On Feb. 24, 2023, Federal Circuit affirmed district court’s decision for delisting of REMS patent of Xyrem®.

Jazz holds NDA for the narcolepsy drug Xyrem (Sodium oxybate). U.S. 8,731,963 is listed in orange book which claims single-pharmacy distribution system, which controls access to abuse-prone prescription drugs. In 2017, three of the ’963 patent’s 28 claims were found unpatentable in IPR proceeding. The remaining claims expired in December 2022. Because Jazz received a grant of pediatric exclusivity, however, the ’963 patent prevents the FDA from approving follow-on products until June 2023. In Dec. 2020, Avadel submitted an NDA for GHB based drug FT218 and filed certification against US’963 patent. Jazz filed infringement suit and Avadel responded with a counterclaim seeking delisting of the ’963 patent for failure to claim a drug or method of use. The district court found that, as a matter of claim construction, the ’963 patent claims a system and thus does not claim an approved ‘method of use’. The district court subsequently ordered Jazz to ask the FDA to delist the ’963 patent. Jazz filed a notice of appeal.

Jazz contended that the district court abused its discretion in finding that the ’963 patent is not a method-of-use
patent for listing purpose and the court abused its discretion in determining that § 355(c)(3)(D)(ii)(I) provides a delisting remedy. Federal Circuit said that inquiry into whether a patent may be properly listed or delisted from
the Orange Book therefore clearly requires a determination of what that patent claims. Jazz contends that the word “system” as it appears in the ’963 patent claims is, essentially, a synonym for “method.” Court said that the method claims require the performance of steps. Each of the ’963 patent’s three independent claims describes a “computer-implemented system” that comprises “one or more computer memories” and a “data processor.” These claims recite “an assemblage of components,” defining a system and not the method. The claimed systems can be used in the course of treating patients suffering from narcolepsy does not alter the fact that these are system claims.

Court next turned to whether the system claimed in the ’963 patent is “an approved method of using the drug” under 21 U.S.C. § 355(c)(2) and § 355(c)(3)(D)(ii)(I). Court said that Jazz misreads the regulation describing method-of-use patents. Section 314.53 does not broaden the term “method” such that reciting a condition of use turns a system patent into a listable method-of-use patent. Rather, this regulation narrows that category of listable patents to those that (1) claim methods of use, wherein (2) those methods of use are directly relevant to the NDA in question. The district court therefore correctly ordered Jazz to seek delisting of the ’963 patent from the Orange Book.