The U.S. Supreme Court issued its decision today in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S on patent listing requirements in the FDA’s “Orange Book” for patented drugs. Caraco, an ANDA filer, brought a counterclaim in Novo’s Hatch-Waxman infringement action seeking an order that Novo correct patent information in the Orange Book on the basis the patent did not claim a use of the drug.
The formal question as posed for the appeal was:
Whether this counterclaim provision applies where (1) there is “an approved method of using the drug” that “the patent does not claim,” and (2) the brand submits “patent information” to the FDA that misstates the patent’s scope, requiring “correct[ion].”
The Supreme Court rejected Novo’s contention that the counterclaim was only available if the patent claims no approved method of use and held that the counterclaim could be used to challenge the brand’s assertion of rights over whichever discrete uses the generic company wishes to pursue.