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

 
• By Brenda Sandburg

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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Court to reconsider ruling that could have tolled ‘Death Knell’ for label carve-outs • Source: Shutterstock

Teva Pharmaceuticals USA Inc. convinced the US Court of Appeals for the Federal Circuit to reconsider its decision that Teva induced infringement of GlaxoSmithKline plc’s Coreg patent despite a label-carveout, arguing that it would put every skinny-labeled generic at risk. The outcome is also critical to biologics and biosimilar makers given the US Food and Drug Administration’s recent labeling guidance.

On 9 February, the Federal Circuit issued an order granting Teva’s petition for rehearing and vacating its ruling that Teva induced infringement of GSK’s method of use patent. Teva...

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