South Africa: Patentability Of Genetic Material

Last Updated: 6 November 2015
Article by Joanne van Harmelen

Most Read Contributor in South Africa, September 2018

The patentability of genetic material has again come into the spotlight with the recent high court decision in Australia in the Myriad Genetics Inc. v D'Arcy case, where the High Court of Australia unanimously ruled that Myriad's patent claims to an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide was not patentable subject matter. The detection of mutations in the BRCA1 gene is able to be used as a diagnostic marker for the risk of a woman developing breast cancer.  The high court decision was similar to the present position in the United States (US), where a number of US Supreme Court decisions have found that isolated genetic material is not patentable. 

Myriad argued that nucleic acid is a chemical compound just like any other and should therefore be patentable if meeting the additional requirements of patentability including novelty and inventiveness. However, the high court agreed with the argument of Ms D'Arcy, the opposing party, that nucleic acid is more than merely a chemical compound and is, in fact, "genetic information" and that the genetic information stored in the isolated nucleic acids was the same information as that contained in the person from whom the nucleic acid was isolated and, hence, was not "artificially created", which would be the requirement for patentability. 

Applying the same logic, the high court further held that even cDNA (a synthetic form of DNA that is produced in the laboratory and that excludes naturally occurring intron sequences) was not patentable, in that cDNA also represented the naturally occurring genetic information that was present in the person from whom the nucleic acid was isolated. It appears from the high court decision that an important factor in its ruling was that the lower courts had attributed "misplaced significance" to the requirement that to be patentable it was sufficient for a product to result in an "artificially created state of affairs" leading to an "economically useful result". The high court considered that it was important to take into consideration wider factors relating to policy and the public interest.

Of some consolation to innovators in the biotech field, is that the Australian High Court did not dispute the patentability of process or method of diagnosis claims as long as the additional requirements for patentability of novelty and inventiveness are met. This is in contradistinction to the present situation in the US where, following the decisions of May v Prometheus, Alice v CLS Bank and Association for Molecular Pathology v Myriad Genetics, the patentability of inventions relating to a method for the diagnosis of disease by determining the levels of a biomarker has been called into question.

Following the "Mayo framework", it is required for the courts in the US, when considering patent eligibility of such a diagnostic method claim, to consider two steps:

  1. whether or not the claim recites a natural phenomenon, natural law or abstract idea (ie, a patent ineligible subject matter); and, if so,
  2. whether or not the claim recites enough additional elements that would make the claim refer to an application of the subject matter rather than to the subject matter per se.

For example, in the recent Ariosa Diagnostics v Sequenom case, the US Court of Appeal for the Federal Circuit held that a method for detecting a paternally inherited nucleic acid of foetal origin from a maternal blood sample by amplification of the nucleic acid from a sample followed by detection of the presence or absence of the nucleic acid was not patentable. The court considered the claims in terms of the Mayo framework and found that, firstly, the claims were directed to a product of nature (the nucleic acid of foetal origin) and that the additional elements or method steps applied were well known and conventional steps.

It seems that in order for diagnostic method claims for detection or assessment of products of nature to be patent eligible, it would be necessary to have a novel and inventive additional element to be present, such as a novel type of assay, detection method, apparatus or the like. Another possibility is to include treatment steps whereby the diagnostic method is coupled with a method of treatment of the subject. 

It is not known, if tested by the courts in South Africa, whether the position of our courts would be similar to that in Europe, where as long as a known material or article has a newly discovered property that can be put to technical effect, the invention is patentable, or whether our courts would follow the Australian or US position.

It is important when considering patent claim construction for biological inventions, that there is flexibility provided for in the scope of the claims, so that depending on the jurisdiction in which applications are ultimately to be filed, claim amendments may be made to provide for at least some patent eligible claims.

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.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Related Articles
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