United States: Impact Of TC Heartland On ANDA And Biosimilar Litigation

In TC Heartland, the Supreme Court held that its 1957 decision in Fourco was still good law that limited the definition of "residence" under 28 U.S.C. § 1400(b) to the state of incorporation for domestic corporate defendants, thus reaffirming its position that the patent venue statute § 1400 (b) "is the sole and exclusive provision controlling venue in patent infringement actions, and is not to be supplemented by § 1391(c)"1. TC Heartland overturned decades of venue regime under the Federal Circuit's 1990 decision in VE Holding that applied § 1391(c)'s definition of "resides" to § 1400(b)2. Pursuant to § 1391(c)(2), "[f]or all venue purposes, an entity... shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court's personal jurisdiction with respect to the civil action in question..."

Following TC Heartland, the brand manufacturer, in the context of abbreviated new drug applications (ANDAs) under the Hatch-Waxman Act, or the reference product sponsor (RPS), in the context of abbreviated Biologic License Applications (aBLAs), under the Biologics Price Competition and Innovation Act (BPCIA) can bring infringement actions against domestic defendants in a district court only under two scenarios: (1) if the court sits in the defendant's state of incorporation; or (2) if the court sits in a district (a) where the defendant has committed acts of infringement; and (b) where the defendant has "a regular and established place of business." TC Heartland's limited reading of § 1400(b) will inevitably shift the focus to the second alternate prong of § 1400.

1. "Where defendant has committed acts of infringement"

The location of the infringing act will inevitably become an important source of litigation in future ANDA and biosimilar cases following TC Heartland. Because the artificial acts of infringement associated with the filing of an ANDA or aBLA occur prior to any commercial sale of an actual product, they present unique venue considerations. Due to the unique nature of ANDAs and aBLAs, TC Heartland will likely cause a focus shift to determining the location of act of infringement in such cases. In this context, how district courts have addressed specific personal jurisdiction is insightful.

The Federal Circuit has taken a broad and forward-looking position on specific personal jurisdiction in ANDA cases. In Acorda Therapeutics Inc. v. Mylan Pharm. Inc., the Federal Circuit found specific personal jurisdiction over the Mylan defendants because the act of ANDA filing indicates plans to engage in the future marketing of the proposed generic drugs in the forum state, and also finding that the paragraph IV certifications "confirm [the] plan to engage in real-world marketing" sufficient to fulfill the minimum contacts requirement for personal jurisdiction3. It is likely to be the subject of debate whether the act of filing the ANDA or aBLA should employ a prospective perspective for ascertaining an infringing act for venue is inevitable in a post TC Heartland era in ANDA and biosimilar litigation. Thus, focus on where the ANDA filer or aBLA applicant is likely to target sales or marketing efforts, based on past activities, may be highly relevant to determining the location of the infringing act for venue purposes.

Some district courts have also looked at past acts in determining specific personal jurisdiction. Although the location of where the ANDA product was developed and tested has been addressed in the context of specific personal jurisdiction, such activity is likely exempt under the "safe harbor" provisions of 35 U.S.C. § 271(e)(1) as "acts of infringement." Similarly, the acts of preparing the ANDA and aBLA materials, strategic decisions concerning the applications, and signing would also likely be exempt under safe harbor. On the other hand, the acts of filing both the ANDA and the aBLA have been declared by Congress as "acts of infringement."

Furthermore, in Acorda, the Federal Circuit expanded its interpretation of the act of filing the ANDA as confirming future intent to market the generic product throughout the United States. Mailing of the paragraph IV letter has been considered a critical factor and sometime sufficient by itself in finding specific personal jurisdiction in ANDA cases because it directly leads to the plaintiff's cause of action4. Similarly, the aBLA applicant's mailing of confidential materials when opting to participate in the patent dance should be considered an important factor in determining the location of the infringing act for venue in a post-TC Heartland era.

