Fresh From the Bench: Latest Federal Circuit Court Case

CASE OF THE WEEK

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023)

In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz Pharmaceuticals to de-list its U.S. Patent No. 8,731,963 from the Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalents Evaluation publication, colloquially known as the “Orange Book.”*  The ’963 patent claimed “a computer-implemented system” for tracking prescriptions of its narcolepsy drug Xyrem®, whose approval had been conditioned on such Risk Evaluation and Mitigation Strategies (REMS) due to the drug’s active ingredient being prone to diversion and abuse.  The Court held that because the claims were not directed to a drug or method of use, the patent was not properly listed in the Orange Book.

The Orange Book is a publication authorized by the Hatch-Waxman Act, which collects patents covering FDA-approved drugs and methods and permits patent owners with listed patents to trigger a presumptive, thirty-month suspension of FDA approval for competing products that infringe such patents.  The FDA describes its role with respect to listed patents as “ministerial,” such that it does not review or adjudicate whether patents are properly listed.  Nonetheless, new drug applicants are required to submit certifications with respect to listed patents that may be infringed by drugs and methods of use for which they seek approval, and the FDA had required such a certification for the ’963 patent from appellee Avadel for its competing narcolepsy drug and related REMS submission for tracking prescriptions.  When Jazz sued Avadel for patent infringement, Avadel thus sought injunctive relief in a counterclaim under 21 U.S.C. § 355(c)(3)(D)(ii)(I) compelling Jazz to de-list the patent.

§ 355(c)(3)(D)(ii)(I) permits an accused infringer to seek an order requiring the patent owner to correct or delete Orange Book listings “on the ground that the patent does not claim either … the drug for which the application was approved; or … an approved method of using the drug.”  The district court held that because the claims of the ’963 patent were directed to a computer-implemented system comprised of apparatus components such as “one or more computer memories” and “a data processor,” the claims were not properly understood as method claims and so were not properly listed in the Orange Book.

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By Jason Wrubleski

Edited by Nika Aldrich and Jason Wrubleski, Schwabe, Williamson & Wyatt