Avadel Sues HHS, FDA Over Delay in Approval for Narcolepsy Treatment

Avadel Pharmaceuticals LLC filed a complaint against the Department of Human Health Services (HHS) and its secretary, alongside the Food and Drug Administration (FDA) and its commissioner, alleging the defendants erred under the Administrative Procedure Act and violated the Food Drug and Cosmetics Act by not approving their application for Lumryz, a narcolepsy treatment.

According to the complaint, the plaintiff submitted a New Drug Application (NDA) for the medication on December 15, 2020. However, 221 days after the FDA was required to file a final decision on the plaintiff’s NDA, the FDA instead rendered a decision on only on one detail of the NDA: they found that the patent as submitted overlaps with Jazz Pharmaceutical’s similar narcolepsy treatment, and required the plaintiff to provide an appropriate patent certification over the alleged overalp.

The complaint said the FDA issued a tentative approval of the NDA on July 18, which would become official if the plaintiffs were not sued over the controversial patent; however, three days before, Jazz Pharmaceuticals sued Avadel over the patent, subjecting the NDA to a stay until next year.

The complaint alleges that the FDA’s patent decision has caused the plaintiff irreparable financial harm, as the plaintiff’s business is “solely dependent” on the commercialization of the drug.

The plaintiff seeks an order setting aside and vacating the FDA’s patent decision, injunctive relief, and an order for the FDA to take direct final action on the plaintiff’s patent within 14 days of the court order.

The plaintiff is represented by Latham & Watkins LLP.