The wait is over for the first pharmaceutical AIA post-grant review final written decisions. Last December, the Board instituted inter partes review (IPR) trials for select claims in three patents listed in the Orange Book for Oracea®, a pharmaceutical approved to treat rosacea. Seeking to market a generic version of the brand name drug, Amneal Pharmaceuticals submitted an ANDA to the FDA with Paragraph IV certifications sparking Hatch Waxman litigation against Galderma Laboratories and Supernus Pharmaceuticals over four Orange Book-listed patents, including U.S. Patent No. 8,206,740. Galderma Labs. Inc. v. Amneal Pharm., LLC, C.A. No. 11-1106-LPS, D.I. 222 (D. Del. May 16, 2014).
