[A]n appropriate order granting relief under 21 U.S.C. § 355(j)(5)(C)(ii)(I) will give the branded company the opportunity to draft its own corrected use code.
On July 30, 2012, in Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., the U.S. Court of Appeals for the Federal Circuit (Rader,* Clevenger, Dyk) issued an order that effectively affirmed-in-part and modified-in-part the district court's injunction following the U.S. Supreme Court decision in Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012), which reversed the Federal Circuit's judgment and remanded for further proceedings. The Federal Circuit stated:
Novo argues that two issues remain to be resolved by this court on remand: (1) whether Novo's current use code is "correct"; and (2) whether the district court erred in issuing a mandatory injunction requiring Novo to reinstate its prior use code.
This court finds, in light of the admitted facts in this case, that the Supreme Court decision forecloses any argument that Novo's use code is "correct." The Court held that the counterclaim provided by 21 U.S.C. § 355(j)(5)(C)(ii)(I) can be used "to force correction of a use code that inaccurately describes the brand's patent as covering a particular method of using the drug in question." The Food and Drug Administration ("FDA") has found Novo's current use code covers all three FDA-approved methods of using repaglinide. It is undisputed that Novo's U.S. Patent No. 6,677,358 ("'358 patent") claims only one of those three approved methods of use. Thus, the current use code inaccurately describes Novo's patent as covering two FDA-approved methods of using repaglinide that the '358 patent admittedly does not cover.
This court reviews a district court's grant of a permanent injunction and the scope of that injunction for abuse of discretion. The counterclaim statute provides that the remedy is "an order requiring the holder to correct or delete the patent information submitted by the holder" to the FDA. Damages are prohibited.
The District Court entered an injunction on September 25, 2009, which provided: Novo Nordisk is hereby directed by mandatory injunction under 21 U.S.C. § 355(j)(5)(C)(ii)(1)(bb) to correct within twenty (20) days from the date of this Order and Injunction its inaccurate description of the '358 patent by submitting to FDA an amended form FDA 3542 that reinstates its former U-546 listing for Prandin and describes claim 4 of the '358 patent in section 4.2b as covering the "use of repaglinide in combination with metformin to lower blood glucose."
The relevant FDA regulations make the branded company responsible for drafting appropriate use codes and submitting them to the FDA. The company must certify under penalty of perjury "that this is an accurate and complete submission of patent information." In this context, an appropriate order granting relief under 21 U.S.C. § 355(j)(5)(C)(ii)(I) will give the branded company the opportunity to draft its own corrected use code. The use code offered by the branded company must not "sweep more broadly than the patent." Rather, the use code must accurately describe "the patented method of use" -- i.e., the approved method of use claimed in the patent. Here, the '358 patent claims "[a] method for treating non-insulin dependent diabetes mellitus (NIDDM) comprising administering to a patient in need of such treatment repaglinide in combination with metformin." An appropriate use code therefore must be limited to use of "repaglinide in combination with metformin" to treat NIDDM.
This court holds that while the District Court was correct in issuing an injunction requiring correction of Novo's use code listing for the '358 patent, it abused its discretion in dictating the precise terms of the use code to be submitted on FDA Form 3542. To be clear, it is appropriate for district courts to construe the scope of the patent claims and provide clear limits on the appropriate scope of the corresponding use code. Within those limits, the branded company is given the opportunity to propose the specific language of the use code. Therefore, this court modifies the injunction as follows to permit Novo to draft an appropriate use code in light of the guidance above. Contrary to the dissent's concerns, this holding does not give Novo unbounded discretion to propose a new overbroad use code. If the revised code offered is overbroad, the district court has the power to correct the error. Therefore,
IT IS ORDERED THAT: Novo Nordisk is hereby directed by mandatory injunction under 21 U.S.C. § 355(j)(5)(C)(ii)(1)(bb) to correct within twenty (20) days from the date of this Order and Injunction its inaccurate description of the '358 patent by submitting to FDA an amended form FDA 3542 for Prandin that accurately describes the scope of claim 4 of the '358 patent in section 4.2b. The description shall be clearly limited to use of repaglinide in combination with metformin to treat non-insulin dependent diabetes mellitus.