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 overly broad injunctive orders that delay FDA approval of generic drug applications beyond t…
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…
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 Whether a brand name drug manufacturer can be held liable for the defective label of a generic drug product
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 Whether a substance that naturally occurs in a plant is a 'constituent' of an 'herb or other botanical' under the Dietary Supplement Health and Educat…
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…