PROSPECTIVE GENERIC DRUG MANUFACTURER CAN CHALLENGE OVERBREADTH OF BRAND MANUFACTURER'S USE CODE BY BRINGING COUNTERCLAIM IN INFRINGEMENT ACTION

摘要

A drug manufacturer seeking approval of an abbreviated new drug application (ANDA) under the Hatch-Waxman Amendments, to allow the manufacturer to market a generic version of a brand name drug that has received Food and Drug Administration (FDA) approval, can challenge the breadth of a use code submitted by the brand manufacturer by bringing a counterclaim against the brand manufacturer in a patent infringement suit, the United States Supreme Court has held, Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 102 U.S.P.Q.2d 1345 (2012), in a unanimous opinion by Justice Kagan. Justice Sotomayor joined the Court's opinion but wrote separately to add several observations.