Australia: Will the Gene Patent debate force changes to the Australian Patent system?

Last Updated: 15 September 2011
Article by Grant Shoebridge and Jacinta Flattery-O'Brien

Introduction

We previously reported that the Australian biotechnology/pharmaceutical patent landscape was in a state a flux. At that time, we were awaiting the recommendations of a Senate Inquiry into the patenting of genes and biological materials. Since then, the recommendations of that Inquiry have been made public. In addition, there have been a number of other significant developments that we believe will inevitably result in significant changes to the patent system in Australia.

Below we discuss the following:

  • The Senate Committee on Community Affairs Inquiry into Gene Patents, November 2010;
  • The Advisory Council on Intellectual Property (ACIP) Report on Patentable Subject Matter, February 2011;
  • The Senate Inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010; and
  • The Intellectual Property Laws Amendment (Raising the Bar) Bill 2011.

Senate Committee on Community Affairs Inquiry into Gene Patents

It is now 12 months since we summarised the issues involved in the Senate Committee on Community Affairs Inquiry into the patentability of genes and other biological material in this journal. On 26 November 2010, the Committee's report was finally released.

The report makes 16 recommendations directed to improving patent quality and the operation of the patent system. Most significantly, the report makes no recommendation that the Patents Act 1990 be amended to expressly prohibit the patenting of genes/biological materials. A copy of the report can be viewed at: http://www.aph.gov.au/senate/committee/clac_ctte/gene_patents_43/report/index.htm.

Interestingly, many of the recommendations appear to go beyond the terms of reference of the Inquiry because they relate to all technology areas. Briefly, the recommendations include increasing the threshold requirements for patentability and increasing the support requirements for claims - presumably in an effort to bring Australia's patentability standard into line with Europe and the United States. Recommendations were also made in relation to reinforcing mechanisms and policies by which the Australian Government can, and should, intervene with the rights of patent holders in relation to compulsory licences. Many of the recommendations were made in view of concerns raised that costs associated with the current patent system outweighed its economic and social benefits.

Specifically, the report recommends expanding the prior art base to be considered when assessing whether a claimed invention meets the "inventive step" requirement for patentability. Currently, the inventive step test requires that the disclosure of the prior art directly lead the person skilled in the art to the invention with a reasonable expectation of success (emphasis added). The proposed amendment to this test is whether it is "obvious for the skilled person to try a suggested approach, alternative or method with a reasonable expectation of success" (emphasis added). This proposal appears to introduce some degree of routine experimentation in order to arrive at the claimed invention.

In response to concerns that very broad patent claims were being accepted, the Committee recommended more stringent requirements for "support" for claims by introducing a requirement that a patent claim be enabled across its entire scope and that the description in the patent specification provide sufficient information to allow the skilled addressee to perform the invention without undue experimentation. This seems to mirror the support requirements in the United States and Europe.

One of the terms of reference for the Inquiry was to consider the impact of gene patents on progress in medical research. Although no direct evidence was produced showing that gene patents were inhibiting research, the Committee made a recommendation that a broad research exemption be codified in the Patents Act. The proposed research exemption would apply to acts done for experimental purposes relating to the subject matter of the invention that do not conflict with the normal exploitation of a patent - for example, how an invention works, determining validity and seeking an improvement.

It was clear that not all of the Senators involved with the Inquiry fully supported the recommendation not to exclude genes and biological materials from the Patents Act because two days before the Committee's report was made public, a private member's Bill in support of a broad-reaching amendment to the Patents Act 1990 to prohibit patenting of genes and biological materials was introduced into the Senate by Senator Bill Heffernan, a staunch supporter of banning gene patents. The Bill proposed to amend the Patents Act 1990 by expressly excluding from patentability "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" (emphasis added).

The Committee also made a recommendation that a Senate inquiry into the amendment Bill be undertaken (Senate Inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010).

Senate Inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010

Over 200 hundred submissions were received by this second Senate inquiry, the majority of which criticised the proposed amendment on the basis that the terms "components" "derivatives", and "substantially identical" as used in the amendment lack clarity and would introduce a great deal of ambiguity into what would be considered patentable subject matter. For example, it is not clear as to how much a protein would have to differ from naturally-occurring material to fall outside the scope of the term "substantially identical" and/or "derivative". In response to this criticism, the proponents of gene patent reform altered the proposed amendment to read "biological materials whether isolated or purified or not and however made which are identical to such materials as they exist in nature" (emphasis added); where biological materials", is defined as including DNA, RNA, proteins, cells and fluids including their components; and "identical" means a biological material which is structurally and functionally identical and where any structural change or difference is immaterial to its function. We believe that despite this attempt to make the proposed amendment more palatable, if implemented it would nonetheless introduce substantial ambiguity into the Australian biotechnology patent landscape as well as threaten to exclude from patentability inventions that, on the face of it, seem eminently suited to patentability eg. genetically-altered microbial enzymes for use in cleaning.

