Jazz Pharmaceuticals, Inc.. v. Amneal Pharmaceuticals, LLC, No. 17-1671 (Fed. Cir. 2018)
Annotate this CaseThe Jazz patents relate to a drug distribution system for tracking prescriptions of a “sensitive drug.” “A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive.” One such sensitive drug is Xyrem®. Jazz exclusively markets Xyrem®, which the FDA has approved to treat symptoms associated with narcolepsy. The active ingredient in Xyrem®, gamma-hydroxybutyrate (GHB), may also be illicitly used as a “date-rape drug.” Under the Controlled Substances Act any approved drug product containing GHB is classified as a Schedule III depressant, so the FDA approved Xyrem® under “restricted distribution regulations contained in [21 C.F.R. 314.500] (Subpart H) to assure safe use of the product.” On inter partes review, the Patent Board found certain claims invalid as obvious. The Federal Circuit affirmed, upholding a conclusion that implementing prior art, consisting of background materials and the meeting minutes, transcript, and slides on the FDA website, on multiple computers “would have been a predictable use of a known distributed data system according to its established function.”
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.