The Hatch-Waxman Act only authorizes a counterclaim to correct or delete a patent number or expiration date listed in the FDA Orange Book; an ANDA defendant does not have standing to challenge any other listed information, including the use code description. For method of use patents, this counterclaim is only available when the listed patent does not claim any approved methods of using the listed drug.

Pursuant to 21 U.S.C. § 355(j)(5)(C)(ii), a counterclaim provision of the Hatch-Waxman Act, the district court granted summary judgment for the generic drug manufacturer on its counterclaim and entered an injunction requiring the patentee to correct the use code description listed in the FDA Orange Book for its repaglinide-related method patent. Initially, the patentee submitted a use code description that described the method patent as claiming only the use of repaglinide in combination with metformin. The generic manufacturer was not seeking approval for that combination of drugs, but only for other approved methods of using repaglinide. The FDA had indicated in a citizen petition ruling that it would approve the proposed labeling carve-out under what is known as a “section viii statement” under the Act. The patentee responded by submitting an amended use code description that broadly covered all approved uses for repaglinide, even though its patent only claimed one of these uses. This amendment effectively eliminated the possibility that the generic manufacturer could avoid infringement under section viii with a carved-out label. Finding that the patentee had improperly submitted an overly broad use code, the district court issued an injunction under the Act that would have forced the patentee to reinstate the original use code description.

In a 2-1 decision, the Federal Circuit reversed and vacated the injunction. The majority found the following statutory language to be clear on its face: “[The ANDA] applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) of this section on the ground that the patent does not claim … an approved method of using the drug.” 21 U.S.C. § 355(j)(5)(C)(ii)(I). According to the majority, this provision applies only when the listed method patent does not claim any approved method of using the drug, reasoning that “an approved method” necessarily means “any approved method.” As the court explained, a “patent listing that covers one amongst several approved methods of using a formulation protects that patented method and thus bears a direct relation to the purpose of Orange Book listings.” The majority further construed the term “patent information” in this provision to mean only “the patent number and the expiration date” submitted by the NDA holder. As a result, the court held that this statute merely allows an ANDA applicant to assert a counterclaim to correct or delete a patent number or expiration date listed in the Orange Book when the listed method patent does not claim any approved method of using the drug. Therefore, the counterclaim provision cannot be used to request an injunction compelling a patentee to correct an overbroad use code description — it “only authorizes suits to correct or delete an erroneous patent number or expiration date.” In this case, the patent did claim an approved method of using repaglinide, so the generic manufacturer could not assert the counterclaim.

A copy of the opinion can be found here.