Several district courts use the location of where the claim arose as one of several private interest factors in analyzing venue transfer under 28 U.S.C. § 1404(a), which may be also be instructive for determining venue in ANDA cases. In reviewing where the claim arose for venue transfer in ANDA cases, the district courts apply a nearly identical set of factors when determining whether personal jurisdiction exists. In this context, district courts have started considering forward-looking activity, such as where the ANDA filer is likely to manufacture its generic product, consistent with future intent a position adopted by the Federal Circuit post Acorda5. Although the venue transfer analysis in ANDA cases does not typically rely on a "sales approach" because actual sales have yet to occur, the location where the ANDA filer or the aBLA applicant intends to sell and market their respective products based on past activity will nevertheless play a role in determining venue under § 1400(b).

2. "Where defendant has a regular and established place of business"

TC Heartland's narrow reading of § 1400(b) will also require analysis of where the defendant has a "regular and established place of business"6. The Federal Circuit has interpreted "regular and established place of business" as requiring "a permanent and continuous presence" and not necessarily "a fixed physical presence in the sense of a formal office or store "7. Although several factors have emerged, the focus is on the "nature of the defendant's presence with the district"8. Although a fixed physical presence is not essential, many courts have found that "the physical location over which defendant exercises control and where defendant engages in a substantial part of its ordinary business in a continuous manner" is sufficient. While registration as a foreign corporation to do business standing alone is not considered sufficient;" a physical office location, phone lines, employees, and/or bank accounts may be sufficient to qualify as a "regular and established business."

Because of the unique artificial nature of infringement in ANDA and biosimilar cases, focus on actual sales and marketing efforts is inapplicable. In this context, lessons from how district courts have addressed general personal jurisdiction in ANDA cases may be insightful. Several factors emerge: (1) sale of past generic products; (2) marketing efforts directed to the district, including internet websites accessible from the district; and (3) registration to do business. Other factors that may be relevant in the ANDA and biosimilar context include: (a) license to distribute and manufacture drugs in the district; and (b) contracts with wholesalers and distributors within the district to market drugs9. Infringement complaints in non-ANDA cases filed after TC Heartland have already started covering in great detail factors including physical offices, websites that promote allegedly infringing product and services, and sales within the district10.

3. Anticipated Trends in ANDA and Biosimilar Cases

Impacting current cases, Supreme Court precedent suggests that TC Heartland should apply retroactively11. In pending cases, one of the critical questions that will apply is whether the defense of improper venue was properly preserved to avoid waiver under Rule 12. Fed. R. Civ. P. 12(h)(1) provides that a party that fails to preserve the defense by filing a Rule 12 motion to dismiss for improper venue, or a motion to transfer venue, or raising the defense in a responsive pleading, waives the right to object. Parties that have failed to adequately preserve the defense are likely to avail of Rule 15's request for leave to amend pleadings. Finally, even if the Court determines there has been a waiver, an exception may apply based on an "intervening change" in the law. However, one district court has already refused to apply the "intervening change" exception, finding that TC Heartland was not a new rule, but rather, re-confirmed the viability of Fourco, which was always good law12.

Furthermore, because TC Heartland is limited to domestic corporations, the venue law is likely unchanged for foreign corporations13. As such, patent owners may elect to sue foreign parents in order to avail the broader reach over foreign entities for venue purposes. On the other hand, we may see an increase in the creation of U.S. subsidiaries for generic and biosimilar manufacturers with a physical office in a district of choice that would control the filing of the ANDA and aBLA applications.

ANDA and biosimilar cases involving the same product, patents, and multiple groups of defendants will likely see an upsurge in the number of protective suits filed in the different districts, depending on where individual defendants are incorporated.

Consequently, in an effort to conserve resources and avoid inconsistent results, there will likely be an increase in the use of judicial panels on Multidistrict Litigation (MDL) to consolidate pretrial proceedings to a single district under 28 U.S.C. § 1407. Historically, MDL panels have been used in ANDA cases to consolidate pretrial proceedings, representing an efficient way to litigate cases involving multiple defendants with similar issues14.

