‘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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Teva will not get a third hearing at the US Court of Appeals for the Federal Circuit in its long-running dispute with GSK over skinny-label generics, after the appeals court rejected a petition for the full bench to re-examine the case.
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.