Federal Circuit Affirms Judgment of Invalidity Concerning Pulmicort Respules® (budesonide inhalation suspension)

May 7, 2015 | Small Molecules

05/07/2015 The U.S. Court of Appeals for the Federal Circuit affirmed judgment holding the asserted claims of U.S. Patent No. 7,524,834 (‘the ‘834 patent’) invalid as obvious under 35 U.S.C. § 103, following appeal from the U.S. District Court for the District of New Jersey. In the litigation, AstraZeneca LP and AstraZeneca AB sought to prevent marketing of a generic equivalent to Pulmicort Respules® (budesonide inhalation suspension) by Watson Laboratories, Inc., a wholly-owned subsidiary of Actavis, Inc. After a 14-day bench trial on remand, the District Court concluded that the ‘834 patent is invalid as obvious, and that Watson’s generic budesonide inhalation suspension products do not infringe the ‘834 patent. In the Opinion and Judgment issued today, the Federal Circuit affirmed that decision. It also vacated an injunction it had previously entered pending appeal.

RMMS attorneys William A. Rakoczy, Heinz J. Salmen, Conly S. Wythers and Natasha L. White tried the case for Watson. Lead counsel William A. Rakoczy argued the case before the Federal Circuit.

This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.