Axinn Secures IPR Victory for Par in Challenge to Horizon’s Ravicti Patent

On behalf of Par Pharmaceutical, Inc., attorneys from Axinn successfully challenged U.S. Patent No. 8,404,215 via an inter partes review (IPR) before the Patent Trials and Appeals Board (PTAB) at the United States Patent and Trademark Office.  The ’215 patent is listed in FDA’s Orange Book for Ravicti (glycerol phenylbutyrate), a brand name drug used to treat urea cycle disorders.  On July 26, 2016, the PTAB heard oral argument on the validity of the ’215 patent, and on September 29, 2016 the PTAB issued a Final Decision finding all claims unpatentable.

The company that markets Ravicti and owns the ’215 patent, Horizon Therapeutics, Inc., had previously asserted the ’215 patent against Par in the United States District Court for the Eastern District of Texas.  In a separate action in the United States District Court for the District of New Jersey, Horizon has also asserted against Par three closely-related patents in the same family as the unpatentable ’215 patent, which claim nearly identical subject matter.  

The Axinn team representing Par in the ’215 patent IPR consisted of Aziz Burgy and Matthew Murphy.