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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

 
• By Dave Wallace

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.

Chisel carve stone
Generics firms must be able to carve out indications, the AAM says • Source: Shutterstock

A controversial ruling by the US Court of Appeals for the Federal Circuit over generic labeling carve-outs should be reheard “en banc” by the full court, to correct a misinterpretation of the rules around so-called skinny labels, the Association for Accessible Medicines has urged in an amicus brief.

The case involving GlaxoSmithKline and Teva over Coreg (carvedilol) made waves earlier this year when a split appeals court decision reversed a lower court ruling on induced infringement, reinstating a finding of infringement and a $235m jury damages award from 2017 against the Israeli firm

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