisaborole ointment)</td> <td style="text-align: center;">8,168,614<br /> 8,501,712<br /> 9,682,092</td> <td style="text-align: center;">All claims, counterclaims, and defenses between the parties are voluntarily dismissed without prejudice.<br /> <br /> Each party shall bear its own costs and attorneys’ fees with respect to any claim, counterclaim, or defense.</td> </tr> <tr> <td style="text-align: center;">Hikma Pharms. USA Inc. v. Annora Pharma Private Ltd., 23-0231 (D. Del.)</td> <td style="text-align: center;">Mitigare® (colchicine capsules)</td> <td style="text-align: center;">8,927,607<br /> 9,399,036<br /> 9,555,029<br /> 9,675,613<br /> 9,789,108</td> <td style="text-align: center;">Hikma provides notice of dismissal of all claims without prejudice.<br /> <br /> No Answer or responsive pleading had been filed by Defendants.<br /> <br /> Each party shall bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 22-0298 (D. Del.)</td> <td style="text-align: center;">Ozempic® (semaglutide injection)</td> <td style="text-align: center;">8,129,343<br /> 8,920,383<br /> 9,132,239<br /> 9,457,154<br /> 9,687,611<br /> 9,775,953<br /> 10,220,155<br /> 10,335,462<br /> 11,097,063<br /> RE46,363</td> <td style="text-align: center;">Sealed.</td> </tr> <tr> <td style="text-align: center;">Ingenus Pharms., LLC v. Nevakar Injectables, Inc., 22-7603 (D.N.J.)</td> <td style="text-align: center;">Cyclophosphamide intravenous solution</td> <td style="text-align: center;">10,993,952</td> <td style="text-align: center;">The parties stipulate and agree that all claims are dismissed without prejudice.</td> </tr> <tr> <td style="text-align: center;">Fresenius Kabi USA, LLC v. Xiromed Pharma Espana, S.L., 22-6220 (D.N.J.)</td> <td style="text-align: center;">levothyroxine sodium for injection</td> <td style="text-align: center;">9,006,289<br /> 9,168,238<br /> 9,168,239</td> <td style="text-align: center;">Patents-in-suit are enforceable and valid and would be infringed by Defendant’s ANDA product.<br /> <br /> All claims, counterclaims, and affirmative defenses are dismissed without prejudice.<br /> <br /> Each party shall bear its own costs, attorneys’ fees, and expenses.</td> </tr> <tr> <td style="text-align: center;">Taro Pharm. Indus. Ltd. v. Encube Ethicals Pvt. Ltd., 21-1614 (D. Del.)</td> <td style="text-align: center;">Ovide® (malathion lotion)</td> <td style="text-align: center;">7,560,445<br /> 7,977,324</td> <td style="text-align: center;">Unless specifically authorized by the parties’ Settlement and License Agreement, Encube is enjoined from infringing the patents-in-suit until the expiration of the last to expire of the patents-in-suit, and the period of any pediatric exclusivity associat</td> </tr> <tr> <td style="text-align: center;">Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 22-0377 (D. Del.)</td> <td style="text-align: center;">Steglatro® (ertugliflozin tablets)</td> <td style="text-align: center;">8,080,580</td> <td style="text-align: center;">Unless specifically authorized by the parties’ Settlement Agreement, Aurobindo is enjoined from infringing the ’580 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or atto</td> </tr> <tr> <td style="text-align: center;">Merck Sharp & Dohme Corp. v. Hetero Labs Ltd., 22-0378 (D. Del.)</td> <td style="text-align: center;">Steglatro® (ertugliflozin tablets)</td> <td style="text-align: center;">8,080,580</td> <td style="text-align: center;">Unless specifically authorized by the parties’ Settlement Agreement, Hetero is enjoined from infringing the ’580 patent.<br /> <br /> All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorn</td> </tr> <tr> <td style="text-align: center;">Merck Sharp & Dohme Corp. v. Zenara Pharma Private Ltd., 22-0379 (D. Del.)</td> <td style="text-align: center;">Steglatro® (ertugliflozin tablets)</td> <td style="text-align: center;">8,080,580</td> <td style="text-align: center;">Unless specifically authorized by the parties’ Settlement Agreement, Zenara is enjoined from infringing the ’580 patent.<br /> <br /> All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorn</td> </tr> <tr> <td style="text-align: center;">Alcon Inc. v. Gland Pharma Ltd., 23-0303 (D. Del.)</td> <td style="text-align: center;">Pataday® Once-Daily Relief 0.7% (olopatadine HCl ophthalmic solution)</td> <td style="text-align: center;">8,791,154<br /> 9,533,053</td> <td style="text-align: center;">Alcon dismissed the action with prejudice.</td> </tr> <tr> <td style="text-align: center;">Novartis Pharms. Corp. v. Crystal Pharm. (Suzhou) Co., Ltd., 19-1979, 20-2930, 21-1452, 22-1395 (D. Del.)</td> <td style="text-align: center;">Entresto® (sacubitril / valsartan tablets)</td> <td style="text-align: center;">8,101,659<br /> 8,877,938<br /> 9,388,134<br /> 11,058,667<br /> 11,096,918</td> <td style="text-align: center;">Sealed. </td> </tr> <tr> <td style="text-align: center;">Pfizer Inc. v. Apotex Inc., 23-0445 (D. Del.)</td> <td style="text-align: center;">Xeljanz® (tofacitinib) tablets</td> <td style="text-align: center;">RE41,783</td> <td style="text-align: center;">Plaintiffs dismissed all claims without prejudice.</td> </tr> <tr> <td style="text-align: center;">Keryx Biopharmaceuticals, Inc. v. Zydus Worldwide DMCC, 23-0331 (D. Del.)</td> <td style="text-align: center;">Auryxia® (ferric citrate tablets)</td> <td style="text-align: center;">7,767,851 <br /> 8,093,423<br /> 8,299,298<br /> 8,338,642<br /> 8,609,896<br /> 8,754,257<br /> 8,754,258<br /> 8,846,976<br /> 8,901,349<br /> 9,050,316<br /> 9,387,191<br /> 9,328,133<br /> 9,757,416<br /> 10,300,039</td> <td style="text-align: center;">All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice.<br /> <br /> Each party shall bear its own costs and attorneys’ fees.<br /> <br /> The parties each expressly waive any right to appeal.</td> </tr> <tr> <td style="text-align: center;">Silvergate Pharms., Inc. v. Annora Pharma Private Ltd., 21-0196 (D. Del.)</td> <td style="text-align: center;">EpanedÒ (enalapril maleate oral solution)</td> <td style="text-align: center;">10,772,868<br /> 10,786,482<br /> 10,799,476</td> <td style="text-align: center;">All claims and counterclaims between Azurity and Annora and Camber are dismissed without prejudice.<br /> Any protective orders entered by the Court shall remain in full force and effect notwithstanding the dismissal of this action.<br /> <br /> Each party shall bear its o</td> </tr> <tr> <td style="text-align: center;">Anacor Pharms., Inc. v. Teva Pharms. Development, Inc., 21-1353 (D. Del.)</td> <td style="text-align: center;">Eucrisa® (crisaborole ointment)</td> <td style="text-align: center;">8,168,614<br /> 8,501,712<br /> 9,682,092</td> <td style="text-align: center;">Sealed.</td> </tr> <tr> <td style="text-align: center;">Azurity Pharms., Inc. v. Accord Healthcare, Inc., 23-0373 (D. Del.)</td> <td style="text-align: center;">Thyquidity® (levothyroxine sodium oral solution)</td> <td style="text-align: center;">9,050,307</td> <td style="text-align: center;">All claims dismissed without prejudice.</td> </tr> <tr> <td style="text-align: center;">Bristol-Myers Squibb Co. v. Biocon Pharma Ltd., 23-0392 (D. Del.)</td> <td style="text-align: center;">Eliquis® (apixaban tablets)</td> <td style="text-align: center;">9,326,945</td> <td style="text-align: center;">All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice.<br /> <br /> Each party shall bear its own costs and attorneys’ fees.<br /> <br /> The parties each expressly waive any right to appeal.</td> </tr> <tr> <td style="text-align: center;">Currax Pharms. LLC v. Aurolife Pharma LLC, 21-20765 (D.N.J.)</td> <td style="text-align: center;">Silenor® (doxepin HCl)</td> <td style="text-align: center;">7,915,307<br /> 8,513,299<br /> 9,107,898<br /> 9,486,437<br /> 9,532,971<br /> 9,572,814<br /> 9,861,607<br /> 9,907,780<br /> 10,238,620<br /> 10,548,871<br /> 10,653,660<br /> 10,653,662<br /> 11,096,920<br /> 11,110,074</td> <td style="text-align: center;">Action dismissed with prejudice and without costs.</td> </tr> <tr> <td style="text-align: center;">Bayer Intellectual Property GmbH v. USV Private Ltd., 22-1492 (D. Del.)</td> <td style="text-align: center;">Xarelto® (rivaroxaban tablets)</td> <td style="text-align: center;">9,539,218<br /> 10,828,310</td> <td style="text-align: center;">Plaintiffs’ action against USV and USV’s action against Plaintiffs are dismissed with prejudice.<br /> <br /> All parties shall bear their own costs, disbursements, and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Bristol-Myers Squibb Co. v. Handa Oncology, LLC, 22-6968 (N.D. Cal.)</td> <td style="text-align: center;">Sprycel® (dasatinib tablets)</td> <td style="text-align: center;">7,491,725<br /> 8,680,103</td> <td style="text-align: center;">All claims, counterclaims, and defenses are dismissed without prejudice.<br /> <br /> Each party shall bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Supernus Pharms., Inc. v. Apotex Inc., 22-0322 (D.N.J.)</td> <td style="text-align: center;">Oxtellar XR® (oxcarbazepine extended-release tablets)</td> <td style="text-align: center;">11,166,960</td> <td style="text-align: center;">All claims, counterclaims, and defenses asserted by the parties are dismissed without prejudice.<br /> <br /> The 30-month stay is terminated.  <br /> <br /> Nothing prevents FDA from granting final approval to ANDA No. 213369 at any time.<br /> <br /> Each party shall bear its own costs an</td> </tr> <tr> <td style="text-align: center;">Merck Sharp & Dohme LLC v. Gland Pharma Ltd., 22-5461 (D.N.J.)</td> <td style="text-align: center;">Noxafil® (posaconazole injection)</td> <td style="text-align: center;">9,023,790<br /> 9,358,297</td> <td style="text-align: center;">Gland is enjoined from infringing the patents-in-suit.<br /> <br /> All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.</td> </tr> <tr> <td style="text-align: center;">Arbor Pharms., LLC v. Amneal Pharms., LLC, 22-2323 (D.N.J.)</td> <td style="text-align: center;">Nymalize® (nimodipine oral solution)</td> <td style="text-align: center;">7,070,581<br /> 8,517,997<br /> 10,342,787<br /> 10,576,070<br /> 11,207,306</td> <td style="text-align: center;">All claims and counterclaims are dismissed without prejudice.<br /> <br /> Plaintiffs and Amneal shall bear their own fees and costs.</td> </tr> <tr> <td style="text-align: center;">Supernus Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 22-4705 (D.N.J.)</td> <td style="text-align: center;">Trokendi XR® (topiramate extended-release capsules)</td> <td style="text-align: center;">8,298,576<br /> 8,298,580<br /> 8,663,683<br /> 8,877,248<br /> 8,889,191<br /> 8,992,989<br /> 9,549,940<br /> 9,555,004<br /> 9,622,983<br /> 10,314,790</td> <td style="text-align: center;">All claims, counterclaims, and defenses asserted by the parties are dismissed without prejudice.<br /> <br /> Each party shall bear its own costs and attorneys’ fees.</td> </tr> <tr> <td style="text-align: center;">Exela Pharma Sciences, LLC v. Hikma Pharms. USA, Inc., 23-0137 (D. Del.)</td> <td style="text-align: center;">Elcys® (cysteine HCl injection)</td> <td style="text-align: center;">10,583,155<br /> 11,510,941</td> <td style="text-align: center;">The case is dismissed without prejudice with each party bearing its own costs and attorneys’ fees. Hikma shall produce any correspondence from FDA [redacted] ANDA No. 213073 within three business days of receiving such correspondence.<br /> <br /> Hikma shall notify </td> </tr> </tbody> </table>Fri, 14 Jul 2023 00:00:00 -0500{65F60CC2-D268-46B5-AD6E-BC3E4FF3E1E2}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/generic-launchesGeneric Launches<p>This Generic Launches chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.