Jazz Pharmaceuticals plc (NASDAQ:JAZZ) has achieved a legal victory in its patent infringement lawsuit against Avadel Pharmaceuticals (NASDAQ:AVDL) plc, as disclosed in a recent SEC filing. On Monday, the United States District Court for the District of Delaware granted Jazz Pharmaceuticals a partial motion for a permanent injunction, effectively barring Avadel from pursuing FDA approval or marketing its drug Lumryz for uses beyond its current labeling as of March 4, 2024.
The court's decision also prohibits Avadel from infringing on Claim 24 of Jazz Pharmaceuticals' '782 patent, which relates to controlled release formulations of oxybate and its safe distribution. This injunction is in effect until the patent's expiration in February 2036, with certain exceptions.
Avadel may continue to use Lumryz to treat narcolepsy, provide treatment for patients already prescribed Lumryz as of the injunction's effective date upon payment of a royalty, and conduct ongoing clinical trials.
Moreover, the court has granted Jazz Pharmaceuticals the right to receive ongoing royalties from Avadel for any future sales of Lumryz to narcolepsy patients, at a rate yet to be established. The ongoing royalty rate will exceed 3.5%, pending further court deliberations to determine the exact figure.
This legal development follows a jury verdict that confirmed the validity of Jazz Pharmaceuticals' patent and awarded damages for Avadel's past sales of Lumryz. However, Jazz Pharmaceuticals notes that the ultimate outcome of the litigation remains uncertain, including the final determination of the royalty rate.
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