Federal Circuit Ruling on Clinical Trials in Jazz v. Avadel

In a recent landmark decision, the Federal Circuit overturned an injunction in the high-profile case of Jazz Pharmaceuticals v. Avadel. The ruling reframed the interpretation of §271(e)(2) within the storied Hatch-Waxman Act, suggesting it may only apply when seeking approval for a drug claimed in an Orange Book patent, a critical reference for FDA approved drugs and therapeutic biologics.

The implications of this interpretation are profound. It aligns with Congress’s goal of fast-tracking the introduction of generic drugs into the market, a move that could potentially boost competition and lower drug prices. This is achieved by triggering litigation if relevant patents are deemed invalid or not infringed. According to the legislative history, infringement actions should only arise under section 271(e)(2) when a party certifies a patent as invalid or non-infringed and subsequently notifies the patent owner.

Historically, there have been no instances where a regulatory filing alone was deemed patent infringement, either before or after the Hatch-Waxman Act’s enactment. This indicates a clear shift in the interpretation of the Act, potentially impacting future patent infringement cases and shaping the biotech landscape.

The Federal Circuit’s decision stemmed from a review of a permanent injunction that prohibited Avadel from conducting certain clinical and regulatory activities for its drug, Lumryz. The District Court had previously enjoined Avadel from initiating new clinical trials, offering open-label extensions of the drug in ongoing clinical trials, and seeking FDA approval or marketing its product for the treatment of idiopathic hypersomnia, a condition characterized by excessive daytime sleepiness.

The court also questioned whether a Hatch-Waxman action could be instituted where the patent-in-suit was not listed in the Orange Book. This scrutiny points to an evolving understanding of the Act and its applications, particularly in complex cases involving multiple patents and competing pharmaceutical products.

In the midst of this legal drama, Jazz Pharmaceuticals continues to market Xyrem® and Xywav®, two sodium oxybate medications used to treat patients with narcolepsy. Xywav® is also the first and only FDA-approved treatment for idiopathic hypersomnia, marking a significant milestone in the narcolepsy treatment landscape.

The ruling in Jazz Pharmaceuticals v. Avadel could set a precedent for future biotech patent litigation, potentially redefining the boundaries of patent infringement within the industry. As biotechnology continues to evolve at a rapid pace, the interpretation and application of the Hatch-Waxman Act will undoubtedly remain a hot topic of discussion, shaping the future direction of this dynamic field.