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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.

The Federal Circuit agreed, rejecting Jazz’s arguments that the Food, Drug, and Cosmetic Act’s (FDCA’s) and related regulations’ description of “method of use” patents was not limited to “method claims” as understood in patent law.  For example, the Court found that 21 C.F.R. § 314.53(b)(1)—which limits listable “method of use” patents to “those patents that claim indications or other conditions of use for which approval is sought or has been granted in the [new drug application]”—did not purport to broaden what a “method” is to encompass any “conditions for use,” and in fact narrowed the permissible methods for which a patent could be listed.  The Court concluded that the “method” provision “must take its meaning from the patent laws,” and that the ’963 patent did not claim any method.  The Court also rejected Jazz’s argument that 21 U.S.C. § 355(c)(3)(D)(ii)(I) did not require a finding that Jazz had acted contrary to law in listing the patent in the first instance, and that by its plain language permitted de-listing of patents not directed to drugs or methods of their use.  Accordingly, the Federal Circuit affirmed the injunction requiring Jazz to have the patent de-listed.

The opinion can be found here.

* While the ’963 patent expired in December 2022, Jazz had secured an effective six-month extension of its monopoly term pursuant to a pediatric exclusivity grant under Section 505A of the FDCA, such that live issues remained for appeal.

By Jason A. Wrubleski

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This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.