Teva Pharmaceutical Industries Ltd. (NYSE: 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
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