‘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.

carve-out
Label-carve out case raises concerns about biosimilar litigation and marketing • Source: Alamy

The US Court of Appeals for the Federal Circuit’s ruling on Teva Pharmaceuticals USA Inc.’s use of a label carve-out is continuing to reverberate through the biopharmaceutical industry, as generic and biosimilar makers consider its impact on labeling, litigation and marketing.

Karin Hessler, deputy general counsel for the Association for Accessible Medicines, laid out their concerns about the decision at the...

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