IP News

On Dec. 5, 2011, the Supreme Court heard oral arguments in Caraco Pharmaceutical Labs. v. Novo Nordisk A/S, No. 10-844. The Federal Circuit previously held that Caraco's counterclaim under 21 U.S.C. ' 355(j)(5)(C)(ii) that requested an order requiring Novo to change the allegedly overbroad use code for the patent-in-suit was improper. Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., No. 2010-1001 (Fed. Cir. 2010). The Federal Circuit held that because the use code contains “an approved method of using the drug” covered by the patent-in-suit, the counterclaim seeking a change of the use code was improper.

The Supreme Court granted certiorari on June 27, 2011, on the question of whether an ANDA applicant may assert a counterclaim under ' 355(j)(5)(C)(ii)(I) by alleging that the brand-name manufacturer's patent information does not accurately and precisely describe the method of use claimed by its parent. During oral arguments, Justice Antonin Scalia mentioned that Caraco's reading of the statute contained “oddities,” while Caraco's counsel argued that under Novo's reading of the statute, the only corrections that could be made using the counterclaim provision are typos in the patent numbers listed in the Orange Book.