lambert-eaton-myasthenic-syndrome

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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 Orphan Drug Act unambiguously foreclose FDA's interpretation that the scope of orphan-drug exclusivity is tied to a drug's approved use?