Jazz Xyrem + Valproate Patent Claims Avoid IPR

The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute proceedings for claims 19-34 of the ‘306 patent, claims 1-18 may be more relevant to the Xyrem® prescribing information, and may present a more significant hurdle to generic competition seeking the same labeling.

The Jazz Xyrem Patent At Issue

U.S. Patent 8,772,306 is one of many patents listed in the Orange Book for Xyrem®, and has an expiration date of March 15, 2033. The claims are directed to methods of adjusting the dose of gamma-hydroxybutyrate (GBH) when the patient also is administered valproate. This is important because, according to the patent, “valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.”