United States: Physicians' Direction Or Control Over Patients' Drug Administration Results In Finding Of Induced Infringement Against Generic Drug Manufacturers


Relying on the recent U.S. Supreme Court decision in Akamai, and the subsequent en banc Federal Circuit ruling, an Indiana court recently concluded that the entire performance of a patented method covering drug administration is attributable solely to a single entity, the physician or other health care provider of the patient. In particular, although patients on their own need to obtain one of three claimed components of the patented dosing regimen, the court found that physicians and other health care providers direct the manner and timing of ingesting that component and that patient compliance with those instructions is necessary to receive the full benefit of treatment. Thus, there would be no defense of divided infringement because through this attribution, physicians would directly infringe the patent claims, and the generic drug manufacturer defendants would induce such infringement because their drug labeling instructs physicians to follow the patented regimen.

Any person who actively induces infringement of a patent is liable as an infringer under 35 U.S.C. § 271(b). This form of indirect infringement is commonly at issue in Hatch-Waxman infringement actions because generic drug manufacturers always provide drug-package inserts containing instructions for healthcare providers and patients, and these package inserts typically correspond to a patented method of treatment.

A finding of induced infringement is predicated on a finding of direct infringement. Direct infringement occurs where all the steps of a claimed method are performed by or attributable to a single entity. Recently, in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc.1 et al the parties disputed whether a patented method of administering a drug would be directly infringed where a physician would administer two of the claimed components, but the patient was required to obtain and take another of the claimed components. The U.S. District Court for the Southern District of Indiana concluded that the entire performance of the patented administration is attributable to physicians and, thus, physicians would directly infringe the patented method. Because the defendants' proposed generic drug-labeling instructs physicians to follow the patented administration, the court found they would be liable for inducing the physicians' infringement.


Eli Lilly owns U.S. Patent No. 7,772,209 (the '209 patent) covering a method of administering a chemotherapy drug, pemetrexed disodium, marketed by Lilly under the trade name ALITMA®. The method of administration requires co-administration of the drug with folic acid and vitamin B12 in order to reduce incidences of patient toxicity caused by pemetrexed disodium.

Several generic drug manufacturers (Defendants) filed Abbreviated New Drug Applications seeking Federal Drug Administration (FDA) approval to market generic forms of pemetrexed disodium. The Defendants sought to sell their generic pemetrex disodium products with drug labeling that instructs physicians to follow the patented administration.

Eli Lilly brought a Hatch-Waxman infringement action against the Defendants, asserting infringement of the '209 patent. The asserted claims required treatment with specified amounts of folic acid and vitamin B12 prior to administering the pemetrexed disodium. During a first trial, only patent validity was at issue because the parties jointly stipulated to induced infringement, but the Defendants reserved the right to litigate the induced infringement issue if the U.S. Supreme Court granted a then-pending petition for writ of certiorari in Limelight Networks, Inc. v. Akamai Technologies, Inc., and either reversed or vacated the Federal Circuit's decision. The Supreme Court did so, and the parties moved to litigate the issue of induced infringement.

The parties' dispute centered on whether the '209 patent would be directly infringed, which is a prerequisite for induced infringement. The experts for both sides agreed that in following the Defendants' proposed drug labeling, a physician will administer the vitamin B12 by injection and the pemetrexed disodium by infusion and that the patient, at the instruction of the physician, must obtain and take the folic acid.

The Eli Lilly Decision

Looking to the U.S. Supreme Court's holding in Akamai, the court observed that for direct infringement to occur, "performance of all of the claimed steps [must] be attributed to a single person." The court then looked to a subsequent en banc decision of the Federal Circuit in which the Court unanimously set forth the present law on divided infringement. Specifically, if more than one actor practices the steps of an asserted claim, a court must decide if the acts of one are attributable to the other such that a single entity is responsible for infringement. The Federal Circuit explained that a court will hold a single entity responsible for others' performance 1) where the entity directs or controls others' performance or 2) where the actors form a joint enterprise. The Federal Circuit found that the first circumstance may be satisfied if an entity conditions others' participation in an activity or receipt of a benefit on performance of a step or steps of a patented method, and also establishes the manner or timing of the performance.

Applying this reasoning to the present case, the court expressed the relevant question as whether the physician sufficiently directs or controls the patient's acts so as to condition treatment with pemetrexed disodium in the manner that reduces toxicities upon the performance of a patented step and establishes the manner and timing of the performance. The court answered this question affirmatively. Although patients on their own obtain and take folic acid, the court found that taking folic acid prior to the administration of pemetrexed disodium—as claimed in the patent and explained in the drug prescribing information and patient information—was critical to lower the chances of harmful side effects. According to the court, therefore, taking the folic acid in the manner specified was a condition of the patient's participation in the pemetrexed disodium treatment to receive the full benefit of treatment. Physicians, the court continued, based upon the patented method, direct the manner and timing of patients' ingestion of folic acid.

Based on these findings, the court determined that the physicians, in accordance with the Defendants' proposed drug-labeling, direct, or control-patients' administration of folic acid "such that the performance of all the claimed steps, including administration of folic acid, can be attributed to a single person, i.e., the physician." Accordingly, the physicians, the Court concluded, would directly infringe the patent, and the defendants would induce such infringement through the instructions in their drug labeling.

Strategy and Conclusion

This decision provides an example of a divided infringement analysis post Akamai within the context of Hatch-Waxman patent-infringement litigation. Generic drug manufacturers will be liable for induced infringement if physicians or other healthcare providers direct or control the performance of patients based upon the manufacturer's proposed drug package insert.


1 The Eli Lilly decision can be found at http://www.finnegan.com/files/upload/LES_Insights_Column/2015/EliLilly_v_Teva.pdf.

Previously published in LES Insights

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.

Events from this Firm
2 Nov 2017, Webinar, Washington, DC, United States

Join us for a two-part webinar series exploring recent developments in machine learning and other technologies that have greatly advanced artificial intelligence (AI) since its origins more than 50 years ago.

9 Nov 2017, Webinar, Washington, DC, United States

As part of Strafford Publications’ webinar series, Finnegan attorneys Adriana Burgy, Chris Johns, and Kai Rajan will discuss the Examiner Count System and provide strategies for interacting with examiners.

15 Nov 2017, Conference, California, United States

Finnegan is a Gold sponsor of the second annual Digital Media & IP Forum, hosted by World Congress.

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.