Supreme Court Rules On Patent Use Codes

On Tuesday, the Supreme Court decided Caraco Pharmaceutical Laboratories v. Novo Nordisk. In a unanimous opinion authored by Justice Kagan, the Court construed the counterclaim provision of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(5)(C)(ii)(I), to permit generic drug manufacturers to challenge in litigation the breadth of a "use code" submitted to FDA by a brand manufacturer to describe its patent coverage for a reference listed drug.

Under FDA regulations, a brand-name drug manufacturer is required to provide a description, known as a use code, of any method-of-use patent it holds that covers the marketed drug. The use code is accepted "as is" by the FDA and published in the Orange Book.