Federal Circuit Clarifies Supreme Court Ruling Regarding FDA Use Codes
August 01, 2012

On July 30, 2012, the Federal Circuit issued a decision in Caraco Pharmaceuticals, Ltd. v. Novo Nordisk on remand from the Supreme Court. As summarized in an earlier client alert (click here for the previous alert), the Supreme Court held in April 2012 that a generic pharmaceutical company may pursue a counterclaim against a brand pharmaceutical company to force a correction of a use code listed with the FDA regarding method-of-use patents. On remand, the Federal Circuit held that even if a court orders the brand company to correct a use code, the brand company must be allowed to come up with its own revised use code. According to the Federal Circuit, a court cannot dictate the precise terms of the use code to be submitted by the brand company, but may only provide general guidance regarding the proper scope of the use code.

If you have any questions or wish to discuss how the Court's decision may impact your company, please contact your attorney at Brinks Gilson & Lione, or one of our BioPharma attorneys.

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