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US Court Offers Second Chance On GSK-Teva ‘Skinny Label’ Ruling

Controversial Appeals Court Decision On Carve-Outs To Be Re-Examined

Executive Summary

A controversial ruling that threatens so-called “skinny label” carve-outs of patented indications by US generics will be re-examined by the Court of Appeals for the Federal Circuit, following a petition by Teva.

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A controversial ruling involving labeling carve-outs that saw Teva hit with $235m in damages over its generic rival to GSK’s Coreg has been upheld after being reheard by the US Court of Appeals for the Federal Circuit. However, the court sought to counter the suggestion that its decision upends Hatch-Waxman labeling carve-out provisions.

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