News > Federal Circuit Affirms Invalidity Judgment Concerning AXIRON® (Testosterone) Transdermal Solution
The U.S. Court of Appeals for the Federal Circuit affirmed an earlier district court decision holding that the asserted claims of U.S. Patent No. 8,435,944 (“the ‘944 patent”) are invalid as obvious under 35 U.S.C. § 103.
After a nine-day bench trial in 2016, the U.S. District Court for the Southern District of Indiana (Judge Sarah Evans Barker) held the asserted claims of the ‘944 patent obvious. The District Court also found non-infringement on behalf of, among others, Perrigo Israel Pharmaceuticals Ltd. (“Perrigo”) with respect to the asserted claims of U.S. Patent No. 8,807,861. Plaintiffs Eli Lilly and Company, Eli Lilly Export S.A., and Acrux DDS PTY. Ltd. did not appeal the judgment of non-infringement. The plaintiffs had asserted the patents to prevent the marketing of generic equivalents to Axiron® (testosterone) solution and the related applicator.
This victory continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.