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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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.
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.
Hikma has pushed back against a further attempt by Amarin to counter its US generic version of Vascepa, this time via a fresh lawsuit claiming that the generic induces infringement of patents protecting cardiovascular indications for which the brand is approved but which are carved out of the generic label.