Sterne, Kessler, Goldstein & Fox is pleased to announce, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. Patent Trial and Appeal Board’s decision on obviousness regarding U.S. Patent No. 6,11,319, in a win for the firm’s client Akorn. The ‘319 patent is listed in the U.S. Food and Drug Administration “Orange Book” for the product, Durezol, and is owned by Senju Pharmaceutical Co., Ltd. and Mitsubishi Chemical Corporation. In May 2015, Sterne Kessler filed a petition at the PTAB on behalf of its client, Akorn, against the ‘319 patent arguing that the patent, claiming a difluprednate emulsion formulation, was obvious over two prior art references. After a full trial before the PTAB on the merits in November 2016, the PTAB agreed with Akorn and found the patent obvious. Senju and Mitsubishi appealed the PTAB’s decision to the Federal Circuit in January 2017. The Federal Circuit, with Judges O’Malley, Reyna, and Taranto on the panel, heard arguments from both sides on August 7, 2018, and today, affirmed the PTAB’s decision in a Rule 36 affirmance.

The Sterne Kessler team was led by Directors Chandrika Vira and Eldora L. Ellison, Ph.D. and included Directors, Jon E. Wright and R. Wilson “Trey” Powers III, as well as Associate, Joseph H. Kim.