United States: Venue In ANDA Cases: The Effect Of The Heartland Decision On The Plaintiff's Choice Of Forum

On May 22, 2017, the Supreme Court issued its decision in T.C. Heartland LLC v. Kraft Foods Group Brands LLC, U.S., No. 16-341, 5/22/17 (slip op.). The dispute arose when Kraft, a Delaware corporation, sued Heartland, an Indiana corporation whose only connection with Delaware was sales of its product, in the U.S. District Court for the District of Delaware. Heartland moved to dismiss or transfer, arguing that venue in Delaware was improper. The statute governing venue in patent infringement cases, 28 U.S.C. § 1400(b), states: "Any civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business." The district court denied the motion, and the Federal Circuit denied Heartland's petition for a writ of mandamus, relying on its 1990 decision in VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990) that § 1400(b) is subject to the general venue provisions that define "residence" for venue purposes as any district that can exercise personal jurisdiction over the defendant. Heartland petitioned the Supreme Court for a writ of certiorari, arguing that the Federal Circuit's reliance on VE Holding was misplaced.

The Supreme Court, agreeing with Heartland, unanimously upended over 35 years of venue jurisprudence and held that a domestic corporation "resides" only in its state of incorporation for purposes of the patent venue statute. The Court agreed with Heartland that the Federal Circuit had improperly ignored a 1957 Supreme Court precedent, Fourco Glass Co. v. Transmirra Products Corp., 353 U.S. 222 (1957) that had held that the patent venue statute should not be read in light of the other venue provisions, but instead was a stand-alone statute that consistently referred only to the state of incorporation from its inception.

The Heartland decision has been widely touted as a game-changing decision, and it is a fair bet that it will affect where Abbreviated New Drug Application (ANDA) litigations will be brought. To understand the impact of Heartland, however, requires an understanding of interplay between venue and personal jurisdiction in ANDA litigations. In 2014, the Supreme Court clarified in Daimler that general personal jurisdiction can be exercised over a defendant where it is "at home," which typically would be its state of incorporation or principal place of business. Daimler AG v. Bauman, et al., 134 S. Ct. 746 (2014). Apparently recognizing the difficulty this standard created for plaintiffs in ANDA litigations, the Federal Circuit more recently held in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), that specific personal jurisdiction in ANDA cases can be based on the filing of an ANDA coupled with the ANDA filer's intent to market its proposed drugs in the forum. Because the Federal Circuit had determined in VE Holding that venue was coextensive with personal jurisdiction, the Acorda decision subjected ANDA filers to suit under the Hatch-Waxman Act in any state in the country.

The Heartland decision, however, has divorced the venue analysis from the personal jurisdiction analysis. The simplest route will be to file suit in the ANDA filer's home state of incorporation which, in one fell swoop, will satisfy both the "residence" standard of § 1400(b) for venue and the "at home" standard under Daimler for general personal jurisdiction. A plaintiff who wishes to look beyond the ANDA filer's home state should be able to establish specific personal jurisdiction under Acorda in any jurisdiction but now must satisfy the "committed acts of infringement and has a regular and established place of business" prong of § 1400(b).

Looking first at the "committed acts of infringement" portion of that test, under the reasoning of the Acorda decision, the situs of infringement is all states in which the ANDA filer intends to market its proposed generic drug product. But, to satisfy § 1400(b), the plaintiff will now have to confine its choice of forum to those venues in which the ANDA filer "has a regular and established place of business." How courts will interpret this language of § 1400(b) remains to be seen, but guidance can be found in the Federal Circuit's 1990 decision in In re Cordis Corp., 769 F. 2d 733, 737 (Fed. Cir. 1985). In Cordis, the Federal Circuit noted that what constitutes a "regular and established place of business" is a fact intensive inquiry centered on whether the corporate defendant does its business in that district through a permanent and continuous presence,"
not "whether it has a fixed physical presence in the sense of a formal office or store." Relevant factors may include whether the ANDA filer maintains an office or facility in the district; the number, nature, and job responsibilities of representatives stationed there; whether sales are continuous or isolated; whether the ANDA filer is registered to do business or registered with the state board of pharmacy—the same factors that were often relied upon for personal jurisdiction prior to the Acorda decision.

Because of its more restrictive reading of the special patent venue provision, the Heartland decision has tempered the effect of the Acorda decision. Arguably Heartland has eliminated the national jurisdiction for cases brought under the Hatch-Waxman Act that was created by Acorda. The practical effect of the Heartland decision may be to simply return forum choice in Hatch-Waxman Act cases to the status quo as it existed prior to Acorda: the same arguments may be made to support the plaintiff's choice of forum, but will be now phrased in terms of venue instead of personal jurisdiction.

Originally printed in  BNA's Pharmaceutical Law & Industry Report on June 16, 2017.

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.

Similar Articles
Relevancy Powered by MondaqAI
Lewis Brisbois Bisgaard & Smith LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Lewis Brisbois Bisgaard & Smith LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Related Articles
Related Video
Up-coming Events Search
Font Size:
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.


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.


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