Canada: Recent Developments On Patent-Eligibility Of Medical Use Claims In Canada

Last Updated: August 5 2015
Article by Alain Dumont and S. Serge Shahinian

Last December, the Federal Court of Canada overturned a decision of the Commissioner of Patents to refuse a patent claiming a fixed dosage regimen for the drug Humira® (Adalimunab) used in rheumatoid arthritis. The Court's decision1 is found here: 2014 FC1251.

This Court decision was an appeal of Decision No. 1362 of the Commissioner of Patents ("the Commissioner"), refusing to grant Canadian Patent Application No. 2,385,745 ("the '745 application") to AbbVie Biotechnology Ltd. ("AbbVie") on the grounds that the claims at issue encompass an unpatentable method of medical treatment.

The claims at issue, relating to the use of Humira® as a treatment using a fixed dosage (40 mg) on a fixed (bi-weekly) schedule, were deemed to be patentable by the Federal Court.

Patent Appeal Board (PAB) Proceedings – Commissioner's Decision

Before the PAB, AbbVie argued that because the claims defined a fixed dose and a fixed dosing schedule, they avoided the exercise of skill or judgment of a medical professional, and thus related to patentable subject matter. However, the PAB interpreted the case law, notably the decision of Janssen Inc. v Mylan Pharmaceuticals ULC2 (Janssen), as having established the rule "that the mere presence of these two features [i.e., a fixed dosage and fixed dosing schedule] in a claim is not always sufficient to avoid the method of medical treatment prohibition", and asserted that the claims at issue, by placing restrictions on "how and when" the drug is to be administered, would interfere with the ability of physicians to exercise their judgment in the administration of Humira® when generic versions of this drug become available. The PAB thus concluded that the claims encompassed an unpatentable method of medical treatment. The Commissioner adopted the PAB's recommendation, and issued a decision confirming the refusal to grant the '745 application.

Federal Court Decision

AbbVie was successful upon appeal of the Commissioner's Decision to the Federal Court of Canada, Trial Division. Justice Kane of the Federal Court acknowledged that the prohibitions against claims to methods of medical treatment and to claims relating to the exercise of professional skill have been consistently applied by Canadian Courts. However, Justice Kane remarked that such decisions are based on the specific facts of each case. Justice Kane referred to three decisions, Merck & Co Inc v Apotex Inc.3, Merck & Co. Inc. v Pharmascience Inc.4, and Bayer Inc. v Cobalt Pharmaceuticals Company5, in which claims comparable to AbbVie's claims had been found to be patent-eligible on the basis that if no professional skill or judgment is involved, the claimed invention is not a method of medical treatment.

The Court noted that the Commissioner overlooked the specific facts of Janssen, more particularly that the Janssen claims involved a dosage range with several variables, and a known approach (a titration regimen), requiring a physician to monitor the patient and make adjustments. Therefore the Commissioner's reliance on the Janssen case was not warranted.

The Federal Court thus drew a clear distinction between cases where professional skill and judgment is exercised, for example where adjustments by the physician would be required, and those where no adjustments and therefore no professional skill and judgement are required, such as in this case where the claims recite a fixed dosage on a fixed schedule.

Revised Examination Guidelines

Taking into consideration the Federal Court Ruling, the Canadian Intellectual Property Office recently issued revised Examination practice guidelines6 and examples of patent-eligible and patent-ineligible medical use claims7, confirming that claims reciting features that do not involve a physician's professional skill or judgment, such as a fixed dosage, a fixed dosage regimen, a patient sub-population or a particular administration site, are patent-eligible.


This decision and the new practice guidelines provides a welcome clarification on the patent-eligibility of claims involving dosage regimens, and indicates that medical use claims that do not entail professional skill and judgment, including those defining fixed dosages and/or dosing schedules, constitute patent-eligible subject matter under Canadian Patent law.

Patent applicants would be well advised to consider this important change to Canadian patent practice when seeking patent protection in Canada.


1. AbbVie Biotechnology Ltd. v Canada (Attorney General), 2014 FC1251.

2. 2010 FC 1123.

3. 2005 FC 755.

4. 2010 FC 510.

5. 2013 FC 1061.

6. PN 2015-01, issued March 18, 2015

7. Examples of purposive construction analysis of medical use claims for statutory subject-matter evaluation,, issued March 31, 2015

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

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Smart & Biggar/Fetherstonhaugh
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Smart & Biggar/Fetherstonhaugh
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 (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

To Use 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