</p> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table"> <tbody> <tr class="tableizer-firstrow"> <th width="119"><span style="color: #000000;">Reference Listed Drug</span></th> <th width="115"><span style="color: #000000;">ANDA Holder</span></th> <th width="185"><span style="color: #000000;">Generic Drug Name</span></th> <th width="134"><span style="color: #000000;">ANDA<br /> Applicant(s)</span></th> <th width="863"><span style="color: #000000;">Indication</span></th> <th width="113"><span style="color: #000000;">Launch Date</span></th> </tr> <tr> <td style="text-align: center;">Noxafil</td> <td style="text-align: center;">Merck</td> <td style="text-align: center;">posaconazole</td> <td style="text-align: center;">Hikma</td> <td style="text-align: center;">Used to  prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection</td> <td style="text-align: center;">4/3/2023</td> </tr> <tr> <td style="text-align: center;">Prolixin</td> <td style="text-align: center;">Apothecon</td> <td style="text-align: center;">fluphenazine</td> <td style="text-align: center;">Upsher Smith</td> <td style="text-align: center;">Used to treat  schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility</td> <td style="text-align: center;">4/3/2023</td> </tr> <tr> <td style="text-align: center;">Noxafil</td> <td style="text-align: center;">Merck</td> <td style="text-align: center;">posaconazole</td> <td style="text-align: center;">Endo</td> <td style="text-align: center;">Used to  prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection</td> <td style="text-align: center;">4/4/2023</td> </tr> <tr> <td style="text-align: center;">Bentyl</td> <td style="text-align: center;">AbbVie</td> <td style="text-align: center;">dicyclomine</td> <td style="text-align: center;">TWi</td> <td style="text-align: center;"> Used to treat functional bowel disorder and irritable bowel syndrome</td> <td style="text-align: center;">4/2023?</td> </tr> <tr> <td style="text-align: center;">K-Tab</td> <td style="text-align: center;">AbbVie</td> <td style="text-align: center;">potassium chloride</td> <td style="text-align: center;">TWi</td> <td style="text-align: center;">Used for prophylaxis and treatment of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient</td> <td style="text-align: center;">4/2023?</td> </tr> <tr> <td style="text-align: center;">Combigan</td> <td style="text-align: center;">AbbVie </td> <td style="text-align: center;">brimonidine / timolol</td> <td style="text-align: center;">Upsher Smith</td> <td style="text-align: center;">Used to treat increased pressure in the eye caused by glaucoma or a condition called hypertension of the eye</td> <td style="text-align: center;">4/13/2023</td> </tr> <tr> <td style="text-align: center;">Depo-Testosterone</td> <td style="text-align: center;">Pfizer</td> <td style="text-align: center;">testoterone cypionate</td> <td style="text-align: center;">Xiromed</td> <td style="text-align: center;">Used as replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone   </td> <td style="text-align: center;">4/13/2023</td> </tr> <tr> <td style="text-align: center;">Argatroban</td> <td style="text-align: center;">Novartis</td> <td style="text-align: center;">argatroban</td> <td style="text-align: center;">Par / Endo</td> <td style="text-align: center;">Used for prophylaxis or treatment of thrombosis in adult patients with heparin- induced thrombocytopenia (HIT)</td> <td style="text-align: center;">4/17/2023</td> </tr> <tr> <td style="text-align: center;">Lexiscan</td> <td style="text-align: center;">Astellas</td> <td style="text-align: center;">regadenoson</td> <td style="text-align: center;">Hikma</td> <td style="text-align: center;">Is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress</td> <td style="text-align: center;">4/17/2023</td> </tr> <tr> <td style="text-align: center;">Daliresp</td> <td style="text-align: center;">AstraZeneca</td> <td style="text-align: center;">roflumilast</td> <td style="text-align: center;">Camber / Hetero</td> <td style="text-align: center;">Used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations</td> <td style="text-align: center;">4/21/2023</td> </tr> <tr> <td style="text-align: center;">Remodulin</td> <td style="text-align: center;">United Therapeutics</td> <td style="text-align: center;">treprostinil</td> <td style="text-align: center;">Dr. Reddy's Labs</td> <td style="text-align: center;">Used to treat pulmonary arterial hypertension (PAH) </td> <td style="text-align: center;">4/21/2023</td> </tr> <tr> <td style="text-align: center;">Zyflo CR</td> <td style="text-align: center;">Chiesi</td> <td style="text-align: center;">zileuton</td> <td style="text-align: center;">Camber / Hetero</td> <td style="text-align: center;">Is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older</td> <td style="text-align: center;">4/26/2023</td> </tr> <tr> <td style="text-align: center;">Delestrogen</td> <td style="text-align: center;">Par</td> <td style="text-align: center;">estradiol valerate</td> <td style="text-align: center;">Xiromed</td> <td style="text-align: center;">Used to treat moderate to severe vasomotor symptoms associated with the menopause</td> <td style="text-align: center;">5/1/2023</td> </tr> <tr> <td style="text-align: center;">Phernegan</td> <td style="text-align: center;">Mylan</td> <td style="text-align: center;">promethazine</td> <td style="text-align: center;">Camber / Hetero</td> <td style="text-align: center;">Used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes; also prevents motion sickness, and treats nausea and vomiting or pain after surgery; also used as a sedative or sleep aid</td> <td style="text-align: center;">5/3/2023</td> </tr> <tr> <td style="text-align: center;">Lexiscan</td> <td style="text-align: center;">Astellas</td> <td style="text-align: center;">regadenoson</td> <td style="text-align: center;">Dr. Reddy's Labs</td> <td style="text-align: center;">Is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress</td> <td style="text-align: center;">5/5/2023</td> </tr> <tr> <td style="text-align: center;">Syprine</td> <td style="text-align: center;">Bausch</td> <td style="text-align: center;">trientine HCl</td> <td style="text-align: center;">Camber / Hetero</td> <td style="text-align: center;">Used to treat patients with Wilson’s disease who are intolerant of penicillamine</td> <td style="text-align: center;">5/8/2023</td> </tr> <tr> <td style="text-align: center;">Cystadane</td> <td style="text-align: center;">Recordati</td> <td style="text-align: center;">betaine anhydrous</td> <td style="text-align: center;">Eton</td> <td style="text-align: center;">Used to treat homocystinuria</td> <td style="text-align: center;">5/10/2023</td> </tr> <tr> <td style="text-align: center;">Prezista</td> <td style="text-align: center;">Johnson & Johnson</td> <td style="text-align: center;">darunavir</td> <td style="text-align: center;">Teva </td> <td style="text-align: center;">Used to treat human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection</td> <td style="text-align: center;">6/1/2023</td> </tr> <tr> <td style="text-align: center;">Prezista</td> <td style="text-align: center;">Johnson & Johnson</td> <td style="text-align: center;">darunavir</td> <td style="text-align: center;">Lupin</td> <td style="text-align: center;">Used to treat human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection</td> <td style="text-align: center;">6/3/2023</td> </tr> <tr> <td style="text-align: center;">Mexitil</td> <td style="text-align: center;">Boehringer Ingelheim</td> <td style="text-align: center;">mexiletine HCl</td> <td style="text-align: center;">Camber / Hetero</td> <td style="text-align: center;">Used to treat documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening</td> <td style="text-align: center;">6/6/2023</td> </tr> <tr> <td style="text-align: center;">Iressa</td> <td style="text-align: center;">AstraZeneca</td> <td style="text-align: center;">gefitinib</td> <td style="text-align: center;">Apotex</td> <td style="text-align: center;">Used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK</td> <td style="text-align: center;">6/14/2023</td> </tr> <tr> <td style="text-align: center;">Treanda</td> <td style="text-align: center;">Teva </td> <td style="text-align: center;">bendamustine </td> <td style="text-align: center;">Apotex</td> <td style="text-align: center;">Used to treat chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen</td> <td style="text-align: center;">6/14/2023</td> </tr> <tr> <td style="text-align: center;">Vasostrict</td> <td style="text-align: center;">Endo</td> <td style="text-align: center;">vasopressin</td> <td style="text-align: center;">Fresenius Kabi</td> <td style="text-align: center;">Used to treat increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines</td> <td style="text-align: center;">6/14/2023</td> </tr> <tr> <td style="text-align: center;">Vimpat</td> <td style="text-align: center;">UCB</td> <td style="text-align: center;">lacosamide</td> <td style="text-align: center;">Apotex</td> <td style="text-align: center;">Used to treat partial-onset seizures in patients aged one month and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients aged four years and older</td> <td style="text-align: center;">6/14/2023</td> </tr> <tr> <td style="text-align: center;">Dexilant</td> <td style="text-align: center;">Takeda</td> <td style="text-align: center;">dexlansoprazole</td> <td style="text-align: center;">Par / Endo</td> <td style="text-align: center;">Used to treat erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)</td> <td style="text-align: center;">6/15/2023</td> </tr> <tr> <td style="text-align: center;">Thiamine</td> <td style="text-align: center;">Fresenius Kabi</td> <td style="text-align: center;">thiamine HCl</td> <td style="text-align: center;">Lupin</td> <td style="text-align: center;">Used to treat thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety </td> <td style="text-align: center;">6/19/2023</td> </tr> <tr> <td style="text-align: center;">Iressa</td> <td style="text-align: center;">AstraZeneca</td> <td style="text-align: center;">gefitinib</td> <td style="text-align: center;">Teva </td> <td style="text-align: center;">Used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK</td> <td style="text-align: center;">6/21/2023</td> </tr> <tr> <td style="text-align: center;">Banzel</td> <td style="text-align: center;">Eisai</td> <td style="text-align: center;">rufinamide</td> <td style="text-align: center;">Lupin</td> <td style="text-align: center;">Used for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in pediatric patients one year of age and older and adults</td> <td style="text-align: center;">6/23/2023</td> </tr> <tr> <td style="text-align: center;">Kinevac</td> <td style="text-align: center;">Bracco Diagnostics</td> <td style="text-align: center;">sincalide</td> <td style="text-align: center;">Fresenius Kabi</td> <td style="text-align: center;">Used to stimulate gallbladder contraction or pancreatic secretion during diagnostic tests, and accelerate fluoroscopy and x-ray examination of the intestinal tract</td> <td style="text-align: center;">6/21/2023</td> </tr> <tr> <td style="text-align: center;">Vancocin</td> <td style="text-align: center;">ANI</td> <td style="text-align: center;">vancomycin</td> <td style="text-align: center;">Amneal</td> <td style="text-align: center;">Used to treat serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci; also indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs</td> <td style="text-align: center;">6/2023?</td> </tr> <tr> <td style="text-align: center;">Noxafil</td> <td style="text-align: center;">Merck</td> <td style="text-align: center;">posaconazole</td> <td style="text-align: center;">Endo / Par</td> <td style="text-align: center;">Indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.</td> <td style="text-align: center;">6/29/2023</td> </tr> <tr> <td style="text-align: center;">Midazolam</td> <td style="text-align: center;">Inforlife </td> <td style="text-align: center;">Midazolam in 0.9% sodium chloride</td> <td style="text-align: center;">Hikma</td> <td style="text-align: center;">Used for continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting</td> <td style="text-align: center;">6/30/2023</td> </tr> </tbody> </table>Fri, 14 Jul 2023 00:00:00 -0500{879E994E-3082-45AB-ABF8-3B15231B2E85}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/new-anda-casesNew ANDA Cases<p>This New ANDA Cases chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.</p> <style type="text/css"> table.tableizer-table { border: 1px solid #666; font-size: 12px; } .tableizer-table td { padding: 4px; margin: 3px; border: 1px solid #666; } .tableizer-table th { background-color: #CCC; color: #FFF; font-weight: bold; text-align:center; border: 1px solid #666; } </style> <table class="tableizer-table" style="text-align: center;"> <tbody> <tr class="tableizer-firstrow"> <th width="488" height="26"><span style="color: #000000;">Case Name</span></th> <th width="88"><span style="color: #000000;">Date Filed</span></th> <th width="167"><span style="color: #000000;">Judge</span></th> <th width="506"><span style="color: #000000;">Drug</span></th> <th width="284"><span style="color: #000000;">Patent No(s).</span></th> </tr> <tr> <td>AbbVie Inc. v. Teva Pharms., Inc., 24-0374 (D. Del.)</td> <td>Apr. 3, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>11,542,239</td> </tr> <tr> <td>Ingenus Pharms., LLC v. Accord Healthcare, Inc., 23-0377 (D. Del.)