Canada: The Myriad Case : Are DNA Molecules Patentable Or Not ?

Last Updated: December 15 2011
Article by Marie-Eve Clavet

The United States Court of Appeals for the Federal Circuit ruled, in July 2011, that claims pertaining to deoxyribonucleic acid (DNA) and related diagnostic tests are patentable.1

Before reviewing the conclusions of this decision that reversed that of the District Court for the Southern District of New York and its impact on our side of the border, we propose to briefly review the circumstances of this judgment.


During the 90s, Myriad Genetics Inc. ("Myriad"), along with several university research centres, conducted studies to identify the BRCA1 and BRCA2 genes, whose mutations are associated with an increased risk of developing certain forms of breast and/or ovarian cancer. These two genes and the methods associated with the diagnostic tests used to identify these mutations were patented by Myriad and other inventors in August 1994 (BRCA1) and December 1997 (BRCA2).

Myriad has granted licences for these tests in several countries. In Canada, MDS Laboratory Services, based in Toronto, has obtained an exclusive licence for the purpose of offering these tests.

Several parties have challenged Myriad's monopoly, alleging that the exclusivity held for the identification of a mutation of these genes in a patient allowed it to charge a price that is higher than the actual cost of the tests, which, in practice, precludes certain patients from undergoing them.


In May 2009, a group composed of medical associations, researchers and patients sought a declaration that fifteen claims from seven patents held, among others, by Myriad and the University of Utah Research Foundation concerning the BRCA1 and BRCA2 genes were drawn to patent-ineligible subject matter. In order to rule on this complaint, the U.S. courts had to review the practices of the United States Patent and Trademark Office (USPTO) respecting the issuance of patents on genes and then rule on the issue of patentability.

In a decision constituting a change of paradigm, the District Court invalidated the claims in certain of Myriad's patents respecting the BRCA1 and BRCA2 genes, particularly those relating to isolated DNA sequences and the methods of DNA comparison and analysis to identify the presence of mutations.

In a split decision, the Court of Appeals reversed the District Court's decision, mainly stating that:

  • The cDNA molecules (complementary DNA) and isolated DNA molecules are patentable. The three judges were unanimous on the issue of patentability of cDNA, except for very short sequences since it results from human manipulation and does not exist in nature. However, the justices were divided over the issue of the patentability of isolated DNA molecules, which have been cleaved or synthesized to consist of just a fraction of a naturally occurring DNA molecule. In fact, the justices disagreed on the scope of manipulation necessary to isolate the DNA in question: the majority was of the view that it amounted to more than a simple purification and the isolated DNA was significantly different, having an identity and chemical composition different from DNA in its natural state, while the minority justice merely saw a simple rupture of covalent bonds;
  • The claims concerning the methods of using of DNA for screening therapeutic agents against cancer meet the requirements of the machine or transformation test and thus, are patentable. These claims concerned the methods for analysing the changes in cell growth with or without treatment, and, according to the Court, include transformation steps and represent functional and palpable applications for the field of biotechnology;
  • The claims respecting the methods for comparison and analysis of the DNA sequences were invalidated since they failed to meet the requirements of the machine or transformation test. In fact, the Court ruled that the wording of the claims only amounted to a simple abstract mental process for comparing DNA sequences.

In doing so, the Court dismissed the approach proposed by the U.S. government who sought to have the patents respecting DNA molecules invalidated by proposing to apply an analysis based on the "magic microscope" test. According to such, if an imaginary microscope could focus in on the claimed DNA molecule as it exists in the human body, the claim covers unpatentable subject matter.

The Court of Appeals also refused to modify the well-established practice of the USPTO to deliver DNA-related patents on the ground that it was up to the legislators to decide whether to prohibit the issuance of such patents. The Court was of the view that to decide otherwise could have significant effects on the industry's expectations and may ultimately hinder innovation. In fact, the Court noted that in the last 29 years, the USPTO had issued 2,645 patents respecting isolated DNA and, since 2005, 40,000 patents respecting DNA without distinction were issued.

It is interesting to note that although underlying moral and ethical issues related to granting ownership rights in portions of human DNA were mentioned by a justice, the Court chose not to use its judicial power, rather referring these issues to the U.S. Congress.


In Canada, the Canadian Commissioner of Patents has issued and is still issuing patents respecting DNA. In 2004, in the Mosanto case, the Supreme Court of Canada issued a close 5 against 4 decision confirming that a gene and a cell are patentable. The Court also noted, on this occasion, that it is incumbent on the person challenging an issued patent to demonstrate that the Commissioner was erred in allowing the patent application.

In view of its potential impacts on our Canadian regime, various industry stakeholders have closely followed the Myriad case. If the U.S. Court of Appeals had invalidated Myriad's patents, it may have had significant effects on the entire Canadian biotechnological industry.

In short, we note that this decision maintains the possibility of patenting DNA in the United States, which indirectly supports the Canadian position in this respect.


1. Moreover, on September 12, 2011, the same court refused to revise its decision.

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.

Similar Articles
Relevancy Powered by MondaqAI
Blake, Cassels & Graydon LLP
Bereskin & Parr LLP
Bennett Jones LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Blake, Cassels & Graydon LLP
Bereskin & Parr LLP
Bennett Jones LLP
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