United States: The First Paragraph IV ANDA Filer´s Potential Delay In Launching Generic Product Does Not Create DJ Jurisdiction For Subsequent ANDA Filer

Judges: Michael, Rader, Moore (author)

[Appealed from D.N.J., Judge Cavanaugh]

In Janssen Pharmaceutica, N.V. v. Apotex, Inc., No. 08-1062 (Fed. Cir. Sept. 4, 2008), the Federal Circuit affirmed the district court's dismissal of Apotex, Inc.'s ("Apotex") DJ suit in favor of Janssen Phamaceutica, N.V. and Janssen, L.P. (collectively "Janssen").

Janssen holds an approved NDA for its drug Risperdal® Oral Solution. The FDA Orange Book listed U.S. Patent Nos. 4,804,663 ("the '663 patent"); 5,453,425 ("the '425 patent"); and 5,616,587 ("the '587 patent"). The '663 patent covers the drug's active compound risperidone. The '425 and '587 patents cover specific aqueous solutions of risperidone and methods for preparing those solutions. The '663 patent expired recently. The '425 and '587 patents are still in force.

Teva Pharmaceuticals USA, Inc. ("Teva") was the first ANDA applicant to file a Paragraph IV Certification under the Hatch-Waxman Act, challenging only the '425 and '587 patents. Janssen did not file suit against Teva on these two patents. As the first ANDA filer, Teva is entitled to 180 days of generic market exclusivity, during which the FDA will not approve a later-filed Paragraph IV ANDA based on the same drug.

Apotex submitted its own ANDA after Teva, challenging all three of Janssen's patents. Janssen sued Apotex for infringing the '663 patent but not the '425 and '587 patents. Apotex counterclaimed for DJ of noninfringement of the two unasserted patents. Janssen moved to dismiss these counterclaims on the ground that the action did not present a case or controversy. Later, Janssen granted Apotex a covenant-not-to-sue with respect to the '425 and '587 patents, then requested that Apotex withdraw its counterclaims. Apotex refused. The district court granted Janssen's motion to dismiss Apotex's counterclaims for lack of subject matter jurisdiction, and Apotex appealed.

On appeal, Apotex argued that it was suffering three actual and continuing injuries that created a substantial controversy of sufficient immediacy to warrant the issuance of a DJ: (1) Apotex was unable to promptly launch its own generic product and compete in the market upon expiration of the '663 patent; (2) the FDA approval of Apotex's product was indefinitely delayed; and (3) Apotex's affiliates, suppliers, or downstream customers faced uncertainty because Janssen's covenant-not-to-sue did not cover them. The Court rejected all three arguments.

First, the Court rejected Apotex's argument that, absent a DJ with respect to Janssen's '425 and '587 patents, Apotex suffered a cognizable harm because it was unable to launch its generic product immediately upon the expiration of Janssen's '663 patent. Without a DJ, Teva's 180-day exclusivity will commence when it launches its product after the '663 patent expires.

Apotex may then enter the market 181 days after expiration of the '663 patent. If, however, Apotex is successful in its DJ action, Teva's 180-day exclusivity will begin at a time that Teva is unable to launch its product and Apotex may enter the market when the '663 patent expires. The Court distinguished the current case from its recent ruling in Caraco Pharmaceutical Laboratories v. Forest Laboratories, 527 F.3d 1278 (Fed. Cir. 2008), which Apotex argued was controlling. In Caraco, the patentee listed two patents in the Orange Book, but sued both the first ANDA filer and the subsequent ANDA filer on only one patent, and also granted the subsequent ANDA filer a covenant-not-to-sue on the unasserted patent. The Federal Circuit held in Caraco that the DJ claim brought by the subsequent ANDA filer, under the Hatch-Waxman Act, presented a justiciable Article III controversy because finding jurisdiction would have permitted the subsequent ANDA filer to obtain DJ on both patents and triggered the 180-day exclusivity period. In the current case, however, the Court noted that Apotex stipulated to the validity, infringement, and enforceability of Janssen's '663 patent. Therefore, the Court held that while the harm that created a justiciable Article III controversy in Caraco was present when Apotex filed its counterclaims, that harm ceased to exist upon Apotex's stipulation. Even if Apotex successfully invalidated the '425 and '527 patents, it could not obtain FDA approval until the expiration of the '663 patent because of its stipulations with respect to that patent. Thus, Apotex was being excluded from the market not by the two Janssen patents it was challenging, but by Teva's 180-day exclusivity period, which was not a cognizable Article III controversy but a result envisioned by the Hatch-Waxman Act.

Second, the Court rejected Apotex's argument that, absent a DJ action, it was subject to indefinite delay in launching its generic product until Teva's 180-day exclusivity period is triggered. The Federal Circuit found that at the time the district court entered final judgment in this case, Apotex's alleged harm of indefinite delay was too speculative to create an actual controversy to warrant issuance of a DJ. Thus, the Court held that a possible delay in the future of a first Paragraph IV ANDA filer in launching its generic product does not give rise to DJ jurisdiction.

Third, the Court rejected Apotex's argument that Janssen's covenant-not-to-sue was deficient because it did not protect Apotex's affiliates, suppliers, and downstream customers. Citing language of the agreement, the Court found that Janssen's covenant-not-to-sue expressly covered all suppliers and affiliates involved in the manufacturing process, and all of Apotex's customers, including downstream customers. Thus, the Court held that the convenant-not-tosue was not deficient.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions