Canada: When It Comes To What You Can Patent, Patent Offices Don't Always Know Best

When organizations invent something, they must decide whether to pursue patent protection. This decision is a consequential one, as patenting involves disclosing one’s invention to the world, and obtaining patent protection may be necessary to secure a company’s future. However, sometimes keeping an invention secret is the better approach, particularly where patent protection is unavailable. Guidance from national patent offices helps organizations determine whether or not to patent an invention by indicating what they perceive to be patentable subject matter.

Against this backdrop, the April 2019 decision of the U.S. Federal Circuit Court of Appeals in Cleveland Clinic Foundation v True Health Diagnostics LLC (Appeal 2018-1218) is of particular interest to a cross-border audience. In Cleveland Clinic, the Federal Circuit considered guidance on patentability rules issued by the United States Patent and Trademark Office (USPTO). The Court reaffirmed that it is not bound by patent office guidance when assessing a patent, even in a situation such as in Cleveland Clinic, where the claimed invention was clearly permissible under the USPTO’s guidance.

The patents at issue in Cleveland Clinic disclosed diagnostic methods consisting of using known techniques to measure the amount of leukocyte and myeloperoxidase levels in blood in order to predict the likelihood of a patient developing or having cardiovascular disease. The Federal Circuit found the patents invalid as covering an ineligible natural law. The Court applied jurisprudence stating that the idea of testing for a naturally occurring bio-marker to predict the likelihood of a patient developing or having a particular disease condition was merely a principle and “[a] principle is not patentable. A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.”

But what of the USPTO guidance suggesting that such an invention was patentable?

Cleveland Clinic had argued that the claims at issue were patentable subject matter based on an example of patentable subject matter including similar claim language contained within a USPTO guidance document. The Federal Circuit responded:

While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.

This case serves as a lesson to patent applicants that patent office policy is not the final word. Where applicants perceive a difference between court jurisprudence and patent office guidance, the jurisprudence takes priority. Where a patent is issued based on erroneous guidance, as in Cleveland Clinic, the patent may not be enforceable in court. Conversely, where a patent is rejected based on erroneous guidance, the applicant may have recourse to challenge the patent office’s decision in court.

As in the United States, Canadian courts are not bound by guidance documents issued by government agencies, such as the Canadian Intellectual Property Office (CIPO). Guidance documents are supposed to be consistent with Canadian jurisprudence, but there is often room for disagreement regarding what cases are controlling and how jurisprudence is to be applied in situations involving new fields of technology.

The current Canadian treatment of patentable subject matter for diagnostic methods flips Cleveland Clinic on its head. Canadian courts have issued no guidance regarding the subject-matter eligibility of patent claims to methods of medical diagnosis; however, CIPO has issued stringent guidance restricting approval of this claim type.

The CIPO guidance document PN2015-02 limits patentability of medical diagnostics to those that solve a “data acquisition problem” (i.e., new techniques for obtaining biological data) or a “data analysis problem” (i.e., new methods for analyzing biological data obtained using known techniques).

On its face, this guidance document construes patent eligibility more narrowly than the Supreme Court of Canada jurisprudence in Shell Oil Co v Commissioner of Patents, [1982] 2 SCR 536. In Shell Oil, the Supreme Court stated the following in deciding that a new use for a known compound constituted patentable subject matter under Canada’s Patent Act:

The appellant’s discovery in this case has added to the cumulative wisdom on the subject of these compounds by a recognition of their hitherto unrecognized properties and it has established the method whereby these properties may be realized through practical application. In my view, this constitutes a “new and useful art” and the compositions are the practical embodiment of the new knowledge.

Another criticism of the CIPO guidance has been that it approaches patent interpretation in a manner different from the Supreme Court’s approach in Free World Trust v Électro Santé Inc., 2000 SCC 66, by de-emphasizing essential elements of patent claims when considering subject-matter eligibility.

Over the past several years, as patent applications directed to medical diagnostics have languished at CIPO, applicants have argued that CIPO’s guidance is overly restrictive and inconsistent with Shell Oil and other Supreme Court and appellate decisions. These arguments have been met with rejection and delay. To date, no patent applicant has challenged CIPO’s decision in the courts.

The Cleveland Clinic decision should remind applicants that patent office guidance does not bind the courts, and that appeal of patent office decisions from time to time is necessary to generate the jurisprudence that allows the patent system to function smoothly. Nowhere would this be more helpful than for medical diagnostic patents, where new jurisprudence interpreting Shell Oil and the applicability of Free World Trust to questions of patentable subject-matter eligibility would be welcome to all.

Entrepreneurs who develop new and innovative medical diagnostics want fair patent protection in exchange for providing improved healthcare. This bargain is what the government intended to recognize by enacting the Patent Act. As technologies advance, patent law must be clear enough to enable entrepreneurs to understand when the patent bargain is available to them. Occasionally, when clarity is lacking, someone needs to rock the boat.

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
Blake, Cassels & Graydon LLP
 
In association with
Practice Guides
by Mondaq Advice Centres
Relevancy Powered by MondaqAI
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Blake, Cassels & Graydon LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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