Caraco Pharmaceutical Laboratories, LTD., et al., Petitioners v. Novo Nordisk A/s et al. (566 U.S. 399)
U.S. Supreme Court · decided April 17, 2012 · Supreme Court Database (Spaeth)
- Citation
- 566 U.S. 399 · 132 S. Ct. 1670
- Decided
- April 17, 2012
- Term
- October Term 2011
- Vote
- 9–0
- Majority author
- Justice Kagan
- Issue area
- Economic Activity
- Disposition
- Reversed and remanded
- Outcome
- Petitioning party won
- Ideological direction
- Liberal
Opinion excerpt
Justice Kagan delivered the opinion of the Court. 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…
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