United States: Federal Circuit Provides Guidance On Divided Infringement, Inducement Of Infringement, And Indefiniteness

Last Updated: January 20 2017
Article by Allen M. Sokal

Patent owners will applaud the Federal Circuit's latest pronouncement on divided infringement, inducement of infringement, and claim definiteness under 35 U.S.C. § 112. Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Appeal No. 2015-2067 (Fed. Cir. Jan. 12, 2017). On all three issues, the opinion, authored by Chief Judge Prost and joined by Circuit Judges Newman and Dyk, explains in language that patent owners will celebrate why several generic pharmaceutical manufacturers are liable to the innovator manufacturer, Eli Lilly, for infringement.

The patented invention, a method for treating certain types of lung cancer and mesothelioma, in practice is performed by both a physician and a patient. Specifically, to prevent serious side effects of the chemotherapy drug pemetrexed, the method requires pretreatment with two common vitamins: folic acid and vitamin B12. The defendants filed abbreviated new drug applications (ANDAs) with the FDA, including the required labeling mimicking the approved drug's labeling with instructions for physicians, and Paragraph IV certifications alleging that Lilly's patent is invalid and would not be infringed. Although the physician administers the vitamin B12 and pemetrexed, the physician, in accordance with the labeling, instructs the patient to administer the folic acid before the physician administers the pemetrexed. 

Asserted claim 12 is representative:

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

a) administration of between about 350 µg and about 1000 µg of folic acid prior to the first administration of pemetrexed disodium;

b) administration of about 500 µg to about 1500 µg of vitamin B12, prior to the first administration of pemetrexed disodium; and

c) administration of pemetrexed disodium.

Slip op. at 4-5 (emphasis added by the court).

Regarding the issue of infringement, Lilly had two hurdles to clear. First, it had to prove inducement of infringement by the defendants. And second, since one cannot be liable for inducing infringement in the absence of direct infringement, Limelight Networks, Inc. v. Akamai Techs., Inc., 134 S. Ct. 2111 (2014), Lilly had to prove direct infringement by the actor the defendants induced to infringe. The district court had found that Lilly cleared both hurdles, and the Federal Circuit agreed.

DIVIDED INFRINGEMENT

The appellate court first addressed direct infringement by the physician. Since the patient performed the step of administering folic acid, the question, one of fact, was whether substantial evidence supported the jury's finding that the patient's performance of that claimed step was sufficiently attributable to the physician that the physician was responsible for direct infringement. The en banc court had unanimously ruled in Akamai Techs, Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015), that a single entity is responsible for another's performance of claimed steps if (1) the entity "directs or controls" the other's performance or (2) the entity and the other constitute "a joint enterprise." Id. at 1022. In this case, only the first prong of that test was at issue. Slip op. at 9.

Overruling earlier cases on divided infringement, the Akamai court broadened the requirement for directing or controlling another's performance from solely an agency or contractual relationship by concluding that "liability under § 271(a) can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance." Id. at 1023 (citing Metro-Goldwin-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S., 930 (2005)). But in fact, Limelight, the alleged infringer, had a contractual relationship with its customers who performed steps of the claimed method. Thus, the question remained how far Akamai's new test reaches.

The opinion in Lilly suggests that the court is prepared to extend liability for divided infringement even further than the two-prong test it announced in Akamai. Specifically, in Akamai, the court introduced its application of its new two-prong test to the facts of that case as follows:

Today we outline the governing legal framework for direct infringement and address the facts presented by this case. In the future, other factual scenarios may arise which warrant attributing others' performance of method steps to a single actor. Going forward, principles of attribution are to be considered in the context of the particular facts presented.

797 F.3d at 1023. In Lilly, however, the court quoted that language in a way that provides a   broader interpretation than the original seems to require:

In addition to this two-prong test, we observed that, "[i]n the future, other factual scenarios may arise which warrant attributing others' performance of method steps to a single actor. Going forward, principles of attribution are to be considered in the context of the particular facts presented."

Slip op. at 9 (quoting 797 F.3d at 1023). Thus, the court may not look kindly on those who attempt to avoid liability for infringing method claims by dividing performance of the claimed method in a way that appears calculated to avoid Akamai's two-prong test.

