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

Summary

The Court held that a generic drug manufacturer may bring a counterclaim under the Hatch-Waxman Amendments to correct a brand manufacturer's inaccurate use code listing in the FDA's Orange Book. The Court rejected the brand's argument that the counterclaim is only available if the patent claims no approved method of use, interpreting the statute to allow challenges to specific unpatented methods. Justice Sotomayor concurred, noting the counterclaim does not eliminate the delays and costs generics face due to overbroad use codes.