Teva Cites ‘Havoc’ as It Takes Drug Label Spat to Supreme Court (1)

Teva Pharmaceuticals USA Inc. is taking a long-running battle over generic drug labeling to the US Supreme Court, asking the justices to hear a case that could have broader ramifications on the cost of medicine.

The petition, obtained by Bloomberg Law, comes after the US Court of Appeals for the Federal Circuit twice ruled that Teva’s label on a copycat version of GlaxoSmithKline Plc’s heart drug Coreg led doctors to prescribe the generic for an infringing use.

The dispute centers on Teva’s “skinny labeling,” a practice under the Hatch-Waxman Act where a generic company leaves a name-brand drug’s patented uses off its labels. Drug industry experts have warned that the case could make it more difficult for other generic drugmakers to use the relatively routine practice to bring products to market.

The appeals court “has blown a hole in the carefully calibrated regime governing the modern prescription-drug marketplace,” Teva said in its petition filed July 11 with the Supreme Court and docketed Wednesday.

“The result is to allow a narrow patent on one way of using a drug to completely block any generic competition, potentially for years—precisely the opposite of what Congress prescribed,” it said.

The Federal Circuit reinstated a $235 million patent infringement verdict against Teva. It held that despite Teva’s certification that it carved out a patented congestive heart failure indication from its label prior to 2011, substantial evidence showed the label still encouraged infringement via another indication—post MI-left ventricular dysfunction—and through marketing materials.

Teva had urged the Federal Circuit to hear the case a third time but was turned down.

Even though its skinny label excluded GSK’s sole patented use, the court found that Teva “could nonetheless be held liable for inducement based on stray sections of the label providing information about unpatented uses,” the company said in its petition.

Teva argued that the decision wreaks “doctrinal havoc” because it “eviscerates the key element of inducement liability” and “makes a hash of Congress’s carefully crafted regime for bringing unpatented generic drugs to market.”

The Biden administration has previously voiced its intention to protect skinny labeling as part of an ongoing fight to curb rising drug prices.

Goodwin Procter LLP is representing Teva. Fish & Richardson PC has represented GSK.

The case is Teva Pharms. USA Inc. v. GlaxoSmithKline LLC, U.S., petition for review filed 7/11/22.