Tag Archives: Xyrem

FDA Xyrem Meeting Materials Qualify As Printed Publication

In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on appeal was whether FDA meeting materials available on a web page published in a Federal Register Notice qualified as a “printed publication” under 35 … Continue reading this entry

Amneal's IPR Challenge Of The Jazz Xyrem + Valproate Patent

In decisions dated April 12, 2016, the USPTO Patent Trial and Appeal Board (PTAB) denied institution as to claims 1-18 of Jazz’s U.S. Patent 8,772,306, finding that neither Ranbaxy Inc. nor Par Pharmaceutical, Inc. had shown a reasonable likelihood of establishing obviousness. Amneal Pharmaceuticals LLC also has filed a petition for IPR of the ‘306 patent. Will … Continue reading this entry

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, … Continue reading this entry