Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that the U.S. Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the Southern District of New York in the appeal filed by Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding the validity and infringement of four patents for Teva’s relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate injection) that expire in May 2014. The appellate court, however, reversed the trial court and declared other patents expiring in May 2014 and one patent expiring in September 2015 to be invalid. The appellate court specifically ruled that asserted claims of these patents are invalid for being indefinite.
Teva Pharmaceuticals Ltd. filed suit against Momenta Pharmaceuticals Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals for infringement of multiple patents covering the chemical composition of COPAXONE®, methods of using the product and processes for manufacturing the product, the latest of which expires on September 1, 2015. Today’s decision maintains exclusivity for COPAXONE® until May 24, 2014.
Teva is disappointed with the court’s decision with respect to four of the 2014 patents and the 2015 patent and will appeal today’s decision. Importantly, any purported generic version of COPAXONE® needs to obtain the Food and Drug Administration’s (FDA’s) approval prior to being made available to the public. At this point, it is unclear what the requirements would be for approval of complex synthetic peptides.
Given the complexity of COPAXONE®, Teva believes unpredictable differences between a proposed generic product and COPAXONE® could lead to immunogenic effects in patients. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.