Originally, the Committee was due to report its recommendations in June 2011. However, since that time the Committee has been granted two extensions of time in which to report. Some commentators have suggested that the extensions are necessary because the Committee is unable to reach consensus on any recommendations. This appears to be a likely scenario, as it is well known that a number of the Senators involved are uncompromisingly in support of gene patent reform while others do not support the proposed amendment. The new deadline for reporting is 21 September 2011 and the recommendations are eagerly awaited.

Information in relation to the Senate Inquiry, including access to submissions made, can be obtained at the following link: http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/index.htm.

ACIP Report on Patentable Subject Matter issued 16 February 2011

Following the 2004 Australian Law Reform Commission (ALRC) report on gene patenting and human health in which it was reported that the key concept of patentable subject matter in Australia was ambiguous and obscure, the Minister for Innovation, Industry, Science and Research asked the Advisory Council on Intellectual Property (ACIP) to conduct a review into the appropriateness and adequacy of the manner of manufacture test. The terms of reference for the review asked the ACIP to inquire, report and make recommendations to the Australian Government on patentable subject matter.

The Report of the ACIP was released on 16 February 2011 and included a number of key recommendations including:

  1. codification of the established principles of patentability by amendment of the Patents Act 1990 to include a statement of the law currently applied by the Courts - namely, that a patentable invention must be an "artificially created state of affairs" in the field of economic endeavour;
  2. maintenance of the current exclusion from patentability of human beings and biological processes for their generation;
  3. amendment of the Patents Act 1990 to include a general exclusion from patentability of inventions whose commercial exploitation would be wholly offensive to the Australian public; and
  4. inclusion in the Patents Act 1990 of a statement of objectives outlining the purpose of the Act so that any test for patentable subject matter must support the objectives of the patent system.

The release of the ACIP Report followed the Report of the Senate Community Affairs Committee Inquiry into the impact of patenting of human genes and biological materials. Significantly, it is noteworthy that the ACIP Report specifically states: "we do not recommend the introduction [into the legislation] of a specific exclusion to prevent the patenting of human genes and genetic products".

The text of the ACIP Report may be viewed at: http://www.acip.gov.au/library/ACIP%20PSM%20final%20report%204%20Feb%202011.pdf.

Intellectual Property Laws Amendment (Raising the Bar) Bill 2011

In June 2011, Senator Kim Carr, the Minister for Innovation, Industry, Science and Research introduced into the Senate the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011. This has added to the momentum of the push towards change in the Australian patent system – which now seems almost inevitable. This Bill contains no specific recommendations in relation to patentable subject matter, such as proposals to exclude biological inventions. However, like the ACIP report, the Bill includes a number of proposed amendments which aim at increasing the quality of granted patents. Accordingly, biological inventions which are currently eligible for protection may not meet the higher threshold for patentability if the proposed amendments are implemented.

The scope of the proposed reforms is extensive. However, it is relevant to note that there is considerable overlap between the reforms of this Bill with the recommendations of the ACIP report. Most notably, the reforms include proposed amendments directed at increasing the inventive step threshold and increasing the description and support requirements in a patent specification.

The intent of increasing the description and support requirements is to reduce the likelihood that the patentee is granted a monopoly extending beyond the information disclosed in the patent specification. Under the proposed reforms, it will also be necessary for patent attorneys to ensure that all of the claims are fully enabled across their scope.

There is also a proposed amendment requiring that provisional applications "disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by the person skilled in the relevant art".

Some commentators have suggested that if these reforms are introduced, there will be a heavy burden placed on Australian patent attorneys because the amount of time, and therefore the cost, involved in the preparation of specifications will be increased. However, we believe that as the reforms are directed to bringing the Australian patent system into line with Europe and the US, jurisdictions with which Australian patent attorneys are familiar, any necessary changes in drafting practice will not be overly onerous.

A copy of the Bill may be view at: http://parlinfo.aph.gov.au/parlInfo/download/legislation/bills/s837_first/toc_pdf/1111920.pdf;fileType=application%2Fpdf.

Summary

It has been over three years since the gene patent debate was initiated in Australia as a result of a Melbourne-based company, Genetics Technologies, deciding to charge licensing fees to conduct tests for determining susceptibility to breast cancer based on mutations in genes BRCA-1 and BRCA-2. Three years on, it seems that the debate is far from being resolved. Nevertheless, it appears that change to the Australian patent system is inevitable and that these changes will most likely impact all patentable technology areas.

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 Mondaq.com.

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

Authors
Grant Shoebridge
Jacinta Flattery-O'Brien
Similar Articles
Relevancy Powered by MondaqAI
DLA Piper Australia
 
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
 
Similar Articles
Relevancy Powered by MondaqAI
DLA Piper Australia
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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

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