On July 30, 2012 the Federal Circuit issued what should be its final decision in the litigation between Caraco Pharmaceutical Labs. and Novo Nordisk A/S surrounding Caraco’s generic version of Novo Nordisk’s Prandin® repaglinide product. Earlier this year the Supreme Court held that 21 USC § 355(j)(5)(C)(ii)(I) provides Caraco with a mechanism for challenging the use code associated with Novo Nordisk’s Orange Book listed patent. In this appeal, Novo Nordisk challenged the district court’s injunction requiring Novo Nordisk to replace the use code with specific language. In this decision, the Federal Circuit modified that injunction to give Novo Nordisk some discretion in drafting the use code language.  The Supreme Court Decision I provided a more detailed discussion of the Supreme Court decision and the underlying regulatory framework in this article from April 2012.  Briefly, the FDA has approved repaglinide for three uses:  

  1. repaglinide by itself (i.e., monotherapy)
  2. repaglinide in combination with metformin
  3. repaglinide in combination with thiazolidinediones

Novo Nordisk had listed two patents for Prandin® in the Orange Book:  

  1. U.S. RE 37,035, which includes product claims and expired March 14, 2009 (this patent is no longer listed)
  2. U.S. 6,677,358, which includes combination product and method claims using repaglinide and metformin, and which is set to expire June 12, 2018. Claim 4 recites:

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.  

The ’358 patent was listed with the following use code:  

U-968–A method for improving glycemic control in adults with type 2 diabetes mellitus  

Caraco brought suit alleging that the use code “was overbroad because it incorrectly suggested that the ’358 patent covered all three approved methods of using repaglinide even though it claimed only one approved method.” Although the Federal Circuit held that 21 U.S.C. § 355(j)(5)(C)(ii)(I) could not be used to bring such a challenge, the Supreme Court disagreed. In particular, the Supreme Court held that the counterclaim provision of 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 District Court Injunction The District Court entered the following injunction:  

Novo Nordisk is hereby directed by mandatory injunction under 21 U.S.C. § 355(j)(5)(C)(ii)(I)(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 Federal Circuit Decision The Federal Circuit reviewed the injunction for abuse of discretion. The Federal Circuit noted that the remedy provided in 21 U.S.C. § 355(j)(5)(C)(ii)(I) is “an order requiring the holder to correct or delete the patent information.” The court noted further that “[t]he relevant FDA regulations make the branded company responsible for drafting appropriate use codes and submitting them to the FDA.” Thus, the court concluded: 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. Thus, the Federal Circuit held:  

[W]hile 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.  

On the other hand, the court stated:

[I]t 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.  

In that vein, the court noted that the use code “must not ‘sweep more broadly than the patent,’” and “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.” ’358 patent, claim 4. An appropriate use code therefore must be limited to use of “repaglinide in combination with metformin” to treat NIDDM.  

The Federal Circuit therefore modified the injunction to read as follows:   

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