Australia: Not just genes: Full Federal Court upholds decision about patentability of isolated DNA

Last Updated: 12 September 2014
Article by Deborah Polites and Richard Hoad

Key Points:

There is now greater certainty about patentable subject matter in the field of genetics, but that's only one element in the broader questions of validity to be considered when assessing any patent.

On 5 September 2014, five judges of the Full Federal Court upheld a lower court's decision that isolated human DNA was patentable subject matter, providing further clarity in this controversial area of law (D'Arcy v Myriad Genetics Inc [2014] FCAFC 115).

There has been ongoing worldwide debate as to whether genetic material should be patentable subject matter. Last year, the US Supreme Court held that isolated genes were not patentable subject matter merely by virtue of being isolated (Association for Molecular Pathology v Myriad Genetics Inc 596 US 12-398 (2013)).

Australian courts have come to a different conclusion.

Cancer Voices Australia's challenge to the patent for the isolated BRCA1 gene

In 2010, Cancer Voices Australia (a network of cancer advocacy groups) and breast cancer survivor Yvonne D'Arcy brought proceedings in the Federal Court of Australia seeking to invalidate claims 1 to 3 of a patent granted to Myriad Genetics.

Myriad Genetics' patent related to the isolated BRCA1 gene which, when mutated, is thought to be responsible for at least 80% of cases of familial breast and ovarian cancer. Myriad Genetics had succeeded in isolating the nucleic acid of the BRCA1 gene from the environment in which it naturally occurs in human cells.

Cancer Voices Australia argued that claims 1 to 3 of the Myriad patent did not satisfy the "manner of manufacture" test for patentable subject matter. In response, Myriad argued that, by virtue of the process of isolation, the isolated genetic material in its artificial environment was different in substance from the naturally occurring genetic material.

Under section 18(1)(a) of the Patents Act, an invention must be a "manner of manufacture" in order to be patentable. The key authority on the "manner of manufacture" concept is the pivotal NRDC decision.1 In that case, the High Court held that the key elements in determining whether an alleged invention is a "manner of manufacture" are whether the invention resulted in an "artificially created state of affairs", and whether it produced an economically useful result.

Justice Nicholas of the Federal Court held the isolated genetic material covered by the Myriad patent constituted an "artificially created state of affairs", qualifying it as patentable subject matter under the Patents Act 1990, as interpreted by case law. He emphasised the importance of isolating the genetic material.

Yvonne D'Arcy appealed Justice Nicholas' decision to the Full Federal Court. Before a specially convened panel of five judges, D'Arcy argued that something that occurs in nature cannot be artificial (and hence cannot amount to an artificially created state of affairs) and that the mere isolation of the genetic material was insufficient to justify the grant of a patent.

The basic principles of patentable subject matter applied by the Full Federal Court

In upholding the decision of Justice Nicholas that the claims were patentable subject matter, the Full Court confirmed the following principles relating to patentable subject matter or "manner of manufacture":

  • The boundaries of patentability must be flexible enough to encompass developments in science and technology, and should not be interpreted too narrowly.
  • An essential component of patentability is an artificial state of affairs with a useful effect, created by human intervention.
  • The concepts of utility, ingenuity and invention may help inform manner of manufacture by illuminating new results of established principles that are brought about by human intervention and which create an artificial state of affairs and some useful result.
  • Expressions such as "the work of nature" or the "laws of nature" are not helpful. If construed too narrowly, almost everything could be said to have some origin in nature. Further, the High Court has rejected the approach that there is a limitation on patentable subject matter on this basis.
  • There is a real distinction between discovery of a scientific principle or fact and actually putting it towards a useful end.

Why was the isolated nucleic acid of the BRCA1 gene patentable?

In relation to the Myriad patent, the Full Court held that:

  • the claims are to the isolated nucleic acid, which should be regarded as a compound, and not merely "information";
  • the nucleic acid has valuable economic use; and
  • the claim is wider than for a "mere discovery"; as the nucleic acid, as isolated from the cell, has structural and functional differences from the nucleic acid as it exists in the human body. The fact that, hypothetically, the sequence could have expressed the same proteins if it were in the human body was irrelevant, because the isolated DNA had characteristics that were fundamentally different from those found in nature.

The Full Court agreed with Justice Nicholas that naturally occurring DNA and RNA as they exist in human cells cannot be patentable subject matter. However, in this case the claims were for the genetic material that had been extracted from human cells, and from which all other biological materials had been removed. Therefore, the Myriad patent could never be infringed by naturally occurring DNA and RNA. This demonstrates the fallacy of concerns expressed following the decision at trial that Myriad now "owned" anyone's genes.

The Full Court held that the isolated material itself is an artificially created state of affairs and, although isolated DNA can be considered to be material derived from naturally occurring material, that does not exclude it from patentability. As such, claims 1 to 3 of the Myriad patent were valid.

In closing, the Full Court also mentioned the 2004 report on gene patents by the Australian Law Reform Commission, and noted that "Parliament has considered, and has specifically declined, to exclude purified and isolated gene sequences from the scope of patentable subject matter." Therefore, the Court was reluctant to decide on an issue which it believed was one for Parliament.

Does this mean any isolated genetic material can be patented?

This case has gained particular attention in the media, not only because of the conceptual questions regarding patentability but also the context in which these questions have arisen. Much commentary has focused on the emotive issue of equitable access to cancer testing (even though Myriad's licensee does not charge any licence fees for genetic testing). That issue is a far broader one than the question of patentability of isolated human DNA; the decision in this case is only a single component in the broader scheme of patent protection, which seeks, through legislation and judicial decisions, to balance the interests of protection of innovation and accessibility of technology.

As with the decision at first instance, there are some limitations on the wider effects of the appeal decision. The case only dealt with the threshold question of whether isolated genetic material is patentable. It did not address any of the other requirements for patentability. It should not be assumed that isolated naturally occurring genetic material would always satisfy the novelty and inventiveness requirements for patentability. In particular, in some cases the isolation of naturally occurring genetic material may well not involve an inventive step – a question that was conceded by both parties in the present case.

Furthermore, only the claims relating to the genetic material itself were challenged. The patent also included claims for methods of diagnosis, and the Full Court noted the recent High Court decision in Apotex v Sanofi in which the patentability of methods of treatment of the human body was confirmed.

Thus, while the decision provides a greater degree of certainty in relation to patentable subject matter in the field of genetics, that question is only one element in the broader questions of validity to be considered when assessing any patent.

You might also be interested in...


1National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252?

Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this bulletin. Persons listed may not be admitted in all states and territories.

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”

Mondaq Advice Centre (MACs)
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.