generic-drugs

9 cases — ← All topics

Case Title Lower Court Docketed Status Flags Tags Question Presented
24-889 Hikma Pharmaceuticals USA Inc., et al. v. Amarin Pharma, Inc., et al. Federal Circuit 2025-02-19 Granted CVSGAmici (4)Relisted (3) carve-out generic-drugs hatch-waxman-act induced-infringement patent-infringement skinny-label QP: When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a 'generic version' and ci…
24-294 Norwich Pharmaceuticals Inc. v. Salix Pharmaceuticals, Ltd., et al. Federal Circuit 2024-09-13 Denied fda-approval generic-drugs hatch-waxman-act injunctive-relief patent-law statutory-interpretation Whether 35 U.S.C. § 271(e)(4)(A) requires courts to issue overly broad injunctive orders that delay FDA approval of generic drug applications beyond t…
23-1320 GlaxoSmithKline, LLC, et al. v. Superior Court of California, Alameda County California 2024-06-18 Denied Amici (1) can the consumer's home state assert specific per brand-name-manufacturer due-process generic-drug generic-drugs innovator-liability personal-jurisdiction preemption product-liability specific-jurisdiction warning-label-liability When a plaintiff alleges injury from the consumption of a generic drug
23A836 GlaxoSmithKline, LLC, et al. v. Superior Court of California, Alameda County California 2024-03-12 Presumed Complete due-process generic-drugs personal-jurisdiction pharmaceutical-litigation specific-jurisdiction warning-label-liability Whether a brand-name pharmaceutical company can be subject to specific personal jurisdiction in a state for warning-label liability claims involving g…
23-395 Alliance for Hippocratic Medicine, et al. v. Food and Drug Administration, et al. Fifth Circuit 2023-10-16 Denied Amici (3) abortion abortion-medication administrative-procedure-act drug-regulation fda fda-approval generic-drugs medical-safety mifepristone subpart-h Whether Cross-Petitioners' challenge to FDA's 2000 mifepristone approval is timely
22-37 Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, et al. Federal Circuit 2022-07-13 Denied CVSGAmici (5)Relisted (3) active-inducement fda-approval generic-drug generic-drugs hatch-waxman-act inducement-doctrine patent-infringement skinny-label Whether a generic drug manufacturer can be held liable for inducing infringement of a patent on a use that its FDA-approved label has expressly carved…
18-817 Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc. Federal Circuit 2018-12-27 Denied CVSGAmici (3)Relisted (2) generic-drugs inventive-concept medical-patent medical-treatment method-of-treatment natural-law patent-eligibility routine-and-conventional section-101 Whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural …
18-546 Brian E. Frosh, Attorney General of Maryland, et al. v. Association for Accessible Medicines Fourth Circuit 2018-10-25 Denied Amici (3)Response RequestedResponse WaivedRelisted (2) commerce-clause consumer-protection dormant-commerce-clause drug-pricing extraterritoriality federalism generic-drugs prescription-drugs price-control price-gouging state-police-powers state-regulation Does the Commerce Clause prohibit a state from protecting consumer access to essential off-patent and generic prescription drugs by requiring manufact…
18-182 AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc., et al. Federal Circuit 2018-08-09 Denied Response Waived actual-controversy article-iii declaratory-judgment drug-exclusivity fda-approval generic-drugs patent-invalidity pharmaceutical pharmaceutical-patents standing Whether the 'actual controversy' requirement of the Declaratory Judgment Act requires a party seeking to introduce a generic drug product to file an a…