</td> <td>Apr. 3, 2023</td> <td>Hon. Colm F. Connolly</td> <td>Cyclophosphamide intravenous solution</td> <td>10,993,952</td> </tr> <tr> <td>Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-0383 (D. Del.)</td> <td>Apr. 4, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Uptravi® (selexipag tablets)</td> <td>7,205,302</td> </tr> <tr> <td>Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-1902 (D.N.J.)</td> <td>Apr. 4, 2023</td> <td>Hon. Stanley R. Chesler</td> <td>Opsumit® (macitentan tablets)</td> <td>7,094,781</td> </tr> <tr> <td>Catalyst Pharms., Inc. v. MSN Labs. Private Ltd., 23-1945 (D.N.J.)</td> <td>Apr. 5, 2023</td> <td>Hon. Karen M. Williams</td> <td>Fycompa® (perampanel oral suspension)</td> <td>8,722,497</td> </tr> <tr> <td>Actelion Pharms. US, Inc. v. Cipla Ltd., 23-0389 (D. Del.)</td> <td>Apr. 6, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Uptravi® (selexipag for injection)</td> <td>8,791,122<br /> 9,284,280</td> </tr> <tr> <td>Bristol-Myers Squibb Co. v. Biocon Pharma Ltd., 23-0392 (D. Del.)</td> <td>Apr. 6, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Eliquis® (apixaban tablets)</td> <td>9,326,945</td> </tr> <tr> <td>Bristol-Myers Squibb Co. v. ScieGen Pharms., Inc., 23-0393 (D. Del.)</td> <td>Apr. 6, 2023</td> <td>Hon. Gregory B. Williams</td> <td>Eliquis® (apixaban tablets)</td> <td>9,326,945</td> </tr> <tr> <td>Catalyst Pharms., Inc. v. MSN Labs. Private Ltd., 23-1961 (D.N.J.)</td> <td>Apr. 6, 2023</td> <td>Hon. Karen M. Williams</td> <td>Fycompa® (perampanel tablets)</td> <td>8,722,497</td> </tr> <tr> <td>Abraxis Bioscience, LLC v. Mylan Pharms. Inc., 23-0033 (N.D.W.V.)</td> <td>Apr. 6, 2023</td> <td>Hon. Thomas S Kleeh</td> <td>Abraxane® (paclitaxel protein-bound particles for injectable suspension)</td> <td>7,820,788</td> </tr> <tr> <td>Novartis Pharms. Corp. v. Nanjing Noratech Pharm. Co., Ltd., 23-0401 (D. Del.)</td> <td>Apr. 10, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Entresto® (sacubitril / valsartan tablets)</td> <td>8,101,659<br /> 11,058,667</td> </tr> <tr> <td>Nexus Pharms., Inc. v. Gland Pharma Ltd., 23-2032 (D.N.J.)</td> <td>Apr. 10, 2023</td> <td>Hon. Christine P. O’Hearn</td> <td>Emerphed® (ephedrine sulfate injection)</td> <td>11,090,278<br /> 11,241,400<br /> 11,478,436<br /> 11,426,369</td> </tr> <tr> <td>Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 23-0410 (D. Del.)</td> <td>Apr. 13, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Xarelto® (rivaroxaban tablets)</td> <td>10,828,310</td> </tr> <tr> <td>Celgene Corp. v. Accord Healthcare Inc., 23-0424 (D. Del.)</td> <td>Apr. 18, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Onureg® (azacitidine tablets)</td> <td>11,571,436</td> </tr> <tr> <td>Pfizer Inc. v. Apotex Inc., 23-0445 (D. Del.)</td> <td>Apr. 24, 2023</td> <td>Hon. Colm F. Connolly</td> <td>Xeljanz® (tofacitinib) tablets</td> <td>RE41,783</td> </tr> <tr> <td>AbbVie Inc. v. Hetero Labs Ltd., 23-0448 (D. Del.)</td> <td>Apr. 24, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>11,542,239</td> </tr> <tr> <td>AbbVie Inc. v. Prinston Pharm. Inc., 23-0470 (D. Del.)</td> <td>Apr. 28, 2023</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>10,537,572<br /> 10,682,351</td> </tr> <tr> <td>Merck Sharp & Dohme LLC v. Hetero USA Inc., 23-2364 (D.N.J.)</td> <td>Apr. 28, 2023</td> <td>Hon. Claire C. Cecchi</td> <td>Isentress® (raltegravir tablets)</td> <td>7,754,731</td> </tr> <tr> <td>Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 23-2367 (D.N.J.)</td> <td>Apr. 28, 2023</td> <td>Hon Madeline Cox Arleo</td> <td>Exparel® (bupivacaine liposome injectable suspension)</td> <td>11,033,495</td> </tr> <tr> <td>Astellas Pharma Inc. v. Ascent Pharms., Inc., 23-0486 (D. Del.)</td> <td>3-May-23</td> <td>Hon. Joseph F. Bataillon</td> <td>Myrbetriq® (mirabegron extended-release tablets)</td> <td>10,842,780</td> </tr> <tr> <td>Bausch & Lomb, Inc. v. Lupin Ltd., 23-2452 (D.N.J.)</td> <td>3-May-23</td> <td>Hon. Georgette Castner</td> <td>Lumify® (brimonidine tartrate ophthalmic solution)</td> <td>11,596,600</td> </tr> <tr> <td>Bausch & Lomb, Inc. v. Slayback Pharma LLC, 23-2454 (D.N.J.)</td> <td>3-May-23</td> <td>Hon. Georgette Castner</td> <td>Lumify® (brimonidine tartrate ophthalmic solution)</td> <td>11,596,600</td> </tr> <tr> <td>Teva Pharms. Int’l GmbH v. BendaRx Corp., 23-0490 (D. Del.)</td> <td>4-May-23</td> <td>Hon. Colm F. Connolly</td> <td>Treanda® (bendamustine HCl for injection) Bendeka® (bendamustine HCl for injection)</td> <td>8,436,190<br /> 8,445,524<br /> 8,609,863<br /> 8,669,279<br /> 8,791,270<br /> 8,883,836<br /> 8,895,756<br /> 9,533,955<br /> 9,572,887<br /> 8,076,366<br /> 8,461,350</td> </tr> <tr> <td>Astellas Pharma Inc. v. Ascent Pharms., Inc., 23-3372 (E.D.N.Y.)</td> <td>4-May-23</td> <td>Hon. Joan M. Azrack</td> <td>Myrbetriq® (mirabegron extended-release tablets)</td> <td>10,842,780</td> </tr> <tr> <td>Gilead Sciences, Inc. v. Lupin Ltd., 23-0508 (D. Del.)</td> <td>9-May-23</td> <td>Hon. Maryellen Noreika</td> <td>Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide tablets)</td> <td>10,039,718<br /> 10,786,518</td> </tr> <tr> <td>Bausch & Lomb Inc. v. Lupin Ltd., 23-2664 (D.N.J.)</td> <td>17-May-23</td> <td>Hon. Julien Xavier Neals</td> <td>Lotemax® SM (loteprednol etabonate ophthalmic gel)</td> <td>11,534,395</td> </tr> <tr> <td>Bausch Health Ireland Ltd. v. Taro Pharms. Inc., 23-2684 (D.N.J.)</td> <td>17-May-23</td> <td>Hon. Stanley R. Chesler</td> <td>Duobrii® (halobetasol propionate / tazarotene lotion)</td> <td>11,648,256</td> </tr> <tr> <td>Acerta Pharma BV v. Alembic Pharms. Ltd., 23-0548 (D. Del.)</td> <td>19-May-23</td> <td>Hon. Gregory B. Williams</td> <td>Calquence® (acalabrutinib capsules)</td> <td>10,272,083</td> </tr> <tr> <td>Novartis Pharms. Corp. v. MSN Pharms. Inc., 23-0550 (D. Del.)</td> <td>19-May-23</td> <td>Hon. Gregory B. Williams</td> <td>Kisqali® (ribociclib tablets) Kisqali® Femara® Co-Pack (ribociclib / letrozole tablets)</td> <td>8,962,630<br /> 9,416,136</td> </tr> <tr> <td>Bayer Pharma AG v. Teva Pharms. USA, Inc., 23-0551 (D. Del.)</td> <td>19-May-23</td> <td>Hon. Richard G. Andrews</td> <td>Xarelto® (rivaroxaban tablets)</td> <td>10,828,310</td> </tr> <tr> <td>Nexus Pharms., Inc. v. Exela Pharma Sciences, LLC, 23-0555 (D. Del.)</td> <td>19-May-23</td> <td>Hon. Maryellen Noreika</td> <td>Akovaz® (ephedrine sulfate solution for injection) Emerphed® (ephedrine sulfate solution for injection)</td> <td>11,571,398</td> </tr> <tr> <td>Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, 23-0556 (D. Del.)</td> <td>19-May-23</td> <td>Hon. Richard G. Andrews</td> <td>Xarelto® (rivaroxaban tablets)</td> <td>9,415,053</td> </tr> <tr> <td>Theravance Biopharma R&D IP, LLC v . Orbicular Pharm. Technologies Private Ltd., 23-2843 (D.N.J.)</td> <td>24-May-23</td> <td>Hon. Karen M. Williams</td> <td>Yupelri® (revefenacin inhalation solution)</td> <td>11,484,531</td> </tr> <tr> <td>Braintree Labs., Inc. v. Lupin Ltd., 23-2853 (D.N.J.)</td> <td>25-May-23</td> <td>Hon. Christine P. O’Hearn</td> <td>Sutab® (sodium sulfate / magnesium sulfate / potassium chloride osmotic laxative tablets)</td> <td>10,143,656<br /> 11,033,498<br /> 11,382,864</td> </tr> <tr> <td>Vertex Pharms. Inc. v. Lupin Ltd., 23-0581 (D. Del.)</td> <td>26-May-23</td> <td>Hon. Richard G. Andrews</td> <td>Kalydeco® (ivacaftor tablets)</td> <td>10,646,481<br /> 11,564,916</td> </tr> <tr> <td>Vertex Pharms. Inc. v. Aurobindo Pharma Ltd., 23-0582 (D. Del.)</td> <td>26-May-23</td> <td>Hon. Richard G. Andrews</td> <td>Kalydeco® (ivacaftor tablets)</td> <td>10,646,481<br /> 11,564,916</td> </tr> <tr> <td>Vertex Pharms. Inc. v. Lupin Ltd., 23-0583 (D. Del.)</td> <td>26-May-23</td> <td>Hon. Richard G. Andrews</td> <td>Kalydeco® (ivacaftor tablets)</td> <td>8,883,206<br /> 10,272,046<br /> 10,646,481<br /> 11,147,770<br /> 11,564,916</td> </tr> <tr> <td>Janssen Pharms., Inc. v. Alkem Labs. Ltd., 23-2939 (D.N.J.)</td> <td>30-May-23</td> <td>Hon. Karen M. Williams</td> <td>Spravato® (esketamine nasal spray)</td> <td>10,869,844<br /> 11,173,134<br /> 11,311,500<br /> 11,446,260</td> </tr> <tr> <td>Janssen Pharms., Inc. v. Hikma Pharms. USA Inc., 23-2942 (D.N.J.)</td> <td>30-May-23</td> <td>Hon. Karen M. Williams</td> <td>Spravato® (esketamine nasal spray)</td> <td>10,869,844<br /> 11,173,134<br /> 11,311,500<br /> 11,446,260</td> </tr> <tr> <td>Janssen Pharms., Inc. v. Sandoz Inc., 23-2943 (D.N.J.)</td> <td>30-May-23</td> <td>Hon. Karen M. Williams</td> <td>Spravato® (esketamine nasal spray)</td> <td>10,869,844<br /> 11,173,134<br /> 11,311,500<br /> 11,446,260</td> </tr> <tr> <td>Janssen Pharms., Inc. v. Hikma Pharms. USA Inc., 23-0595 (D. Del.)</td> <td>31-May-23</td> <td>Hon. Colm F. Connolly</td> <td>Spravato® (esketamine nasal spray)</td> <td>10,869,844<br /> 11,173,134<br /> 11,311,500<br /> 11,446,260</td> </tr> <tr> <td>Janssen Pharms., Inc. v. Sandoz Inc., 23-0597 (D. Del.)</td> <td>31-May-23</td> <td>Hon. Colm F. Connolly</td> <td>Spravato® (esketamine nasal spray)</td> <td>10,869,844<br /> 11,173,134<br /> 11,311,500<br /> 11,446,260</td> </tr> <tr> <td>Celgene Corp. v. Deva Holding A.S., 23-2992 (D.N.J.)</td> <td>31-May-23</td> <td>Hon. Susan D. Wigenton</td> <td>Revlimid® (lenalidomide capsules)</td> <td>7,465,800<br /> 7,855,217</td> </tr> <tr> <td>Evofem Biosciences, Inc. v. Padagis Israel Pharms. Ltd., 23-3003 (D.N.J.)</td> <td>1-Jun-23</td> <td>Hon. Zahid N. Quaraishi</td> <td>Phexxi® (lactic acid / citric acid / potassium bitartrate vaginal gel)</td> <td>10,568,855<br /> 11,337,989<br /> 11,439,610</td> </tr> <tr> <td>Bayer Intellectual Property GmbH v. Auson Pharms. Inc., 23-3020 (D.N.J.)</td> <td>1-Jun-23</td> <td>Hon. Evelyn Padin</td> <td>Xarelto® (rivaroxaban tablets)</td> <td>9,539,218<br /> 10,828,310</td> </tr> <tr> <td>Evofem Biosciences, Inc. v. Padagis Israel Pharms. Ltd., 23-0606 (D. Del.)</td> <td>2-Jun-23</td> <td>Hon. Colm F. Connolly</td> <td>Phexxi® (lactic acid / citric acid / potassium bitartrate vaginal gel)</td> <td>10,568,855<br /> 11,337,989<br /> 11,439,610</td> </tr> <tr> <td>AbbVie Inc. v. Prinston Pharm. Inc., 23-0607 (D. Del.)</td> <td>2-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>11,542,239</td> </tr> <tr> <td>Horizon Therapeutics USA Inc. v. Dr. Reddy’s Labs., Ltd., 23-0623 (D. Del.)</td> <td>7-Jun-23</td> <td>Hon. Maryellen Noreika</td> <td>Rayos® (prednisone delayed-release tablets)</td> <td>9,504,699</td> </tr> <tr> <td>Array BioPharma Inc. v. Teva Pharms., Inc., 23-0625 (D. Del.)</td> <td>8-Jun-23</td> <td>Hon. Gregory B. Williams</td> <td>Mektovi® (binimetinib tablets)</td> <td>9,562,016<br /> 9,598,376<br /> 9,980,944</td> </tr> <tr> <td>Teva Pharms. Int’l GmbH v. BendaRx Corp., 23-0633 (D. Del.)</td> <td>9-Jun-23</td> <td>Hon. Colm F. Connolly</td> <td>Treanda® (bendamustine HCl for injection) Bendeka® (bendamustine HCl for injection)</td> <td>8,436,190<br /> 8,445,524<br /> 8,609,863<br /> 8,669,279<br /> 8,791,270<br /> 8,883,836<br /> 8,895,756<br /> 9,533,955<br /> 9,572,887<br /> 8,076,366<br /> 8,461,350</td> </tr> <tr> <td>Pfizer Inc. v. Annora Pharma Private Ltd., 23-0634 (D. Del.)</td> <td>9-Jun-23</td> <td>Hon. Colm F. Connolly</td> <td>Xeljanz® (tofacitinib oral solution)</td> <td>RE41,783</td> </tr> <tr> <td>Jazz Pharms. Ireland Ltd. v. Alkem Labs. Ltd., 23-3182 (D.N.J.)</td> <td>9-Jun-23</td> <td>Hon. Stanley R. Chesler</td> <td>Xyrem® (sodium oxybate oral solution)</td> <td>8,772,306<br /> 9,050,302<br /> 9,486,426<br /> 10,213,400<br /> 10,864,181<br /> 11,253,494</td> </tr> <tr> <td>Hikma Pharms. USA Inc. v. Padagis Israel Pharms. Ltd., 23-0654 (D. Del.)</td> <td>14-Jun-23</td> <td>Hon. Gregory B. Williams</td> <td>Kloxxado® (naloxone HCl nasal spray)</td> <td>10,722,510<br /> 10,973,814<br /> 11,135,155<br /> 11,617,713<br /> 11,628,139</td> </tr> <tr> <td>Merck KGaA v. Apotex Inc., 23-0655 (D. Del.)</td> <td>15-Jun-23</td> <td>Hon. Gregory B. Williams</td> <td>Mavenclad® (cladribine tablets)</td> <td>7,713,947<br /> 8,377,903<br /> 10,849,919</td> </tr> <tr> <td>Bayer Pharma AG v. Macleods Pharms. Ltd., 23-0665 (D. Del.)</td> <td>16-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Xarelto® (rivaroxaban tablets)</td> <td>10,828,310</td> </tr> <tr> <td>Vertex Pharms. Inc. v. Sun Pharm. Indus. Ltd., 23-0666 (D. Del.)</td> <td>16-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Kalydeco® (ivacaftor tablets)</td> <td>10,646,481<br /> 11,564,916</td> </tr> <tr> <td>Hikma Pharms. USA Inc. v. Padagis Israel Pharms. Ltd., 23-0630 (W.D. Mich.)</td> <td>16-Jun-23</td> <td>Hon. Paul L. Maloney</td> <td>Kloxxado® (naloxone HCl nasal spray)</td> <td>10,722,510<br /> 10,973,814<br /> 11,135,155<br /> 11,617,713<br /> 11,628,139</td> </tr> <tr> <td>Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 23-3333 (D.N.J.)</td> <td>16-Jun-23</td> <td>Hon. Stanley R. Chesler</td> <td>Trulance® (plecanatide tablets)</td> <td>11,142,549<br /> 11,319,346</td> </tr> <tr> <td>Teva Pharms. Int’l GmbH v. BendaRx USA Corp., 23-0788 (E.D. Va.)</td> <td>16-Jun-23</td> <td>Hon. Rossie D. Alston, Jr.</td> <td>Treanda® (bendamustine HCl for injection) Bendeka® (bendamustine HCl for injection)</td> <td>8,436,190<br /> 8,445,524<br /> 8,609,863<br /> 8,669,279<br /> 8,791,270<br /> 8,883,836<br /> 8,895,756<br /> 9,533,955<br /> 9,572,887<br /> 8,076,366<br /> 8,461,350</td> </tr> <tr> <td>Actelion Pharms. Ltd. v. MSN Labs. Private Ltd., 23-3371 (D.N.J.)</td> <td>20-Jun-23</td> <td>Hon. Stanley R. Chesler</td> <td>Opsumit® (macitentan tablets)</td> <td>7,094,781</td> </tr> <tr> <td>Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., 23-3393 (D.N.J.)</td> <td>21-Jun-23</td> <td>Hon. Stanley R. Chesler</td> <td>Arazlo® (tazarotene lotion)</td> <td>11,679,116</td> </tr> <tr> <td>Padagis Israel Pharms. Ltd. v. Bausch Health US, LLC, IPR2023-01114 (PTAB)</td> <td>21-Jun-23</td> <td>N/A</td> <td>Arazlo® (tazarotene lotion)</td> <td>11,311,482</td> </tr> <tr> <td>Merck Sharp & Dohme LLC v. Biocon Pharma Ltd., 23-0683 (D. Del.)</td> <td>23-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Januvia® (sitagliptin phosphate tablets)</td> <td>7,326,708</td> </tr> <tr> <td>AbbVie Inc. v. Sun Pharm. Indus. Ltd., 23-0684 (D. Del.)</td> <td>23-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Orilissa® (elagolix sodium tablets)</td> <td>11,542,239</td> </tr> <tr> <td>Boehringer Ingelheim Pharms. Inc. v. Apotex Inc., 23-0685 (D. Del.)</td> <td>23-Jun-23</td> <td>Hon. Colm F. Connolly</td> <td>Tradjenta® (linagliptin tablets)</td> <td>9,486,526<br /> 10,034,877</td> </tr> <tr> <td>Astellas Pharma Inc. v. MSN Pharms. Inc., 23-0689 (D. Del.)</td> <td>23-Jun-23</td> <td>Hon. Joseph F. Bataillon</td> <td>Myrbetriq® (mirabegron extended-release tablets)</td> <td>10,842,780</td> </tr> <tr> <td>Bayer Intellectual Property GmbH v. Indoco Remedies Ltd., 23-0690 (D. Del.)</td> <td>23-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Xarelto® (rivaroxaban tablets)</td> <td>9,539,218<br /> 10,828,310</td> </tr> <tr> <td>Celgene Corp. v. MSN Labs. Private Ltd., 23-0699 (D. Del.)</td> <td>27-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Onureg® (azacitidine tablets)</td> <td>8,846,628<br /> 11,571,436</td> </tr> <tr> <td>Bausch & Lomb Inc. v. Dr. Reddy’s Labs. Ltd., 23-3463 (D.N.J.)</td> <td>27-Jun-23</td> <td>Hon. Robert Kirsch</td> <td>Vyzulta® (latanoprostene bunod ophthalmic solution)</td> <td>7,273,946<br /> 7,629,345<br /> 7,910,767<br /> 8,058,467</td> </tr> <tr> <td>Amring Pharms. Inc. v. Rubicon Research Private Ltd., 23-3494 (D.N.J.)</td> <td>28-Jun-23</td> <td>Hon. Susan D. Wigenton</td> <td>Lysteda® (tranexamic acid tablets)</td> <td>7,947,739<br /> 8,022,106<br /> 8,273,795<br /> 8,487,005<br /> 8,791,160<br /> 8,809,394<br /> 8,957,113<br /> 9,060,939</td> </tr> <tr> <td>Boehringer Ingelheim Pharms., Inc. v. Anobri Pharms. US, LLC, 23-3530 (D.N.J.)</td> <td>29-Jun-23</td> <td>Hon. Claire C. Cecchi</td> <td>Spiriva® Respimat® (tiotropium bromide inhalation spray)</td> <td>7,284,474<br /> 7,896,264<br /> 7,396,341<br /> 9,027,967<br /> 7,837,235<br /> 8,733,341</td> </tr> <tr> <td>Boehringer Ingelheim Pharms., Inc. v. Anobri Pharms. US, LLC, 23-3531 (D.N.J.)</td> <td>29-Jun-23</td> <td>Hon. Claire C. Cecchi</td> <td>Combivent® Respimat® (ipratropium bromide / albuterol inhalation spray)</td> <td>7,284,474<br /> 7,896,264<br /> 7,396,341<br /> 9,027,967<br /> 7,837,235<br /> 8,733,341</td> </tr> <tr> <td>Otsuka Pharm. Co., Ltd. v. Apotex Inc., 23-0710 (D. Del.)</td> <td>30-Jun-23</td> <td>Hon. Richard G. Andrews</td> <td>Jynarque® (tolvaptan tablets)</td> <td>8,501,730<br /> 8,273,735</td> </tr> <tr> <td>Galderma Labs., L.P. v. Dr. Reddy’s Labs., Ltd., 23-0711 (D. Del.)</td> <td>30-Jun-23</td> <td>Hon. Stephanos Bibas</td> <td>Oracea® (doxycycline capsules</td> <td>7,749,532<br /> 8,206,740</td> </tr> <tr> <td>Intercept Pharms., Inc. v. Zenara Pharma Private Ltd., 23-0714 (D. Del.)</td> <td>30-Jun-23</td> <td>Hon. Maryellen Noreika</td> <td>Ocaliva® (obeticholic acid tablets)</td> <td>RE48,286</td> </tr> <tr> <td>Boehringer Ingelheim Pharms. Inc. v. Anobri Pharms. US, LLC, 23-0715 (D. Del.)</td> <td>30-Jun-23</td> <td>Hon. Gregory B. Williams</td> <td>Spiriva® Respimat® (tiotropium bromide inhalation spray)</td> <td>7,284,474<br /> 7,896,264<br /> 7,396,341<br /> 9,027,967<br /> 7,837,235<br /> 8,733,341</td> </tr> <tr> <td>Boehringer Ingelheim Pharms. Inc. v. Anobri Pharms. US, LLC, 23-0716 (D. Del.)</td> <td>30-Jun-23</td> <td>Hon. Gregory B. Williams</td> <td>Combivent® Respimat® (ipratropium bromide / albuterol inhalation spray)</td> <td>7,284,474<br /> 7,896,264<br /> 7,396,341<br /> 9,027,967<br /> 7,837,235<br /> 8,733,341</td> </tr> <tr> <td>Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0717 (D. Del.)</td> <td>30-Jun-23</td> <td>Hon. Colm F. Connolly</td> <td>Xeljanz® XR (tofacitinib citrate extended-release tablets)</td> <td>RE41,783</td> </tr> <tr> <td>Pfizer Inc. v. Sun Pharm. Indus. Ltd., 23-0718 (D. Del.)</td> <td>30-Jun-23</td> <td>Hon. Colm F. Connolly</td> <td>Xeljanz® XR (tofacitinib citrate extended-release tablets)</td> <td>RE41,783</td> </tr> </tbody> </table>Fri, 14 Jul 2023 00:00:00 -0500{37EEC821-9539-4FAB-A44F-B09C493D68C4}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/orexo-ab-v-sun-pharm-indus<i>Orexo AB v. Sun Pharm. Indus. Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>Orexo AB v. Sun Pharm. Indus. Ltd.</span></em><span>, Civ. No. 20-12588 (GC/DEA), 2023 WL 4492095 (D.N.J. July 12, 2023) (Castner, J.)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Zubsolv® (buprenorphine/naloxone); U.S. Patents Nos. 9,439,900 (“the ’900 patent”) and 11,020,387 (“the ’387 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> Orexo sued Sun based on its ANDA seeking to make and sell generic Zubsolv. Formulators developed Zubsolv to improve upon Suboxone® (also buprenorphine/naloxone), specifically, to formulate a drug with improved buprenorphine bioavailability. The asserted patents issued “because [the] formulation of Zubsolv® unexpectedly, and significantly improved bioavailability compared to the prior-art Suboxone®.” The court cited the drug’s ingredients and structural characteristics. The critical issue was whether Sun’s formulation, and/or the prior art, satisfied claim limitations reciting <em>separate</em> buprenorphine and weak acid particles.</span> <span>After a bench trial, the court issued findings of fact and conclusions of law finding that Sun’s ANDA products would infringe the valid asserted claims of the patents-in-suit.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Orexo Prevailed: </span></strong><span>With respect to infringement, in sum, the court did not find Sun’s expert persuasive, noting that Sun’s process “seems consistent with the [asserted patents’] specification.” In crediting Orexo’s expert over Sun’s on the separate particles issue, the court found that Orexo had proven infringement. Orexo also offered separate Raman and SEM evidence and testimony to show that Sun’s ANDA products met the separate particles limitation. Sun’s expert disagreed with the Raman and SEM results and opined that he saw “a composite particle based on his years of experience looking.” But again, the court credited Orexo’s expert. In particular, the court noted that Sun’s expert had not cited any academic literature to support certain opinions, nor did he perform his own Raman or SEM testing, nor did he review the electronic Raman data underlying Orexo’s expert’s work, because he did not have “the exact software package.” Important, the court noted—and Sun’s expert agreed—that the patent did not have to disclose all methods of testing for infringement. Finally, though the court did not rely on Sun’s PK data or its bioequivalence studies, the court did find that Orexo’s additional pH testing further supported a “separateness” finding and, thus, infringement.</span></p> <p style="margin-bottom: 12pt;"><em><span>With respect to validity, a</span></em><span>t trial Sun argued that the asserted claims were indefinite, lacked adequate written description, not enabled, and obvious. The court found that Sun had not proven invalidity under any of its theories. Sun’s indefiniteness argument—tethered to the separate particles limitation—failed because contrary to its arguments, all testing pointed in the same direction. Sun failed “to show how different tests lead to different infringement conclusions,” and the court instead found “that the different tests support the same infringement conclusion.”</span></p> <p style="margin-bottom: 12pt;"><span>Sun’s written description argument also failed. Sun argued that the specification disclosed only one way—and not Sun’s way—to achieve separate particles. But the asserted claims were <em>composition</em> claims, not method claims. Thus, the written description requirement does not demand that all methods of making the product, including those followed by Sun, be described in the specification. Sun’s enablement argument failed for a similar reason (“For product claims, such as those asserted here by virtue of the now-governing broad claim construction, the enablement requirement is satisfied if the specification provides a single way to make the claimed product.”).</span></p> <p style="margin-bottom: 12pt;"><span>Finally, the court determined that Sun had not met its burden in proving obviousness. First, Sun’s asserted references were before the Examiner during prosecution. Second, Sun did not demonstrate that the combined references disclosed all limitations of all asserted claims—in particular, that the weak acid particles are separate from buprenorphine microparticles, or the claimed dosage strengths. Perhaps most significant, the court determined that Sun had not shown a motivation to combine or a reasonable expectation of success—POSA did not have clear guidance on how to improve buprenorphine bioavailability in a sublingual tablet during the opioid crisis. The art “would not motivate a POSA to combine to get separate and distinct buprenorphine microparticles and a weak acid as claimed in the asserted patents with reasonable success.” Moreover, the court determined that Orexo had shown that Zubsolv®’s increased bioavailability was unexpected, and that there is a nexus between the increased bioavailability and the claimed inventions. The court also found evidence of unexpected patient preference (Zubsolv® over Suboxone®) and industry praise.</span></p>Wed, 12 Jul 2023 00:00:00 -0500{946EF335-ACC3-4C00-9CC5-3C91296A07A2}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/in-re-entresto-patent-litigation<i>In re Entresto Patent Litigation</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>In re Entresto (Sacubitril/Valsartan) Patent Litigation</em>, C.A. </span><span>Nos. 19-1979, 19-2021, 19-2053, 2023 WL 4405464 (D. Del. July 7, 2023) (Andrews, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Entresto® (sacubitril/valsartan); U.S. Patent No. 8,101,659 (“the ’659 patent”) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Novartis holds the NDA for Entresto, which the FDA approved “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction,” “for treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older,” and “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.” The ’659 Orange Book-listed patent has a priority date of January 17, 2002. It claims compositions of valsartan and sacubitril and the use of those compositions to treat hypertension and heart failure. Defendants seek FDA approval to market generic equivalents of Entresto. They have stipulated that their ANDA products would infringe the ’659 patent, and assert that the claims are invalid as obvious, lacking adequate written description, not enabled, and indefinite. After a three-day bench trial, the court found that the asserted claims lacked adequate written description and were therefore invalid. </span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Defendants Prevailed</span></strong><span>: The court noted that the touchstone of written description is possession as of the priority date. Defendants argued that because sacubitril/valsartan complexes were unknown as of the 2002 priority date, Plaintiff did not possess such complexes and therefore could not have described them. Plaintiffs responded that the ’659 patent satisfied the written description requirement by disclosing valsartan and sacubitril—the structural features (i.e. chemical names and/or chemical formulas) common to the members of the claimed genus of the pharmaceutical composition containing the valsartan and sacubitril combination. Plaintiff further pointed out that physical mixtures of valsartan and sacubitril, and complexes of valsartan and sacubitril, are mere subsets of the claimed genus. But “Plaintiff’s trouble is that written description also requires that common structural features be described ‘with enough precision that a relevant artisan can visualize or recognize the members of the genus.’” The ’659 patent specification described physical mixtures only. It did not, and could not, allow a POSA to visualize the members of the entire genus sufficient to show possession of complexes, which, to a POSA’s knowledge, had not yet been discovered.