United States: Federal Circuit Hears Arguments In Hatch-Waxman Personal Jurisdiction Challenge: Mylan Argues Brands Should Sue Them In West Virginia

On Monday January 4, the Federal Circuit heard oral arguments in a pair of appeals—Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 15-1456, and AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 15-1460—that may potentially clarify how personal jurisdiction in litigation under the Hatch-Waxman Act is impacted by the Supreme Court's recent decision in Daimler AG v. Bauman, 134 S. Ct. 746 (2014). This is the first time the Federal Circuit has had the opportunity to address whether there is sufficient personal jurisdiction for branded pharmacetical companies to bring consolidated Hatch-Waxman patent infringement suits against generic manufactures in a single jurisdiction, such as Delaware.

District Court Proceedings

The two appeals stem from suits filed in Delaware by AstraZeneca and Acorda under the Hatch-Waxman Act based on Mylan's filing of Abbreviated New Drug Applications ("ANDA") seeking FDA approval to market drug products containing saxagliptin, which AstraZeneca markets under the brand names Onglyza® and Kombiglyze® for treatment of type 2 diabetes, and dalfampridine, which Acorda markets as the multiple sclerosis drug, Ampyra®. Mylan moved to dismiss each suit arguing a lack of personal jurisdiction under Daimler. Mylan contended that Delaware lacked general personal jurisdiction because Mylan is incorporated in and headquartered in West Virginia and thus is not at "home" in Delaware as required for general jurisdiction under Daimler. Mylan also argued that no specific personal jurisdiction existed over Mylan in Delaware because its suit-related conduct did not create a substantial connection with Delaware.

The District of Delaware denied Mylan's motions to dismiss for lack of jurisdiction in both cases, but for different reasons. In the AstraZeneca case, U.S. District Judge Gregory Sleet agreed with Mylan that no general jurisdiction existed in Delaware under Daimler. Judge Sleet, however, denied Mylan's motion to dismiss because specific personal jurisdiction existed as a result of Mylan sending a Paragraph IV certification notice letter to AstraZeneca's Delaware office as is required under the Hatch Waxman Act. In contrast, U.S. District Judge Leonard Stark denied Mylan's motion to dismiss in Acorda on the basis of general personal jurisdiction, holding that Mylan had "consented to jurisdiction" by registering as a business in Delaware in 2010.

Appellate Argument

At argument, Judges Pauline Newman, Kathleen O'Malley and Richard Taranto grappled with the interplay between the requirements for personal jurisdiction and the artificial act of infringement that occurs under 35 U.S.C. § 271(e)(2) upon filing an ANDA containing a certification that a patent is invalid or not infringed under 21 U.S.C. § 355(b)(2)(A)(iv).

During the arguments, Judge Taranto immediately directed Mylan to the issue of specific personal jurisdiction and noted that Mylan "plan[s] to compete in Delaware." He inquired, "Why isn't that enough?" and further questioned why if Mylan's conduct were sufficient for an Article III case or controversy under the 35 U.S.C. § 271(e)(2), it would not suffice for specific personal jurisdiction. At argument, Mylan noted that it had "not purposely availed [itself] of Delaware" and that all of Mylan's pre-litigation activities were performed in West Virginia, prompting questions from Judge O'Malley as to whether the types of activities that are protected from suit for infringement under the safe harbor of 35 U.S.C. § 271(e)(1), such as preparing the ANDA, can form the basis for specific jurisdiction. By contrast, appellees took the position that the ANDA filing creates nationwide contacts because the "generic manufacturer is seeking . . . to essentially declare nationwide war on the rights of a brand name manufacturer" and entreated the court to rule that specific jurisdiction exists nationwide upon filing of an ANDA subject to the limitations of fairness and reasonableness.

With respect to general jurisdiction, the court engaged counsel in a lengthy discussion of Delaware's requirement that any corporation conducting business in Delaware register and appoint an agent for service of process under Del. Code tit. 8, § 371(b). That certificate of registration states that Mylan intended to engage in pharmaceutical manufacturing, distribution, and sales in Delaware. At argument, Mylan portrayed the registration and accompanying statement as "compulsory" and posited that only voluntary conduct can establish general jurisdiction under Daimler. Judge O'Malley countered, "Daimler never had the opportunity to address consent via registration," because that case involved jurisdiction in California. She also questioned why "choosing to do business in the state" is not a voluntary act. By contrast, the appellees portrayed the Delaware statute as a sufficient basis for conferring personal jurisdiction over Mylan.

Potential Impact

Mylan alone has filed over a dozen motions to dismiss for lack of personal jurisdiction in Hatch-Waxman suits since the Supreme Court decided Daimler. And Mylan is not alone. Several other generic manufactures have also challenged personal jurisdiction in Delaware and other venues such as the Eastern District of Texas. Decisions on many of these dismissal motions may be impacted by the outcome of the early Acorda and AstraZeneca appeals.

It may be possible for the Federal Circuit to decide both the Acorda and AstraZeneca appeals on bases that might limit the impact of the court's holding such as finding that Mylan's Delaware corporate registration establishes general jurisdiction over Mylan or that specific jurisdiction exists in the AstraZeneca action based on the fact that Mylan sent its notice letter to AstraZeneca's Delaware offices. However, both parties entreated the court to provide a broader ruling that would clarify the parameters of general and specific personal jurisdiction in Hatch-Waxman cases.

This article is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Gilson & Lione lawyer.

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
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

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