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ALRC : A question of patents

Every Issue

The ALRC is considering whether gene patents should be treated differently under Australian patent law from other inventions.

The Australian Law Reform Commission (ALRC) has released an issues paper (IP 27) in the first stage of its inquiry into gene patenting and its impact on healthcare and the biotechnology industry in Australia. At the heart of the inquiry is a tension between the use of patents to encourage research and development in Australia’s growing biotechnology sector, and the potential for some patents – if overly broad or inappropriate – to increase the cost of healthcare and hinder research and development.

IP 27 identifies a number of areas in which there may be scope for reform, and invites public comment. Although not all potential reforms would require legislation, possible changes to the Patents Act 1990 (Cth) are central to the inquiry. IP 27 discusses new defences to claims of infringement of gene patents, such as where patents are used for research, private non-commercial purposes or medical treatment.

One key issue is whether gene patents should be treated differently under the Patents Act to inventions involving other types of technology. The Patents Act expressly excludes certain categories of subject matter from patentability (such as human beings and the biological processes for their generation) and grants the Commissioner of Patents the discretion to refuse a patent application for other types of inventions.

For an invention to be granted a patent in Australia, it must satisfy the requirements for a “patentable invention” in s18 of the Patents Act. Section 18 provides that a patentable invention is one which:

  • is a manner of manufacture within the meaning of s6 of the Statute of Monopolies 1623 (UK);
  • is novel when compared to the prior art;
  • involves an inventive (or innovative) step when compared to the prior art;
  • is useful; and
  • has not been secretly used in Australia before the priority date by or with the authority of the patent holder.

It has been suggested that isolated genetic materials are “discoveries” rather than “inventions”, and thus not an appropriate subject matter for patent protection. A “discovery” does not constitute a “manner of manufacture” under Australian patent law. Most jurisdictions draw a distinction between naturally occurring genetic material, which is not patentable, and isolated genetic sequences, which may be.

However, some critics have questioned reliance on this distinction.

Others suggest that the existence of genetic materials in nature is enough to characterise isolated genetic materials as insufficiently novel for the purposes of patent law. However, this proposition is contrary to the approach currently adopted under Australian law and under the patent laws and practices of many other jurisdictions.

It is argued that in some circumstances there is no inventive step involved in isolating genetic material because technological advances in DNA sequencing mean that this has become a routine and industrialised process. The European Patent Office regards the isolation of genetic sequences that have a structure closely related to existing sequences for which the function is known as being insufficient to satisfy the requirement of “inventive step”. In the US, the requirement of inventive step (or “non-obviousness” under US law) has been applied to inventions involving genetic sequences in a different manner. US courts have held that the existence of a general method of isolating genetic sequences is irrelevant.

It is not yet clear whether Australian law in this area will favour the US or the European approach. The issue has only arisen for consideration by the Patent Office in opposition proceedings. The ALRC understands, however, that the inventive step requirement has not presented a significant obstacle to the patenting of genetic materials and technologies in Australia to date.

There has been considerable international debate about whether various isolated genetic materials fulfil the legislative requirement that an invention be “useful”. Australian patent examiners are not required to consider the usefulness of an invention in assessing a patent application and the Commissioner of Patents does not need to be satisfied that an invention is useful before accepting a patent application. In some other jurisdictions the requirement that an invention be useful is more stringent and is highly relevant in the examination of a patent application.

Any change to Australian patent law to address issues that may be raised by the grant of gene patents would require consideration of a number of matters. The requirements for patentability set out in the Patents Act are technology-neutral. If provisions were introduced to apply specifically to inventions involving genetic materials and technologies, the impact of such an approach on the current statutory framework would need to be assessed. Further, the basis for introducing specific requirements in relation to the patentability of genetic materials and technologies, but not other types of inventions, would need to be justified. Finally, consideration must be given to Australia’s obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The TRIPS Agreement provides that patent protection will be afforded to any inventions regardless of the type of technology.

Copies of IP 27 are available free from the ALRC in hardcopy or CD-ROM or from its website The closing date for submissions is 30 September 2003. Details on how to make submissions are included in IP 27.

A discussion paper containing draft proposals for reform will be published early next year. The ALRC is due to complete its final report and recommendations by 30 June 2004.

Contributed by the AUSTRALIAN LAW REFORM COMMISSION, GPO Box 3708, Sydney 2001, tel (02) 8236 6333; fax (02) 8238 6363; website


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