Mylan Wins Appeal to Reinstate Validity of COPD Drug Patents

On May 20, 2013, the U.S. Court of Appeals for the Federal Circuit issued a decision in favor of Cravath client Mylan Inc.’s subsidiaries Dey L.P. and Dey, Inc. (now known as “Mylan Specialty L.P.” or “Mylan”) reversing a grant of partial summary judgment by the U.S. District Court for the Southern District of New York, which had invalidated five Mylan patents related to Perforomist® and other compounds used in the treatment of chronic obstructive pulmonary disease (COPD).

Mylan brought the underlying suit in district court in 2007 alleging that Sunovion Pharmaceuticals’ COPD medication Brovana® infringed Mylan’s patents. In March 2012, the district court partially granted Sunovion’s motion for summary judgment, holding that a clinical trial conducted by Sunovion prior to the filing of Mylan’s patent applications constituted “public use” under 35 U.S.C. § 102(b), precluding the patentability of several of the asserted patents‑in‑suit. Although Cravath did not represent Mylan in the district court, plaintiffs turned to Cravath to handle their appeal. After oral argument on February 4, 2013, the Federal Circuit held that summary judgment was inappropriate because a finder of fact could conclude that Sunovion’s clinical study was conducted with a reasonable degree of confidentiality as to the nature of the formulations being tested, and that the test, therefore, did not constitute prior “public use” invalidating Mylan’s patents. The Federal Circuit’s reversal of the summary judgment decision reinstates Mylan patents as valid and enforceable.

The Cravath team included partners Evan R. Chesler and Roger G. Brooks.