Natco Loses Patent Case Against Teva of Anti-Sclerosis Drug

New Delhi: Natco Pharma has lost a patent litigation against Israel's Teva Pharmaceutical Industries in the U.S. over multiple sclerosis treatment drug, Copaxone. The US District Court of Southern District of New York has upheld the contention of Teva Pharmaceuticals that Natco Pharma's abbreviated new drug application (ANDA) for the generic version of Copaxone infringes all the asserted claims of Teva Pharmaceuticals, the Hyderabad-based firm said in a statement. "While the company has not yet had the opportunity to review the court's decision, it will fully investigate all available options once the court full opinion becomes available," it said. Natco, along with its partner Mylan Inc had filed ANDA with the U.S.Food and Drug Administration in June 2008 seeking approval for marketing generic version of Copaxone and had also obtained a Para IV certification, which essentially challenged the existing patents held by Teva. Momenta Pharmaceuticals, and Sandoz Inc had also similar litigation against Teva which has also been struck down by the court. In a separate statement, Teva Pharmaceutical Industries said the judge rejected Momenta/Sandoz and Mylan/Natco's claims that the Copaxone patents are invalid and unenforceable and found that their purported generic versions of Copaxone infringed those patents. Commenting on the development, Teva President and Chief Executive Officer Jeremy Levin said: "Teva is confident Copaxone will remain a proprietary, global market leading product for the reduction of relapses in patients with relapsing-remitting multiple sclerosis over the product's lifecycle given the strength of its intellectual property (IP) rights." Teva further said: "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, it added. Scrips of Natco Pharma Ltd were trading at 350.50 per share in the afternoon trade, down 5.99 per cent from the previous close on BSE.