The U.S. Supreme Court’s brief involvement in the “skinny label" feud between GSK and Teva Pharmaceuticals has ended in a rejection—even after the U.S.’ top lawyer urged the Justices to take up the case.
Teva’s bid to have the Supreme Court hear its case—and potentially reverse a $235 million loss to GSK—has fallen on deaf ears, according to an order from the High Court issued Monday.
The legal kerfuffle revolves around skinny labels, a common type of generic carve-out that allows drugmakers to get generic medicines approved for one or several—but not necessarily all—of a brand-name counterpart’s approved indications.
Teva is "disappointed that the Supreme Court denied its petition to review the case, a company spokesperson said over email. She added that "Teva still has additional defenses that it will present to the Delaware District Court once the case is sent back to that court."
The case dates to 2007, when Israeli-American generics giant Teva launched a generic version of GSK’s heart med Coreg in two of the brand-name drug’s three indications. GSK subsequently sued in 2014 after Teva added a third indication for congestive heart failure to the drug's label at the direction of the FDA.
In 2017, a Delaware court ruled Teva’s label encouraged doctors to prescribe its generic to treat heart failure despite GSK owning a patent on that use. The court awarded the $235 million verdict to GSK.
A district court subsequently overturned that verdict, passing the win to Teva. But in 2020, a U.S. appeals court restored the verdict.
Teva didn’t take the repeat loss lying down. It appealed to the Supreme Court in July 2022.
At the time, Teva argued the case could have “enormous” implications for the common carve-out practice. It contended that upholding its loss could sow “competition-killing uncertainty” that the U.S. healthcare system “cannot sustain.”
GSK, for its part, argued the case presents “no threat” to generic drugmakers that operate “properly under the law of induced infringement as applied to generic drug labels—‘skinny’ or not.”
The Supreme Court last year asked the Biden Administration for its opinion on whether to reconsider the verdict. In March, the administration’s solicitor general Elizabeth Prelogar told the justice that the case was a “suitable” vehicle to address the larger existential question for the industry over skinny labels.
Editor's note: This story was updated with comment from Teva.