hatch-waxman-act
5 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… |
| 24A652 | Hikma Pharmaceuticals USA Inc., et al. v. Amarin Pharma, Inc., et al. | Federal Circuit | 2024-12-31 | Presumed Complete | generic-drug hatch-waxman-act induced-infringement patent-infringement section-viii skinny-label | Whether a generic drug manufacturer can be held liable for induced patent infringement when its label complies with the Hatch-Waxman Act's 'skinny lab… | |
| 24-428 | Edwards Lifesciences Corporation, et al. v. Meril Life Sciences Pvt. Ltd., et al. | Federal Circuit | 2024-10-16 | Denied | Amici (1)Response RequestedResponse WaivedRelisted (2) | federal-circuit hatch-waxman-act patent-infringement regulatory-use safe-harbor statutory-interpretation | Whether, under Hatch-Waxman's safe harbor, an infringing act is 'solely for uses reasonably related' to the federal regulatory process, when the infri… |
| 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… | |
| 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… |