On Nov. 18, 2022, Delaware court granted Avadel CNS Pharmaceuticals LLC’s motion for judgment on the pleadings with respect to its counterclaim seeking delisting of Jazz Pharmaceuticals, Inc.’s U.S. Patent No. 8,731 ,963.

Jazz manufactures and sells a Xyrem®, an FDA-approved drug for treating cataplexy and excessive daytime sleepiness associated with the sleep disorder narcolepsy. The active ingredient in Xyrem® is sodium oxybate, a form of gamma-hydroxybutyrate (“GHB”) that has been recognized as a dangerous substance. Given GHB’ s potential for misuse, the FDA conditioned its approval of Xyrem® on the implementation of a Risk Evaluation and Mitigation Strategy (REMS) to control Xyrem®’s distribution. Jazz’ s US’963 patent is directed toward using a computer implemented system to address certain FDA-required REMS conditions of using Xyrem® according to its approved labeling. Jazz listed the ‘ 963 patent in the Orange Book on the basis that it claims a method of using Xyrem®.

In December 2020, Avadel submitted an NDA pursuant to Section 505(b)(2) seeking approval to manufacture and sell FT218, its once-nightly formulation of sodium oxybate for the treatment of narcolepsy. In May 2021, Jazz initiated patent infringement action against Avadel asserting five patents including the ‘ 963. Avadel counterclaimed, seeking a declaration pursuant to 21 U.S.C. § 355(c)(3)(D)(ii)(I) that orders Jazz to remove the ‘ 963 patent from the Orange Book because it does not claim a method of using the approved drug.

Court said that for listing of patent in OB, the patent must claim one of the following three categories of subject
matter: “a drug substance (active ingredient),” “a drug product (formulation or composition),” or “a method of using such drug for which approval is sought or has been granted”. The FDA does not make a determination as to whether particular patents should be listed in the Orange Book. Instead, the FDCA creates a unique right of action under which an ANDA/NDA applicant may “assert a counterclaim seeking an order requiring the patent holder to correct or delete” an Orange Book listing blocking the FDA’ s approval of its application. Here, the ‘936 patent does not belong in the Orange Book. The ‘ 963 patent does not claim “an approved method of using the drug” because the claims of ‘ 963 patent are directed to systems, not methods. Accordingly, the Court will order Jazz to request deletion of the ‘ 963 patent from the Orange Book listing for Xyrem® within 14 days of the Court’s Order.