Federal Court Overturns LUMRYZ Restrictions: Avadel Gets Green Light for New FDA Approvals and Clinical Trials

Clinical Trials Get a Legal Shield: Federal Circuit Reverses Pharma Patent Injunction

by Dennis Crouch The Federal Circuit's May 6, 2025 decision in Jazz Pharmaceuticals v. Avadel focuses on the scope of injunctive relief for infringement under 271(e).  The appellate court held that a district court may not enjoin a pharmaceutical company from initiating new clinical trials or offering open-label extensions where such activities are protected by the Hatch-Waxman Act's safe harbor provision, even when the company's commercial prod…

Federal Court Overturns LUMRYZ Restrictions: Avadel Gets Green Light for New FDA Approvals and Clinical Trials

Federal Circuit ruling enables Avadel to pursue FDA approval for LUMRYZ in Idiopathic Hypersomnia. Phase 3 trial enrolling 150 patients. See expansion plans.