Jazz holds the NDA for Xyrem®. The active ingredient, sodium gamma-hydroxybutyrate (GHB), is a sedative that can be misused. Id. at *1. Thus, the FDA conditioned approval of Xyrem® “upon development of Risk Evaluation and Mitigation Strategies (REMS), which include protocols that must be followed prior to prescribing or dispensing Xyrem®.” Id. Jazz developed a distribution system that satisfied the FDA’s REMS requirement, and the patent at issue claims that system. Jazz listed the patent in the Orange Book as a method of using Xyrem®.
In 2020, Avadel submitted a 505(b)(2) NDA for FT218—which shares the same GHB active ingredient but is a different drug product that is dosed less frequently—with a REMS distribution system that was similar to that used for Xyrem®. As part of the 505(b)(2) NDA, Avadel submitted a paragraph IV certification against the Xyrem® Orange Book patents, which led to the patent infringement lawsuit under the Hatch-Waxman Act. After Avadel challenged the propriety of the Orange Book listing, the District Court concluded that the “patent claims a system and thus does not claim an approved method of use,” and ordered Jazz to ask the FDA to delist the patent from the Orange Book. Id. at *3.
On appeal, the question of whether the patent was properly listed in the Orange Book turned on the following questions: “(1) what does the patent claim, and (2) is the patented invention either ‘the drug for which the application was approved’ or ‘an approved method of using the drug?’” Id.
First, under 21 U.S.C. § 355(b), an Orange Book-listed patent must, inter alia, “claim a method of using [the] drug for which approval is sought or has been granted in the application.” Id. at *4. The parties agreed that the patent’s claims describe “elements of the REMS-based procedure to ensure that Xyrem® can be safely prescribed.” Id. The panel determined that the claims are directed to a “‘computer-implemented system’ that comprises ‘one or more computer memories’ and a ‘data processor.’” Id. The panel noted that these are not claims for a method of use because such “method claims require the performance of steps; claims that describe physical components of a whole are system, or apparatus, claims.” Id.
Second, the panel explained that the fact that the “claims recite a system that was, at least prior to 2017, implicated in a condition of using Xyrem®, does not disturb the determination that the claims do not recite a listable method of use, which makes this regulatory provision inapplicable.” Id. at *5. Thus, the patent did not meet the statutory requirement that the claims be to “‘an approved method of using the drug’ under 21 U.S.C. § 355(c)(2) and § 355(c)(3)(D)(ii)(I).” Id.
Because the patent’s claims are not for a drug or method of using the drug, the panel affirmed the injunction requiring Jazz to “ask the FDA to delist” the patent from the Orange Book pursuant to the delisting remedy under 21 U.S.C. § 355(c)(3)(D)(ii)(I). Id. at *6.
The Jazz decision demonstrates that whether a patent may be eligible for Orange Book listing requires a case-by-case analysis. Whether a patent is listed in the Orange Book may have ramifications in Hatch-Waxman Act litigation because a delisted patent may (1) no longer satisfy the “artificial act of infringement” that provides standing in such lawsuits, and (2) not be a basis for maintaining the statutory 30-month stay preventing final FDA approval of a 505(b)(2) NDA or ANDA. Thus, given the right facts, challenges to the Orange Book listing of patents may be a consideration for Hatch-Waxman Act litigants.