The Supreme Court rendered a decision yesterday, in Caraco Pharmaceutical Laboratories, LTD. v. Novo Nordisk A/S, 566 U.S. ___ (2012). This case deals with the right to contest patent information submitted to the FDA to support market exclusivity. The holding, copied below, is self explanatory: 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. *** The statutory counterclaim we have considered enables courts to resolve patent disputes so that the FDA can fulfill its statutory duty to approve generic drugs that do not infringe patent rights. The text and context of the provision demonstrate that a generic company can employ the counterclaim to challenge a brand’s overbroad use code. We accordingly hold that Caraco may bring a counterclaim seeking to “correct” Novo’s use code “on the ground that” the ‘358 patent “does not claim . . . an approved method of using the drug” – indeed, does not claim two.
Richard Neifeld, Ph.D. Patent Attorney
President, Neifeld IP Law, PC
4813-B Eisenhower Avenue
Alexandria Virginia 22304
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