The US Supreme Court has declined to hear Israel-based Teva Pharmaceuticals USA’s challenge to a $235m award to US-based GSK in a patent dispute over generic drugs involving a heart drug, with the judges turning away Teva’s appeal of a lower court’s ruling reinstating the jury award for GSK.
The case involves “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if a generic drug’s label omits potentially infringing uses of a brand-name drug, reports BusinessLIVE.
GSK sued Teva in Delaware federal court in 2014 over its generic version of GSK’s heart drug Coreg. Teva argued that it followed US Food and Drug Administration (FDA) instructions to “carve out” from its label a patented method for using the drug to treat heart failure.
A jury awarded GSK $235m in 2017. A judge then overturned the verdict, but the patent-focused US Court of Appeals for the Federal Circuit reinstated it in 2020.
After a re-hearing last year, the Federal Circuit affirmed that Teva’s label, combined with its marketing materials, encouraged doctors to prescribe the generic in a way that constituted patent infringement.
In its appeal, Teva told the Supreme Court the ruling would cause “havoc” and discourage the use of skinny labels, which it called “extraordinarily common” and which “save patients and the government billions”.
President Joe Biden’s administration also urged the Supreme Court to hear the case, arguing that the Federal Circuit’s decision created “significant uncertainty” for generic drugmakers.
GSK said the case “presents no threat to generic companies who operate properly under the law”.
A Teva spokesperson said the company was disappointed with the Supreme Court’s decision but has other defences it will present at the Delaware court.
BusinessLIVE article – US court declines to hear Teva challenge to GSK award (Open access)
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