IP Update, Vol. 15, No. 5, May 2012- PART 1

Edited by Paul Devinsky and Rita Weeks

Patents / Hatch-Waxman

Supreme Court: Generic Drug Manufacturers Have Counterclaim Right to Correct Improper Use Codes

by William (Bill) Gaede

The U.S. Supreme Court has now addressed for the first time the scope of a statutory provision authorizing generic drug companies to counterclaim in Hatch-Waxman litigation against a branded company to correct or delete patent information submitted to the U.S. Food and Drug Administration (FDA) and listed in the Orange Book. The Supreme Court unanimously held that a generic drug company has the statutory right to counterclaim against a branded company to force correction of a "use code" provided to the FDA that inaccurately describes the brand's patent as covering a particular method of using a drug. Caraco Pharmaceutical Laboratories v. Novo Nordisk, Case No. 10-844 (Supr. Ct., April 17, 2012) (Kagan, J.) (Sotomayor, J., concurring).