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NOVO NORDISK A/S v. CARACO PHARMACEUTICAL LABORATORIES, Appeal No. 10-1001 (Fed. Cir. April 14, 2010). Before Rader, Clevenger and Dyk. Appealed from E.D. Mich. (Judge Cohn). Background: Novo holds the approved New Drug Application ("NDA") for the diabetes drug repaglinide, which it markets as Prandin®. The FDA approved Prandin® for three uses: (1) repaglinide by itself; (2) repaglinide in combination with metformin; and (3) repaglinide in combination with thiazolidinediones. As required by the FDA, Novo listed in the Orange Book its method-of-use patent directed to the combination treatment of repaglinide and metformin. The FDA initially assigned the method patent the Orange Book use code "U-546–Use of repaglinide in combination with metformin to lower blood glucose." Caraco filed an Abbreviated New Drug Application ("ANDA") for generic Prandin®, including a proposed drug product label and a paragraph IV certification for Novo's patent. In response, Novo sued Caraco for infringement. Caraco then submitted an amended ANDA with a Paragraph IV certification of Novo's patent and a section viii statement declaring that Caraco was not seeking approval for the repaglinide-metformin combination therapy covered by Novo's patent, and the FDA accepted Caraco's proposed label. Novo subsequently updated its Orange Book use code narrative for its patent to the much broader "U-968–A method for improving glycemic control in adults with type 2 diabetes mellitus." The FDA then disallowed Caraco's section viii statement because its proposed label overlapped with the U-968 use code for Novo's patent. Caraco counterclaimed, requesting an order requiring Novo to change the use code for its patent back to the original U-546 use code, and thereby "correct the patent information." Caraco claimed that use code U-968 was overbroad because it incorrectly suggested that Novo's patent covered all three approved methods of using repaglinide, even though it only claimed one of the approved methods. The district court granted summary judgment on Caraco's counterclaim and entered an injunction directing Novo to replace its Orange Book patent use code listing for Prandin® with its former use code. Issue/Holding: Did the district court abuse its discretion in granting an injunction? Yes, reversed and A 2003 Hatch-Waxman Act amendment provides a limited counterclaim to ANDA applicants in Paragraph IV infringement actions to seek a judicial order to correct or delete "the patent information" from the Orange Book on the ground that the patent does not claim either: (1) the drug for which the application was approved; or (2) an approved method of using the drug. The Federal Circuit noted that the statutory language is clear on its face, and that "an approved method" means "any approved method." Thus, because the Novo patent claims an approved method, the Federal Circuit held that Caraco did not have a statutory basis to assert a counterclaim requesting injunctive relief. The majority also concluded that "patent information" referred to in the counterclaim provision means "the patent number and expiration date" and does not include the use code narrative because the term "patent information" is used elsewhere in the statute to refer only to the patent number and expiration date. Thus, the Federal Circuit held that the counterclaim provision only authorizes suits to correct or delete an erroneous patent number or expiration date, and does not extend to the use code narrative.

Source: http://dev.oliff.com/wp-content/uploads/2012/federalCircuit/2010/2010-1001(O&B).pdf