Discussion Paper 68: Gene Patenting and Human Health

by Caroline Ryan

AAR Senior Associate Caroline Ryan provides an overview of Discussion Paper 68: Gene Patenting and Human Health, released by the Australian Law Reform Commission as part of the current Inquiry into the impact of patenting genetic materials and related technologies on research and healthcare.

Background
Gene patenting laws in Australia
Significant proposals
The next step

Background

As reported previously in Biotech News, the origins of Discussion Paper 68 date back to 17 December 2002, when Attorney General Daryl Williams framed the Terms of Reference for a major new Inquiry by the Australian Law Reform Commission (the ALRC).

The purpose of the Inquiry is to comprehensively review and critically analyse the impact of Australia's current patent laws and practice as applied to genetic material, research and technology, on healthcare, while considering the implications of any proposed changes for Australia's biotechnology industry and the health care sector.

Under the Terms of Reference, the ALRC is to ensure widespread public consultation and identify and consult with key stakeholders, including relevant government agencies, the research community, the health and medical sector, the biotechnology sector and industry bodies. To the extent that the ALRC determines changes are warranted to the current patent law framework, the ALRC is required to recommend proposals for reform.

On 4 March 2004, the ALRC released Discussion Paper 68: Gene Patenting and Human Health , outlining 49 proposals for reform . This edition, we provide an overview of some of the key proposals outlined in Discussion Paper 68, and preview the next stage of the Inquiry.

Gene patenting laws in Australia

Section 18 of Australia's Patents Act 1990 (Cth) (the Patents Act) provides that an invention is a patentable invention if the invention is a manner of manufacture within the meaning of Section 6 of the Statute of Monopolies, is novel and involves an inventive (or, in the case of an innovation patent, involves an innovative) step when compared to the prior art, is useful, and has not been secretly used in Australia before the priority date.

The Patents Act expressly excludes certain subject matter from patentability, including human beings, and the biological processes for their generation.

In practice, Australia's patent system (as with most other jurisdictions) makes a distinction between the patentability of isolated genetic material, and genetic material in its natural state. A gene (or gene fragment) in its natural state is not patentable per se. A gene (or gene fragment) that has been extracted from an organism, isolated and purified may be patentable, subject to complying with the normal requirements for patentability as set out in Section 18 of the Patents Act.

The Inquiry has canvassed and identified a broad range of public concerns or perceptions surrounding the current practices of patenting genetic materials and technologies, including the following:

  • current patent legislation fails to account for the ethical considerations surrounding this particular subject matter;

  • genetic material should not be patentable subject matter as it represents discoveries and not inventions. Further, the level of inventiveness required to isolate and purify such genetic material is insufficient to justify the grant of a patent;

  • patents over genetic material are often too broad, and are too easily granted in Australia; and

  • restrictive licensing practices create obstacles to accessing genetic research and development, and drive up the associated costs for research and development stakeholders, to the detriment of research into public health.
Despite the general perception that there is a climate of apprehension surrounding the patenting of genetic material, Discussion Paper 68 states that the Patents Act should not be amended to exclude genetic materials or technologies from patentability. Further, Discussion Paper 68 identifies that there is limited evidence that patents and the associated licences have had any significant adverse impact on the conduct of research, or on the provision of healthcare in Australia to date.

Discussion Paper 68 also outlines that any proposals for legislative reform must be considered in the context of Australia's international obligations under multilateral agreements relating to intellectual property (such as TRIPS), and under bilateral free trade agreements with other states.

In this context, the ALRC has indicated that it will adopt a cautious approach in recommending changes to Australia's patent law and practice.

Significant proposals

Discussion Paper 68 proposes means by which Australia's patent law and practice could be 'finetuned' in relation to the patenting of genetic materials and technology, and the subsequent exploitation of such patents. Discussion Paper 68 contains 49 proposals and has raised 19 questions for consideration and comment.

Key proposals include:

  • IP Australia should assess patent applications relating to genetic materials and technologies according to the same legislative criteria for patentability that apply to patent applications relating to any other type of technology;

  • the responsible Minister requesting the Advisory Council on Intellectual Property review the appropriateness and adequacy of the manner of manufacture test as the threshold requirement for patentable subject matter;

  • the Patents Act should not be amended to specifically exclude genetic materials or technologies, methods of diagnostic, therapeutic or surgical treatment from patentable subject matter;

  • amending the Patents Act to include a usefulness requirement in the assessment of an application for a standard patent and in the certification of innovation patents. In addition to being a ground for revocation, lack of usefulness should also be a basis upon which the grant of a standard patent can be opposed;

  • amending the Patents Act to allow IP Australia to establish panels of experts to assist Examiners in assessing complex subject matter, and revising IP Australia's examination guidelines to assist Examiner's in applying the criteria for patentability to inventions involving genetic material and technology;

  • reviewing the Australian Research Council and the National Health and Medical Research Council's current principles and guidelines to ensure that publicly funded research results in appropriate public benefit.Conditions such as requiring that research be placed in the public domain, or that patented inventions be widely licensed, should be attached where appropriate to grants of funding for genetic research;

  • amending the Patents Act to introduce a new defence to infringement based on the use of the invention for study or experiment on the subject matter;

  • establishing special offices at both Commonwealth and State Health Department levels to monitor and manage intellectual property issues relating to genetic materials and technologies, including intervening where particular gene patent applications, granted patents or patent licensing practices are considered to have an adverse impact to research or the provision of healthcare;

  • increasing the role of the ACCC in monitoring uncompetitive conduct. It is proposed that the ACCC should conduct informal price monitoring of patented medical genetic tests and other genetic inventions involved in the provision of healthcare services, in addition to liaising with the various Health Departments and other stakeholders to identify and review the conduct of organisations dealing with patented material and technology;

  • amending the Patents Act to clarify the provisions relating to Crown use or Crown acquisition. This includes provisions clarifying that an invention is exploited for the services of the Commonwealth or the State if exploitation is for the provision of healthcare services or products to the members of the public;

  • introducing the competition based test proposed by the Intellectual Property and Competition Review Committee as an additional ground for the grant of a compulsory licence; and

  • amending the Copyright Act 1968 (Cth) to clarify the extent to which fair dealing for the purpose of research or study applies to commercial genetic research.
Other significant proposals relate to education programs and the development of model agreements and guidelines for patent licences by AusBiotech Ltd, in consultation with Biotechnology Australia, State and Territory Governments and other relevant stakeholders.

The next step

The ALRC is currently canvassing comments from national and international experts in the fields of gene patenting and human health, in addition to calling for general submissions on any aspect of Discussion Paper 68. The closing date for submissions on Discussion Paper 68 is 16 April 2004.

The Inquiry's final report and recommendations is due to be delivered to the Attorney General by 30 June 2004, and will be available to the public once tabled in Federal Parliament.

AAR will continue to keep you up to date of the progress of this Inquiry, and the associated legal developments in this area.



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