PRINCETON, N.J. — A federal court has ruled in favor of generic drug maker Sandoz in a case involving a drug for multiple sclerosis, Sandoz said.
Sandoz, the generics division of Switerland-based Novartis, said the U.S. Federal Circuit Court of Appeals invalidated nine patents owned by Israel-based Teva Pharmaceutical Industries covering the drug Copaxone (glatiramer acetate).
The ruling includes the only patent asserted by Teva that expires in September 2015 and reverses a decision last year by the U.S. District Court for the Southern District of New York, and potentially clears the way for Sandoz to market a generic version of Copaxone as early as May 2014, which is when eight of the nine patents expire.
Such an early entry could be a big loss for Teva. According to IMS Health, Copaxone was the fourth top-selling specialty drug in 2012, with sales of $3.6 billion and 13.3% growth over 2011. Sandoz is working with Momenta on the drug, and it is still under Food and Drug Administration review.
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