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Teva back on the hook for $235M to GSK for heart drug infringement

After a jury in 2017 ordered Teva to pay $235 million for patent infringement of a GlaxoSmithKline heart drug, the generics giant convinced a district judge to nix the verdict. But now, its fortunes have changed again.

The U.S. Federal Circuit Court of Appeals Friday overturned the judge’s ruling, meaning Teva will owe GSK $235 million for infringing on patents for heart med Coreg. In statements to the Insurance Journal, Teva said it was disappointed and would appeal—plus introduce new defenses—while GSK said it was pleased with the decision.

The case stems way back to Teva’s 2007 launch of generic Coreg. For years, the company could only market its copycat for two out of Coreg’s three approved indications. But in 2011, the FDA instructed Teva to add the branded drug’s third use—congestive heart failure—to its generic label.

GSK’s patent for congestive heart failure didn’t expire until 2015, though, and in a lawsuit, GSK argued Teva sought to induce doctors to prescribe the drug in congestive heart failure before the expiration. A jury sided with the British pharma giant and awarded a $235 million verdict in 2017.

Defending itself, Teva argued it never promoted its generic in congestive heart failure, and U.S. District Judge Leonard Stark in Delaware ruled that GSK didn’t bring enough evidence to show that Teva persuaded doctors to prescribe the drug for the patent-protected use.

In the recent appeals court ruling, though, judges wrote that they found “substantial evidence” that Teva sought to induce doctors to prescribe the medicine in that use. 

Teva’s press releases and promotional materials supported the jury’s original decision, Circuit Judge Pauline Newman wrote. Plus, a GSK witness and doctor testified that physicians are “completely reliant” on such materials from generics makers, meaning they wouldn’t have prescribed Coreg in the new indication if Teva hadn’t promoted it.