GSK v. Teva: The Skinny On Induced Infringement And Label Carve-Outs

Statutory Basis For Label Carve-Outs - Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use where the reference listed drug (RLD) has multiple indications, not all of which are covered by a method-of-use patent....
By: Kilpatrick Townsend & Stockton LLP