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 www.dlapiper.com

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
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”

Practice Guides
by Mondaq Advice Centres
Relevancy Powered by MondaqAI
Canada
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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

Mondaq.com (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 www.mondaq.com

To Use Mondaq.com 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.

Disclaimer

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.

General

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