Australia: Will the Australian High Court Myriad gene patent decision impact the patenting of all isolated biological material?

Last Updated: 23 November 2015
Article by Grant Shoebridge

Last week, Shelston IP reported that the Australian High Court (the Australian equivalent to the US Supreme Court) unanimously ruled that isolated naturally-occurring nucleic acids were not patentable subject matter in Australia. The decision itself has been widely reported. There has, however, been little or no commentary regarding the ramifications of the decision and, in particular, whether it will impact the patentability of isolated biological material other than naturally-occurring genes.

In the corresponding US Supreme Court Myriad case, a finding that isolated naturally-occurring genes were not patentable was interpreted by the United States Patent and Trademark Office as extending to all isolated biological material and preliminary reports by some Australian commentators suggest that there is no reason why Australian law will not follow suit and exclude all isolated naturally occurring material from patentability. It has also been reported that the High Court decision goes further than the US Myriad decision because artificially synthesised nucleic acids, such as cDNA, may also be excluded from patentability.

The Myriad ruling consists of three separate decisions: the majority decision by French CJ, Kiefel, Bell and Keane JJ; and two minority decisions, one by Gageler and Nettle JJ and another by Gordon J. Generally speaking the reasoning of a minority judgement insofar as it differs from the majority judgement would not be relied on for setting precedent law because one assumes that the majority did not agree with the minority reasoning. As such, the discussion below predominantly considers the majority decision.

The intent of the Myriad action

In reaching an understanding of how the Myriad decision should be interpreted, it may be useful to initially consider the intent of the High Court Appeal.

In her special leave submission to the High Court, D'Arcy states "the applicants intended this to be a test case on the patentability of human genes". This is reaffirmed in D'Arcy's written submission to the High Court, which states, "[t]his appeal presents the question whether an isolated human gene is a patentable invention, being a manner of manufacture within the meaning of s18(1)(a) of the Patents Act 1990 (the Act)". Nothing in D'Arcy's submissions relate to the patentability of isolated biological material other than human genes.

Given that all isolated naturally-occurring material became patent ineligible after the US Supreme Court Myriad ruling, the Institute of Patent and Trademark Attorneys Australia (IPTA) made a submission to intervene in this case and submitted affidavits from senior patent attorneys (including the author of this article) and scientists indicating that excluding isolated naturally-occurring biological material generally from patentability would adversely impact the Australian biotechnology industry.

In her reply to IPTA's intervention application, D'Arcy stated at paragraph 21 that "no question concerning the patentability of 'other material isolated from nature' arises on the facts of the present case". Accordingly, D'Arcy's appeal had no intention of challenging the patentability of anything other than isolated human genes.

The intervention application by IPTA was ultimately rejected by the High Court, and thus it is reasonable to assume that D'Arcy's position, namely that the case only relates to the patentability of human genes, was accepted by the High Court. Support for this view is provided at paragraph 37 of the majority decision, which states that "this Court is not concerned in this appeal with 'gene patenting' generally but whether the invention as claimed in claims 1 to 3 fall within the established concept of manner of manufacture".

Isolated biological material other than nucleic acids

In coming to its decision the Court followed the principles of the High Court's decision in National Research Development Corporation v Commissioner of Patents ('NRDC') [1959] HCA 67 and thus considered the "artificialness" and "economic significance" of the defined nucleic acid sequences. In this regard, the majority decision identified that the essential integer of the claimed invention is "information" rather than an isolated chemical product since the nucleic acid sequence is used in a genetic diagnostic screening test. The majority decision also states (in relevant part) that the specified mutations or polymorphisms, i.e. the "information", "... has nothing to do with the person who isolates the nucleic acid bearing the mutant sequence".

Thus, it was found that the "information" defined by the disputed claims was identical whether isolated or not and further that the information had not been made by Myriad. On that basis the High Court found that the isolated sequences did not satisfy the artificialness requirement.

Regarding the second requirement for determining patentable subject matter, namely economic significance, the majority decision states:

"The economic significance necessary to the patentability of an "artificially created state of affairs" in the sense used in NRDC is not demonstrated by stating that the artificially created state of affairs is a step along the way to a process or method itself claimed as an artificially created state of affairs of economic significance".

This statement is critical in understanding the position of the majority decision because it forms a nexus between the "artificialness" required for patentable subject matter and the "economic significance" of an invention. As the economic significance of the Myriad patent resides in conducting a genetic screening test (a process), the "step along the way to a process", namely the isolation of the nucleic acid sequence was found to be insufficient to make the isolated sequence itself (which is not sold and therefore does not have a direct economic benefit) patentable subject matter.

