United States: The Federal Circuit Found Direct Infringement Attributable To Physicians Where "No Single Actor Performs All Steps Of A Claim"

Last Updated: March 8 2017
Article by Mae Hong and Andrew W. Wahba

Can a patient's action in taking a generic drug be attributable to a physician such that it can support a finding of the physician's direct patent infringement? According to a recent precedential opinion of the Court of Appeals for the Federal Circuit (the "Federal Circuit"), at least in some circumstances, it is possible.

On January 12, 2017, the Federal Circuit in Eli Lilly and Company v. Teva Parenteral Medicines, No. 2015-2067 ("Eli Lilly") affirmed a district court's findings of (1) direct infringement attributable to physicians and (2) Defendants' liability for inducing physicians' infringement, even though "no single actor performs all steps of the asserted claims." The Federal Circuit at the same time affirmed that the asserted claims were not invalid for indefiniteness, obviousness, or obviousness-type double patenting (invalidity issues are not discussed in this blog).

Eli Lilly is a Hatch-Waxman lawsuit in which Eli Lilly asserted U.S. Patent No. 7,772,209 ("the '209 patent"). The '209 patent claims methods of administering the chemotherapy drug pemetrexed disodium after pretreatment with folic acid and vitamin B12. Eli Lilly has marked Pemetrexed disodium under the name ALIMTA®. Defendants filed Abbreviated New Drug Applications ("ANDA") to seek FDA's approval of generic versions of ALIMTA®. Eli Lilly sued Defendants for liability of inducing infringement. Defendants counterclaimed that the asserted claims of the '209 patent were invalid and that there was no infringement.

All asserted claims include a step of administering certain amount of folic acid and methylmalonic acid, such as vitamin B12, prior to administering pemetrexed disodium. For example, asserted claim 12 recites:

12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:

  1. administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
  2. administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
  3. administration of pemetrexed disodium.

Both parties agreed that the steps as recited in the asserted claims were divided between physicians and patients, where physicians administer vitamin B12 and pemetrexed and patients self-administer folic acid. Id. at 5.

In light of the Supreme Court's holding that liability for inducement cannot be found without direct infringement, id. at 6 (citing Limelight Networks, Inc. v. Akamai Techs., Inc. (Akamai III), 134 S. Ct. 2111 (2014)), the Federal Circuit first considered the direct infringement issue. According to the Federal Circuit, where no single actor performs all steps of a method claim, direct infringement only occurs if "the acts of one are attributable to the other such that a single entity is responsible for the infringement." Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai V), 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc) (per curiam), cert. denied, 136 S. Ct. 1661 (2016). The performance of method steps is attributable to a single entity when that entity "directs or controls" others' performance, or when the actors "form a joint enterprise." Eli Lilly, at 9 (citing Akamai V). Since Eli Lilly did not pursue a joint enterprise theory, the Federal Circuit only considered whether physicians direct or control their patients' administrations of folic acid.

In considering the "direct or control" issue, the Federal Circuit applied the two-prong test set up in Akamai V:

  1. "conditions participation in an activity or receipt of a benefit' upon others' performance of one or more steps of a patented method,"
  2. "establishes the manner or timing of that performance." Id. (citing Akamai V, at 1023).

The Federal Circuit's determination relied on the evidence of product labeling and Eli Lilly's expert testimony. Defendants' proposed generic product labeling was similar to the ALIMTA® product labeling, which specified that physicians should instruct patients to take folic acid and included information about folic acid dosage ranges and schedules. Id. Eli Lilly's expert testified that taking folic acid was "an absolute requirement" before pemetrexed treatment and a physician would not give the pemetrexed if a patient did not follow his or her instructions to take folic acid. Id. at 12.

With respect to the first prong, the Federal Circuit first agreed that the district court "correctly identified pemetrexed treatment as the benefit to be conditioned" and concluded that the product labeling, combined with the testimony, provided sufficient evidence that physicians condition pemetrexed treatment on folic acid pretreatment. Id. at 13. According to the Federal Circuit, the record was "replete with evidence that physician[s] delineate the step of folic acid administration that patients must perform if they wish to receive pemetrexed treatment." Id. at 12. The Federal Circuit rejected the Defendants' argument that mere guidance or instruction was insufficient to show "conditioning" under Akamai V, stating "that evidence regarding the critical nature of folic acid pretreatment and physicians' practices support a finding that physicians cross the line from merely guiding or instructing patients to take folic acid to conditioning pemetrexed treatment on their administration of folic acid." Id. at 12.

With respect to the second prong, the Federal Circuit stated that the product's Physician Prescription Information instructed physicians not only to tell patients to take folic acid orally, but also informed the dosage range of folic acid and schedules. Id. at 14. In addition, the expert testified that it is the doctor "who decides how much [folic acid] the patient will take and when the patient takes it." Id. Accordingly, the district court's finding that physicians establish the manner and timing of patients' folic acid intake was not clearly erroneous. Id. at 14-15.

After establishing physicians' direct infringement, the Federal Circuit went further to find liability for induced infringement. According to the Federal Circuit, the mere existence of direct infringement by physicians was not sufficient for inducement. Id. at 15. To show inducement, there must be specific intent and action to induce infringement. Id. According to the Federal Circuit, the product labeling included repeated instructions and warnings regarding the importance of and reasons for folic acid treatment. The instructions are unambiguous on their face and encourage or recommend infringement of the asserted claims. Id. at 16-18. Because the product labeling "would inevitably lead some physicians to infringe establishes the requisite intent for inducement," the district court did not clearly err in finding Defendants' inducement. Id. at 18.

In sum, the Federal Circuit upheld a district court's finding of performance of method steps being attributable to physicians, even though steps of the asserted claims were divided between physicians and patients. The Federal Circuit, however, particularly pointed out that the holding did not assume that patient action is attributable to a prescribing physician solely because they have a physician-patient relationship. The Federal Circuit left open for future determination whether other scenarios may also be found to satisfy the "direction or control" requirement. Id. at 15.

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 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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.