Canada: Medical Treatment vs. Medical Use: The Shifting Ground Of Patentable Subject Matter In Canada

Last Updated: June 17 2015
Article by Graeme Boocock, Ph.D.

Most Read Contributor in Canada, September 2016

In Canada, methods of medical treatment are not considered to be patentable due to a long-standing, court-created exclusion established under an old compulsory licensing regime (Tennessee Eastman Co. et al. v Commissioner of Patents, (1972), 8 C.P.R. (2d) 202 (S.C.C.)). The exclusion has persisted in Canadian law, despite the regime no longer being in force. Separately, the Supreme Court has considered and upheld medical 'use' claims (Apotex Inc. v. Wellcome Foundation Ltd., (2002), 21 C.P.R. (4th) 499 (S.C.C.)). The tension between these two precedents can be a significant source of confusion for applicants and foreign practitioners with applications in Canada.

More recently, decisions of the Federal Court have expanded the exclusion, striking down 'use' claims in instances when the claimed invention was deemed to inhibit or require the professional skill or judgement of a physician (e.g., Axcan Pharma Inc. v Pharmascience Inc. et al., 2006 FC 527; Janssen Inc. v. Mylan Pharmaceutical ULC et al., 2010 FC 1123; Bayer Inc. v. Cobalt Pharmaceutical et al., 2013 FC 1061). Claims limited by dosage range, for example, have been invalidated on this basis when the Court found that a physician's skill would be required to select an appropriate dose from within the range.

Prospective patentees accordingly face a somewhat paradoxical situation in Canada: broad 'use' claims are generally permissible from the perspective of statutory subject matter, while narrower claims limited in particular ways can be problematic.

Against this backdrop, the Canadian Patent Office issued a Practice Notice to its examiners in 2014 with guidelines on the examination of medical 'use' claims. Under these guidelines, claims limited by 'what' to use were generally permissible, while those limited by features perceived to require 'how' or 'when' determinations were generally impermissible.

The Practice Notice and its attendant examples were revised in March 2015. The reason for the update is a 2014 decision of the Federal Court, which criticized an earlier decision of the Commissioner of Patents for over-reliance on policy considerations (AbbVie Biotechnology Ltd. v. The Attorney General of Canada, 2014 FC 1251 at [120]-[125]). The most notable changes in the new Practice Notice are a softening of its language, and stark reversal of two previous policies concerning new sites of administration and patient populations.

Whereas the previous Notice indicated that a 'use' claim limited by a 'how' element "will lead to the conclusion that the claimed 'use' encompasses a method of medical treatment", the revised Practice Notice inserts a passage before this to indicate that "it must be determined whether the essential element prevents, interferes with or requires the professional skill of a physician" (emphasis added in both instances). The intention, it seems, is greater deference to an Examiner's determination based on the facts at hand.

Pertinent examples from the revised Practice Notice are summarized below.

Uses of new compounds and new uses of known compounds

Claims to 'uses' of both new and known compounds remain statutory under the revised Notice when the invention rests in the new compound or the new 'use', respectively. Dosage range features do not make claims non-statutory in these circumstances if they are deemed "unnecessary limitations to the scope of the monopoly" (it is unclear, however, how such "unnecessary limitations" would be subsequently interpreted in the courts).

New fixed dosage form of a known drug for a known use

'Use' claims reciting fixed dosage units are judged to be directed to specific products, and remain statutory.

New dosage range of a known drug for a known use

'Use' claims reciting dosage ranges remain non-statutory, when the invention resides in the dosage range. The example indicates that "the dosage range... requires the skill and judgment of a physician to make a determination as to the dose the patient receives". Features such as "13 to 15 mg/kg/day" and "14 mg/kg/day" are considered to be equally problematic, because the physician has to make a determination in each case.

New dosage regimen of a known drug for a known use

'Use' claims including dosage regimens with fixed time points and fixed amounts remain statutory, though a new cautionary note indicates that such claims would not be statutory if "it is determined that the schedule claimed is a titration", which "always requires monitoring by a professional". Likewise, a new example involving a time range of "3-5 weeks" is deemed to be non-statutory due to the requirement for a physician's judgement.

New physical formulation of a known drug for a known use (new area of administration)

The revised Practice Notice reverses previous examination policy on use claims for inventions involving sites of administration. The two examples involve an orally administrable pharmaceutical composition (the same drug was used previously to treat the same condition), and a 'use' of an existing patch on a new site on the body (the upper leg instead of on the arm). Both are considered to be patentable subject matter.

Known compound, for a specific group of patients

The Practice Notice also reverses earlier examination practice for 'uses' of known compounds in a specific group of patients: a key area for personalized medicine. Application of a known drug to either an entirely new patient group or a patient sub-population (e.g. bearing a specific mutation) is deemed to be statutory. However, a new cautionary note indicates that the latter would be considered anticipated, and would also not qualify as a selection.

While the deference to the determination of an examiner afforded by the revised Practice Notice is a positive development, the foray into anticipation in the example concerning patient subpopulations is a puzzling development. No precedent is referenced to support the example, and the resolution of a previously homogenous patient group into new sub-groups (with attendant inventive advantages) is conceptually similar to the resolution of an existing drug based on racemic mixture. Claims to purified enantiomers with special advantages have been upheld as a selection on more than one occasion by the courts (e.g., Sanofi-Synthelabo v. Apotex, 2008 SCC 61; Sanofi-Aventis v. Apotex, 2013 FCA 186), and this may provide a basis for applicants to argue against application of the revised Practice Notice where 'use' claims involving personalized medicine are concerned.

About BLG

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.

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 (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

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’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 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

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

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

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