The above analysis has important implications in determining the scope of the High Court's ruling. Firstly, it is reasonable to interpret the majority decision insofar as it relates to the requirement for "artificialness" as being limited to isolated biological matter where the essential integer of the claimed invention relates to sequence information and, in particular, nucleic acid sequences that are used in genetic screening tests and other applications that rely on a review of the relevant sequence information. This would not be the case for an isolated naturally-occurring protein, or an isolated naturally-occurring nucleic acid sequence capable of use as a medicament or even an isolated micro-organism because such isolated materials do not relate to "information" in the sense described by the High Court. Moreover, these types of isolated biological materials can be sold. In other words, their state of being isolated provides a direct economic significance rather than a "step along the way" to economic significance. And finally, the state of being isolated is linked to their utility. Accordingly rather than information, an isolated naturally occurring medicament is a product that has been made by human activity and therefore should satisfy the requirement of patentability in view of the Myriad decision.

Finally, if the High Court had intended that its decision be interpreted to include biological material other than isolated naturally-occurring genes, it is logical that it would have mentioned such material in their ruling. Consistent with this view, is the statement made in relation to cDNA in paragraph 89. However, no mention of biological material other than nucleic acid sequences is made in any of the rulings. Thus, for all of the reasons provided above, it seems clear that the Myriad decision cannot be determinative in relation to excluding from patentability isolated biological material other than isolated naturally-occurring nucleic acid sequences where the sequence information is considered to be an essential part of the claimed invention, such as inventions directed to genetic diagnostic testing.

The patentability of cDNA

There have been a number of reports that the majority decision to exclude isolated naturally-occurring gene sequences extends to cDNA. This is based on paragraph 89 of the decision, which states in relevant part that "[t]hat characteristic (i.e. the information which is an essential element of the invention claimed) also attaches to cDNA, covered by the claims, which is synthesised but replicates a naturally occurring sequence of exons".

In my view, this paragraph only extends to certain cDNA that is used for genetic diagnostic testing and similar applications that rely on a review of the relevant nucleic acid sequence information. This is clear because paragraph 89 makes mention of cDNA with specific reference to the invention of the patent-in-suit. In particular, paragraph 89 states "the existence of that information which is an essential element of the invention as claimed", where the term "that information" relates to "the information stored in the nucleotides coding for the mutated or polymorphic BRCA1 polypeptide". The "coding for" language simply means that the mutations and/or polymorphisms reside in the exons of the BRCA gene. Thus, the cDNA derived from the genomic BRCA gene will also include the mutations and polymorphisms associated with a predisposition for cancer. However, that will not always be the case. As indicated at paragraph 108, mutations and polymorphisms can also occur in introns. A cDNA derived from such a gene could not be used in a genetic diagnostic assay and, as such, would not have the same information as the naturally-occurring genomic DNA from which it is derived and therefore be patent eligible.

It is also correctly stated at paragraph 102 that "although the introns do not encode a polypeptide or protein, they contain information which helps regulate and execute the cell's response to the information encoded in the exon. Thus, an isolated cDNA that is used to express a protein or peptide contains different information to that which is contained within a cell because the introns, and the information they contain, have been removed. As cDNA lacks the intron information, it logically represents information that has been made as a result of a human action. Moreover, the removal of introns has advantages that permit more efficient expression of proteins. Accordingly, in cases where genomic DNA and cDNA ultimately code for the same protein, the information contained in these different nucleic acid molecules is nonetheless distinct.

There are also instances where differential splicing of exons in genomic DNA is required for protein expression, for example the generation of antibodies. Production of antibodies is further complicated by the process of somatic hypermutation (ie random mutations introduced in the DNA to increase antibody affinity), which occurs after the rearrangement of various antibody genes. Exon rearrangement and somatic hypermutation that occurs for a particular antibody cannot be predicted.

Given the diversity of information that exists between naturally-occurring genomic DNA and artificially-created cDNA it would be illogical for this decision to be interpreted broadly as excluding all cDNA from patentability.


The Australian High Court Myriad decision has resulted in some observers "hitting the panic button" and demanding immediate legislative change. However, a reasoned review of the decision suggests that it should be applied very narrowly and if that occurs its impact on the Australian biotechnology industry will be limited. At this stage, IP Australia is considering the decision with a view to revising their examination guidelines. Once the revised guidelines are made available, Shelston IP will be well placed to provide advice in relation to how the decision will ultimately impact the patentability of biological inventions in Australia.

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.

Shelston IP ranked one of Australia's leading Intellectual Property firms in 2015.

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.

Grant Shoebridge
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 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
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.