Jazz Pharmaceuticals Loses REMS Patent Appeal

A federal appeals court has rejected Jazz Pharmaceuticals’ attempt to overturn a lower court ruling invalidating a patent claim covering the company’s Risk Evaluation and Mitigation Strategies (REMS) distribution system for its blockbuster narcolepsy therapy Xyrem (oxybate).

The case dates to July 2022 when Jazz sued Avadel Pharmaceuticals over the company’s new drug filing for a rival narcolepsy drug, Lumryz (sodium oxybate), which Jazz claimed infringed on its REMS patent protections for Xyrem.

The FDA requires a REMS for drugs with a high abuse potential — such as oxybate, which depresses the central nervous system. But Avadel maintains that Lumryz would be distributed under a decentralized REMS using multiple databases and pharmacies, with no overlap with the Jazz’s REMS system, which relies on a single, centralized pharmacy and database.

In November, the U.S. District Court for the District of Delaware ruled against Jazz, saying the company had wrongly used its REMS patent protections.

Jazz appealed the district court decision, prompting the U.S. Court of Appeals for the Federal Circuit to issue a ruling last week in favor of Avadel.