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Intellectual Property – patents — counterclaims

U.S. Supreme Court


Intellectual Property – patents — counterclaims

A generic manufacturer may employ the counterclaim provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using a drug.

The parties first dispute the meaning of “not an” in the phrase “the patent does not claim . . . an approved method of using the drug.” Novo contends that the counterclaim is available only if the patent claims no approved method of use, but Caraco reads this language to permit a counterclaim whenever a patent does not claim the particular method that the ANDA applicant seeks to market. In isolation, either of these readings is plausible, so the meaning of the phrase “not an” turns on statutory context, see Johnson v. United States, 559  U. S. ___, ___. This context favors Caraco: Congress understood that a drug may have multiple methods of use, not all of which a patent covers; and a section viii statement allows the FDA to approve a generic drug for unpatented uses so that it can quickly come to market. The statute thus contemplates that one patented use will not foreclose marketing a generic drug for other unpatented ones. Within this scheme, the counterclaim naturally functions to challenge the brand’s assertion of rights over whichever discrete uses the generic company wishes to pursue; the counterclaim’s availability matches the availability of FDA approval under the statute.

601 F. 3d 1359, reversed and remanded.

10-844 Caraco Pharmaceutical Laboratories, Ltd., v. Novo Nordisk, A/S

Kagan, J.; Sotomayor, J., concurring.

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