The United States Supreme Court has again reversed the Federal Circuit, ruling unanimously that a generic drug manufacturer may file a counterclaim to force correction of an overbroad use code that encompasses unclaimed methods of using the drug at issue. In interpreting the text of 21 U.S.C. § 355(j)(5)(C)(ii)(I), the Court in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, No. 10-844, 566 U.S. __ (2012), gave substantial weight to ensuring that the FDA fulfill its statutory duty to approve non-infringing generics in accord with Congressional intent. Brand manufacturers are advised to review active use codes to ensure that they reasonably reflect the scope of any claimed methods of use.

Statutory and Regulatory Framework

When a brand manufacturer seeks to market a new drug, it must file a New Drug Application ("NDA") with the FDA detailing clinical studies of the drug's safety and efficacy. As part of this process, the brand manufacturer must identify by number and expiration date all patents that claim the drug or any methods of using that drug. 21 U.S.C. § 355(b)(1), (c)(2). For any patent claiming a method of use, the FDA also requires that the brand manufacturer describe the claimed methods, a description commonly referred to as the "use code." 21 C.F.R. § 314.53(c)(2)(ii)(P)(3), (e). The FDA does not verify the accuracy of use codes, instead viewing its role as purely ministerial.

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