Canada: Medical Diagnostics Patenting Faces Increased Challenges In Canada

Last Updated: August 17 2016
Article by Melanie Szweras and Carmela De Luca

Intellectual property rights (IPR) are a key component for most if not all innovative activities.

For biotech companies in particular, one of the pillars for building value is a sound patent strategy and robust patent position for the key assets of the company.

Uncertainty in three areas can negatively impact innovation for IPR-driven sectors: uncertainty in the courts (i.e., litigation); uncertainty in patent office examination (i.e., whether patents will be granted and for what scope); and uncertainty in the laws protecting innovations in the innova­tors' home country compared with laws in other countries. Although there is little case law to judge in terms of uncertainty in the courts, recent changes in patent office examination policy with respect to medical diagnostics may have negative long term impacts on the innovative diagnostics in­dustry in Canada.

The Canadian Intellectual Property Of­fice (CIPO) released a Patent Notice to Ex­aminers in the summer of 2015 announcing changes to its examination of medical diagnostic methods - guidance that had been highly anticipated since CIPO had suspended its prosecution of diagnostic claims several years earlier.

Diagnostic innovations typically relate to the discovery of a correlation between genetic alterations or level of an analyte and a disease or disorder. The correlation discovery was viewed as able to generate the most valuable IP, and particularly so for companion diagnostics (after claims to the therapeutic composition or use thereof). Such IPRs related thereto have the ability to impact exclusivity for both the drug and the associated diagnostic.

The availability of IPRs directed to such a correlation discovery has been curtailed. Under the current Practice Notice, if the Examiner determines that the innovation is directed to improvements in measuring or detecting an analyte, it is more likely to be considered patentable subject matter whereas if the Examiner determines that the innovation is directed to the discovery of a correlation between an analyte and a diagnosis (without more), it is more likely to be considered unpatentable. CIPO's Practice Notice was introduced without significant consultation and without any clear basis in Canadian law. Although CIPO's interpretation of patentability does not have the force of law and can be challenged, the Notice has effectively cast more than a little doubt on the pat­ent eligibility of some precision medicine claims. Furthermore, CIPO acts as the gate-keeper to get an issued patent and under the current Practice Notice, innova­tors have no choice but to live within this system.

The changes to examination practice also put Canadian innovators in this sector at a disadvantage in their home country compared to, for example, their European counterparts.

The United States Patent and Trade­mark office over the last several years has been reducing the extent of protection available for diagnostics innovation. How­ever, such changes have been met with extensive scrutiny.

This shift in the CIPO examination pro­cedure seems to contradict the current Canadian Government focus on innova­tion, at least in relation to the life sciences industry. On January 20, 2016, Prime Minis­ter Trudeau provided a direct reference to the focus on innovation during his speech at the World Economic Forum in Davos, Switzerland. In his speech, Trudeau said "We need policies that encourage science, innovation and research. ... And we need governments willing to invest in making all that happen, while recognizing the dynamic innovation that happens in the private sector"1. This platform was backed up by the 2016 Canadian Federal Budget, which provided extensive funding com­mitments to scientific research, including funding for Genome Canada and other life science organizations as well as commit­ting to strengthen innovative networks and clusters2. However, the innovation agenda needs to be promoted in the government agencies that directly impact innovation in Canada, particularly innovation in the private sector. Otherwise, the govern­ment's focus on research will not translate innovation into the Canadian market. In other words, products and services stem­ming from these important correlation discoveries will not be brought to market by Canadian innovators and/or may not be readily available to Canadians.

Interestingly, there has been little objec­tion by the Canadian innovative diagnos­tics community to the clear diminishment of what is patentable for medical diagnos­tics. The reason behind this lack of reaction is unclear, but the changes have yet to have significant effect or to be appreciated fully (the second round of examination of diagnostic patent applications under these new guidelines is just emerging). One thing is clear: unless challenged or changed by the legislation, the current patent office practice will dramatically reduce the scope and type of claims and consequently the protection available for medical diagnos­tic innovations. In an era where precision medicine is positioned to transform the delivery of healthcare, reducing the incen­tives for innovation may negatively impact the Canadian diagnostics industry and place Canada at a disadvantage vis-à-vis other countries.


1 "The Canadian Opportunity", Davos, Swit­zerland, January 20, 2016, http://pm.gcca/eng/news/2016/01/20/canadian-opportunity-address-right-honourable-justin-trudeau-prime-minister-canada

2 Canadian Federal Budget 2016: Research & Innovation Investment Summary, Rob­ert Merson, Biotechnology Focus, March 23, 2016,

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.

Melanie Szweras
Carmela De Luca
In association with
Related Topics
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