drug-exclusivity
2 cases — ← All topics
| Case | Title | Lower Court | Docketed | Status | Flags | Tags | Question Presented |
|---|---|---|---|---|---|---|---|
| 21-1342 | Jacobus Pharmaceutical Company, Inc. v. Catalyst Pharmaceuticals, Inc., et al. | Eleventh Circuit | 2022-04-11 | Dismissed | administrative-law circuit-split drug-exclusivity fda fda-regulation lambert-eaton-myasthenic-syndrome orphan-drug-act rare-disease statutory-interpretation | Does the ODA unambiguously foreclose FDA's decades-long, consistent interpretation that the scope of orphan-drug exclusivity is tied to a drug's appro… | |
| 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.… |