The Federal Circuit on February 24th affirmed
the Delaware District order in Jazz Pharm., Inc. v. Avadel
CNS Pharm., LLC., 2023-1186, that Jazz delist from the Orange
Book its Patent 8,731,963 directed to a REMS to control access to
its drug Xyrem, also known as gamma hydroxyl butyrate (GHB) which
was misused to facilitate rape, the “date rape”
drug.” The decision considered whether to list a drug in the
Orange Book was proper. Patents may be listed in the
Orange Book if it either claims the drug or methods of using the
drug. 21 U.S.C. § 355(b)(FDCA) and 21 C.F.R. §
314.53(b)(1). Jazz contended that patent law did not provide the
correct framework determining whether a patent should be listed in
the Orange Book. Both the statute and rule look to the patent
claims to determine if a patent claims either the drug or a method
of using the drug. Here the issue was whether the ‘963
claims were directed to a method of using Xyrem.
