US Supreme Court to Hear Teva’s Appeal on Copaxone PatentBy
Teva Pharmaceutical Industries Ltd. reports the US Supreme Court has granted the company's COPAXONEÂ® 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 US 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, COPAXONEÂ® (glatiramer acetate injection) 20 mg/mL.
Teva previously prevailed in the District Court regarding nine COPAXONEÂ® patents, including the ‘808 patent, according to the company. A ruling last year by the US Court of Appeals for the Federal Circuit upheld some of the COPAXONEÂ® patents that expire in May 2014 while invalidating the ‘808 patent that is the subject of Teva's now-granted certiorari petition.
Any generic version of COPAXONEÂ® would be required to obtain FDA 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 COPAXONEÂ® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients,” said the company in a press release.
“The Company is confident COPAXONEÂ® 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,” the company said in a press release.