Mylan Wins Trial Upholding Perforomist® Patents and Enjoining Proposed Generic

On March 21, 2014, the U.S. District Court for the Northern District of West Virginia ruled in favor of Cravath clients, Dey L.P. and Dey, Inc. (now known as “Mylan Specialty,” a subsidiary of Mylan, Inc.), after a seven‑day bench trial in a patent infringement lawsuit. Judge Irene M. Keeley upheld the validity of Mylan’s patents on its drug Perforomist®, which is used in the treatment of emphysema and other bronchoconstrictive diseases, and enjoined Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (collectively, “Teva”) from marketing a generic version of that drug until Mylan’s patents expire in 2021. The patents concern ready‑to‑use, aerosolizable formulations of Perforomist®’s active ingredient, formoterol fumarate, that have commercially practical and medically useful storage periods and shelf‑lives.

In her decision, Judge Keeley held that Teva had failed to prove that the Mylan patents were invalid in light of prior art concerning aqueous formulations of formoterol and related compounds, or that the transfer of such a formulation by an independent drug formulation company to a Mylan competitor before Mylan had applied for certain of the patents‑in‑suit was a pre‑application sale that invalidated patents for which Mylan later applied.

Cravath was retained in April 2013 to serve as trial counsel in this action, which was filed in 2009. On July 17, 2013, the court granted partial summary judgment in favor of Mylan on the issue of infringement. The trial on Teva’s invalidity defenses took place between July 29, 2013, and August 6, 2013.

The Cravath lawyers representing Mylan included partners Evan R. Chesler, Roger G. Brooks and David Greenwald.