Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, No. 21-691-GBW, 2022 WL 17084371 (D. Del. Nov. 18, 2022) (Williams, J.) 

Drug Product and Patent(s)-in-Suit: Xyrem® (sodium oxybate); U.S. Patent No. 8,731,963 (“the ’963 patent”)

Nature of the Case and Issue(s) Presented: FDA approved Xyrem for the treatment of cataplexy and excessive daytime sleepiness. The active ingredient in Xyrem is sodium oxybate, a form of gamma-hydroxybutyrate, which is subject to abuse. For this reason, Xyrem is subject to a Risk Evaluation and Mitigation Strategy (“REMS”) protocol. Jazz’s ’963 patent, which was Orange-Book listed, claims a computer-implemented system to address certain FDA-required REMS conditions of using Xyrem. Jazz listed the ’963 patent on the basis that it claims a method of using Xyrem.

Avadel submitted an NDA requesting approval for a once-nightly formulation of sodium oxybate for the treatment of narcolepsy. In May 2021, Jazz initiated litigation, asserting the ’963 patent and five additional non-Orange Book listed patents. Avadel counterclaimed, seeking an order requiring Jazz to delist the ’963 patent. The motion was granted.

Why Avadel Prevailed: The Hatch-Waxman Act outlines three categories of patents eligible for listing in the Orange Book: a drug substance, a drug product, or a method of using such a drug for which approval is sought or has been granted in the patent holder’s NDA. As the court explained, FDA does not make a determination as to whether particular patents should be listed in the Orange Book and instead creates a cause of action under which an applicant can seek an order requiring the NDA holder to de-list the patent.

The parties agreed that the ’963 patent did not claim a drug substance or a drug product, and in light of the Court’s claim construction, the ’963 patent did not claim an approved method of using the drug. Jazz argued that de-listing the ’963 patent would be improper, though, because doing so would impermissibly apply the Orange Book Transparency Act (“OBTA”). According to Jazz, the OBTA, enacted in 2021, could not retroactively apply to ’963 patent that was listed in the Orange Book in 2014. But the court found that the de-listing statute that Avadel relied on in its motion was enacted in 2003—well before listing of the ’963 patent or enactment of the OBTA. As a result, the court issued an order requiring Jazz to delist the ’963 patent from the Orange Book.