Thursday, June 22, 2017

Carvedilol - USA

On Jun 20, 2017 a Delaware federal jury ordered Teva Pharmaceuticals USA Inc. to pay GlaxoSmithKline LLC more than $235 million for willfully infringing a patent tied to the hypertension drug Coreg (Carvedilol). The jury found that GlaxoSmithKline lost $234.11 million in profits and deserved an additional $1.4 million in royalties.

The U.S. Food and Drug Administration approved Teva's generic version of Coreg, or carvedilol, in 2007. GSK said that while Teva's FDA application had a carve-out to address its use for treating chronic heart failure, which GSK said remained under patent, the generic drugmaker changed its label in 2011 to add that use. GSK said that as a result, Teva induced healthcare providers to infringe its patent by selling a generic version of the drug and marketing it as a substitute for Coreg.

GSK alleges that Defendants induce infringement of United States Patent No. RE40,000 by making, offering to sell, selling, importing, and otherwise promoting and distributing generic carvedilol tablets in the period between January 2008 and May 2011.

GSK in a statement said that it was pleased with the trial's outcome. Teva said it was disappointed. "We still intend to present our equitable defenses to the court at a separate hearing which could eliminate the liability determination or significantly reduce the assessed damages," Teva said in a statement. "We are also considering an appeal."

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