</span></p>Fri, 07 Jul 2023 00:00:00 -0500{A96C646A-E30B-41EB-A8C4-F7EC82B8BA4D}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q3/novartis-pharms-v-mylan-pharms<i>Novartis Pharms. Corp. v. Mylan Pharms. Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Novartis Pharms. Corp. v. Mylan Pharms. Inc.</em>, Civ. </span><span>No. 19-cv-201, 2023 WL 4375445 (N.D.W.V. July 6, 2023) (Kleeh, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Entresto® (sacubitril / valsartan); U.S. Patents Nos. 8,877,938 (“the ’938 patent”) and 9,388,134 (“the ’134 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Mylan filed an ANDA seeking approval to market a generic </span><span>sacubitril/valsartan tablet for the treatment of heart failure. The parties dispute whether claims 1 and 11 of the ’938 patent and claim 5 of the ’134 patent are valid and enforceable. The parties also dispute whether Mylan’s ANDA product infringes the asserted claims. After a bench trial, the court found that Novartis had shown by a preponderance of the evidence that Mylan’s API is a substantially pure hemipentahydrate and Mylan’s API and ANDA products would infringe the patents-in-suit.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Novartis Prevailed:</span></strong><span> The patents-in-suit recited substantially pure trisodium sacubitril-valsartan (“TSVH”) hemipentahydrate in crystalline form. Mylan argued that its API was not substantially pure and that it was not hemipentahydrate.</span></p> <p style="margin-bottom: 12pt;"><span>The court construed “substantially pure” to mean that the API had at least 90% chemical purity. Mylan’s ANDA specification required that its Form II API had not more than 2.95% w/w impurities and residual solvents. Further, Plaintiff’s expert tested Mylan’s finished dosage form, finding that it had less than 0.50% w/w total impurities and residual solvents. Plaintiff’s expert also explained that although Mylan’s Form II contained amorphous material, he found that there was not a substantial amount in the final product (i.e., less than about 0.5% w/w.). Finally, the court concluded that the additional XRPD peaks not corresponding to Form II were from inactive ingredients (i.e., excipients) used to make the final formulation and did not corresponding to impure Form II.</span></p> <p style="margin-bottom: 12pt;"><span>Mylan also argued that its API was not hemipentahydrate. In so doing, it relied on a single crystal analysis performed by the DMF holder to posit that its Form II API was a trihydrate, not a hemipentahydrate. Plaintiff’s expert analyzed the Form II single crystal structure proffered by Mylan and found that the occupancies for certain water molecules were chemically impossible. Instead, when the occupancies for those water molecules were corrected based on known chemistry, Plaintiff’s expert found that the single crystal structure for Form II was hemipentahydrate. In particular, hemipentahydrate in TSVH refers to 2.5 bound water molecules per molecule of trisodium sacubitril-valsartan.</span> <span>As summarized by Plaintiff’s expert, Mylan’s Form II contained an estimated 4.70% to 4.71% w/w bound water, which was within 0.01% of the theoretical 4.70% w/w for 2.5 bound waters.</span></p>Thu, 06 Jul 2023 00:00:00 -0500{971E52CD-AC94-4428-9EB0-78D0CBC33CB7}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/sanofi-aventis-us-v-sandoz<i>Sanofi-Aventis U.S. LLC v. Sandoz, Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Sanofi-Aventis U.S. LLC v. Sandoz, Inc.</em>, </span><span>No. 20-804-RGA, 2023 WL 4175334 (D. Del. June 26, 2023) (Andrews, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Jevtana® (cabazitaxel); U.S. Patent No. 10,716,777 (“the ’777 patent”) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Jevtana is administered “in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.” Metastatic castration-resistant prostate cancer (“mCRPC”) is prostate cancer that has spread beyond the prostate and has become resistant to the hormonal therapies used as a first line of defense. The </span><span>‘</span><span>777 patent claims a method for increasing survival when administering an H2 antagonist prior to administering 20 to 25 mg of cabazitaxel to a patient with mCRPC that has progressed through treatment with docetaxel. After a four-day bench trial, the court found the ’777 patent infringed and not invalid for obviousness.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Sanofi-Aventis Prevailed</span></strong><span>: With respect to infringement, Sandoz argued that its label did not establish a specific intent to induce infringement. In particular, Sandoz argued that its label did not establish that cabazitaxel be administered with the “intentional purpose” of increasing survival. Sanofi argued that when a health care professional (“HCP”) looks at the label, his or her main goal when administering the drug is to extend the patient’s life. In response, Sandoz argued that “its product is indicated not for increasing mCRPC patient’s survival, but for the treatment of patients with mCRPC.” Next, Sandoz argued that where its label mentions “survival,” it is not referring to “increasing survival” as used in the </span><span>’</span><span>777 patent. Moreover, Sandoz argued that its product must have benefits beyond just increasing overall survival since it removed certain prescribing information from its label. The court disagreed with all four of Sandoz’s arguments, finding that a POSA reading the label would conclude that its goal was to improve “overall survival.” </span></p> <p style="margin-bottom: 12pt;"><span>With respect to obviousness, the parties agreed that although the compound cabazitaxel was known, the prior art did not teach that it could be used to increase survival rates of patients with mCRPC. The parties also agreed that the art did not teach using a H2 antagonist as a premedication for cabazitaxel. As to motivation to combine, Sandoz argued that the prior art teachings in combination with a Sanofi clinical trial would have provided the motivation for a skilled artisan to use cabazitaxel to increase a patient's survival. In response, Plaintiffs argued, at least with respect to docetaxel-sensitive patients, that a skilled artisan would continue to treat with docetaxel rather than switch to a new drug. The court agreed with Sandoz and concluded that a POSA would have been motivated to administer cabazitaxel to mCRPC patients with the hopes of increasing survival. With respect to expectation of success, Sandoz acknowledged that a</span><span> skilled artisan </span><span>might not have had a reasonable expectation of success for all patients, but that the art suggested increased survival for at least some patients having received a 20-25 mg dose of cabazitaxel. Further, Sandoz pointed to Sanofi’s clinical trial as support for a skilled artisan’s reasonable expectation of success. Sanofi argued that Sandoz misinterpreted the art and explained that the sample size in each paper was “small” and that the patients’ responses were not significant. Sanofi also explained that the prior art “questioned whether the drug would be tolerable at the doses necessary for anticancer activity.” Finally, Sanofi argued that the clinical trial was irrelevant because it was “conducted on a different cancer.” The court concluded that “cautious optimism” was not sufficient and found that Sandoz has not demonstrated a reasonable likelihood of success.</span></p>Mon, 26 Jun 2023 00:00:00 -0500{02C2051C-6811-48B8-8E13-5DD7265C6897}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-june-2023/lessons-from-the-trial-trenchesLessons from the Trial Trenches: How to Avoid Large Adverse Verdicts<p>The Spotlight had a chance to sit down with Robins Kaplan trial attorney Mike Collyard after his historic and latest trial result—the largest verdict in the State of Minnesota—to glean some practical advice on how companies and those in positions of trust can avoid massive (or even moderate) liability that Mike’s adversaries have endured.</p> <p><strong>The Spotlight</strong>: Mike, some of your cases involve scenarios where there is not one evil mastermind to blame, but rather a series of repeated failings by a number of people that add up to serious liabilities. Can you explain some of those scenarios and how that could happen?</p> <p><strong>Collyard</strong>: When we are the plaintiff suing another company, we always want to make the corporate defendant the bad guy (not its individual employees). Juries will punish companies for doing bad (or stupid) things, but human nature is to be more forgiving of an individual or two who did something wrong or fell short of a standard. And jurors might be able to relate to those individuals when they tell their story on the stand. So we try to take the individual failings as a whole and make them part of a systematic business problem that we can blame the company for. That gives you a far better shot at a bigger damages pool when you tell your plaintiff-side story to a jury who is generally less sympathetic to corporations.  </p> <p><strong>The Spotlight</strong>: Based on what you’ve learned in those cases, how would you advise your clients and others to mitigate the risks of those scenarios occurring on their watch?</p> <p><strong>Collyard</strong>: In defending a case, it’s just the opposite. We often use the individual employees to be the company’s face. Use a sympathetic employee who jurors can relate to who can tell the company’s story. This gives the company a persona that the jurors can connect with and not want to punish. Also, make sure your employees are following good guidelines and policies. If employees are doing that, it gives you a better chance of telling a story about how the company always chose to do the right thing and the individuals were doing exactly what they were told. Jurors can easily relate to that type of story and defense.  </p> <p><strong>The Spotlight</strong>:<strong> </strong>You’ve also been able to capitalize on missteps of your adversaries during the litigation process. Can you describe how companies can make their situation worse and what they should do to avoid that fate?</p> <p><strong>Collyard: </strong>There are easily three parts to this: a court part, a jury part, and a discovery part. First, always maintain credibility with the court. We often decide early on to not fight certain things and to only fight things we win. So every time we speak, we win. That creates credibility with the court, and the court knows we’re right every time we speak. The court knows when you’re being reasonable and will appreciate it. That will pay off throughout the case when it comes time for the court to make hard decisions. </p> <p>Second, create credibility with jurors through your witnesses. Teach your witnesses how to properly give testimony during depositions and at trial. Teach them to not say things like “I don’t recall” after an objection. Instead, teach them a factual story to tell, and, if the question calls for something they don’t exactly remember, have them say something like “I knew that before, but I can’t think of it sitting here right now without having my computer.” That keeps the door open for them to fix that testimony later and maintains credibility so they can’t be impeached. They look like they’re being helpful and not hiding something from the jury. </p> <p>Third, don’t be your worst enemy in discovery. There are so many ways to get in the way of yourself during discovery. The biggest example is document preservation and production. Preserve documents and produce documents. Don’t be afraid of producing documents. As a plaintiff, you can make so much out of a defendant not preserving or producing documents. Have the big picture in mind no matter which side of the case you’re on, and don’t get too greedy where you get caught withholding things because you just don’t want to produce them. We like to go in with a “we have nothing to hide” approach if possible and really only fight on the most sensitive issues. Taking the opposite approach can be very detrimental. In my most recent trial, we were able to obtain an adverse-inference instruction due to the other side’s destruction of evidence and repeated misrepresentations about it to the court. That played right into our narrative about the defendant being the bad guy and gave us a tremendous advantage at trial.