Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Supreme Court has granted the Company's COPAXONE® certiorari petition and will hear its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808 (the "'808 patent"). The 808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva's relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate injection) 20mg/mL. Teva is pleased that the Court has agreed to hear its appeal and Teva remains committed to pursuing all options to protect its intellectual property for COPAXONE®.
Teva previously prevailed in the District Court regarding nine COPAXONE® patents, including the '808 patent. A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld some of the COPAXONE® patents that expire in May 2014, while invalidating the '808 patent that is the subject of Teva's now-granted certiorari petition.
Any purported generic version of COPAXONE® would be required to obtain the Food and Drug Administration's (FDA's) approval prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.
The Company is confident COPAXONE® will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product's lifecycle, given the strength of its intellectual property (IP) rights.
Teva Pharmaceutical Industries Ltd.