GSK's win over Teva could spell trouble for 'skinny' labels

Aug. 6, 2021

The U.S. Court of Appeals for the Federal Circuit ruled to reinstate GlaxoSmithKline's $235 million wins against Teva for patent infringement, after a years-long legal back-and-forth.

But according to Circuit Judge Sharon Prost, who dissented on past rulings, the decision has "troubling implications" for skinny labels — a key tool used by generics manufacturers to head off patent infringement claims under federal law. "Skinny" labels don't include all of the reference product’s indications and come into play when brand drugs get approved for new indications.

The litigation surrounds GSK's drug, Coreg. The drug, which was initially approved by the U.S. FDA to treat hypertension, ventricular dysfunction after a heart attack, and then later for congestive heart failure, lost patent protection in 2007 for everything EXCEPT the method used to treat congestive heart failure. That patent expired in 2015.

Teva launched its generic version in 2007, omitting its use for congestive heart failure from the skinny label. In 2011, the FDA required Teva to make labels identical to GSK's, including congestive heart failure.

But GSK argued that information on Teva’s website encouraged doctors to prescribe the generic for heart failure even before the label change, and sued Teva in 2014. A Delaware jury in 2017 awarded GSK $234 million in profits lost, plus $1.4 million in royalties on the Teva sales. The U.S. District Judge later threw out the verdict, but a federal appeals court reinstated it this past October.

The concern over the ruling to back the controversial October decision from the nation’s top patent court is that other brand-drug companies may now look to sue generic drugmakers — further impeding the rollout of lower-cost medications.

Read the Reuters coverage