Federal Circuit Restricts Injunctions To Correct Brand’s FDA Use Codes

Originally published in V&E IP Insights E-communication, July 31, 2012

On July 30, 2012, the Federal Circuit issued an opinion on remand in the Novo Nordisk v. Caraco Pharm. Labs case holding that injunctions issued to correct use codes cannot specify the particular use codes and descriptions to be listed in the FDA's Orange Book.

Previously in this case, the U.S. Supreme Court held that the Hatch Waxman Act provides a generic drug manufacturer (generic) with a counterclaim to force the branded drug manufacturer (brand) to correct a use code that inaccurately describes the brand's patent as covering a particular use for the drug. Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012).