Mal Washer (Moore, Liberal Party) Share this | Hansard source

I wish to thank the member for Fremantle for moving this motion on gene patents and to let her know that Senator Bill Heffernan is very passionate and agrees with you, and so do I. Systems for protecting commercial rights stretch back for centuries, with patents being recorded in Britain under the Statute of Monopolies of 1623. In Australia an invention may be patented under the Patents Act 1990, if the invention is a manner of manufacture, is novel, involves an inventive step and is useful. Inventions which are patented give the patent holder an exclusive right to sell their invention for a standard term of 20 years. A mere discovery or bare principle is not a manner of manufacture.

In Australia the Patent Office manual refers to the distinction between discovery and invention. A chemical substance which is discovered in nature without any practical application is a ‘mere chemical curiosity’ and not patentable. However, if the isolated gene has some practicable application it is potentially patentable. IP Australia has also indicated that ‘the building blocks of living matter, such as DNA and genes which have for the first time been identified and copied from their natural source and then manufactured synthetically as unique materials with a definite industrial use’ are not discoveries and are therefore patentable. In June 2004 the Australian Law Reform Commission stated that a new approach to the patentability of genetic materials was not warranted. One of the reasons provided was that it would represent a departure from accepted international practice and may adversely affect investment in the Australian biotechnology industry.

Currently in the EU, isolated genetic sequences are patentable following the Biotechnology Directive in 1998; and in the US the Patent and Trademark Office has issued patents on genes and other DNA sequences covering up to 40 per cent of the human genome. But there are real concerns over the correctness of this policy. Apart from US President Clinton and Prime Minister Blair issuing a joint statement some 10 years ago saying that the human genome should be made freely available to scientists everywhere, recent decisions of both UK and US courts have cast a shadow over the legality of this policy.

In October 2004 the Judicial Committee of the House of Lords, sitting as the final court of appeal in the UK, invalidated the patent claims over a synthetically made human protein because the protein was identical in its genetic structure and function to the protein as it existed naturally in the human body. According to their lordships the protein was not ‘new’.

In March this year the US Federal Court ruled that seven US patents on the BRCA1 and BRCA2 human genes and the genetic mutations to those genes, which are causative of breast and ovarian cancers, are invalid. These patents have allowed Myriad to secure a near monopoly on diagnostic tests for BRCA gene mutations in the US. It is interesting to note that one of Myriad’s patents on BRCA1 was found to be so broad that it covered genetic sequences found in 80 per cent of all human genes. What is important to note is what the judge said: because the claimed isolated DNA is not markedly different from the native DNA as it exists in nature, it constitutes unpatentable subject matter under US patent law.

Applied properly, patents protect investors’ rights to be rewarded for their hard work and investment, whilst enabling others to improve on their innovations. Without patents there would be little incentive for researchers to invest their time, money and effort. Pharmaceutical and medical device manufacturers can legitimately argue that the patent system is crucial for stimulating research and development which leads to new products to improve medical care.

The problem with gene patents is that there are legitimate arguments that, rather than promoting biomedical innovation, they actually inhibit it. The process of determining which relevant patents are important to a research project, and the negotiations for access to them, can delay or even kill innovation. Unfortunately, IP Australia has told the Senate Standing Committee on Community Affairs, which has been conducting an inquiry into the impact of gene patents for nearly two years, that, unless directed by an Australian court to do otherwise, it will continue to grant patents over naturally occurring biological materials. And although the Federal Court of Australia has finally been given an opportunity to review this policy—thanks to Cancer Voices Australia and Mrs Yvonne D’Arcy, a woman suffering from breast cancer—Myriad has responded by surrendering its patents over BRCA1 gene mutations. This move, if it is successful, will bring that opportunity to a premature end. So it is now a matter of critical importance that this parliament consider this motion and take this subject seriously.

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