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Expert Analysis

Case Study: Caraco V. Novo Nordisk

Law360, New York (April 20, 2012, 7:10 PM EDT) -- On April 17, 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. See Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, No. 10-884 (U.S. 2012) (Slip Op.). This expanded counterclaim is likely to become a recurring issue in Hatch-Waxman litigation regarding branded drugs with multiple approved methods of use....

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