United States: GSK Survived Teva's Third Motion To Dismiss Allegations Of Indirect Infringement Because Of The Totality Of Teva's Skinny Label

In this ongoing patent infringement case, Magistrate Judge Burke issued a report and recommendation to deny Teva’s Rule 12(b)(6) motion to dismiss GlaxoSmithKline’s (GSK) induced infringement allegations relating to generic product sales during a select time period (January 2008‒May 2011). The magistrate determined that while Teva carved out the patented indication of use, other instructions in the generic product label plausibly evidence Teva’s intent to induce infringement of the patented methods. GlaxoSmithKline LLc, et al. v. Teva Pharmaceuticals USA, Inc., Case No. 14-cv-0878, slip op. July 20, 2016 (D. Delaware, Magistrate Judge Christopher J. Burke)

In 2014, GSK filed this patent infringement action relating to the active ingredient carvedilol (Coreg®) which was initially identified for the treatment of hypertension. Coreg® then became the first beta blocker the US Food and Drug Administration (FDA) approved for the treatment of congestive heart failure (CHF) after observation that the long term use reduced mortality in CHF patients. Coreg® was initially approved in 1997 for treatment of mild-to-moderate CHF in conjunction with other therapies, and subsequently in 2001 was approved for treatment of mild-to-severe CHF. Although initially contraindicated for heart attack patients, in 2003, GSK obtained an expanded indication for these patients based on positive clinical studies. Thus, the Coreg® label includes three indications relating to use for: hypertension, mild-to-severe CHF and heart dysfunction after heart attack.

Teva filed an abbreviated new drug application (ANDA) in 2002, submitting a Paragraph IV certification of invalidity against the then-Orange Book-listed ‘069 patent method of treatment claims. The ‘069 patent was later reissued and relisted by GSK as the ‘000 patent. In 2007, Teva submitted an amended ANDA including a Section VIII carve out for the indication of use for the treatment of mild-to-severe CHF. Teva obtained FDA approval in 2007 based on the skinny label (lacking the mild-to-severe CHF indication) and the labelling remained the same until 2011.

In this suit, GSK’s complaint initially asserted indirect infringement allegations against generic filers Teva and Glenmark for the method of treatment claims of the ‘000 patent. Teva and Glenmark successfully moved to dismiss these original allegations, as well as allegations indirect infringement allegations in GSK’s first amended complaint because Teva’s label carved out the indication for the treatment of mild-to-severe CHF (pre-2011). Although Teva’s motion was granted, the court granted GSK leave to amend its pleadings, and GSK filed second amended complaint alleging indirect infringement of the ‘011 patent based on Teva’s pre-2011 product sales. Teva filed another motion to dismiss claims relating to pre-2011 carvedilol product sales.

In considering the present motion to dismiss, the magistrate judge applied the Rule 12(b)(6) pleading standards to this case inquiring whether GSK’s second amended complaint plead facts plausibly showing that in spite of its carve out, “Teva specifically intended third parties to infringe the ‘000 patent and knew that the third party’s acts constituted infringement.” Teva contended that GSK failed to state facts showing Teva’s specific intent to induce or knowledge of infringement, although GSK alleged that Teva actively publicized the “AB-rating” for generic carvedilol without highlighting that its product was not approved for all of the same indications as Coreg®.

The magistrate found GSK’s allegations that Teva was promoting its product as AB-rated alone was not sufficient to make out a claim for inducement at least because: (1) the Orange Book explains that an AB-rating means that the product is therapeutically equivalent to the brand product, but only for the conditions or uses specified in the labeling for the generic product, and in view of that explanation; (2) it cannot be assumed that third parties will necessarily mistake the generic product for being fully-substitutable; or that (3) Teva had the intent for third parties to be mistaken. However, the court found “a small piece of intent” in GSK’s allegations that Teva’s press releases evidenced an intent to capture sales for all therapeutic uses of the generic product because Teva’s press releases referenced the total annual sales of Coreg®, which included sales for treatment of CHF. More significantly, the court found GSK’s allegations relating to Teva’s labelling may indicate the plausibility that Teva specifically intended third parties to infringe the ‘011 patent. Specifically, the Coreg® indication of use for heart dysfunction after heart attack (included in Teva’s label) is drafted such that it includes reference to CHF patients, such as: “Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure)” (emphasis added, citing also to language in the clinical studies, “heart failure/fluid retention” adverse event and patient advise sections referencing “heart failure”). The magistrate’s analysis analogized the facts in this case to the Federal Circuit’s decision in AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010). In that case the generic manufacturer’s approved labeling included an indication for a non-patented twice-daily use, but instructions on dose titration could lead to a once-daily dose that was patented. In AstraZeneca, the court found the “pertinent question is whether the proposed label instructs users to perform the patented method [if it does then] the proposed label may provide evidence of [a generic manufacturer’s] affirmative intent to induce infringement.” Here, the court determined that it was plausible that in spite of Teva’s carve out, the broader labeling and instructions may be viewed as an encouraging consumers to infringe the ‘000 patent because there is a relationship between the two patient populations—heart attack patients may also be CFH patients—as the labelling suggests.

Finally, the magistrate found further support of Teva’s inferred intent to induce infringement in the fact that allegedly there are not substantial non-infringing uses for Coreg®. Specifically, Teva was aware that: (1) GSK has marketed the product in the United States only for treatment of CHF and (2) uses for the other approved indications are purportedly minimal.

Therefore, the magistrate found GSK’s pleaded facts sufficient to survive Teva’s Rule 12(b)(6) challenge and recommended that the District Court deny Teva’s motion. On August 25, 2016, Teva filed a memorandum in opposition to the magistrate’s report and recommendation. Trial is scheduled to begin in this case on June 12, 2017.

Practice Note

Patents that issue after an ANDA is filed cannot serve as the basis for an infringement claim under §271(e)(2).

GSK Survived Teva's Third Motion To Dismiss Allegations Of Indirect Infringement Because Of The Totality Of Teva's Skinny Label

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.

In association with
Related Topics
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