Canada: Patentability Of Higher Life Forms In Canada

Last Updated: August 6 2001
Article by Margaret H McKay

Transgenic non-human animals may now be patentable subject matter in Canada. This is the result of the decision of a majority of the Federal Court of Appeal in President and Fellows of Harvard College v. Commissioner of Patents ([2000] 4 F.C. 528), commonly known as "the Harvard mouse case." The Canadian government has obtained leave to appeal this decision to the Supreme Court of Canada.

To be patentable in Canada, an innovation must qualify as an "invention" as defined in the Patent Act. An "invention" is "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter."

The Harvard mouse case arose from the refusal of the Canadian Patent Office to allow claims to "a transgenic non-human mammal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage." The transgenic animal claimed is useful in testing substances to determine if they are carcinogenic.

A key issue in this case was whether a transgenic animal fell within the definition of an invention, for example as a composition of matter or a manufacture. In particular, it had been argued that the transgenic offspring of a transgenic animal could not be "inventions," as they were produced from their transgenic parents by purely natural processes.

Prior to this decision, the Patent Office had taken the position that "higher life forms", such as plants and animals, were not patentable subject matter, whereas "lower" life forms, such as bacteria and viruses were.

Justice Rothstein, writing for the majority, held that a transgenic mammal was patentable as a "composition of matter" within the meaning of the Patent Act. In reaching his conclusion, Mr. Justice Rothstein adopted the definition of "composition of matter" used by the majority of the Supreme Court of the United States in Diamond, Commissioner of Patents and Trademarks v. Chakrabarty (447 U.S. 303 (1980)) where it was determined that human-made micro-organisms were patentable subject matter in the United States.

In addressing the question of whether the transgenic offspring of a transgenic animal were patentable, Mr. Justice Rothstein noted that most inventions involve some use of the laws of nature. Thus, the mere fact that the laws of nature play a role in the development of the invention does not prevent it from being patentable. In this case, human intervention was needed to create the first transgenic animals. The fact that these animals, once produced, can reproduce to create transgenic off-spring does not render them unpatentable. The offspring exist due to a human-controlled process (the creation of the first transgenic animal). The fact that nature also plays a role in the creation of transgenic animals does not detract from the key role of human intervention. Thus, in Mr. Justice Rothstein’s view transgenic animals and their offspring can be patentable subject matter in Canada.

It had been suggested that the transgenic mouse was not patentable because it was not sufficiently reproducible. Two types of variability were discussed: (a) control over features of the mice other than the presence of the transgene; and, (b) the percentage of mice produced which contained the transgene. In relation to (a), the majority of the Court held that so long as the inventor controlled the feature necessary for usefulness, namely the transgene, it was not necessary to control other features. In relation to (b), the majority of the Court held that a low percentage of production of transgenic mice did not mean that the invention was not reproducible. It was sufficient that the invention could be reproduced, and was therefore useful.

If upheld, this decision would pave the way for much broader protection of transgenic organisms then is presently available in Canada. In particular, novel, non-obvious plant varieties created by genetic engineering would be patentable. Although some protection is currently available for plant varieties under the Plant Breeders’ Rights Act, patent law would provide further and better protection for those plants which qualify.

The decision in the Harvard mouse case is consistent with the earlier decision in Pioneer Hi-Bred case (1 S.C.R. 1623), which distinguished between plant varieties created by crossbreeding and those created by genetic engineering. Thus, organisms created by crossbreeding alone may not be patentable in Canada, unless inventive human intervention can be proven.

The current Harvard Mouse decision is a step toward bringing Canadian patent law in line with the law of the United States and Europe, which permit patents to transgenic plants and animals. (The corresponding United States patent application issued as United States Patent 4,736,866.) The Canadian government is presently looking into public opinion and concerns relating to the patenting of living materials, including higher life forms. Thus, any decision of the Supreme Court in the Harvard mouse case may be overshadowed by subsequent legislative changes.

As with any issue relating to genetically modified organisms, some public concern is to be expected. However, what must be emphasized is that patents provide protection only for novel and non-obvious products or processes disclosed and claimed. Thus, naturally occurring organisms and organisms created by third parties and known to the public before the filing of a patent application, will not be patentable. Additionally, the decision in the Harvard mouse case dealt only with non-human animals, and suggests that transgenic humans would not be patentable.

Any views expressed in this article are strictly those of the author and may not represent the views of Ridout & Maybee LLP or its clients. This article is intended for information purposes only and does not constitute legal advice.

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
 
In association with
Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

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