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AAM Steps Into GSK-Teva Case To Defend Carve-Outs

Ruling On Skinny Labels Must Not Become ‘Road Map’ For Originators

Executive Summary

The AAM has stepped into controversial litigation between Teva and GSK over generic labelling carve-outs, urging the US Court of Appeals for the Federal Circuit to rehear the case to prevent the rules on so-called skinny labels from being subverted.

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

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.

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

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.

Generic ‘Skinny Labels’ Get Reprieve As Court Agrees To Rehear Teva/GSK Case

Federal Circuit panel to reconsider whether Teva induced infringement of GSK Coreg patent despite label carve-out. Biologics and biosimilars could be particularly hurt if ruling stands given FDA’s recent guidance requiring reference to branded product.

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