United States: Canada Provides More Guidance On Patent Eligibility Of Diagnostic Method Claims

While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and cannot–be patented in Canada. Since most stakeholders in this field pursue patent protection internationally, it can be important to know the standards that will be applied in different jurisdictions.

Thanks to Carmela De Luca at Bereskin & Parr for preparing this article that tipped us off to the new CIPO guidance.

The Canadian Analytical Framework

Where current U.S. jurisprudence calls for application of the two-step Mayo/Alice analytical framework (Is the claim directed to a "judicial exception"? Does the claim recite "significantly more" than the exception"), Canada applies a different two-step analysis. In Canada, a problem-solution approach is used to determine whether the claimed diagnostic method pertains to patent-eligible "data acquisition" or patent-ineligible "data analysis":

  1. Determine the problem and solution in view of common general knowledge (CGK).
  2. Determine if the claimed solution to the problem involves data acquisition or data analysis.

The guidance found in Chapter 17 of CIPO's Manual of Operating Practice illustrates disclosures that "may indicate the existence of a data acquisition problem," including the following:

  • disclosure of a novel or non-CGK analyte
  • disclosure of a novel or non-CGK combination of biomarkers
  • disclosure that a CGK means to identify or quantify an analyte is applied to a sample or subject population that is not standard to that means

The guidance also illustrates disclosures that "may indicate the existence of a data analysis problem," including the following:

  • an emphasis on the discovery of an allegedly new correlation between a condition and an analyte that is CGK with a relative absence of technical details pertaining to how to acquire the data about the analyte

The Canadian Diagnostic Examples

The new guidance includes four examples that apply the analytical framework to different claims based on different states of common general knowledge (CGK).

In Example 1, a diagnostic method based on detection of a novel mutation is patent-eligible, but a diagnostic method based on correlating a known mutation to a new disease is not.

Example 1. A method of diagnosing whether a human subject is at risk for developing thyroid cancer comprising:

  1. providing a biological sample from the subject;
  2. analysing the sample of step (a) to determine the identity of the nucleotide at position 123 of gene XYZ; and

wherein the subject is at risk for thyroid cancer if the identity of the nucleotide at position 123 is nucleotide A.

When the mutation is novel, the claim solves a patent-eligible data acquisition problem because there was a need to detect and identify the nucleotide at position 123 of gene XYZ in a human subject.

When the mutation is already known to be correlated with a different cancer, the claim only solves a patent-ineligible data analysis problem relating to the correlation between the known mutation and the new condition (thyroid cancer).

In Example 2, a diagnostic method is eligible based on detection of a known analyte in a novel sample type.

Example 2. A method of diagnosing disease P in a subject comprising:

  1. providing a dried blood sample from said subject;
  2. measuring the activity of enzyme E in the sample, wherein enzyme E activity is detected by mass spectrometry; and
  3. diagnosing the subject as having disease P when the activity of enzyme E is lower than the activity of enzyme E in a control sample representative of normal subjects.

The claim solves a patent-eligible data acquisition problem because there was a need for an improved method of detecting E in biological samples.

In Example 3, a diagnostic method based on combinations of markers is patent-eligible.

Example 3. A method of screening for pathogenic bacteria comprising:

  1. providing a stool sample from a subject;
  2. detecting a combination of two or more protein markers in the sample selected from G, U, T and S; and

wherein the presence of the two or more markers in the sample indicates that the subject is likely to have a gastrointestinal infection.

The claim solves a patent-eligible data acquisition problem of providing means for detecting combinations of two or more markers selected from G, U, T and S within the same stool sample.

In Example 4, a diagnostic method that uses a commercially available microarray chip is patent-eligible if the diagnosis is based on a novel subset of markers.

Example 4. A method for determining the risk of developing persistent organic pollutant (POP)-associated diabetes, comprising:

  1. using a microarray to measure the expression levels of genes T, O, X, I and C in a blood sample obtained from a patient, wherein the microarray comprises oligonucleotide capture probes that are complementary to nucleic acids corresponding to T, O, X, I and C and wherein each probe is attached to a solid support at a discrete position; and
  2. wherein the patient is at risk of developing diabetes if the expression levels of genes T, O, X, I and C are increased relative to the expression levels of the genes in a control sample representative of normal subjects.

The claim solves a patent-eligible data acquisition problem relating to "the determination of the expression levels of only genes T, O, X, I and C" out of the thousands that could be detected by the microarray.

(Unlike the USPTO's Patent Eligibility examples, the guidelines also discuss novelty and non-obviousness of the example claims, which is beyond the scope of this article.)

Would Any Of These Claims Be Eligible In The U.S.?

As much as we'd like to leave this as a rhetorical question, we would be remiss if we didn't point out that the diagnostic "wherein" clauses in the Canadian example claims might undermine the eligibility of such claims under current U.S. jurisprudence. This is highlighted by Example 29 of the USPTO's Subject Matter Eligibility Examples for Life Sciences.

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.

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

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.


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