On April 17, 2012, the U.S. Supreme Court issued a unanimous decision delivered by Justice Kagan in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, reversing the Federal Circuit and holding that a generic manufacturer (Caraco) may force correction of an Orange Book use code that inaccurately describes a brand company’s (Novo’s) patent as covering a particular method of using the drug in question under 21 U.S.C. §355(j)(5)(C (ii)(I) (“the counterclaim provision”). Justice Kagan’s opinion was accompanied by a concurring opinion by Justice Sotomayor.

As background, when submitting a New Drug Application (“NDA”), an innovator (or “brand”) pharmaceutical company must identify any patents that claim the drug that is the subject of the application or any method of using such drug. Once the NDA is approved, the FDA publishes the patent information in a database commonly known as the “Orange Book.” Specifically for patents that claim a method of use, the FDA requires that the NDA holder provide a description of the relevant claimed subject matter (“use code”), for which the FDA then assigns a use code number based on that description. A drug product may be approved for multiple uses and have more than one use code.

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