Teva Announces Favorable Court Ruling in COPAXONE Patent Infringement Litigation

Teva Pharmaceutical Industries Ltd. TEVA announced today the U.S. District Court for the Southern District of New York has found in favor of Teva in the Company's patent infringement lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding Teva's relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE®. Teva filed suit against Momenta/Sandoz and Mylan/Natco for infringement of multiple patents covering the chemical composition of COPAXONE®, methods of using the product and processes for manufacturing the product. This decision covers several patents, the last of which expires on September 1, 2015. The judge rejected Momenta/Sandoz and Mylan/Natco's claims that the COPAXONE® patents are invalid and unenforceable and found that the purported generic versions of COPAXONE® for which Momenta/Sandoz and Mylan/Natco seek Food and Drug Administration (FDA) approval infringe those patents. This ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of COPAXONE® in the U.S. until the Orange Book patents expire on May 24, 2014. As a result of this ruling, Teva also believes that the defendants will be enjoined from selling their products until the process patent expires on September 1, 2015. Furthermore, any purported generic version of COPAXONE® would need to obtain FDA approval prior to being made available to the public. At this point, it is unclear what the requirements would be for approval of a purported generic synthetic peptide.