Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2012)

by McDonnell Boehnen Hulbert & Berghoff LLP
Contact

[author: Andrew Williams]

Novo NordiskOn Monday, the Federal Circuit issued an Order in the Novo Nordisk A/S v. Caraco Pharm. Labs. Ltd. case, modifying an injunction against Novo issued by the lower court from one dictating express language to amend its Orange Book use code to one that required Novo to amend the use code.  The Order, however, provides flexibility for the exact language, provided that the language accurately describes the scope of the Orange Book-listed patent claim.  Judge Dyk dissented in part because he believed that the lower court's injunction should not have been modified because district courts are supposed to have broad authority to shape remedial injunctive orders.

Caraco Pharmaceutical LaboratoriesThe Novo case had an extensive history, with the most recent stop at the Supreme Court, resulting in a reversal of the Federal Circuit's previous opinion and a remand for further proceedings consistent with the Supreme Court's decision.  The history and outcome of the Supreme Court's opinion has been discussed here, and therefore this summary will only provide a brief introduction to provide the proper context for the Federal Circuit's recent order.  Novo markets the drug PRANDIN® for the treatment of Type 2 (adult-onset) diabetes.  Repaglinide, the active ingredient in PRANDIN®, is covered by Reissue Patent No. RE37,035, and the use of repaglinide in combination with metformin is covered by U.S. Patent No. 6,677,358 ("the '358 patent").  However, PRANDIN® was also approved for use as a monotherapy and in combination with thiazolidinediones, and the use code listed in the Orange Book was broad enough to cover these other non-patented uses.  Caraco filed an ANDA to market a generic version of PRANDIN®, and included a Section viii statement to "carve-out" the claimed method of use in an attempt to circumvent the '358 patent.  Nevertheless, because the use code was overly broad, the FDA rejected Caraco's carve out label.  As a result, Caraco sought a court order requiring the FDA to narrow the Orange Book listed use code.  After the District Court granted such an order, and the Federal Circuit vacated the injunction, the Supreme Court held that 21 U.S.C. § 355(j)(5)(c)(ii)(I) provided an ANDA applicant an opportunity to challenge inaccurate use codes and designations.  The current order is a result of Caraco's motion for a summary affirmance of the injunction based on the Supreme Court's remand of the case.

The first issue raised by Novo's challenge to the motion was whether the current use code was actually incorrect.  All three members of the panel believed that, based on the admitted facts of this case, the Supreme Court's decision foreclosed any argument to the contrary.  Therefore, the only remaining issue advanced by Novo was whether the mandatory injunction of the District Court was in error.

The majority answered this question in affirmative.  It began with the language of the counterclaim statue, which provides that the court can issue "an order requiring the holder to correct or delete the patent information submitted by the holder" to the FDA.  The Court also noted that the FDA regulations make the branded company responsible for drafting the use code in the first place, and in fact must certify that the information was accurate and complete.  When viewed in combination, these two provisions provide that the only appropriate order would allow the branded company to draft its own corrected use code.  The District Court's injunction, however, dictated the exact language of the modification (even if the exact language was a previously appearing use code for PRANDIN®):

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."

As a result, the Court found that the District Court had abused its discretion.  Of course, the Court noted that the use code must accurately describe the patented use, and that it is appropriate for a district court to construe the scope of the patent claims (which will influence the scope of the use code).  Also, in response to the dissent's concerns, the majority pointed out that the district court always has the power to correct any attempt to submit an overly broad revised use code.  Therefore, the majority revised the injunction to read:

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.

In dissent, Judge Dyk also began with the language of the statue, as provided above.  However, he could find no prohibition from allowing the district court to dictate the particular use code as a corrective measure.  The dissent also pointed out that district courts have traditionally had broad authority to shape injunctive orders.  Finally, Judge Dyk pointed out that there is no statute or regulation that says that a district court cannot correct a use code under the counterclaim statute, which would be required to prevent a court from doing so (citing Weinberger v. Romero-Barcelo, 456 U.S. 305, 313 (1982) ("[T]he comprehensiveness of this equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command.")).  By way of illustration, it analogized this current situation to an order from a lower court amending the inventorship of a patent, noting that the Federal Circuit has never limited a lower court to ordering a general correction of an incorrect list of inventors rather than directing exactly how the inventorship should be changed.  This might not be a completely appropriate analogy, but the dissent had a valid point when it noted that a patent holder should not be allowed to continue to "throw a wrench" into the ability of the FDA to approve generic drugs, and such a ruling by the majority would have this effect.  Whether Novo in this case, or some future NDA holder in a separate case, could craft a revised use code that still accurately reflects the patented use but also thwarts the attempts of an ANDA applicant to obtain a "carve out" remains to be seen.

Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2012)
Panel: Chief Judge Rader and Circuit Judges Clevenger and Dyk
Order for the court by Chief Judge Rader; opinion concurring in part and dissenting in part by Circuit Judge Dyk

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP
Contact
more
less

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!