Teva Pharmaceutical Industries has won Copaxone patent infringement litigation lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals in the US District Court for the Southern District of New York. Teva has filed patent infringement lawsuit regarding it's relapsing-remitting multiple sclerosis (RRMS) product, Copaxone. This decision covers several patents, the last of which expires on September 1, 2015.
Natco has filed, with its partner Mylan Inc., in June 2008, an ANDA seeking approval for marketing of the generic version of the relapsing, remitting multiple sclerosis drug Copaxone and obtained a Para IV certification with essentially challenges the existing patents held by Teva. Natco has stated that it is disappointed in the Court's decision and it will fully investigate all available options for appeal once the Court's full opinion becomes available. With unfavourable decision, Natco scrip lost over 5 per cent in the morning session to Rs. 353 on BSE today.
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 US 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.
Dr Jeremy Levin, Teva’s president and CEO stated, “Teva is confident Copaxone will remain a proprietary, global market leading product for the reduction of relapses in patients with RRMS over the product’s life cycle given the strength of its intellectual property (IP) rights.”