A Hatch-Waxman Litigation Bulletin
Case Alert: Supreme Court Rejects “Possibility” Standard for Induced-Infringement Claims Against Skinny-Label Generics.
The Supreme Court issued a unanimous decision for Hikma in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. It reversed the Federal Circuit and held that Amarin failed to state a claim that Hikma induced infringement through its skinny-labeled generic icosapent ethyl product.
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin 2026 Q2
The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to present the latest edition of GENERICally Speaking, a quarterly bulletin covering ANDA patent litigation. Providing you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.
In this issue:
- Hikma Pharms. USA Inc. v. Amarin Pharma, Inc.
Vascepa® (icosapent ethyl)
Federal Circuit reversed where brand manufacturer failed to plausibly plead that generic manufacturer took affirmative steps to actively induce infringement through its skinny label, website statements, and press releases. - Norwich Pharms., Inc. v. Kennedy, Jr.
Xifaxan® (rifaximin)
FDA neither acted arbitrarily nor contrary to law in granting only tentative approval to Norwich’s amended ANDA and delaying final approval until expiration of the applicable patent term in October 2029. - Knoa Pharma LLC v. Accord Healthcare, Inc.
OxyContin® (oxycodone hydrochloride extended-release tablets)
Finding of obviousness affirmed where the prior art taught abuse-deterrent PEO opioid tablets and a POSA would have been motivated to use a coating pan as a scalable heating device. - Melinta Therapeutics, LLC v. Nexus Pharms., Inc.
Minocin® (minocycline hydrochloride)
Findings of infringement and no invalidity affirmed where the district court correctly construed the asserted method claims to allow dilution before IV administration and the specification adequately described the claimed reduction in injection-site hemolysis. - Advanced Accelerator Applications, USA, Inc. v. Lantheus Medical Imaging, Inc.
Lutathera® (lutetium Lu 177 dotatate)
Asserted patents invalid under the on-sale bar where patentee commercially sold the claimed invention more than one year before the priority date through European expanded access programs. - Otsuka Pharm. Co., Ltd. v. Lupin Ltd.
Jynarque® (tolvaptan)
Findings of no infringement and obviousness affirmed when plaintiffs’ expert provided unconvincing testimony and the prior art would have motived a POSA purify the API for a variety of technical reasons. - Actelion Pharms. Ltd. v. Mylan Pharms. Inc.
Veletri® (epoprostenol)
Given no literal infringement and the application of prosecution history estoppel and the dedication-disclosure rule prevented infringement by equivalents, the appellate court affirmed in favor of the generic manufacturer. - UCB, Inc. v. Cipla Ltd.
Nayzilam® (midazolam)
Generic defendant did not meet its burden to prove API/excipient combination was either anticipated or rendered obvious by the prior art.
Relevant ANDA Updates highlighted in this issue:
