U.S. Supreme Court Restores Generic Pharma's Ability To Challenge Orange Book Use Code Information

The U.S. Supreme Court's unanimous ruling on April 17, 2012, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S was a resounding win for both Caraco and the generic pharmaceutical industry as a whole. Specifically, the Court held that a generic manufacturer may employ the counterclaim provision of 21 U.S.C. § 355(j)(5)(C)(ii)(I)—part of the Medicare Modernization Act of 2003 amendments to the Hatch-Waxman Act—to force correction of an Orange Book use code that inaccurately describes the brand's patent as covering a particular method of using the drug. Allowing generic manufacturers to counter-claim for correction of overly broad use codes provides a faster, more efficient means for bringing non-infringing generic products to market, while hopefully curtailing abuses of use codes by brand pharmaceutical companies seeking to delay generic competition.