‘Skinny Label’ Case Gives Brands A ‘Blueprint’ To Alter Use Codes In Patent Litigation
Implications Of GSK v. Teva 'Scarier For Biosimilars'
Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.
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Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.
By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.
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.