Patent Directed to System for Controlling Access to Drugs Is Not Listable in the Orange Book

| Tyler S. CoxKendall Loebbaka


Before Lourie, Reyna, and Taranto. Appeal from the United States District Court for the District of Delaware.

Summary: A patent directed to a system to reduce the misuse of a drug is not a listable patent in the FDA’s Orange Book because the patent does not claim a method of using the drug.

Jazz sued Avadel for infringement of a patent directed to a pharmacy distribution system that controls access to abuse-prone prescription drugs by using a central pharmacy and computer database to track prescriptions, patients, and prescribers. Jazz listed the patent in the FDA’s Orange Book as covering a method of using its narcolepsy drug, which contains GHB. Avadel counterclaimed, seeking to delist the patent from the Orange Book. Jazz argued that the patent should not be delisted from the Orange Book because it is a method-of-use patent and that the Hatch-Waxman Act does not provide Avadel a delisting remedy. The district court disagreed, finding the patent claims a system, not a method of use. The district court ordered Jazz to ask the FDA to delist the patent.

The Federal Circuit affirmed. To determine whether a patent is properly listed in the Orange Book, the Federal Circuit noted that a court must first determine what the patent claims, which raises issues of patent law. The Federal Circuit affirmed the District Court because Jazz’s patent is directed to system claims because the claims describe physical components of a system and do not require the performance of specific steps, as method claims do. The Federal Circuit thus concluded that the patent is not listable in the Orange Book because the Hatch-Waxman Act limits listable patents to those that cover a drug itself or those that cover methods of using the drug. Finally, the Federal Circuit held that delisting is available as a remedy to Avadel because the Hatch-Waxman Act allows for accused infringers to request an order requiring the patent holder to correct or delete Orange Book listings that do not claim the drug or a method of using the drug.

Editor: Paul Stewart