ARTICLE
11 August 2012

Federal Circuit Clarifies Supreme Court Ruling Regarding FDA Use Codes

On July 30, 2012, the Federal Circuit issued a decision in Caraco Pharmaceuticals, Ltd. v. Novo Nordisk on remand from the Supreme Court.
United States Food, Drugs, Healthcare, Life Sciences

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.

This article is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Hofer Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Hofer Gilson & Lione lawyer.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More