The U.S. Court of Appeals for the Federal Circuit has affirmed judgment of noninfringement for Locke Lord client Zydus Pharmaceuticals (USA) Inc., rejecting Shire Development LLC’s effort to prevent Zydus from bringing to market a generic version of the drug LIALDA® (mesalamine). Judge Kent Jordan, a Third Circuit appellate judge sitting by designation in the U.S. District Court for the District of Delaware, previously ruled that Zydus’ proposed generic product would not infringe Shire’s U.S. Patent No. 6,773,720. LIALDA® is the first and only FDA-approved once-daily oral formulation of mesalamine and is indicated for the induction of remission of active, mild-to-moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. LIALDA® is also the number one prescribed mesalamine product in the United States. Shire has reported annual global sales of approximately $800 million for this product (which is sold under the name MEZAVANT outside the United States). The Locke Lord team representing Zydus included Michael J. Gaertner (argued), Hugh S. Balsam, James T. Peterka, David B. Abramowitz, Andy J. Miller, Wasim K. Bleibel and Timothy F. Peterson (all of Chicago) and Andrea L. Wayda (New York).
Posted May 11, 2017