Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC (D.N.J.)

by Robins Kaplan LLP

Case Name: Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC, Case No. 12-5311 (JLL), 2014 U.S. Dist. LEXIS 49857 (D.N.J. April 9, 2014) (Linares, J.)

Drug Product and Patent(s)-in-Suit: Intermezzo® (zolpidem tartrate); U.S. Pats. Nos. 7,658,945 (“the ’945 patent”), 7,682,628 (“the ’628 patent”), 8,242,131 (“the ’131 patent”), and 8,252,809 (“the ’809 patent”)

Nature of the Case and Issue(s) Presented: Plaintiffs hold an NDA covering tablets containing two strengths of zolpidem tartrate, which is used in the treatment of middle-of-the-night insomnia. In July 2013, TWi Pharms., Inc. (“TWi”) submitted an ANDA containing a paragraph IV certification, indicating that the patents covering the drug were invalid or not infringed by the proposed ANDA product. At least four other generic manufacturers had filed ANDAs seeking to manufacture and sell generic Intermezzo® before TWi filed its application. In response to TWi’s ANDA, plaintiffs filed a lawsuit in August of 2013 seeking declaratory judgment that TWi had infringed the ’131 and ’809 patents. But plaintiffs did not assert against TWi any claims from the ’945 or ’628 patents. In response, TWi filed counterclaims seeking declaratory judgment that all four patents covering Intermezzo were not infringed by TWi’s proposed ANDA product. Thereafter, in January 2014, plaintiffs tendered a covenant not to sue TWi under any claims of the ’945 or ’628 patents. Plaintiffs moved to dismiss pursuant to Fed. R. Civ. P. 12(b)(1) TWi’s counterclaims seeking declaratory judgment of non-infringement with respect to the ’945 and ’628 patents. TWi opposed the motion and filed a cross-motion requesting judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c).

Two issues were presented: (i) whether a district court may assert declaratory judgment jurisdiction over counterclaims related to patents that are the subject of a covenant not to sue within the context of a Hatch-Waxman litigation; and (ii) whether TWi was entitled to judgment on the pleadings in the event that their counterclaims were determined to be ripe for adjudication.

Why Neither Party Prevailed:  TWI’s counterclaims were particularly noteworthy because it had the potential to trigger the first ANDA filer’s 180-day exclusivity period, which would have the effect of expediting TWi’s ability to market its ANDA product. In order to support their position that the court could not properly assert jurisdiction over the matter, plaintiffs presented three separate arguments that no case or controversy existed and that the court lacked jurisdiction: first, the covenant not to sue rendered moot any such controversy; second, the court could not redress TWi’s alleged injury; and third, the dispute was not ripe in light of TWi’s inability to obtain tentative approval.

The court disagreed with the argument that TWi’s counterclaims were mooted by the covenant not to sue. The court found that that there was ample authority supporting the proposition that a later ANDA filer’s declaratory judgment claims involving patents covered by a covenant not to sue were justiciable. The court cited binding Federal Circuit precedent that compelled it to conclude that plaintiffs’ covenant not to sue TWi did not moot TWi’s counterclaims seeking declaratory judgment.

The court also found that TWi’s injury was redressable. Plaintiffs argued that even if TWi were able to obtain a favorable judgment in relation to the ’945 and ’628 patents, this would not redress any injury arising from a delay in TWi’s ability to market its ANDA product. Plaintiffs reasoned that such a judgment would not independently trigger the first ANDA filer’s exclusivity period because TWi had not yet received tentative approval from the FDA to market its ANDA product. Essentially, plaintiff’s position was that a non-first-filed ANDA holder could not trigger the first-filed ANDA holder’s exclusivity period through a declaratory judgment action unless it had first received tentative approval from the FDA. The court noted that whether a subsequent ANDA filer must have tentative approval to maintain a declaratory judgment action was an issue that had not yet been considered by the Federal Circuit. Despite the fact that it appeared to be an issue of first impression, the district court rejected plaintiffs’ argument, relying on case law that recognized that the Hatch-Waxman Act created a civil action to obtain patent certainty that could be brought by an ANDA applicant at a time when it likely would not have tentative approval, indicating that other declaratory judgment actions did not require that the ANDA filer have tentative FDA approval. The court ultimately determined that tentative FDA approval was not a condition precedent for TWi to maintain its counterclaim.

Next, the court concluded that the case was ripe for determination because delaying judicial consideration of TWi’s counterclaims could result in depriving TWi of the ability to trigger the first ANDA filer’s 180-day exclusivity period, thus causing TWi to lose profits during the period of time it is excluded from the market. Therefore, the court found that delay in resolving TWi’s counterclaims would have an immediate and substantial impact on TWi. Accordingly, the court determined that it had jurisdiction to consider the matter, and dismissed plaintiffs’ motion.

The court then turned its attention to TWi’s cross-motion for judgment on the pleadings. TWi based its motion on the fact that there were no disputed facts and nothing to resolve with respect to the ’628 and ’945 patents. Plaintiffs’ opposition requested leave to amend in the event that the court determined that TWi’s counterclaims were justiciable. The court found that there was no reason not to allow plaintiffs to amend their pleadings in light of its decision to assert jurisdiction over counterclaims related to the ’628 and ’945 patents. The court held that plaintiffs were permitted to amend their pleadings, and that TWi’s motion should be denied. The court did note that TWi could renew its motion for judgment on the pleadings if it were still warranted after the plaintiffs amended their complaint.

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.

© Robins Kaplan LLP | Attorney Advertising

Written by:

Robins Kaplan LLP

Robins Kaplan 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.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

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.


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.