Federal Circuit Has Final Say in Caraco Prandin Case

09 August 2012 PharmaPatents Blog

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:  

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.


This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services


RCE PTA Carve-Out Resumes After Interference
18 September 2019
The Ninth Circuit Expected to Rule that Doctors Can Be Wrong in the Winter v. Gardens False Claims Act Case
18 September 2019
Legal News: Government Enforcement Defense & Investigations
Upcoming Webinar: Maximizing Solar Tax Credits - Navigating the Start of Construction Rules (Part 1)
17 September 2019
Renewable Energy Outlook
When Birds Finally Find a Nest
17 September 2019
Dashboard Insights
Lacktman, Ferrante Cited in mHealth Intelligence About Ryan Haight Act
19 September 2019
mHealth Intelligence
Tinnen Discusses How Viewpoint Diversity Helps Businesses Thrive
18 September 2019
Vernaglia Comments on AHA v Azar Decision
18 September 2019
MedPage Today
Lach Comments on Launch of New Group
16 September 2019
BizTimes Milwaukee
MedTech Impact Expo & Conference
13-15 December 2019
Las Vegas, NV
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
BRG Healthcare Leadership Conference
06 December 2019
Washington, D.C.
CTeL Telehealth Fall Summit 2019
04-06 December 2019
Washington, D.C.