In Caraco Pharm. Labs. Ltd. V. Novo Nordisk A/S, the Supreme Court held unanimously that a generic drug maker may bring a counterclaim under 21 U.S.C. § 355(j)(5)(C)(ii)(I) to force the correction of an FDA use code that inaccurately describes a branded drug maker’s patent as covering a method of using the drug in question. For Hatch-Waxman litigation, the practical effects of the Caraco decision likely will include an increase in the number of counterclaims filed by generic defendants challenging such use codes.
As part of the drug approval process, a branded drug maker must identify under 21 U.S.C. § 355(b) and (c) patents that claim the drug for which it is seeking approval and patents that claim methods of using the drug. Once the drug is approved, FDA regulations further require that the brand select a use code to describe the identified method-of-use patents. The FDA does not verify the accuracy of those codes; it simply publishes them in its “Orange Book.”
21 U.S.C. § 355(j)(2)(A)(viii) permits a generic drug maker to seek and obtain FDA approval to market a generic drug that is labeled for uses not covered by the brand manufacturer’s patents. Under that procedure, commonly referred to as a “section viii carve-out,” a generic maker need not litigate the infringement or validity of the brand manufacturer’s method-of-use patents. However, a section viii carve-out is unavailable if the uses listed on a generic’s proposed label overlap with the brand’s use codes.
In Caraco, Caraco filed an abbreviated new drug application (ANDA) seeking FDA approval to make a generic version of Novo’s diabetes drug repaglinide, thereby provoking HatchWaxman litigation over Novo’s patent claiming that drug. In addition to the patent on the drug, Novo owned a ‘358 patent claiming the FDA-approved use of a combination of repaglinide and metformin to treat diabetes—but not the use of repaglinide alone. At the time Caraco filed its ANDA, the use code for Novo’s ‘358 patent indicated that it covered only the use of repaglinide in combination with metformin. The FDA thus told Caraco that it could avail itself of a section viii carve-out with respect to the ‘358 patent if it did not seek to market repaglinide for use with metformin. Caraco acted accordingly, and submitted a section viii statement to the FDA with proposed labeling carving out Novo’s patented use.