Momenta Pharmaceuticals Announces Supreme Court Decision to Remand Generic Copaxone(R) Case Back to CAFC

Momenta Pharmaceuticals, Inc.

today announced that the United States Supreme Court has vacated the 2013 decision of the Court of Appeals for the Federal Circuit ("CAFC") which found several of the Copaxone (20 mg injection) patents, including the one patent expiring September 1, 2015, invalid for being indefinite. The Supreme Court has overturned the long standing practice whereby the CAFC reviewed a District Court's claim interpretation "de novo," without deference to the District Court's claim interpretation, and ruled that the CAFC must instead give deference to the district court's findings of fact on issues of claim interpretation. The Supreme Court did not rule on the validity or invalidity of the patents per se, but has sent the case back to the CAFC to be reheard under the new deference standard. "We continue to believe that the patents should be held invalid under the Supreme Court's new standard for claim construction and we plan to aggressively pursue our case on remand," said Craig Wheeler, President and Chief Executive Officer of Momenta. "We expect that the CAFC could rehear the case and issue a new decision within a year. We remain optimistic that the ANDA for M356, our generic Copaxone, could be approved by the FDA in the near term, providing patients with a more affordable generic alternative for the treatment of multiple sclerosis." The case involved patents asserted by Teva against Momenta for patent infringement associated with the submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for generic Copaxone by Momenta's commercial partner for the product, Sandoz Inc. The case is Teva Pharmaceuticals v. Sandoz and Momenta and Mylan et al., case numbers 2012-1567, -1568, -1569, -1570. The asserted patents included eight listed in the FDA Orange Book and one non-Orange Book patent. About M356, a generic version of Copaxone (glatiramer acetate injection) M356 (glatiramer acetate injection) is a generic version of Copaxone, a synthetic polypeptide medicine, developed in collaboration with Sandoz and currently under review by FDA. Copaxone is prescribed for patients with relapsing-remitting multiple sclerosis, a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. Copaxone is one of the leading products marketed for treating multiple sclerosis.