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Supreme Court Allows Generics to Challenge Orange Book Use Codes in Hatch-Waxman Litigation

April 17, 2012

By GERALD J. FLATTMANN, ANTHONY MICHAEL, & EVAN D. DIAMOND

Today, the United States Supreme Court held that a generic drug manufacturer who is sued for infringement of a method-of-use patent pursuant to the Hatch-Waxman Act may assert a counterclaim alleging that the use code listed in the Orange Book inaccurately characterizes the uses claimed in the listed patent and requesting that the branded drug manufacturer correct the use code characterization accordingly. This expanded counterclaim is likely to become a recurring issue in Hatch-Waxman litigation regarding branded drugs with multiple approved methods of use.