Generic Drug Manufacturer May Force Correction of Inaccurate Orange Book Patent Information: Supreme Court | Practical Law
On April 17, 2012 in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, the US Supreme Court held that a generic drug manufacturer may file a counterclaim in a Hatch-Waxman patent litigation seeking an order requiring the branded drug manufacturer to correct Orange Book patent use code information that inaccurately describes the branded drug patent as covering a particular FDA-approved method of using the drug.