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

The Hatch-Waxman Act's counterclaim provision allows generic drug manufacturers to seek an FDA order requiring changes by the patent holder both to approved uses of the drug and to corrections of the patent's scope.

In 2005, Petitioner filed an abbreviated new drug application (ANDA) for a generic form of the drug Prandin manufactured and patented by Respondent. Respondent brought suit, claiming that Petitioner’s ANDA infringed on its patent. The FDA initially signaled it would approve Petitioner’s application, given that it planned to market the drug under two FDA-approved methods of use not covered by Respondent’s patent. In 2009, Respondent submitted an amendment to its use code for Prandin to include the other two methods of use, and the FDA subsequently denied Petitioner’s application as infringing upon the Respondent’s patent. Petitioner filed suit, asserting that Respondent misrepresented the scope of use in its patent amendment. The trial court found that the use code was overbroad and entered an injunction requiring Respondent to amend its patent. The Court of Appeals for the Federal Circuit reversed, finding that the counterclaim provision in the Hatch-Waxman Act permits deletion of improperly listed patents but does not require a patent holder to correct information that a generic drug manufacturer asserts is a misrepresentation of the scope of approved use.

The Supreme Court reversed, holding that the counterclaim provision in the Hatch-Waxman Act permits generic drug manufacturers to force patent holders to correct use codes that inaccurately include methods of use not actually covered by the patent, and to force correction when the patent use description was either overbroad or completely baseless. The Court rejected Respondent’s assertion that the counterclaim provision is only available when a drug patent claims no approved method of use, and found that Congress intended to permit applications for unpatented uses in order to get generic drugs to market quickly.