Canada: Supreme Court of Canada Reaffirms the Doctrine of Sound Prediction in Canadian Patent Law

Apotex Inc. v. Wellcome Foundation Ltd.
Last Updated: April 9 2003

By John Bochnovic, Ottawa

Originally published in February, 2003

In a unanimous decision released on December 5, 2002, the Supreme Court of Canada has upheld the validity of the AZT patent held by the Wellcome Foundation Limited and Glaxo Wellcome Inc. (Glaxo/Wellcome). The decision is of particular interest for its detailed review of the requirement of utility in Canadian patent law and the extent to which the doctrine of sound prediction can be relied upon in supporting the utility of a patent claim.

In the early 1980s, testing of the previously synthesised compound AZT on murine retroviruses led Glaxo/Wellcome researchers to believe the compound might have a use as a treatment for HIV. Glaxo sent the compound to two scientists at the U.S. National Institutes of Health (NIH) for further testing. Based on the success of those in vitro tests on human cells, Glaxo/Wellcome submitted a patent application to the U.K. patent office, and subsequently filed a patent application in Canada, claiming priority from the U.K. application. In 1990, the generic manufacturers Apotex and Novopharm instituted an action in Canada against Glaxo/Wellcome, claiming that the patent at issue was invalid.

The central issue of the case was a challenge to validity based on the argument that the necessary utility had not been established as of the priority date of the Canadian patent - the filing of the U.K. application on March 16, 1985. The specific allegation was that the compound’s prophylactic properties, as opposed to its treatment properties, had not been established as of that date. Validity was also challenged on the basis of a failure to name all of the inventors, because Glaxo/Wellcome did not name as co-inventors two individuals from the NIH who carried out in vitro testing of AZT in a human cell line.


Section 2 of the Canadian Patent Act requires that an invention be "new and useful." The Court confirmed that a claimed invention must have "utility" — i.e., it must be useful for the purpose claimed. The Court stated that where the new use is the invention, "the utility required for patentability must, as of the priority date, either be demonstrated or be a sound prediction based on the information and expertise then available."

The Doctrine of Sound Prediction

The doctrine of sound prediction has been established in Canadian law for some time. However, the Court, in this decision, has extensively reviewed the history, scope and applicability of the doctrine, noting that it balances the public interest in having early disclosure of new and useful inventions prior to full verification of utility, while avoiding a grant of patent rights based on the disclosure of speculative information. The Court identified a three-component requirement of the doctrine:

  1. There must be a factual basis for the prediction;
  2. The inventor must have at the date of the patent application an articulable and "sound" line of reasoning from which the desired result can be inferred from the factual basis; and
  3. There must be proper disclosure of the foregoing.

The Court was careful to note that the soundness of the prediction is a question of fact and each case will turn on the particular details associated with the discipline to which the subject matter relates, and the evidence in respect thereof.

The Court reaffirmed a long-standing position that sound prediction will not successfully support a patent claim if either the prediction at the date of the application was not sound or, irrespective of the soundness of the prediction, there is evidence of lack of utility in respect of some of the areas covered by the claim.

Sound Prediction and Pharmaceuticals

The Court has provided noteworthy clarification of certain issues that are of particular relevance to the pharmaceutical field.

  • The Court recognized comments from earlier jurisprudence that the predictability of chemical reactions differed from the predictability of pharmacological effects and utility, while confirming that pharmacological utility is capable of prediction.
  • The Court affirmed factual conclusions from the trial judge that the inventors possessed and disclosed in the patent application both the factual data on which to base the prediction and a line of reasoning to enable them to make a sound prediction at the time they applied for the priority patent.
  • Moreover, the Court affirmed the trial judge’s conclusion that the in vitro tests to the human cell line would be adequate where the art would accept this as appropriately correlated to in vivo utility — i.e., testing in humans.
  • The Court rejected the suggestion that Glaxo/Wellcome was required to demonstrate utility through prior human clinical trials.

After-the-fact Validation

The Court confirmed that bare speculation, even if it afterwards turns out to be correct, will not amount to sound prediction. It rejected the suggestion, arising from earlier Canadian Federal Court of Appeal decisions, that mere speculation which later turned out to be true would be considered a sound prediction.


In reviewing inventorship, the Court characterized the ultimate question as: who is responsible for the inventive concept? The Court distinguished those who participate in the conception of the invention from those who participate in its verification. Notwithstanding the significant contribution made by the two individuals from the NIH, which served to support the utility through sound prediction, the Court concluded that they were not co-inventors.

This decision of the Supreme Court of Canada provides an extensive and valuable review of the doctrine of sound prediction. The decision is a reminder of the importance to be placed on the documentation of invention and testing activity.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific 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 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