Blow For Industry As GSK-Teva ‘Skinny Label’ Decision Upheld

Split Ruling Plays Down Label Aspects As Appeals Court Backs Coreg Damages

A controversial ruling revolving around labelling 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 the Hatch-Waxman framework’s labelling carve-out provisions.

Chisel Carve Out Wood
Labelling carve-outs are once again in the spotlight in the US • Source: Alamy

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