US appeals court reinstates GSK $235.5m ruling against Teva

5 October 2020 (Last Updated October 6th, 2020 11:04)

The US Federal Circuit Court of Appeals in Washington, DC has reinstated a 2017 ruling that Teva Pharmaceutical should pay $235.5m to GlaxoSmithKline (GSK) for inducing infringement of a patent covering GSK’s heart drug Coreg.

GSK holds US approval for the sale of Coreg (carvedilol), an alpha / beta-adrenergic blocker used to treat left ventricular dysfunction following myocardial infarction, hypertension and congestive heart failure.

In a 2-1 decision, the majority panel at the Circuit Court found substantial evidence that Teva prompted doctors to recommend its generic tablets to treat medical conditions covered by a GSK patent, according to Reuters.

Teva, in a statement reported by the news agency, said it was disappointed with the outcome and plans to appeal and introduce additional defences. The company added that it did not engage in patent infringement.

Teva started marketing a Coreg generic in 2007 with ‘skinny’ labels indicating treatment for the left ventricular dysfunction and hypertension.

In 2011, the US Food and Drug Administration (FDA) required Teva to amend its label to be identical in content to the approved GSK labelling.

Teva then updated its label to include the indication for the treatment of congestive heart failure.

GSK, with a patent that expired in 2015, filed a lawsuit against Teva for ‘induced infringement’ in 2014.

A Delaware jury ruled that Teva should pay $234.1m for lost profit, along with $1.4m in royalties, but US District Judge Leonard Stark overturned the verdict.

Stark said that other factors could have prompted doctors to prescribe the generic.

Circuit Judge Pauline Newman concluded last week that promotional materials, press releases, product catalogues, the FDA labels and witness testimony supported the earlier verdict for Teva’s induced infringement of GSK’s patent.