- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
April 15, 2024Robins Kaplan Named to 2024 BTI Client Service A-Team
-
April 9, 2024Robins Kaplan LLP Files Complaint Against Social Media Giants Meta, Snap, TikTok on Behalf of Spirit Lake Nation, Menominee Indian Tribe of Wisconsin
-
April 8, 2024Tara Sutton, Emily Tremblay Shortlisted for Euromoney’s Women in Business Law Awards
-
April 24, 2024IP Leadership Executive Summit
-
April 24, 2024IP Odyssey: Navigating the Latest Developments in Intellectual Property Law
-
April 30, 2024Navigating Generational Dynamics
-
March 2024e-Commerce: Pitfalls and Protections
-
March 22, 2024‘In re Cellect’:
-
March 14, 2024How Many Cases Have You Tried to a Verdict?
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Read our attorneys' take on the latest news and trends in the legal and business industries.
GENERICally Speaking Hatch Waxman Bulletin
The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.
Vol. 7, No. 3
Fall 2017
Relevant court decisions highlighted in this issue:
- Millennium Pharms., Inc. v. Sandoz Inc.
In reversing the district court’s finding of obviousness, the Federal Circuit found flaws in the district court’s lead-compound analysis and its dismissal of objective indicia of non-obviousness. - Merck Sharp & Dohme Corp. v. Actavis Labs. Fl, Inc.
Because plaintiff was able to swear behind a 102(a) and 102(e) reference, defendants’ anticipation and obviousness arguments were rejected. - Kowa Co. Ltd. v. Amneal Pharms. LLC
Because the prior art did not explicitly or inherently disclose the claimed polymorphs, the court found the patent-in-suit valid and infringed.
- ANDA Approvals
- ANDA Litigation Settlements
- Generic Launches
- New ANDA Cases
Related Professionals
Miles A. Finn, Ph.D.
Counsel
Generic company’s original ANDA, though amended, provided subject-matter jurisdiction for patent litigation, and its recertification under PIV did nothing to change that, particularly when the reformulated product was not significantly different from the original product.
Failing to find a likelihood of success, urgency, or irreparable harm, the court denied plaintiff’s request that defendants provide notice of a potential at-risk launch.
Because defendant is part of a corporate family that includes approximately forty Delaware entities, has regularly litigated in the District, targeted at least some Delaware physicians, consistent with its having an integrated distribution network for all its generic products, the court cannot say that defendant does not have a regular and established place of business in Delaware.
The court found Plaintiff’s expert’s qualifications were more closely aligned with the technology at issue in the case, and credited his testimony in finding that Defendant’s ANDA product infringed the asserted claims.
Given two critical differences between the invention and the prior art, the claims of the patents-in-suit were not obvious; they were adequately described, and were infringed.
One of the patents-in-suit was not infringed because the IR spectrum of the generic product did not include each claimed peak, and the remaining patents-in-suit were invalid as obvious.
Because the prior art did not explicitly or inherently disclose the claimed polymorphs, the court found the patent-in-suit valid and infringed.
Asserted claims were not patentable because they claimed natural phenomena without containing any inventive concept sufficient to transform the claimed phenomena of nature into a patent-eligible application.
Because plaintiff was able to swear behind a 102(a) and 102(e) reference, defendants’ anticipation and obviousness arguments were rejected.
In reversing the district court’s finding of obviousness, the Federal Circuit found flaws in the district court’s lead-compound analysis and its dismissal of objective indicia of non-obviousness.
Defendants’ lead-compound analysis failed to persuade the court that the patents-in-suit were invalid, and even had that argument been successful, the court found that Defendant did not establish that modifying the lead compound to the claimed prodrug would have been obvious.
In view of its claim construction and expert credibility findings, the Court found generic manufacturers’ proposed products did not infringe the patents-in-suit.
The court applied the dedicated disclosure rule to find no infringement.
Because the prior-art disclosure would lead one of skill to the purported invention, the asserted claims were found invalid as obvious.
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.