US Court Offers Second Chance On GSK-Teva ‘Skinny Label’ Ruling
Controversial Appeals Court Decision On Carve-Outs To Be Re-Examined
A controversial ruling that threatens so-called “skinny label” carve-outs of patented indications by US generics will be re-examined by the Court of Appeals for the Federal Circuit, following a petition by Teva.
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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.
As one of the leading players in the US, albeit with a declining core business, Sandoz is naturally watching developments from the Federal Circuit’s precedential ruling on induced infringement for carved out indications. Management discussed the topic as Sandoz reported third-quarter financials.