Federal Circuit Affirms Invalidity Judgment Concerning COPAXONE® (Glatiramer Acetate)

October 12, 2018 | Small Molecules

10/12/2018 The U.S. Court of Appeals for the Federal Circuit today affirmed an earlier district court decision holding that the asserted claims of four U.S. patents directed to methods of dosing glatiramer acetate 40mg/mL injection are invalid as obvious. Each of the patents-in-suit is owned byYeda Research & Development Co., Ltd.and licensed toTeva Pharmaceuticals Industries, Ltd., and relate to Teva’s COPAXONE® (glatiramer acetate) injection, 40mg/mL.

After a seven-day bench trail held in the fall of 2016, the District Court of the District of Delaware (Judge Gregory Sleet) held the asserted claims of U.S. Patent Nos. 8,399,413, 8,232,250, 8,969,302, and 9,155,776 invalid as obvious under 35 U.S.C. § 103. In the litigation, Plaintiffs Teva Pharmaceuticals USA Inc., Teva Pharmaceutical Industries Ltd., Teva Neuroscience Inc., and Yeda Research and Development Co. Ltd. (collectively ‘Teva’), sought to prevent marketing of a generic equivalent to Copaxone® 40 (glatiramer acetate 40 mg/ml) by a number of ANDA filers, including Sandoz Inc. (‘Sandoz’).

RMMS attorneys appearing for Sandoz were William A. Rakoczy, Deanne M. Mazzochi, Rachel Pernic Waldron, Matthew V. Anderson, Thomas H. Ehrich and Christopher P. Galligan.