- 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
-
November 11, 2024Tommy Du Honored With 2024 Sheila Sonenshine Associate Pro Bono Award
-
November 7, 2024Robins Kaplan Achieves National Tier 1 Rankings in Multiple Practice Areas on 2025 Best Law Firms List
-
November 1, 2024Robins Kaplan Recognized for “Tipping the Scales” by Diversity & Flexibility Alliance
-
November 14, 2024Roots, Branches, and Wings: Risks and Rewards of Generational Wealth
-
November 18, 2024Careers in Litigation
-
December 11, 20242024 Year in Review: eDiscovery and Artificial Intelligence
-
November 8, 2024Destination Skiing And The DOJ's Mountain Merger Challenge
-
November 6, 2024How Recent Patent Damages Precedent May Increase Reasonable Royalty Awards
-
September 2024Meet Our New Partner and Trial Advocacy Seminar Keynote Speaker: B. Todd Jones
-
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.
GENERICally Speaking Q3
The Fall 2022 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.
In this issue we review Q3 cases and issue(s) presented:
- Par Pharm., Inc. v. Eagle Pharms., Inc.
Vasostrict® (vasopressin)
Because the ANDA specification controls and defines a non-infringing product under § 271(e)(2), and the district court did not abuse its discretion, the Federal Circuit affirmed a finding of non-infringement and a denial of plaintiff’s request for declaratory judgment. - In re Entresto (Sacubitril/Valsartan) Patent Litigation
Entresto® (sacubitril and valsartan)
Because the Hatch-Waxman Act is silent on the issue of subject matter jurisdiction for an ANDA applicant’s counterclaims, the court found that the Act bars declaratory judgment counterclaims against late-listed Orange Book patents when Defendants never submit paragraph IV notice letters for those patents. - Bial-Portela & Ca. S.A. v. Alkem Labs. Ltd.
Aptiom® (eslicarbazepine acetate)
After a three-day bench trial, the court presented its infringement and invalidity findings concerning various patents claiming methods of administration and the formulation of an anti-seizure medication. - United Therapeutics Corp. v. Liquidia Technologies, Inc.
Tyvaso® (treprostinil)
A product-by-process patent was found invalid as anticipated because an identical product was in the prior art while defendant was found to induce infringement of a method patent, which also held not invalid. - Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc.
Velphoro® (sucroferric oxyhydroxide)
Given statements in its proposed label, and the fact that the prior art did not teach the claimed dosing regimen, the patent-in-suit was found infringed and not invalid. - Chiesi USA, Inc. v. Aurobindo Pharma USA, Inc.
Cleviprex® (clevidipine injectable emulsions)
After a seven-day bench trial, the court found the asserted claims infringed, not obvious, and not unenforceable on the basis of inequitable conduct. - Tris Pharma, Inc. v. Teva Pharms. USA, Inc.
QuilliChew ER® (methylphenidate)
After a bench trial, the court found all asserted claims infringed and rejected the ANDA filer’s invalidity defenses. - Salix Pharms., Ltd. v. Norwich Pharms., Inc.
Xifaxan® (rifaximin)
After a bench trial, the court found one set of asserted patents infringed and not invalid, while the remaining two sets of asserted patents were invalid as obvious. - AstraZeneca AB v. Mylan Pharms., Inc.
Symbicort® (budesonide and formoterol)
A complaint that identifies the ANDA and alleges that the ANDA will infringe has enough facts to state a claim for relief under § 271(e)(2), even when asserted patent had not issued until after ANDA was approved. - Sanofi-Aventis U.S. LLC v. Apotex Corp.
Jevtana® (cabazitaxel)
Magistrate Judge recommends that patentee’s assertion of amended claims that issued out of an IPR proceeding may be the basis for res judicata.
Relevant ANDA updates highlighted in this issue:
Related Professionals
New Drug Applications and 505(b)(2) Applications
Reported settlements in federal district court cases
Abbreviated New Drug Applications and 505(b)(2) Applications
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Entresto® (sacubitril and valsartan)
Aptiom® (eslicarbazepine acetate)
Tyvaso® (treprostinil)
Vasostrict® (vasopressin)
Velphoro® (sucroferric oxyhydroxide)
Cleviprex® (clevidipine injectable emulsions)
QuilliChew ER® (methylphenidate)
Xifaxan® (rifaximin)
Symbicort® (budesonide and formoterol)
Jevtana® (cabazitaxel)
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.