The “Orange Book”, more formally known as Approved Drug Products with Therapeutic Equivalence Evaluations, identifies U.S. Food and Drug Administration (FDA) approved drug products as well as any related patent and exclusivity information.[1] After FDA approval of a New Drug Application (NDA) filed on a drug, pharmaceutical patents are only listable in the Orange Book if they claim either a method of using the drug or the drug product itself. Once a patent is listed in the Orange Book, the NDA filer can gain a number of regulatory benefits under the Hatch-Waxman Act, including the possibility of preventing FDA approval of potentially infringing products by generic manufacturers. For example, if a manufacturer seeks to market a generic version of an Orange Book listed drug, the manufacturer must certify that (1) the patent has expired, (2) they will only market the drug after patent expiry, or (3) the patent is invalid, unenforceable, or won’t be infringed by the use or sale of the new drug. Additionally, the mere act of filing an abbreviated new drug application (ANDA) is patent infringement, which gives the patent owner the right to sue before the generic hits the market. If the patent owner files suit within 45 days of notice, the generic manufacturer is placed under a 30 month stay during which the FDA will not approve their generic drug application, unless the stay is lifted earlier.
In Jazz Pharmaceuticals, Inc. v Avadel CNS Pharmaceuticals, LLC Case No. 2023-1186 (Fed. Cir. 2023), the Federal Circuit affirmed a district court decision to delist a Jazz Pharmaceutical patent from the Orange Book. Jazz Pharmaceuticals sued Avadel CNS Pharmaceuticals in the District Court of Delaware for patent infringement of Jazz’s Orange Book listed U.S. Patent No. 8,731,963 (the ‘963 patent) after Avadel filed a new drug application (NDA) for a “generic” version of Jazz’s drug Xyrem. The ‘963 patent covered a single-pharmacy distribution system for abuse prone drugs for narcolepsy patients such as Jazz Pharmaceutical’s Xyrem, which contains the restricted drug gamma-hydroxybutyric acid (GHB). Avadel counterclaimed, arguing that the ‘963 patent was not directed to a drug or method of use of a drug and should be removed from the Orange Book. The District Court of Delaware agreed, holding that the patent was not directed to a drug or method of use of a drug but rather a computer implemented system, and therefore ordered Jazz to delist the ‘963 patent.
The Federal Circuit affirmed, holding that the Hatch-Waxman Act only permits patents to be listed in the Orange Book that are either methods for using a drug or the drug product, and Jazz’s patent was neither. Instead, the ‘963 patent was directed to a computer implemented system, including specific computer components and a computer database for tracking prescriptions rather than a method of use for the drug itself. As the ‘963 patent was not directed to either the drug product or a method of use of the drug, the ‘963 patent was improperly listed in the Orange Book and had to be removed.
The recent Jazz decision affirms the intent of the Orange Book it its inclusion of patents. Specifically, to include only patents that are directed to an FDA approved drug or a method of using the drug.
Editor: Brenden S. Gingrich, Ph.D.
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.
