“When the Food and Drug Administration (FDA) evaluates an application to market a generic drug, it considers whether the proposed drug would infringe a patent held by the manufacturer of the brand-name version. To assess that matter, the FDA requires brand manufacturers to submit descriptions of the scope of their patents, known as use codes. . . . In this case, we consider whether Congress has authorized a generic company to challenge a use code’s accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit.”
“The relevant statute provides that a generic company ‘may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted … under [two statutory subsections] on the ground that the patent does not claim … an approved method of using the drug.’ 117 Stat. 2452, 21 U.S.C. ยง 355(j)(5)(C)(ii)(I). We hold that a generic manufacturer may employ this provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using the drug in question.”
