Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS patent from the Orange Book, as the patent covers neither the drug itself nor a method of using it. Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, Case No. 2023-1186 (Fed. Cir. Feb. 24, 2023).

When Avadel CNS Pharmaceuticals, Inc. (“Avadel”) submitted an NDA under the § 505(b)(2) pathway for a drug containing the same active ingredient as Jazz’s narcolepsy drug XYREM®, the FDA required Avadel to submit a Paragraph IV certification for Jazz’s Orange Book-listed Patent No. 8,731,963 (“the ’963 patent”).  Jazz then sued Avadel for infringement. In response, Avadel filed a counterclaim seeking to delist the patent from the Orange Book because it did not claim a drug or method of use. The district court eventually ordered Jazz to remove the ’963 patent from the Orange Book.

On appeal, the Federal Circuit affirmed the district court’s determination that the ’963 patent, which covered a single pharmacy distribution system that was part of the REMS program for Xyrem®, was a system patent and not a method patent. The patent recited “an assemblage of components,” which defines a system. The Federal Circuit also examined whether the claimed system was “an approved method of using the drug,” as Jazz had argued. The Court held that Jazz “misread[] the regulation describing method-of-use patents” and that the FDA listing regulations set forth in 21 C.F.R. § 314.53(b)(1) did not broaden the definition of “method” to include system claims. These regulations only apply to patents that “claim[] the drug or a method of using the drug.” Therefore, the district court’s decision to delist the system patent from the Orange Book was affirmed under 21 U.S.C. § 355(c)(3)(D)(ii)(I), which provides accused parties the opportunity to request that the patent holder correct or delete listings for patents that do not claim the drug or a method of using the drug.

ANDA filers should closely scrutinize Orange Book-listed patents purporting to cover methods of use to determine whether the listing can be challenged under 21 U.S.C. § 355(c)(3)(D)(ii)(I).