GSK Opposes Teva Coreg ‘Skinny Label’ Appeal

GlaxoSmithKline is asking the Supreme Court not to hear Teva’s appeal of a “skinny label” case involving the heart drug Coreg (carvedilol). In its appeal, Teva framed the question for the high court as: If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses.

The GSK brief opposing the appeal says Teva “resorts to a blatantly misleading ‘question presented’ that relies on a premise — that Teva’s label carved out the patent use — rejected by the jury and the Federal Circuit Court of Appeals.” Glaxo says a properly-instructed jury and then the appeals court found liability because “Teva sold a generic drug with a patented use on its label and marketed the drug, with the intent to capture the sales for that patented use. Liability here under the law of induced patent infringement is clear.”

Glaxo says that nothing about the potential legal consequences of the case warrants re-visiting the fact-specific decision of the appeals court or reversing the jury’s verdict.

“In short,” the Glaxo brief concludes, “this case presents no novel issues under the law and concerns the liability of a party whose problems are of its own making. It represents no threat to generic companies who operate properly under the law of induced infringement as applied to generic drug labels, skinny or not. And, it concerns circumstances highly unlikely to be repeated, as well as regulations and policies FDA has changed multiple times since the events relevant to this case occurred.”