The US Supreme Court has in effect allowed generic versions of the MS drug from next month.
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Teva Pharmaceutical Industries Ltd. TEVATEVA (NYSE: ; TASE: ) has suffered a setback in its attempt to preserve patent protection on its multiple sclerosis treatment Copaxone, which accounts for half of its profits.
In the US Supreme Court, Chief Justice John Roberts found that Teva had demonstrated “a fair prospect of success on the merits” in 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”), but he denied the company’s application to stay the Federal Circuit’s decision, saying that Teva could recover patent infringement damages.
The 808 patent expires on September 1, 2015. It claims a process for manufacturing the active ingredient of Teva’s Copaxone. Teva says that it will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone.
The ruling represents a vitory for three of Teva’s competitors, Mylan, Sandoz and Momenta, which have generic versions of Copaxone in preparation.
Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the 808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the Copaxone patents that expire in May 2014, while invalidating the ‘808 patent. At the end of March, the Supreme Court said it would hear Teva’s appeal against this ruling only in October, which will be five months after patent protection on Copaxone expires.
According to Teva, any purported generic version of Copaxone will be required to obtain the approval of the US Food and Drug Administration prior to being made available to the public in the US. The company claims that this will require full clinical trials, and that it 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 rights.”
Teva has been fighting mightily to prevent generic versions of Copaxone from reaching the market, in order to gain time to switch patients to a new version of the drug which it has developed. Sales of Copaxone were $3.2 billion in the US in 2013, and $4 billion worldwide.
Published by Globes [online], Israel business news – www.globes-online.com