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Novo Nordisk sued Caraco Pharmaceutical Laboratories and Sun Pharmaceutical Industries Inc. for infringement in the wake of Caraco filing an abbreviated new drug application for a generic version of the Type 2 diabetes drug Prandin. Caraco and Sun promptly countersued. While the litigation was pending, Novo changed the FDA Orange Book's use code — a description of the scope of the patent —undermining Caraco's argument that patent did not apply to the purpose for which the generic product would be marketed. Caraco filed a counterclaim requesting an order that would require Novo Nordisk to change back the use code. The U.S. District Court for the Eastern District of Michigan granted the counterclaim and issued an injunction ordering Novo Nordisk to change the code. Novo appealed to the Federal Circuit, arguing the district court had abused its discretion. The U.S. Court of Appeals for the Federal Circuit ruled in favor of Novo.

(1) Does the counterclaim provision of the Hatch-Waxman Act apply when there is "an approved method of using the drug" that "the patent does not claim"?

(2) Does the counterclaim provision of the Hatch-Waxman Act apply when the brand submits "patent information" to the FDA that misstates the patent's scope, requiring "correct[ion]?"