Skinny-Label Saga Hangs In Balance As Supreme Court Seeks Input

Top US Court Asks Solicitor General For Views Of US On GSK-Teva Case

As the US Supreme Court deliberates on whether to grant Teva’s petition to review its litigation with GSK over “skinny label” generics that carve out patented indications, Aziz Burgy, partner at Axinn, Veltrop & Harkrider LLP, talks to Generics Bulletin about the key issues at stake.

Lady Justice Scales
The Supreme Court is weighing whether to take up the case • Source: Shutterstock

Few cases have captured the attention of the US generics industry like the long-running litigation between Teva and GlaxoSmithKline over “skinny label” US generics that carve out patented indications.

The case – which has potentially huge significance for generic carve-outs more widely – has over the years proceeded through the district and appeals court stages, with GSK ultimately seeing reinstated an early jury finding of infringement and a $235m damages award from 2017, based on Teva’s generic version of Coreg (carvedilol) that carved out a congestive heart failure indication protected by GSK’s reissued US patent RE40,000

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