</p> <p><strong>The Spotlight</strong>:<strong> </strong>You’ve handled cases where trust and duty can play a key role in your trial themes. Explain why that can be effective and what companies can do to increase their chances of having those themes work in their favor?</p> <p><strong>Collyard: </strong>Choices and taking responsibility are always good themes on both sides of the “v,” depending how you spin it. So we like to position ourselves to be able to say our client chose to do the right thing and our client takes responsibility, while the bad guys chose to do the wrong thing and refuse to take responsibility. You say it like “you could have done this, but you chose not to.” So help yourself out by creating a culture that not only has good policies and procedures but supports your people in sticking to them. That can give you a solid foundation to incorporate these themes throughout your trial story, and these are both themes that sell easily.   </p>Tue, 13 Jun 2023 00:00:00 -0500{DDECC2F5-56B8-4C7D-A127-0F796C9CF3F4}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-june-2023/on-the-emotional-costs-of-litigationOn the Emotional Costs of Litigation<p> </p> <p style="text-align: center;"><em>“Mr. Kenge,” said Allan, appearing enlightened all in a moment. “Excuse me, our time presses. Do I understand that the whole estate is found to have been absorbed in costs?”</em><br /> <em>“Hem! I believe so,” returned Mr. Kenge.</em><br /> <em>[…]</em><br /> <em>“My dearest life,” whispered Allan, taking me hurriedly from them, “this will break Richard’s heart!”</em></p> <p>Anyone familiar with Charles Dicken’s <em>Bleak House</em> will recall the gloomy dénouement regarding the eternally litigated Jarndyce and Jarndyce case and the sudden reckoning that the cost of the fight had, like the snake eating its own tail, negated the reason for the fight. </p> <p> While lawyers will often counsel clients facing or navigating litigation about the emotional toll that the litigation inflicts on the parties, in practical reality, those same emotions can bring high economic costs. Particularly with disputes among former business partners or family members, such costs are not only difficult to quantify, but they also present challenging topics for clients and potential clients in the early throes of a dispute. The early stages are, however, the best time to frame the role that emotion may play for a client or potential client. Toward that end, a discussion agenda should include the following:</p> <p style="margin-left: 40px;"><strong>1. Justifiable Emotions Do Not Necessarily Correspond With Illegality.</strong></p> <p style="margin-left: 40px;">Even in highly sympathetic situations, the adage “there ought to be a law” remains an unanswered call for many people who harbor grievances with a former partner, business associate, or family member. This discussion is perhaps the first and most important between a potential client and lawyer before embarking on a process that looks cathartic at the start but that assuredly will not remain in that vein beyond the early stages of the fight. The earlier that an honest assessment of what part of a potential client’s plight are ethical, moral, human, or consumer, as opposed to grounded in statutory or common law, the better the emotional and real prospects for the potential client. This early, honest conversation can be the most valuable service a lawyer provides.  </p> <p style="margin-left: 40px;"><strong>2. Define a Win. </strong></p> <p style="margin-left: 40px;">If the conversation survives an honest discussion regarding the nature of a potential client’s grievance, an equally important topic is discussing the nature of potential outcomes. Even the most sophisticated of potential clients can feel so strongly about their experience that they will yearn for validation from a fact-finder who will adjudge them the winner. What lawyers know but sometimes do not discuss early enough is the challenging duality that, though few cases go to trial, if parties are not settlement minded, it can be exceedingly difficult to step off the trial treadmill. An early discussion of satisfactory outcomes, alternatives, and flexible paths that leave open such alternatives is key early in the attorney-client relationship.</p> <p style="margin-left: 40px;"><strong>3. Emotions Abhor a Budget.</strong></p> <p style="margin-left: 40px;">We cannot predict the future, but we know with near certainty that parties will be even more motivated to seek a psychological upper hand in emotionally charged cases. In cases involving family and former business associates, that means parties know one another and have, consciously or unconsciously, amassed a bank of knowledge for pushing one another’s buttons. If one is not strategic, this can become a very expensive game of psychological warfare. Picking one’s battles (because they are not free) is a plan best made very early, so you can revisit it when a client’s instinct to “win every battle at all cost” is neither economical nor strategic.  </p> <p style="margin-left: 40px;"><strong>4. The Right Services From the Right Professional.</strong></p> <p style="margin-left: 40px;">One of the most delicate but invaluable conversations with clients is informing them of limits to your professional services and the need for other support and professionals. This is all the truer with emotionally charged matters where the line between the client’s need for advice and their emotional state can become blurred inadvertently. In disputes involving business interests and family, financial and tax planning will likely be required, and if not attended to early can restrict options for resolution or present unforeseen consequences for the client. A client’s physical and mental health is equally or more important than other aspects of the dispute, and the stress of litigation can adversely impact both. Specific to the client’s mental well-being, it is understandably easy for the legal counseling role played appropriately by a lawyer to bleed into acting as a support person, a role for which the lawyer isn’t properly trained. This situation disadvantages both client and attorney when the client requires and deserves a different level and type of support than the lawyer is qualified to provide. An early conversation about having the appropriate professionals in place, including counselors, benefits both client and lawyer. </p> <p style="margin-left: 40px;"><strong>5. The Price of Peace.  </strong></p> <p style="margin-left: 40px;">Resolution can be surprisingly difficult in cases involving high emotion. Balanced against the potential to shed a large burden are perceptions of justice, fairness, and right and wrong. Faced with a dispute with personal dimensions involving family or a business, the practical benefits of controlling your own destiny by settling out of court can be difficult to appreciate when the dispute is in full wind-up mode. But most cases do and should resolve through some form of settlement, and talking about it as early as possible, if not at the point of retention, can benefit both the lawyer and the client, and save costs. </p> <p> Disputes with emotional aspects are destined to have a longer arc than even standard litigation. For that reason, early and frank conversation about their real and potentially costly dynamics can help lawyers and their clients make informed decisions about engaging in litigation in the first place—and how to navigate it if they decide to do so.</p>Tue, 13 Jun 2023 00:00:00 -0500{5C88D956-8948-4EA4-A876-195EF0FC6E24}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-spotlight/2023/spotlight-june-2023/understanding-fiduciary-duties-and-obligations-in-investment-and-divestmentUnderstanding Fiduciary Duties and Obligations in Investment and Divestment <p> Fiduciaries, such as trustees, financial advisors, corporate directors, and fund managers are legally bound to act in the best interests of their beneficiaries and/or clients. Duties owed by fiduciaries, including duties of prudence, diligent monitoring, loyalty, and disclosure often arise in the context of asset investment and divestment. Understanding the contours of these fiduciary duties as shaped by caselaw is important to evaluate potential exposure for breach. </p> <p>One of the fundamental principles guiding fiduciary obligations is the duty to invest and manage trust assets, also known as the prudent investor rule.<sup><span style="font-size: 10px;">1</span></sup> Governed by the Uniform Prudent Investment Act (“UPIA”), the rule requires trustees to exercise reasonable care, skill, and caution in managing trust investments.<sup><span style="font-size: 10px;">2</span></sup> This includes the duty to diversify the investments so as to minimize the risk of loss, unless it is reasonably determined that it is better not to do so.<sup><span style="font-size: 10px;">3</span></sup> For instance, a trustee managing a trust fund should avoid concentrating investments in limited vehicles, instead spreading them across asset classes to ensure prudent risk management.<sup><span style="font-size: 10px;">4</span></sup> However, stock in closely held businesses need not be sold for diversification reasons if the stock has a special relationship to a trust purpose or to the beneficiaries.<sup><span style="font-size: 10px;">5</span></sup>  </p> <p> However, the duty to diversify is not absolute. Fiduciaries must balance diversification with other factors, such as the specific needs and circumstances of the different beneficiaries, the purposes of the trust, and the nature of the trust assets. Thus, the level of diversification required may vary depending on factors such as the size of the trust, the investment goals, and the risk tolerance of the beneficiaries. </p> <p><strong>Duty to Monitor Investments </strong></p> <p> Fiduciaries also have a duty to actively review investments to ensure their continued suitability. For example, in <em>Tibble v. Edison International</em>,<sup><span style="font-size: 10px;">6</span></sup> beneficiaries of a defined-contribution retirement savings plan brought an Employee Retirement Income Security Act (“ERISA”) action for breach of fiduciary duties, seeking to recover damages for losses suffered by the plan, among other relief. The Supreme Court held that “a trustee has a continuing duty to monitor trust investments and remove imprudent ones.”<sup><span style="font-size: 10px;">7</span></sup> This continuing duty exists “separate and apart from the trustee’s duty to exercise prudence in selecting investments at the outset.”<sup><span style="font-size: 10px;">8</span></sup> </p> <p><strong>Duty of Loyalty and Conflicts of Interest</strong></p> <p> The duty of loyalty is another essential aspect of fiduciary obligations. Fiduciaries must act in the best interests of beneficiaries, avoid conflicts of interest, and disclose any potential conflicts to ensure transparency and maintain the trust placed in them. The widely cited case <em>Meinhard v. Salmon, et al.</em> established this principle.<sup><span style="font-size: 10px;">9</span></sup> The court held that the defendant breached his fiduciary duty of loyalty by exploiting a business opportunity for his personal gain that rightfully belonged to the partnership. The court further held that fiduciaries must disclose any conflicts of interest and have an ongoing duty to fully disclosure opportunities that may arise during their fiduciary relationship.