Caraco v. Novo Nordisk

Whether the provision in the Hatch-Waxman Act allowing generic drug manufacturers to “counterclaim” and seek an FDA order requiring changes by the patent holder applies to (1) approved methods of use of the drug and (2) corrections to the patent’s scope.

In 2005, Caraco filed an abbreviated new drug application for a generic form of the drug PRANDIN, manufactured and patented by Novo Nordisk (Novo). The Food and Drug Administration (FDA) initially signaled it would approve Caraco’s application. In 2009 Novo submitted an amendment to its patent for PRANDIN and the FDA subsequently denied Caraco’s application as infringing upon the Novo-held patent. Caraco filed suit, asserting that Novo misrepresented the scope of use in its patent amendment. The Federal Court for the Eastern District of Michigan found that the use code was overbroad and entered an injunction requiring Novo to amend its patent. The Court of Appeals for the Federal District 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.

Petitioner argues that, the Hatch-Waxman Act specifically authorizes generic drug manufacturers to counterclaim against brand-name patent holders to request a correction or deletion from the FDA, if there is an approved method of using the drug that the patent does not claim. Arguing that the FDA lacks authority and expertise to construe patents, Petitioner asserts that the Court of Appeals’ ruling permits drug patent-holders to submit overbroad use descriptions in a patent application, thereby making it very difficult for generic drug manufacturers to gain FDA approval. Further, Petitioner argues that the Court of Appeals erred by limiting the information from which a generic drug manufacturer may request changes to only erroneous patent numbers or expiration dates.