Teva Pharmaceutical Industries announced that the U.S. Supreme Court has granted its COPAXONE certiorari petition. The Court will hear the company’s appeal of a decision regarding the claim invalidation of the U.S. “808 Patent” for the drug.
COPAXONE (glatiramer acetate injection) is a daily injection used to reduce the frequency of relapses in people with relapsing-remitting multiple sclerosis (RRMS). This includes patients who have experienced a first clinical episode of multiple sclerosis (MS)-like symptoms accompanied by brain lesions, which characterize MS. The drug is thought to modify immune processes believed to trigger MS.
The U.S. Patent 5,800,808 (the “808 patent”) is set to expire next year and claims a process for manufacturing the active ingredient of COPAXONE. “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,” Teva stated in its press release.
The District Court has previously ruled in Teva’s favor regarding nine COPAXONE patents, including the U.S. 808 patent. The U.S. Court of Appeals for the Federal Circuit also gave a ruling last year which upheld some COPAXONE® patents set to expire in May 2014. But the ruling also invalidated the “808 patent,” prompting the company to submit a certiorari petition.
The company said it is confident that COPAXONE will retain its position in the global market as a leading product for the reduction of relapse frequency in RRMS patients, based on the strength of its intellectual property (IP) rights. “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,” announced the company.