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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
US court ruled in favor of Teva in its patent-infringement lawsuit against Momenta and Mylan's generic versions of Teva's Copaxone.
The U.S. District Court for the Southern District of New York found in favor of Teva Pharmaceuticals in the company’s patent-infringement lawsuit against Momenta Pharmaceuticals/Sandoz and Mylan Laboratories/Natco Pharmaceuticals regarding Teva’s relapsing-remitting multiple sclerosis (RRMS) product, Copaxone, the company said in a June 23, 2012 press release. The suit included infringement of multiple patents covering the chemical composition of Copaxone, methods of using the product, and processes for manufacturing the product. The defendants had claimed that the patents were invalid and unenforceable, but the judge rejected this claim and ruled that the generic versions of Copaxone infringe upon Teva’s patents. This ruling should prevent FDA approval of generic versions in the US at least until the Orange Book patents expire on May 24, 2012. Teva believes the decision will further prevent the sale of generics until the process patent expires on September 1, 2015.
Mylan expressed its disappointment in the decision. “While we have not yet had the opportunity to review the Court's opinion, we fully intend to evaluate our options for an appeal once the Court's full opinion becomes available,” stated Heather Bresch, CEO of Mylan, in a June 25, 2012 press release. Mylan’s earnings guidance for 2012 and earnings targets for 2013 remain unchanged because they were not reliant on the launch of a generic Copaxone, Bresch added. In 2008, Mylan had signed an agreement to license and supply India’s Natco Pharma’s glatiramer acetate prefilled syringes, a generic version of Copaxone.
Momenta, which had partnered with Sandoz, a division of Novartis, also stated its intention to appeal the decision. "We are disappointed that the court determined that Teva's patents were valid and infringed, and we look forward to reading the full opinion to understand its reasoning," commented Craig Wheeler, president and chief executive officer of Momenta in a June 22, 2012 press release. "We remain confident in our legal position and we intend to appeal."