Patent on Controlling Access to Drug Delisted From Orange Book

Written by: Nima Zargari, Ph.D.

On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an injunction directing Jazz Pharmaceuticals, Inc. (“Jazz”) to delist U.S. Patent 8,731,963 (“the ’963 patent”) from the Orange Book.

The ’963 patent is directed to Jazz’s single-pharmacy distribution system, which controls access to abuse-prone drugs prescribed to narcolepsy patients, such as Jazz’s narcolepsy drug—XYREM^®.  In 2014, Jazz listed the ’963 patent in the Orange Book as covering a method of using sodium gamma hydroxybutyrate (GHB), the active ingredient of XYREM^®.  After Avadel CNS Pharmaceuticals, Inc. (“Avadel”) submitted a New Drug Application (NDA) for GHB-based drug FT218, Jazz sued Avadel for infringement.  Avadel counterclaimed seeking to delist the ’963 patent for failing to claim a drug or method of use.

Under 21 U.S.C. § 355(b), a patent may be listed in the Orange Book if the patent claims an approved drug or “claims a method of using such drug for which approval is sought or has been granted in the application.”  Here, the Federal Circuit held that the ’963 patent is not a properly listable method-of-use patent, as the claims are directed to a “computer-implemented system.”  Accordingly, the Federal Circuit affirmed the district court’s decision to delist the ’963 patent from the Orange Book.

Since 2020, combination products, such as pre-filled syringes, inhalers, and transdermal patches, have become more prevalent.  Similar trends are anticipated for drug-delivery devices, which contain an approved drug and have a device primary mode of action.  Section 3038 of the 21st Century Cures Act incorporated several provisions of the Hatch-Waxman Act into the clearance and approval process for drug-delivery devices.  However, the Federal Circuit highlighted the differences between method claims, as requiring the performance of steps, and system or apparatus claims, as describing physical components of a whole.  Thus, patentees of combination products and drug-delivery devices seeking Orange Book listing should consider both system and methods of use claims.

The Federal Circuit’s decision is available here.