The 808 patent expires on 01 September 2015 and claims a process for manufacturing the active ingredient of the company’s relapsing-remitting multiple sclerosis (RRMS) product, Copaxone (glatiramer acetate injection) 20mg/mL.
The company is happy that the Court has agreed to hear its appeal and it remains committed to pursuing all options to protect its intellectual property for Copaxone.
Previously, the company has prevailed in the District Court regarding nine Copaxone patents, including the ‘808 patent.
A ruling last year by the US 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 the company’s now-granted certiorari petition.
Any purported generic version of Copaxone would be required to secure the Food and Drug Administration’s (FDA’s) approval before 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 in RRMS patients.
Teva is confident that 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.