Biden admin urges Supreme Court to hear ‘skinny labels’ case between Teva, GSK

By Blake Brittain

(Reuters) – The Biden Administration told the U.S. Supreme Court on Wednesday that it should agree to hear a patent appeal over drug labels involving Teva Pharmaceuticals USA Inc and GlaxoSmithKline (NYSE:) LLC that could have significant ramifications for the generic-drug industry.

The U.S. Solicitor General said Teva’s generic version of GSK’s heart drug Coreg could not have violated GSK’s patent rights because Teva omitted the infringing use of the drug from its labeling.

Such “skinny labels” typically allow generic drugmakers to launch their products earlier while avoiding liability for infringing brand-name drugmakers’ patents.

A Teva spokesperson said Thursday that the company was pleased with the Solicitor General’s recommendation on an “important issue impacting both the pharmaceutical industry and U.S. patent law.”

GSK declined to comment on the brief. The Solicitor General’s office did not immediately respond to a request for comment Thursday.

GSK sued Teva for patent infringement in Delaware federal court in 2014 over its generic version of Coreg. Teva argued that it followed U.S. Food and Drug Administration instructions to “carve out” a patented method for using the drug to treat heart failure from its label.

A jury sided with GSK and awarded it $235 million in 2017.

The U.S. Court of Appeals for the Federal Circuit affirmed in 2021 that Teva’s label, combined with its marketing materials, encouraged doctors to prescribe the generic in an infringing way.

In its petition to the Supreme Court last year, Teva said the ruling would cause “havoc” for skinny labels, which it said are “extraordinarily common” and “save patients and the federal government billions.” GSK countered that the case does not threaten generic drugmakers that “operate properly under the law.”

The Biden Administration backed Teva on Wednesday, arguing generic drugmakers should be entitled to rely on the FDA’s carve-out instructions, which are based on brand-name drugmakers’ own statements to the agency.

“The decision below subverts the balance struck by Congress, creates significant uncertainty for FDA and generic manufacturers, and invites gamesmanship by brand-name manufacturers,” the government’s brief said.