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

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

 
• By David Wallace
  
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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

Labelling carve-outs of patented indications are once again at the heart of legal controversy in the US, after a split 2-1 appeals court for the second time backed a decision to impose fines of $235m on Teva for inducing infringement of patented indications for GlaxoSmithKline’s Coreg (carvedilol) antihypertensive with its generic version, despite these indications being carved out of Teva’s label.

The latest decision comes after the US Court of Appeals for the Federal Circuit earlier this year agreed to rehear...

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