Federal Circuit Agrees Generics Can Force Brands To Correct Overbroad Use Codes

In April 2012, the Supreme Court ruled in favor of Winston & Strawn client Caraco Pharmaceutical Laboratories in a case against Novo Nordisk A/S, stating that generic drug manufacturers can countersue to force branded-drug companies to correct overbroad patent descriptions submitted to the FDA (known as “use codes”) aimed at restricting generic competition.

The case was remanded to the Federal Circuit to determine whether Novo’s use code was misleading the FDA.  On July 30, 2012, the court ruled for Caraco and approved an injunction that required Novo to revise its use code to ensure it properly characterizes the limited method of use claimed in Novo’s patent.

Charles Klein represented Caraco Pharmaceutical Laboratories.