Thursday, June 12, 2014

Appeals Court Backs Teva Over Hepatitis Drug's Patent

Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) said an appeals court upheld a federal judge's ruling that Bristol-Myers Squibb Co.'s ( BMY ) patent for hepatitis B treatment Baraclude is invalid, allowing Teva to sell a generic version.

Teva said its abbreviated new drug application for its generic copy had received tentative approval from the U.S. Food and Drug Administration, and that it would finalize its launch plans after getting final FDA approval.

The Israel-based drug maker had challenged a patent for Baraclude in filing an application to the FDA to sell a generic version of the drug before the patent expires in February 2015. Bristol-Myers filed a patent-infringement lawsuit against Teva in 2010 in U.S. District Court in Delaware to keep Teva's product off the market until the patent expires, but in February 2013 a judge ruled the patent was invalid.

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