Supreme Court Allows Generic Drug Manufacturer to Counterclaim To Challange Use Code in Patent Infringement Action

The Supreme Court yesterday issued a unanimous opinion, per Justice Kagan, in CARACO PHARMACEUTICAL LABORATORIES, LTD. v. NOVO NORDISK A/S, No. 10–844 (U.S. April 17, 2012), 2012 WL 1288732:

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. The FDA does not attempt to determine if that information is accurate. Rather, the FDA assumes that it is so and decides whether to approve a generic drug on that basis. As a result, the breadth of the use code may make the difference between approval and denial of a generic company's application.

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. § 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.

PM