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Tuesday, 3 December 2002
Page: 7031

Senator PATTERSON (Minister for Health and Ageing) (5:37 PM) —I would like to refer to the act that covers intellectual property, which has an express exclusion concerning the patenting of human beings. Section 18(2) of the Patents Act prohibits the patenting of `human beings and the biological processes for their generation'. In their submission to the House of Representatives Standing Committee on Legal and Constitutional Affairs inquiry into the scientific, ethical and regulatory aspects of human cloning, IP Australia stated:

Consistent with the provisions of subsection 18(2) of the Act, IP Australia will not grant patents for the following:

· human beings, foetuses, embryos or fertilised ova; or

· wholly biological processes that begin with fertilisation and end with birth of a human being.

The practice of IP Australia is to grant patents on applications in respect of inventions involving human genes, tissues and cell lines, and non-human clones and cloning procedures, providing such inventions meet the statutory patentability requirements such as novelty, inventive merit, industrial application and adequate disclosure of the invention in the patent specification. (A human cell line is different from naturally occurring cells in the human body. It is capable of continuous propagation in an artificial environment by continual division of the cells, unlike naturally occurring cells which die after a limited number of divisions.)

A mere discovery of a gene implicated in a condition such as multiple sclerosis would not be granted a patent, unless that gene had been isolated and purified, and a full description of an actual use of that gene was included.

It is the understanding of IP Australia that its practice in granting patents for inventions involving human genes, cell lines and tissue is consistent with the provisions of subsection 18(2) of the Act. This is premised on a widely accepted view that human genes, cell lines and tissues are not regarded as human beings, as distinct from foetuses and embryos which are regarded as human beings and hence are not patentable.

However, while the applicability or otherwise of section 18(2) is reasonably straightforward, there is a grey area and the potential for ambiguity, and I believe that this is one of the reasons why we need this review. If you are going to stop research going ahead you should actually also stop research on adult stem cells, as I have argued. If you do not believe that there is an argument that the patent issue should be addressed before anything goes any further then I think the argument holds for adult stem cells. I do not believe that that is necessary and I will not be supporting the amendment.