Caraco Holds That Statutory Counterclaim To Correct Patent Information Submitted By Branded Drug Makers To FDA Applies To Inaccurate Use Codes For Method-Of-Use Patents

Fitzpatrick Case Update
April 18, 2012

In Caraco Pharm. Labs. Ltd. V. Novo Nordisk A/S, the Supreme Court held unanimously that a generic drug maker may bring a counterclaim under 21 U.S.C. § 355(j)(5)(C)(ii)(I) to force the correction of an FDA use code that inaccurately describes a branded drug maker’s patent as covering a method of using the drug in question. For Hatch-Waxman litigation, the practical effects of the Caraco decision likely will include an increase in the number of counterclaims filed by generic defendants challenging such use codes.

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