United States Federal Circuit

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Novo Nordisk v. Caraco Pharm. Lab., 10-1001

In a patent suit involving a use code related to a method for treating non-insulin dependent diabetes mellitus, the district court's issuance of a mandatory injunction is affirmed in part and modified in part where: 1) the Supreme Court decision forecloses any argument that the plaintiff's use code is "correct" as the Court held that the counterclaim provided by 21 U.S.C. section 355(j)(5)(C)(ii)(I) can be used to force correction of a use code that inaccurately describes the brand's patent as covering a particular method of using the drug in question; and 2) although the district court was correct in issuing an injunction requiring correction of plaintiff's use code listing the patent at issue, it abused its discretion in indicating the precise terms of the use code to be submitted on FDA form 3542.

Appellate Information

  • Decided 07/30/2012
  • Published 07/30/2012


  • Rader


  • United States Federal Circuit