Supreme Court Unanimously Reverses Hatch-Waxman Counterclaim Ruling

WASHINGTON, D.C. - Generic drug manufacturers may employ the Hatch-Waxman Act's counterclaim provision - known as a Section viii statement - to force correction of an inaccurate label when the brand-name drug's description overstates a particular method of use, the U.S. Supreme Court held April 17 (Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmaceutical Industries Ltd. v. Novo Nordisk A/S/ and Novo Nordisk Inc., No. 10-844, U.S. Sup.).

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