NOVO NORDISK v. CARACO PHARMACEUTICAL LABORATORIES

No. 2010-1001.

601 F.3d 1359 (2010)

NOVO NORDISK A/S and Novo Nordisk, Inc., Plaintiffs-Appellants, v. CARACO PHARMACEUTICAL LABORATORIES, LTD., and Sun Pharmaceutical Industries, Ltd., Defendants-Appellees.

United States Court of Appeals, Federal Circuit.

April 14, 2010.


Attorney(s) appearing for the Case

Mark A. Perry, Gibson, Dunn & Crutcher LLP, of Washington, DC, argued for plaintiffs-appellants. With him on the brief were Josh A. Krevitt, of New York, NY; Wayne Barsky, of Los Angeles, CA; and Michael A. Sitzman, of San Francisco, CA.

James F. Hurst, Winston & Strawn LLP, of Chicago, IL, argued for defendants-appellees. With him on the brief were Charles B. Klein and Scott H. Blackman, of Washington, DC; David S. Bloch, of San Francisco, CA. Of counsel was Andrew Nichols, of Washington, DC.

Opinion for the court filed by Circuit Judge RADER. Concurring opinion filed by Circuit Judge CLEVENGER. Dissenting opinion filed by Circuit Judge DYK.


The United States District Court for the Eastern District of Michigan entered an injunction directing Novo Nordisk A/S and Novo Nordisk, Inc. (collectively, "Novo") to request the U.S. Food and Drug Administration ("FDA") to replace Novo's patent use code U-968 listing for Prandin® in the Orange Book with the former U-546 listing. Because Caraco Pharmaceutical Laboratories, Ltd. ("Caraco") does not have a statutory basis to assert a counterclaim requesting such injunctive...

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