Supreme Court Decision Alert - April 17, 2012

Originally published April 17, 2012

Keywords: Hatch-Waxman Act, counterclaims, unexpired patents, FDA, Caraco

Hatch-Waxman Act—Counterclaims

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, No. 10-844 (previously discussed in the June 27, 2011 Docket Report).

The FDA is authorized to approve generic drugs only if they do not infringe the patent of a brand manufacturer. For drugs that are covered by unexpired patents, the Hatch-Waxman Amendments permit generic manufacturers to show that a proposed generic drug will not infringe the patent. One method of doing that, a "section viii statement," asserts that the generic drug will be marketed only for uses that the patent does not cover. In evaluating section viii statements, the FDA relies on "use codes" submitted by the patent holder. Today, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, No. 10-844, the Supreme Court held that a generic manufacturer may file a