The court in Lilly had no difficulty affirming the district court's finding of direct infringement by the physician. The defendants' labeling provided that the physician would condition the benefit of administration of pemetrexed upon the patient's first administering folic acid. The Physician Prescribing Information in the defendants' labeling emphasized that physicians should instruct patients on dosage and scheduling of taking folic acid, and the Patient Information informed patients that physicians might withhold treatment. Lilly's expert witness reinforced the criticality of following those instructions. That evidence satisfied also the physician's establishing the manner or timing of the patient's performance under the Akamai test. The court rejected the defendants' argument that that was "mere guidance or instruction . . . insufficient to show 'conditioning' . . . . [T]he 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." Slip op. at 12. The court similarly rejected the defendants' arguments that conditioning requires double-checking another's performance or making threats, or imposing a legal obligation as in Akamai. Id. at 13.

In concluding its discussion of divided infringement, the court again hinted that an even broader test than Akamai's two-prong test might apply in the future. "We leave to another day what other scenarios also satisfy the 'direction or control' requirement. The two-prong test that we set forth in Akamai V is applicable to the facts of this case and resolves the existence of underlying direct infringement." Id. at 15.

INDUCEMENT OF INFRINGEMENT

The court next addressed whether the district court clearly erred in finding that the defendants induced physicians to infringe, noting that Lilly had the burden of proving the defendants' specific intent and action to induce infringement. Id. Relying again on the defendants' labeling, the court upheld that finding. The court reasoned that the instructions in the labeling satisfied the requirement for encouraging, recommending, or promoting the physicians' infringement. Id. at 16. Because the instructions were clear regarding the claimed method, they sufficiently evidenced the defendants' specific intent to induce infringement, regardless of whether some physicians might not follow the instructions. But the court observed that vague instructions, requiring one to go beyond the label to understand allegedly implicit encouragement, would not suffice. Id. at 17. The court concluded, "[i]n sum, evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishes the requisite intent for inducement." Id. at 18.

INDEFINITENESS

The court's ruling on indefiniteness, applying the more lenient standard for proving the defense the Supreme Court announced in Nautilus, Inc. v. Biosig instruments, Inc., 134 S. Ct. 2120 (2014), leans toward the stricter standard that Nautilus overruled. The court observed that under 35 U.S.C. § 112, claims read in view of the intrinsic evidence must inform those of ordinary skill in the art about the scope of the invention with reasonable certainty, a question of law that the court reviews de novo. Slip op. at 19. The court further observed, however, that it reviews "subsidiary factual determinations made by the district court based on extrinsic evidence for clear error." Id. at 20.

The evidence demonstrated some ambiguity regarding the construction of "vitamin B12." It had two meanings in the art–cyanocobalamin and also a class of compounds including cyanocobalamin–and the patent's written description used the term both ways. Id. But based on expert testimony (extrinsic evidence) that "vitamin B12" refers to cyanocobalamin when prescribed in the medical field, the court affirmed the district court's holding that the claims were not invalid.

The defendants relied on additional evidence, however, of indefiniteness. Claim 1, which Lilly did not assert, reads as follows:

  1. A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein

the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

Id. at 22 (emphasis added). The defendants argued that if vitamin B12 means cyanocobalamin, the Markush group, a methylmalonic acid lowering agent, lists the same compound twice. Id. But the court reasoned that although it has in some instances construed claim terms to avoid redundancy, in this instance doing so would violate the doctrine of claim differentiation. Id. at 23. Specifically, because claim 2, which depends on claim 1, requires that the methylmalonic acid lowering agent is vitamin B12, claim 2 would not further limit claim 1 if "vitamin B12" referred to a class of compounds rather than cyanocobalamin. "[F]aced with an interpretation that would read redundancy into claim 1 and another that would violate the doctrine of claim differentiation, we hold that the claims here support the former result over the latter." Id.

On all three issues discussed above, patent owners will want to rely on this case.  Regarding indefiniteness, however, a safer course would be to define in the patent's written description all claim terms that could possibly be deemed ambiguous rather than create ambiguity with conflicting definitions.

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
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