Australia: Australia's changing patent law landscape

Life Sciences Spotlight
Last Updated: 1 March 2012
Article by Nicholas Tyacke and Ryan Cable

Over the course of 2012, the patent law landscape for life science companies in Australia has the potential to change quite significantly, with a number of major legislative amendments to come before Federal Parliament during this period. We discuss the most significant of these proposed changes in this article.

Raising the Bar Bill

The broadest area of change to the patent law landscape so far as life sciences companies are concerned is likely to come about as a result of the Intellectual Property Laws Amendment (Raising the Bar) Bill (Raising the Bar Bill). As we reported here more fully in September 2011, the Raising the Bar Bill, if enacted in its current form, will amend Australia's patent laws in a number of ways that are of key relevance to companies in the life sciences industries, including the below.

Experimental and regulatory exemptions to infringement
The Patents Act 1990 (Cth) (Patents Act) currently includes a 'springboarding' provision that provides that a pharmaceutical patent is not infringed by exploitation of an invention for purposes solely in connection with obtaining regulatory approval in Australia or overseas of goods intended for therapeutic use. However, where foreign regulatory approval is sought, the pharmaceutical product cannot be exported from Australia for regulatory purposes unless the relevant patent has been granted an extension of term.

The Raising the Bar Bill proposes two new exemptions from patent infringement, which are of particular relevance to companies in the life sciences industries. Firstly, it proposes an amendment that effectively broadens the 'springboarding' provision referred to above to exempt from infringement of patents other than pharmaceutical patents the exploitation of an invention for purposes solely in connection with obtaining regulatory approval in Australia or overseas. Secondly, it proposes an experimental exemption that exempts from infringement acts done for experimental purposes relating to the subject matter of the invention. 'Experimental purposes' are defined to include determining the properties of the invention, determining the scope of a claim relating to the invention, improving or modifying the invention, determining the validity of the patent or of a claim relating to the invention, and determining whether the patent for the invention would be, or has been, infringed by the doing of an act.

Inventive step (non-obviousness)
One of the requirements for an invention to be protectable by a standard patent in Australia is that it possess an inventive step. An invention will satisfy this requirement if a person skilled in the relevant art would not, at the priority date, have considered it obvious in light of the common general knowledge in the field, together with pertinent publicly-available information. Under current law, the relevant common general knowledge is limited to that which exists in Australia and publicly available information is limited to information that the skilled person could be reasonably expected to have ascertained, understood and regarded as relevant. The Raising the Bar Bill proposes the removal of these limitations.

Usefulness (utility)
To be patentable in Australia, an invention must also be useful. Under current law, an invention will not satisfy this requirement if it does not work, or if it fails to deliver on the promises made in the patent specification. The Raising the Bar Bill proposes an amendment that specifies that an invention is taken not to be useful unless a specific, substantial and credible use for the invention (so far as claimed) is disclosed in the complete specification.

Full description
At present, the Patents Act requires that a complete specification 'describe the invention fully, including the best method known to the applicant of performing the invention'. The full description requirement will be met if the description enables the skilled person to produce anything falling within the scope of each claim without exercise of inventive ingenuity or undue experimentation. The Raising the Bar Bill proposes to amend the Patents Act in a manner that is intended to require the specification to enable the skilled person to produce inventions across the full scope of each claim.

Fair basis
Australian patent law currently requires that each claim be 'fairly based' on the matter disclosed in the specification. This requirement is satisfied if the scope of the claims is consistent with 'what the body of the specification read as a whole discloses as the invention'. The Raising the Bar Bill proposes replacing the fair basis requirement with a 'support' requirement, which is intended, in addition to requiring that there be appropriate 'basis' in the body of the specification for each claim, that the scope of the claim not exceed that which is justified by the extent of the disclosure and the technical contribution to the art that the inventor has made.

The Raising the Bar Bill was passed by the Senate on 27 February 2012 and is likely to be enacted later this year.

Implementing the Doha Declaration on compulsory licensing

At present, the Patents Act grants the Federal Court of Australia the power to grant a compulsory licence to work a patented invention in limited circumstances.

In March 2011, the Federal Government announced its intention to implement measures consistent with the Doha Declaration on a Protocol under the Agreement on Trade-Related Intellectual Property (TRIPS). Pursuant to those measures, the Federal Court of Australia will be able to grant compulsory licenses for the manufacture and export of generic copies of patented medicines to the world's least developed countries that are facing specific and prolonged health emergencies.

The Intellectual Property Laws Amendment (TRIPS Protocol Implementation) Bill implementing these measures is expected to be introduced in the 2012 autumn sitting of Federal Parliament.

Patenting biological materials

At present, the Patents Act bans the patenting of human beings and the biological processes for their generation. The Patent Amendment (Human Genes and Biological Materials) Bill initially proposed to broaden this ban to exclude the patenting of "biological materials, including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to, such materials as they exist in nature". 'Biological material' was defined to include DNA, RNA, proteins, cells and fluids.

In September 2011, the Senate Committee (Committee) reviewing these proposed amendments recommended that the Senate not pass the Bill. A number of Senators dissented from the Committee's report and recommended that the Senate pass an amended version of the Bill that would seek to ban the patenting of "biological materials, whether isolated or not and however made, which are identical to such materials as they exist in nature". 'Identical' was defined to mean structurally and functionally identical.

The Patent Amendment (Human Genes and Biological Materials) Bill is due to come back before Federal Parliament later this year.

We will continue to monitor the progress of, and report on, these, and any other, Bills that may potentially alter the patent law landscape for life science companies in a significant way.

© DLA Piper

This publication is intended as a general overview and discussion of the subjects dealt with. It is not intended to be, and should not used as, a substitute for taking legal advice in any specific situation. DLA Piper Australia will accept no responsibility for any actions taken or not taken on the basis of this publication.

DLA Piper Australia is part of DLA Piper, a global law firm, operating through various separate and distinct legal entities. For further information, please refer to

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.