</p> <p><strong>Duty to Disclose Material Facts</strong></p> <p> Transparency and full disclosure of material facts are essential components of fiduciary obligations. <em>Lingsch v. Savage</em>,<sup><span style="font-size: 10px;">10</span></sup> a formative California case, established that fiduciaries, such as real estate brokers, have a duty to disclose all material facts to beneficiaries or clients, especially when making investment decisions on their behalf. In this example, the real estate broker was found to have breached its fiduciary duty to disclose material facts to the purchasers, including that the property was in a state of despair and the building had been placed for condemnation by city officials, among other things. The duty to disclose material facts ensures that beneficiaries can make informed decisions based on complete and accurate information. Failing to disclose relevant information may not only lead to a breach of fiduciary duty, but also a finding of fraud.</p> <p><strong>Divestment Strategies and Winding Up Assets</strong></p> <p> Divestment from certain investments has also become a significant consideration for fiduciaries. In a New York district court case involving an employment benefit fund against an insurer and insurance agent, <em>Buccino v. Continental Assurance Co., et al</em>.,<sup><span style="font-size: 10px;">11</span></sup> the court found that the fiduciaries’ failure to advise the investment fund to divest itself of unlawful and imprudent investments resulted in a continuing breach of its fiduciary obligations, giving rise to a new cause of action each time the fund was injured by its continued possession of the investments. Therefore, fiduciaries are obligated to properly divest of assets when reasonably necessary, and the continued failure to do so can result in a continuing breach of the fiduciary duty.</p> <p> The obligation to properly divest of assets also may arise in “wind-up” scenarios of trust affairs. In a well-known California case, <em>Sterling v. Sterling</em>,<sup><span style="font-size: 10px;">12</span></sup> the court held that the trustee’s act of selling a professional basketball team held by a revoked trust was not only a valid exercise of the trustee’s power to wind up trust assets, but also in the best interest of the beneficiaries. The sale of assets during the wind-up process was challenged for increasing the trust assets in violation of Section 15407(a)(5). However, the court rejected this notion, instead noting that even when acting within its “wind-up” powers, a trustee must still abide by the obligation of seeking the best possible result for the beneficiaries.<sup><span style="font-size: 10px;">13</span></sup></p> <p><strong>Conclusion</strong></p> <p> It is critical for fiduciaries to exercise due diligence in assessing investment opportunities, monitoring the performance of investments, and regularly reviewing the composition of portfolios. Understanding these and other obligations is important to avoid exposure, ensure the protection of beneficiary interests, and maintain the integrity of the fiduciary relationship.</p>Tue, 13 Jun 2023 00:00:00 -0500{EB61307A-4CF1-46B3-97C7-D5E7258384B2}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/astellas-pharma-v-sandoz<i>Astellas Pharma Inc. v. Sandoz Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Astellas Pharma Inc. v. Sandoz Inc.</em>, Civ. No. 20-1589, </span><span>2023 WL 3934386 (D. Del. June 9, 2023) (Bataillon, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Myrbetriq® (mirabegron); U.S. Patent No. 10,842,780 (“the ’780 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> Astellas sued to enjoin a number of Defendants from marketing generic versions of Myrbetriq, an extended-release formulation of mirabegron for the treatment of overactive bladder. The ’780 patent claims overcoming “food effect,” described as a drug’s dangerous potency on an empty stomach contrasted by its inefficacy on a full one, by describing an extended-release formulation of mirabegron comprising a hydrogel-forming polymer, hydrophilic additive, and a dissolution limitation: that the dosage has dissolved no more than 39% at 1.5 hours and at least 75% after 7 hours. The parties engaged in a five-day bench trial. The court found that the asserted claims were invalid.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Defendants Prevailed: </span></strong><span>Defendants argued that the ’780 patent was invalid for not meeting the enablement requirement of 35 U.S.C. § 112. Specifically, Defendants argued that the patent specification did not offer sufficient clarity to enable a skilled artisan to make the invention without undue experimentation. Astellas countered that the specification directs routine activity by highly-skilled artisans in a predictable art. Taking Astellas at its word, the court found that Astellas conceded that the ’780 patent was enabled because it claimed invalid subject matter: a natural law applied via routine, conventional, and well-known methods. Relying extensively on Astellas’s expert conceding at trial that sustained release hydrogel formulations were well-known, well-characterized, not difficult to formulate, and not difficult to tune to arrive at a suitable dissolution profile, the court found that “Astellas’s zealous defense has conceded more fundamental ground. Embodying no more than the discovery of a natural law applied via well-known techniques for formulating sustained release tablets, the ’780 patent claims ineligible subject matter.”</span></p>Fri, 09 Jun 2023 00:00:00 -0500{240067C7-63BF-4D31-B50A-236DA45F7E4E}https://www.robinskaplan.com/resources/legal-updates/the-robins-kaplan-justice-report/2023/the-robins-kaplan-justice-report/raoul-shah-keeping-humanity-and-compassion-closeRaoul Shah: Keeping Humanity and Compassion Close<p> For Raoul Shah, the decision to become a lawyer was always about helping people. His passion stems from validating victims’ experiences and helping them hold their wrongdoers accountable.</p> <p>Before joining Robins Kaplan in early 2023, Raoul spent two-and-a-half years as a Hennepin County prosecutor, focused on violent adult crimes. He worked on everything from DWI to murder cases, spending most of his time on the team that prosecuted adults who committed crimes against children. Before that, he was a child protection attorney for two years, representing child protective services.</p> <p>“Seeking justice and accountability on behalf of children has always been very important to me,” he said. “I tried several child sexual assault cases where almost no one believed the child. It was crucial for me to give children a voice in the court process.”</p> <p> During his two years in the child protection division, Raoul tried eight court trials. Those cases often involved multiple years of history, staying on top of documents, and being very familiar with files. On the criminal side, he tried approximately 15 trials in his two-and-a-half years as a prosecutor. Each case has had a lasting impact on him.</p> <p>“Every conversation I’ve had with someone who’s been personally harmed or lost someone close to them–especially when it involves children–has stuck with me. Some have reminded me of the importance of being a voice for those who otherwise wouldn’t have one in the system. Some have been, and continue to be, humbling reminders to do better–to not let the system fail those who have already been harmed,” he said.</p> <p> From his extensive trial experience, Raoul has learned to think on his feet and react quickly to the unexpected. He found that being ready to pivot at a moment’s notice is just as important as being familiar with the case and prepared for trial. </p> <p>“Trials are very dynamic and the worst thing you can do is go into it expecting everything to go your way or exactly as planned,” he said.</p> <p> Raoul has also learned the importance of building rapport and credibility with juries. This has been especially imperative in his role as a prosecutor over the past few years, when there has been a lot of criticism of the criminal justice system, law enforcement, and prosecutors. </p> <p>“I had to be even more sure that I was credibly and effectively portraying the facts to the jury,” he said. “I’m not someone who will put on a mask or a face when talking to a client, a judge, opposing counsel, or the jury. Everyone will get the same Raoul Shah throughout the entirety of the case, because authenticity and humanity are extremely important as a trial attorney.” </p> <p> Now, as an associate in the firm’s Personal Injury and Medical Malpractice Group, Raoul looks forward to continuing to grow his trial experience in his new role as a plaintiff’s attorney.</p> <p>“My goal has always been to validate the experiences of those harmed, and as a plaintiff’s attorney now, that translates perfectly,” he said. “I get to help share the client’s experience with the court, with opposing parties, and with the jury to make them see that the client’s experience mattered, and to seek accountability and compensation for the harm.”</p> <p> While the work may be slightly different, Raoul still approaches it with the same mission in mind: helping people.</p> <p>“We see people on their worst days, and we must try to make things better,” he said.</p> <p>“One of the things that has always been important to me is keeping humanity and compassion close. It’s something that can easily get lost in the legal profession. I keep these things close to my heart as I work with clients who have experienced a significant injury or loss and continue to live with that every day.”</p>Wed, 24 May 2023 00:00:00 -0500{5152141D-2058-4AF7-ADF5-A9B2B0C3788F}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/janssen-pharms-v-mylan-labs<i>Janssen Pharms., Inc. v. Mylan Labs. Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Janssen Pharms., Inc. v. Mylan Labs. Ltd.</em>, </span><span>No. 20cv13103, 2023 WL 3605733 (D.N.J. May 23, 2023) (Padin, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Invega Trinza® (paliperidone palmitate); U.S. Patent No. 10,143,693 (“the ’693 patent”) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Injectable paliperidone palmitate is indicated for the treatment of schizophrenia and other similar conditions. The reference-listed drug is administered by subcutaneous injection once every three months (“PP3M”). The </span><span>’</span><span>639 patent relates to a method of treating patients that missed a treatment of PP3M. In particular, the asserted claims recite a dosing schedule, including a one-month, reinitiation dose on day 1 (“PP1M”), a second PP1M on about day 4 to day 12, and then a PP3M on about day 23 to day 37. Mylan sought to market a generic paliperidone palmitate. Janssen sued for patent infringement and the court found that Mylan’s ANDA product would infringe the valid patent claims.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Janssen Prevailed: </span></strong><span>The court first addressed the issue of infringement. Janssen argued that Mylan’s proposed label would induce health care professionals (“HCPs”) to induce infringement by administering the drug. In response, Mylan raised a divided infringement defense, contending that there would be no direct infringement because the reinitiation dosing regimen would be carried out by two independent actors: the patient, who missed a dose of PP3M and chose to return for treatment three times, and that patient’s HCP, who administers the claimed dosing regimen. As a threshold matter, the court found that Mylan waived its divided infringement theory because it was not properly disclosed in its contentions and appeared for the first time in Mylan’s rebuttal expert report. But even if that argument had been preserved, the court held that a single entity, the HCP, performed the claimed reinitiation dosing regimen. Mylan interpreted the claimed method as having seven, not three, steps: the patient missing a dose and returning three times for the injections (four steps), plus the injections administered by the HCP (three steps). The court rejected this interpretation, finding that the injections comprise the only three steps, and that each was administered by a HCP.</span></p> <p style="margin-bottom: 12pt;"><span>Next, the court addressed Mylan’s obviousness defense. Mylan failed to demonstrate that the claimed limitations were present in the prior art, that a POSA would have reason to combine the prior art references, and that the skilled artisan would have a reasonable expectation of success in doing so. The half-life of PP3M was not known in the prior art. But in arguing that the claimed dosing regimen was obvious, Mylan’s expert assumed that PP3M’s half-life could be extrapolated from PP3M’s dosing interval (every 3 months). The expert then extrapolated from the half-life of PP1M, 30 days (based on its dosing interval), and multiplied by three to arrive at a 90-day half-life for PP3M. Janssen’s experts argued, however, that a POSA would not have relied on simple extrapolation of PP1M data to arrive at conclusions about PP3M pharmacokinetics. The court also explained that there was no motivation or expectation of success to use PP3M without first stabilizing the patient for four or more months on PP1M. In particular, every PP3M reference Mylan relied on required patient stabilized on PP1M for at least 4 months prior to advancing to PP3M.