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‘Skinny Label’ Case Gives Brands A ‘Blueprint’ To Alter Use Codes In Patent Litigation

Implications Of GSK v. Teva 'Scarier For Biosimilars'

Executive Summary

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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Appeals Court Rehearing Rejected In Teva-GSK Skinny-Label Saga

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.

Is CREATES Act Equipped To Handle Biosimilar Complaints?

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.

AAM Warns Of Dangerous Precedent In Vascepa 'Skinny Label' Case

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.

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