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Generic ‘Skinny Labels’ Get Reprieve As Court Agrees To Rehear Teva/GSK Case

Executive Summary

Federal Circuit panel to reconsider whether Teva induced infringement of GSK Coreg patent despite label carve-out. Biologics and biosimilars could be particularly hurt if ruling stands given FDA’s recent guidance requiring reference to branded product.

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‘Skinny Label’ Litigation: Generic Firms Rethinking Strategy, May Pursue Legislation

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.

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

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.

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

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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