United States: CAFC's First Take On Divided Infringement For Method-Of-Treatment Claims

On January 12, 2017, the Federal Circuit decided Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., providing its first opinion on divided infringement for pharmaceutical method patents under the Akamai framework.

In June 2014, the Supreme Court decided Limelight Networks, Inc. v. Akamai Technologies, Inc. ("Akamai III"), which held that there can be no induced infringement under 35 U.S.C. § 271(b) without direct infringement under 35 U.S.C. § 271(a). 134 S. Ct. 2111, 2117 (2014). The Court further held that all claimed steps of a method patent must be attributable to a single person to support a finding of direct infringement of a method patent under § 271(a). Id. at 2118. The Supreme Court then invited the Federal Circuit to revisit its § 271(a) case law on remand.

On remand, an en banc Federal Circuit accepted the Supreme Court's invitation and unanimously set forth the law of divided infringement. Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed Cir. 2015) ("Akamai V"). Direct infringement, the judges decided, "occurs where all steps of a claimed method are performed by or attributable to a single entity." Id. at 1022. An entity is responsible for others' performance of infringing steps in two circumstances: "(1) where that entity directs or controls others' performance, and (2) where the actors form a joint enterprise." Id.

The Federal Circuit in Akamai V articulated a nonexclusive, two-part test for determining when a party is directing or controlling another's actions, and is therefore committing direct infringement. Specifically, a party can be liable for directing or controlling others' performance: (1) when the party "conditions participation in an activity or receipt of a benefit" upon performance of a step or steps of a patented method, and (2) the party "establishes the manner or timing of that performance." Id. at 1023. Akamai V broadened the circumstances under which others' performance may be attributed to a single actor.

Eli Lilly v. Teva presented another case of divided infringement to the Federal Circuit, this time a method patent covering the administration of the chemotherapy drug pemetrexed disodium ("pemetrexed"). 845 F.3d at 1361. The claimed method teaches that pemetrexed, an antifolate, should be administered following pretreatment with folic acid and vitamin B12. The two vitamins help to reduce the toxicity of pemetrexed. The prescribing information (also known as the product labeling) for pemetrexed instructs patients to take folic acid prior to and during treatment with pemetrexed. The physician administers vitamin B12 and pemetrexed. Thus, no single actor performs all steps of the asserted claims—both patients and physicians must act to satisfy every claim limitation.

The issue before the district court, then, was whether the physicians "direct or control" their patients' administration of folic acid. As announced in Akamai V, a two-prong test must be satisfied for determining if a party is directed or controlled. First, an entity must condition participation in an activity or receipt for a benefit upon others' performance of one or more steps of the patented method. Second, the entity must establish the manner and timing of that performance.

The district court found that both prongs of the Akamai V test were satisfied here. Under the first prong, the "benefit" to be received was the pemetrexed treatment. Id. at 1365. The record was replete with evidence that physicians delineate the folic acid administration step and, further, that physicians often decline to provide pemetrexed if the folic acid regimen was not followed. Id. at 1366. Defendants argued that the product labeling simply provided "guidance" and was insufficient to show "conditioning" under Akamai V. Id. The district court disagreed, instead finding that where the administration of folic acid was so critical to the safe administration pemetrexed, the physician may be said to be conditioning treatment based on folic acid intake. Id. The Federal Circuit determined that the district court's findings were supported by the record and not clearly erroneous. Id. Defendants further argued at the Federal Circuit that "conditioning" under Akamai V would require physicians to verify compliance, of which the record showed no evidence. Id. The Federal Circuit rejected Defendants' argument, however, concluding that "conditioning" "does not necessarily require double-checking another's performance or making threats." Id. The Federal Circuit similarly rejected Defendants' argument that a party may only condition performance of a step by imposing legal obligations or technological prerequisites. Id. at 1367. Rather, the "principles of attribution are to be considered in the context of the particular facts presented." Id.

The second prong—establishing the manner and timing of performance—was also satisfied by the product labeling. The district court found that the physician is responsible for deciding how much folic acid the patient will take and the timing of the patient's ingestion. Id. The Federal Circuit found no clear error. Id. Defendants argued that physicians are not the only source of information or assistance for folic acid administration, and, therefore, do not solely direct the manner and timing of performance. The Federal Circuit, however, rejected that argument because physicians, though they may not be the only resource, provide sufficient guidance to establish the manner and timing of performance for their patients.

The Federal Circuit declined to extend its holding under the manner-and-timing-of-performance prong to attribute patient action to the physician solely because of the established physician-patient relationship. The facts as presented here were sufficient to establish that the physicians were responsible for the patients' performance. Id. But the Federal Circuit left "to another day what other scenarios also satisfy the 'direction or control' requirement." Id. at 1368.

The Federal Circuit concluded that the two-step Akamai V test was met here. But Eli Lilly still had the further burden of proving the intent element for induced infringement. That is "specific intent and action to induce infringement." Takeda Pharm. USA, Inc. v. West-Ward Pharm Corp., 785 F.3d 625, 631 (Fed. Cir. 2015). The district court concluded that Defendants would induce infringement of the '209 patent in light of two findings: (1) that the administration of folic acid was a "critical step" and (2) that Defendants induce physicians' infringement because physicians are acting "in accordance with Defendants' proposed labeling." Eli Lilly Co., 845 F.3d at 1368.

At the Federal Circuit, Defendants argued that the product labeling does not induce infringement. Defendants' argued that they could not be inducing infringement because physicians must go further than the labeling instructions (by prescribing specific doses of folic acid) to infringe the patent. Id. Defendants also argue that Plaintiffs failed to produce any evidence of what physicians do "in general." Id. The Federal Circuit first makes clear that the "intent" element is with respect to the actions of the underlying direct infringer; i.e., Defendants must intend that the physicians infringe. Id. Additionally, the Federal Circuit does not require proof of a general prevalence of the induced activity. Id. Rather, "when the alleged inducement relies on a drug label's instructions the question is ... whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent." Id. (quoting Takeda, 785 F.3d at 631) (internal quotation marks omitted).

For pharmaceutical method patents, the product labeling is, typically, the best evidence to show that the generic company is encouraging, recommending, or promoting infringement to patients or physicians. Indeed, the Federal Circuit determined that, depending on the preciseness of the instructions in the product labeling, the decision to seek FDA approval, alone, may be sufficient to establish specific intent to induce infringement. Id. On the other hand, "vague instructions that require one to look outside the label to understand the alleged implicit encouragement" are insufficient to induce infringement. Id. (quoting Takeda, 785 F.3d at 632, 634). The evidence presented to the district court, here, supported a finding of induced infringement because the instructions would "inevitably" lead some physicians to infringe. Id. at 1369.

The Federal Circuit relied primarily on two bodies of case law—Akamai and Takeda—to hold that a pharmaceutical manufacturer may be liable for induced infringement through a divided-direct infringement theory between the physician and the patient. Under Akamai, the physicians' direction and control of patients' folic acid administration in conjunction with physicians' own actions satisfied each step of the claimed method, and, therefore, resulted in the physicians' direct infringement. The product labeling provided further evidence under the Takeda precedent that Defendants intended to induce the physicians to infringe the claimed method. Thus, Defendants were held liable for inducing infringement under 35 U.S.C. § 271(b).

Footnote

1. 845 F.3d 1357 (Fed. Cir. 2017)

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.

Authors
 
In association with
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
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.

Disclaimer

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.

Registration

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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Security

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.