Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd.

In 2003, Congress enacted the counterclaim provision of the Hatch-Waxman Act in order to prevent manipulative practices by patent holders with respect to the Orange Book listings. These practices were designed to delay the onset of competition from generic drug manufacturers. See Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub.L. No. 108-173, § 1101(a)(2)(C), 117 Stat.2066, 2452 (codified at 21 U.S.C. § 355(j)(5)(C)(ii)) (“the counterclaim amendment”). In my view, the majority, in reversing the district court, now construes the statute contrary to its manifest…