fda-approval
8 cases — ← All topics
| Case | Title | Lower Court | Docketed | Status | Flags | Tags | Question Presented |
|---|---|---|---|---|---|---|---|
| 25-5147 | Mingguo Cho v. Donald J. Trump, President of the United States, et al. | Second Circuit | 2025-07-18 | Denied | IFP | citizens-rights constitutional-rights emergency-use-authorization fda-approval judicial-review medical-facts | JUDGEMENTS WITHOUT VERIFICATION OF THE PLAINTIFF'S MEDICAL FACTS. Plaintiff had filled LAWSUIT many times and cases, trying to solve the big problems… |
| 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 injunctive orders that are broader in scope than the underlying infringement, thereby delayi… | |
| 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 | 1. Whether Cross-Petitioners' challenge to FDA's 2000 mifepristone approval is timely. 2. Whether FDA's 2000 approval of mifepristone under Subpart H… |
| 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 | If a generic drug's FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can th… |
| 20-1572 | Ramon D. Johnson, II v. Novartis Pharmaceuticals Corporation, et al. | Fifth Circuit | 2021-05-13 | Denied | Response WaivedRelisted (2) | brand-name-liability brand-name-manufacturer FDA-approval generic-drug generic-drug-liability label-defect leave-to-amend preemption product-liability state-law-claims texas-presumption-of-no-liability unapproved-indication | In Pliva, Inc. v. Mensing 564 U.S. 604 (2011) the only question before this Court was whether a state law duty for a generic drug manufacturer to p… |
| 20-779 | Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corporation | Federal Circuit | 2020-12-08 | Denied | Amici (1)Response RequestedResponse WaivedRelisted (2) | administrative-proceeding article-iii-standing article-three-standing fda-approval inter-partes-review joint-venture leahy-smith-america-invents-act patent-challenge patent-validity pharmaceutical-industry pharmaceutical-patent | Did the Federal Circuit categorically and erroneously preclude redress for injured members of joint ventures in the pharmaceutical industry by only re… |
| 20-295 | Hi-Tech Pharmaceuticals, Inc., et al. v. Food and Drug Administration, et al. | Eleventh Circuit | 2020-09-08 | Denied | Response Waived | botanical-ingredients constituent-definition dietary-supplements dmaa DSHEA FDA-approval federal-food-drug-and-cosmetic-act geranium-plants prior-history-of-use trace-quantities | Did the Eleventh Circuit err in holding that a substance that naturally occurs in a plant is not a "constituent" of an "herb or other botanical"—and t… |
| 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 | In the context of patent cases involving pharmaceutical products, does the "actual controversy" requirement of the Declaratory Judgment Act, 28 U.S.C.… |