Home > CAFC, Hatch-Waxman, Supreme Court > New Federal Circuit Action in Novo Nordisk v. Caraco

New Federal Circuit Action in Novo Nordisk v. Caraco

On April 17, 2012, the Supreme Court issued its opinion in Caraco v. Novo Nordisk, holding that “Congress has authorized a generic company to challenge a [brand manufacturer’s] use code’s accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit.”  In so holding, the Supreme Court reversed a Federal Circuit ruling from 2010, which vacated an injunction of the lower court requiring the brand manufacturer to change its use code at the FDA.  In that lower court ruling, the Eastern District of Michigan entered the following injunction:

Novo Nordisk is hereby directed by mandatory injunction under 21 U.S.C. § 355(j)(5)(C)(ii)(1)(bb) to correct within twenty (20) days from the date of this Order and Injunction its inaccurate description of the ‘358 patent by submitting to FDA an amended Form FDA 3542 that reinstates its former U-546 listing for Prandin and describes claim 4 of the ‘358 patent in section 4.2b as covering the “use of repaglinide in combination with metformin to lower blood glucose.”

In light of the Supreme Court’s decision, Caraco on May 1 filed a motion at the Federal Circuit, seeking to have the Eastern District of Michigan’s injunction affirmed (text from the Federal Circuit’s docket):

5/1/2012 MOTION: Entry 85 :by Appellees – Motion to Affirm Injunction of the District Court pursuant to U.S. Supreme Court decision Reversing the Court’s Judgment. SERVICE : by Mail on 5/1/2012

Today, the Federal Circuit entered an order [PDF] giving Novo Nordisk until tomorrow to file its response to Caraco’s motion.  The full text of the order reads:

Novo Nordisk A/S et al. (Novo Nordisk) move for an extension of time to respond to Caraco Pharmaceutical Laboratories, Ltd. et al. (Caraco)’s motion to affirm the injunction of the United States District Court for the Eastern District of Michigan. Caraco opposes. Novo Nordisk replies.

The court notes that on April 17, 2012, the Supreme Court of the United States in Caraco Pharm. Lab., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012) reversed the judgment of this court and remanded the case for further proceedings.

Upon consideration thereof,


(1) This court’s opinion of April 14, 2010 is vacated, the mandate of this court issued on August 5, 2010 is recalled, and the appeal is reinstated.

(2) The motion is granted to the extent that Novo Nordisk’s response is due May 24, 2012.

Should be interesting to see what comes of this in the near future.

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