</span></p> <p style="margin-bottom: 12pt;"><span>The court also concluded that secondary indicia supported a conclusion of non-obviousness. Trinza met a long-felt need by offering a three-month dosing interval. Further, the court found commercial success because the dosing regimen added significant “‘option value’ like an airbag or other safety feature in a vehicle; though it is not certain, or even probable, that the airbag will ever be needed, it is a significant purchase factor for many buyers.” Finally, the court concluded that there was skepticism that Trinza would provide the promised therapeutic benefit for the full 3-month dosing interval.</span><span> </span></p> <p style="margin-bottom: 12pt;"><span>Finally, the court addressed Mylan’s Section 112 defenses. Mylan argued that the </span><span>’</span><span>963 patent was invalid for non-enablement and lack of written description. As to enablement, the court found that the specification of the </span><span>’</span><span>693 patent taught the concentration and ingredients necessary for the PP1M and PP3M formulations. Moreover, the patent specification taught the particle size range for PP1M and PP3M and provided general and specific manufacturing instructions sufficient to enable a skilled artisan to prepare the particles.</span><span> </span><span>The </span><span>’</span><span>693 patent also described “preferred” examples. The court further explained that the patent claims were not unduly broad because they are directed to dosing regimens listing specific formulations, amounts, timing, and injection sites. Nor are “PP1M” or “PP3M” themselves unduly broad because a skilled artisan would understand the </span><span>’</span><span>693 patent to limit PP1M and PP3M formulations to the specific ingredients. Finally, the court concluded that Mylan’s expert offered contradictory positions: “[h]ere his arguments in the alternative simply emphasize the contradiction between testifying, on the one hand, that the prior art makes the Asserted Claims obvious, and on the other, that they are not enabled because they are too vague.” As to written description, Mylan argued that there were no working examples of PP3M. The court disagreed and explained that the patent had sufficient written description support because the specification included information about the structural features of PP1M and PP3M, such as the ingredients, concentrations, particle size, and manufacturing information.</span></p>Tue, 23 May 2023 00:00:00 -0500{4CD23BA8-1F62-4054-BA11-0C8E2EAD96F6}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/in-re-sugammadex<i>In re Sugammadex</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>In re Sugammadex</span></em><span>, No. 20-CV-2576 (CCC/LDW), 2023 WL 3966146 (D.N.J. June 13, 2023) (Cecchi, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Bridion® (sugammadex sodium); U.S. Patent No. RE44,733 (“the ’733 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> In Merck’s consolidated action against various ANDA filers, the court took up one issue: whether a patent term extension (PTE) was invalid. The ANDA filers challenged the reissue patent’s five-year PTE (a consequence of FDA’s nearly 12-year regulatory review of Bridion). Specifically, Defendants contended that calculation of a PTE for a reissue patent must be based on the date that the reissue patent issued, pursuant to § 156(c) of the Patent Act. Defendants argued that reading § 156(c) in this way entitles Merck to only 686 days PTE, rather than the five years that the PTO granted. Defendants’ validity challenge, if meritorious, would render the portion of the patent after December 14, 2022, invalid under 35 U.S.C. § 282(c). In response, Merck argued that “the date the patent is issued,” read in the proper context, refers to the date that the <em>original</em> patent issued. </span></p> <p style="margin-bottom: 12pt;"><span>Thus, “the crux of the legal dispute concerns whether the Patent Act requires a patent term extension of a reissued patent to be calculated based on the issue date of the original patent—the term of which is inherited by the reissue patent—or, conversely, based on the issue date of the reissued patent.” After a one-day bench trial, the court found that the PTE was not invalid under § 282(c).</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Merck Prevailed:</span></strong><span> The facts of the case were almost entirely undisputed. Merck’s original patent covering sugammadex issued on December 20, 2003. But Merck could not market its product until December 15, 2015, nearly 12 years later. Because the Hatch-Waxman Act allows for restoration of patent term lost to lengthy FDA regulatory review, Merck sought a PTE (maximum five years). And the PTO granted it.</span></p> <p style="margin-bottom: 12pt;"><span>The issue here arises from the reissue patent. When Merck applied for a PTE in 2016, the original patent had been surrendered and the reissue patent put in its place. 35 U.S.C. § 156(c) requires calculation of PTE based on the “regulatory review period for the approved product” that “occurs after the date the patent is issued.” Understanding “the date the patent is issued” in § 156(c) to refer to the term of the <em>original</em> patent, Merck calculated that it was entitled to the maximum allowable five-year PTE. The PTO agreed. But the ANDA filers contended that the PTO should have used the date that the <em>reissue</em> patent issued—which reduces the PTE to less than two years.</span></p> <p style="margin-bottom: 12pt;"><span>The court ultimately determined that, when read in the proper context alongside statutes addressing reissue, the issue date of the <em>original</em> patent is used for calculating PTE. Defendants’ proposal creates an untenable reading of the statutory scheme on the whole and conflicts with other provisions of the Patent Act. Moreover, Defendants’ interpretation would undermine the purpose of the Hatch-Waxman Act, in contrast to Merck's interpretation, which aligns with it. Using the original issue date also comports with the PTO’s policy and longstanding practice of treating reissued patents as if they were originally granted in amended form for purposes relevant to the PTO’s administration of the Patent Act.</span></p>Sat, 13 May 2023 00:00:00 -0500{F7734F93-3F07-4A87-B8C3-8F9467F19713}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/vanda-pharms-v-teva-pharms<i>Vanda Pharms. Inc. v. Teva Pharms. USA, Inc.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><em><span>Vanda Pharms. Inc. v. Teva Pharms. USA, Inc.</span></em><span>, No. 2023-1247, 2023 WL 3335538 (Fed. Cir. May 10, 2023)</span><span> </span><span>(Circuit Judges Dyk, Bryson, and Prost presiding; Opinion by Dyk, J.) (Appeal from D. Del., Connolly, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit: </span></strong><span>Hetlioz® (tasimelteon); U.S. Patents Nos. RE46,604 (“the ’604 patent”), 10,149,829 (“the ’829 patent”), 9,730,910 (“the ’910 patent”), and 10,376,487 (“the ’487 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented:</span></strong><span> Vanda sued Teva and Apotex, alleging that their ANDAs infringe four patents. The asserted claims relate to methods of treating Non-24-Hour Sleep-Wake Disorder (“Non-24”) with tasimelteon. The district court held that all of the asserted claims were invalid as obvious. The Federal Circuit affirmed.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Defendants Prevailed: </span></strong><span>On appeal, the Federal Circuit held that the district court did not err in finding an expectation of success, crediting expert testimony explaining similarities between melatonin and tasimelteon, or in relying on ramelteon studies to inform tasimelteon drug interactions. Vanda asked for too high a standard, essentially a confirmation of success. But “[o]bviousness does not require certainty—it requires a reasonable expectation of success.”</span></p> <p style="margin-bottom: 12pt;"><span>Further, the Federal Circuit held that the district court did not err in determining that it would have been obvious to try administering tasimelteon without food. Citing <em>KSR</em> and established case law regarding a “finite number of identified, predictable solutions,” the Federal Circuit determined that the district court had sufficient evidence (e.g., market pressure to determine if food would have an effect on the efficacy of a drug, FDA food-effect guidance) to find it “obvious to try” administering the drug without food.</span></p>Wed, 10 May 2023 00:00:00 -0500{8DC2B9C8-1973-46BC-8A03-1DED57EAD193}https://www.robinskaplan.com/resources/legal-updates/generically-speaking-hatch-waxman-bulletin/2023/generically-speaking-q2/azurity-pharms-v-alkem-labs<i>Azurity Pharms., Inc. v. Alkem Labs. Ltd.</i><p style="margin-bottom: 12pt;"><strong><span>Case Name: </span></strong><span><em>Azurity Pharms., Inc. v. Alkem Labs. Ltd.</em>, </span><span>No. 20-cv-1094, 2023 WL 3254117 (D. Del. May 4, 2023) (Goldberg, J.) </span></p> <p style="margin-bottom: 12pt;"><strong><span>Drug Product and Patent(s)-in-Suit:</span></strong><span> Firvanq® (vancomycin); U.S. Patent No. 10,959,948 (“the ’948 patent”)</span></p> <p style="margin-bottom: 12pt;"><strong><span>Nature of the Case and Issue(s) Presented: </span></strong><span>Vancomycin is an antibiotic used to treat clostridium difficile bacterial infections. The </span><span>’</span><span>948 patent claims a non-sterile stable liquid formulation consisting of a buffering agent, water, sweetener, a preservative, a flavoring agent, and vancomycin hydrochloride. Alkem argued that its ANDA product did not infringe the </span><span>’</span><span>948 patent. The court agreed.</span></p> <p style="margin-bottom: 12pt;"><strong><span>Why Alkem Prevailed:</span></strong><span> To prove infringement Azurity had to “fit each ANDA ingredient within the asserted claims.” In other words, no ANDA ingredient could be left over because any remaining ingredient would violate the “consisting of” preamble limitation. Azurity disagreed and argued that it had proven that mixing and matching certain ANDA ingredients turned them into the claimed ingredients. More particularly, Azurity argued that when grape flavor is mixed with propylene glycol, the combination is a “flavoring agent.” Because flavoring agent is a claimed ingredient, Alkem’s propylene glycol, which otherwise did not have a claimed function, would not violate the “consisting of” language. </span></p> <p style="margin-bottom: 12pt;"><span>As a threshold matter, Alkem argued that it could not infringe because its ANDA described the propylene glycol as a co-solvent. But the court explained that the ANDA was not determinative and that it did not preclude Azurity from offering evidence that propylene glycol also functioned as a flavoring agent. </span><span></span></p> <p style="margin-bottom: 12pt;"><span>Alkem argued that Azurity disclaimed propylene glycol during prosecution. In response, Azurity explained that this was a claim construction issue and that Alkem waived this argument by agreeing that no claim terms require construction. The court disagreed, finding that Alkem’s disclaimer argument was not a surprise given it was raised in its Answer to the Complaint. Additionally, the court explained that refusing to consider evidence on the meaning of “flavoring agent” would make the infringement inquiry more difficult. Specifically, without claim construction, the court could not decide whether grape flavor and propylene glycol combine to make a “flavoring agent.”</span></p> <p style="margin-bottom: 12pt;"><span>On the merits, the court found that disclaimer applied to Azurity’s claims. Specifically, the court found that during prosecution, Azurity argued that the absence of propylene glycol and polyethylene glycol in the claimed invention, distinguished it from the Examiner’s cited art. The court explained that because Azurity used the words “absence” and “does not include,” it could not now reverse course and say its invention includes propylene glycol.</span></p>Thu, 04 May 2023 00:00:00 -0500