Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd.

A court may issue an injunction requiring correction of an improper use code, but may not dictate the precise terms of the corrected code.

October 16, 2012

GENERICally Speaking

Case Name:  Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., Case No. 2010-1001, 688 F.3d 766 (Fed. Cir. July 30, 2012) (Circuit Judges Rader, Clevenger, and Dyk presiding; Opinion by Rader; Dissent-in-part by Dyk.) (Appeal from E.D. Mich., Cohn, J.)

Drug Product and Patent(s)-in-Suit:  PrandiMet® (repaglinide/metafomin hydrochloride extended-release tablets); U.S. Patent No. 6,677,358 (“the ’358 patent”)

Nature of the Case and Issue(s) Presented:  Caraco moved for summary affirmance of the district court’s injunction pursuant to the Supreme Court’s decision, which reversed the Federal Circuit’s judgment and remanded for further proceedings.  Novo Nordisk argued that the two main issues on remand are whether (i) Novo Nordisk’s current use code is correct; and (ii) whether the district court erred in issuing a mandatory injunction requiring Novo Nordisk to reinstate its prior use code.  The Federal Circuit affirmed-in-part and modified-in-part the district court’s injunction.

Why Caraco Prevailed:  The Federal Circuit found that the Supreme Court’s decision forecloses any argument that Novo Nordisk’s use code is “correct.”  The Supreme 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.”  Because the FDA found that Novo Nordisk’s current use code covers all three FDA-approved methods of using repaglinide, and that it is undisputed that the ’358 patent claims only one of those three approved methods of use, the current use code inaccurately describes Novo Nordisk’s patent as covering two FDA-approved methods of using repaglinide that the ’358 patent does not cover.

The district court’s injunction instructs Novo Nordisk to correct its use code and file an amended Form 3542 “that reinstates its former U-546 listing for Prandin and describes claim 4 of the ‘’358 patent…as covering the use of repaglinide in combination with metformin to lower blood glucose.”  The Court held that while the district court was correct in issuing an injunction requiring correction of the use code, it abused its discretion in dictating the precise terms of the use code to be submitted on FDA Form 3542.  The majority opinion reasoned that FDA regulations make the branded company, not the courts, responsible for drafting appropriate use codes and submitting them to the FDA.

In his dissent, Judge Dyk took issue with the majority’s ruling that a district court cannot order a party to adopt a compliant use code, but only enjoin the use of one.  Judge Dyk noted that no statute or regulation says that a use code cannot be corrected by a court under the counterclaim provision, and that Courts “routinely construe the scope of patent protection, so there is hardly anything unusual in the court’s doing exactly the same thing in the context of the counterclaim provision.”  Finally, he reasoned that “Novo should not be permitted to throw a new wrench each time one code is removed by offering new overbroad ones and forcing Caraco to seek correction of each one.”

Back to Top