Carevdilol Phosphate – Induce Infringement and Skinny Labelling US Supreme Court

GSK sued Teva in Delaware federal court in 2014 over its generic version of GSK’s heart drug Coreg. Teva argued that it followed U.S. Food and Drug Administration instructions to “carve out” from its label a patented method for using the drug to treat heart failure.

A jury found Teva still infringed the patent and awarded GSK $235 million in 2017. A judge then 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 an infringing way. The appeals court rejected GSK’s bid for a full-court rehearing in February in a 7-3 decision.

Teva, in its Supreme Court petition, told the justices 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.”

GSK responded in a court brief that the case “presents no threat to generic companies who operate properly under the law.”

The U.S. Supreme Court is yet to decide for its opinion on whether the court should hear Teva Pharmaceuticals USA Inc’s challenge to a $235 million award for GlaxoSmithKline LLC in a patent dispute over generic heart medication.

Tags: No tags

Add a Comment

Your email address will not be published. Required fields are marked *