Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules
By EsqSocial Corporation 29/10/20
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of “induced infringement,” placing the sponsor at risk of substantial damages for relying on a section viii statement and labeling carve-out to address the innovator's Orange Book patent....
By: Hogan Lovells