U.S. Supreme Court rejects Teva challenge to $235M GSK award in patent dispute over generic drugs involving Coreg
The Supreme Court declined to hear Teva's challenge to a $235 million award to GlaxoSmithKline in a patent dispute over generic drugs involving heart medication Coreg, according to a Reuters report.
The justices rejected Teva's appeal of a lower court's ruling reinstating the jury award for U.K.-based GSK. The report said 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.
GSK sued Teva in Delaware federal court in 2014 over its generic of Coreg. According to the report, Teva argued that it followed Food and Drug Administration instructions to "carve out" from its label a patented method for using the drug to treat heart failure.
[Read more: Teva rolls out generic Nexavar tablets]
The report also noted that a jury awarded GSK $235 million in 2017. A judge overturned the verdict, but the patent-focused U.S. Court of Appeals for the Federal Circuit reinstated it in 2020. The Federal Circuit affirmed after a rehearing last year 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 that the ruling would cause "havoc" and discourage the use of skinny labels, which it said are "extraordinarily common" and "save patients and the federal government billions."
The report said that 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 while noting GSK responded in a court brief that the case "presents no threat to generic companies who operate properly under the law."
[Read more: Teva to pay Florida $6.73M to settle state’s price fixing claims]
According to the Reuters report, a Teva spokesperson said the company was disappointed with the Supreme Court's decision but has other defenses it will present at the Delaware court. A GSK spokesperson said the company was pleased with the decision.
The Association for Accessible Medicines interim CEO, David Gaugh commented on the Supreme Court's decision to decline hearing the GSK v. Teva case, stating, "AAM is disappointed that the U.S. Supreme Court denied certiorari in the GSK v. Teva case. AAM will continue to support the Hatch-Waxman framework which expressly contemplates prompt generic drug availability through patent carve-outs, also known as skinny labeling."