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Supreme Court of the United States
December 5, 2011, Argued; April 17, 2012, Decided
[*403] 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.
[*404] 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] [****11] on the ground that the patent [***687] 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 FDA regulates the manufacture, sale, and labeling of prescription drugs under a complex statutory scheme. To [**1676] begin at the beginning: When a brand manufacturer wishes to market a novel drug, it must submit a new drug application (NDA) to the FDA for approval. The NDA must include, among other things, a statement of the drug's components, scientific data showing that the drug is safe and effective, and proposed labeling describing the uses for which the drug may be marketed.  See §§355(b)(1), (d). The FDA may approve a brand-name drug for multiple methods of use--either to treat different conditions or to treat the same condition in different ways.
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566 U.S. 399 *; 132 S. Ct. 1670 **; 182 L. Ed. 2d 678 ***; 2012 U.S. LEXIS 3106 ****; 102 U.S.P.Q.2D (BNA) 1345; 80 U.S.L.W. 4324; 23 Fla. L. Weekly Fed. S 259; 2012 WL 1288732
CARACO PHARMACEUTICAL LABORATORIES, LTD., et al., Petitioners v. NOVO NORDISK A/S et al.
Subsequent History: On remand at, Motion granted by Novo Nordisk A/S v. Caraco Pharm. Labs., 2012 U.S. App. LEXIS 10357 (Fed. Cir., May 23, 2012)
Prior History: [****1] ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT.
Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 2010 U.S. App. LEXIS 7621 (Fed. Cir., 2010)
Disposition: Reversed and remanded.
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