In declaratory judgement actions for invalidity or non-infringement, the general venue provision set forth in 28 U.S.C. § 1391 applies rather than 28 U.S.C. § 1400(b)15. As a consequence, the generic filer proceeding with a Declaratory Judgment action can still itself avail of the broader personal jurisdiction regime to support venue against the brand manufacturer.

Lastly, the proposed Senate Bill 2733 – Venue Equity and Non-Uniformity Elimination Act was introduced in 2016 in order to ensure fairness in patent venue cases, but it was not enacted. In a post TC Heartland regime, patent owners, brand manufacturers, RPSs, and other entities that support the broadening of §1400(b)'s reach are likely to advocate in support of reintroducing Senate Bill 2733 in the 115th Congress.


1. TC Heartland LLC v. Kraft Foods Group Brands LLC, 16-341, 2017 WL 2216934, at *5 (U.S. May 22, 2017) (quoting Fourco Glass Co. v. Transmirra Products Corp., 353 U.S. 222, 229 (1957)).

2. VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990).

3. Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 760, 761 (Fed. Cir. 2016), cert. denied sub nom. Mylan Pharm. v. Acorda Therapeutics, 137 S. Ct. 625 (2017).

4. See, e.g., AstraZeneca AB v. Mylan Pharm., Inc., 72 F. Supp. 549, 559 (D. Del. 2014), aff'd sub nom. Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 559 (Fed. Cir. 2016).

5. Teva Pharm. USA, Inc. v. Sandoz Inc., CV 17-275(FLW), 2017 WL 2269979, at *7 (D.N.J. May 23, 2017).

6. French-Brown W.D., "TC Heartland's Restraints on ANDA Litigation Jurisdiction," Law360, March 29, 2016, at 2.

7. In re Cordis Corp., 769 F.2d 733, 737 (Fed. Cir. 1985).

8. MAGICorp. v. Kinetic Presentations, Inc., 718 F. Supp. 334, 337, 341 (D.N.J. 1989).

9. French-Brown W.D., "TC Heartland's Restraints on ANDA Litigation Jurisdiction," Law360, March 29, 2016, at 2-3.

10. See, e.g., Uniloc USA, Inc. et al. v. Apple Inc., Civ. A. No. 2:17-cv-00469, D.I. 1 at 1-2 (E.D.Tex. Jun. 2, 2017); Uniloc USA, Inc. et al. v. Google Inc., Civ. A. No. 2:17-cv-00465, D.I. 1 at 2-32- (E.D.Tex. Jun. 1, 2017).

11. Harper v. Virginia Dept. of Taxation., 509 U.S. 86, 97 (1993) ("When [the Supreme Court] applies a rule of federal law . . ., that rule is the controlling interpretation of federal law and must be given full retroactive effect in all cases still open on direct review and as to all events, regardless of whether such events predate or postdate our announcement of the rule.").

12. Cobalt Boats, LLC v. Sea Ray Boats, Inc., et al., No. 2:15-cv-21, 2017 WL 2556679, at *3 (E.D. Va. June 7, 2017).

13. TC Heartland LLC v. Kraft Foods Group Brands LLC, 16-341, 2017 WL 2216934, at *7, n.2.

14. See, e.g., In re: Nebivolol ('040) Pat. Litig., 867 F. Supp. 2d 1354, 1355–56 (U.S. Jud. Pan. Mult. Lit. 2012); In re: Fenofibrate Pat. Litig., 787 F. Supp. 2d 1352, 1353 (U.S. Jud. Pan. Mult. Lit. 2011); In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Pat. Litig., 693 F. Supp. 2d 409, 412, n.2 (D. Del. 2010); In re Rosuvastatin Calcium Pat. Litig., CIV. A. No. 07-805-JJF-LPS, 2008 WL 5046424, at *7 (D. Del. Nov. 24, 2008).

15. Pro Sports Inc. v. West, 639 F. Supp. 2d 475, 483 (D.N.J. 2009) (citing Horne v. Adolph Coors Co., 684 F.2d 255, 260 (3d Cir. 1982)).

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
Oblon, McClelland, Maier & Neustadt, L.L.P
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Oblon, McClelland, Maier & Neustadt, L.L.P
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must 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