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ALRC: Patently healthy

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Cite as: (2004) 78(1-2) LIJ, p. 86

The public will be consulted widely on a range of proposals concerning the management of intellectual property rights relating to genes and health care.

An Australian Law Reform Commission (ALRC) discussion paper on intellectual property rights over genes and genetic materials, due for release later this month, signals the start of an intensive round of public consultations.

The paper – Gene Patenting and Human Health (DP 68) – outlines possible amendments to the Patents Act 1990 (Cth) (the Act), along with a range of other proposals around the management of intellectual property rights related to genes and health care.

The ALRC has been asked to consider the impact of gene patents and licences particularly on health care, as well as on the biotechnology sector and on research and its application and commercialisation. The ALRC’s task is complex and calls for a careful balancing of potentially competing interests. Reforms that may be attractive to health providers might have an adverse impact on Australian biotechnology companies or be contrary to Australia’s obligations under the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement.

The release of DP 68 follows publication of an issues paper (IP 27) in July last year. While IP 27 defined the scope of the inquiry, DP 68 invites comment on specific proposals for reform.

Ethical issues

One of the threshold issues for the inquiry is the extent to which ethical concerns should be part of the patent process. In some jurisdictions patent laws explicitly require decision-makers to consider ethical and social issues as part of the patent granting process. For example, under Article 53(a) of the European Patent Convention “inventions, the publication or exploitation of which, would be contrary to ordre public or morality” are specifically excluded from patentability. Similar provisions also exist in the UK, New Zealand and Japan. However, to date these ethical exceptions have rarely been invoked with any degree of success.

In Australia, the Act allows some consideration of social and ethical concerns. Human beings and the biological processes for their generation are specifically excluded from patentability under the Act. Moreover, s50(1)(a) grants the Commissioner of Patents discretion to refuse to grant a patent for an invention the use of which would be contrary to law. It has also been suggested that the “manner of manufacture” requirement in s18 of the Act provides limited scope for ethical and social concerns to be considered.

The inquiry asked whether it would be appropriate to include within the legislation something equivalent to Article 53(a) of the European Patent Convention.

Submissions received to date have been mixed about the value of such a proposal. Some suggest that it will not address concerns about the desirability of patenting genetic inventions; rather, its concern is with the commercial exploitation of an invention. There are also arguments that patent law and the patent process are not suitable vehicles for addressing the ethical and moral concerns raised by patents and that asking patent examiners to address such complex concerns as part of the examination process would be well beyond their range of expertise. Some submissions have, however, countered this view with suggestions about the use of expert advisory panels to advise on ethical matters.

DP 68 proposes that the Act not be amended along the lines of the European Patent Convention.

The Patents Act

There are problems with treating patents over genes in any different way from any other technology. However, the ALRC is concerned that there is appropriate examination in each case and to that extent DP 68 raises some proposals directed towards Patent Office practice.

DP 68 also discusses possible reforms in relation to the Crown use or compulsory licensing provisions of the Act and canvasses, for further discussion, the possibility of a statutory licensing scheme.

Research and experimental use

Gene patents and licences are said by some to have an adverse impact on the conduct of genetic research. The Act does not expressly except experimental or research use of patented inventions from liability for infringement. However, an implied experimental use defence may exist in Australian law, as it does in other common law jurisdictions. The ALRC inquiry has asked whether there needs to be a statutory research or experimental use defence in Australia.

To date there has been considerable support in submissions for clarification of the research use defence in Australia and some support for a statutory exemption. However, a statutory exemption may not be as broad as some researchers assume. In particular, there is a real issue about the scope of such an exemption given the growing commercialisation of research by universities and other publicly-funded bodies and the growth in collaborative research between the public and private sectors.

One possible model, which is canvassed in DP 68, is that of the UK Patents Act which allows a defence based on private and non-commercial purposes; or to study the subject-matter of the patented invention, to investigate its properties, improve on it or create a new product or process.

DP 68 outlines the ALRC’s proposals for reform. Submissions on the proposals, or any matter relevant to the inquiry, are welcome.

DP 68 is free and will be available in hard copy or CD from the ALRC as soon as it is released. It will also be available on the ALRC’s website.


Contributed by the AUSTRALIAN LAW REFORM COMMISSION, GPO Box 3708, Sydney 2001, tel (02) 8238 6333; fax (02) 8238 6363; email patents@alrc.gov.au; website http://www.alrc.gov.au.

natlawreform@liv.asn.au

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