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Monday, 21 May 2012
Page: 4977

Ms PARKE (Fremantle) (21:10): I wish to speak tonight about a matter that has grieved me for three years, ever since I became aware that companies were taking out patents over human genes and of the consequences of this in restricting science and health research, as well as the cost not only in human lives and quality of life but also in the massive expense to the taxpayer through additional imposts on the health system, including the PBS. This issue is essentially about who gets to own and control genetic information.

At the moment, corporations can patent human genes and have monopoly control over those genes to the exclusion of all others. This is wrong on a number of levels. Firstly, it is wrong because genetic information belongs to all of us. It should not be the subject of private property. Genes contain information fundamental to humanity and this information should be freely available to all. Secondly, it is wrong as a matter of legal principle. It is a bedrock principle of patent law, indeed it is the basis for the entire patent system, that there must be an invention. Clearly, no-one invented our genes, not even the defective cancer-causing ones. Genes are natural phenomena: they are products of nature, not of any corporation, and as such they should not be patentable. Thirdly, it is wrong as a matter of public policy to grant monopoly control over fundamental genetic information that has the effect of stymieing research and innovation and preventing health researchers and clinicians from having access to genes in order to diagnose disease and develop health treatments.

We are only at the beginning of what we know about human genes. Scientists are finding that diseases are often caused by multiple genes acting in concert. If these genes are owned by different companies, how will a researcher ever be able to freely carry out the research that is necessary to discover new cures and treatments? Genes are going to play an even greater role in diagnostic treatments and personalised medicine—for example, developing medicines that react with a certain genetic profile. The more patents we grant over the genes, the more complex we are making the landscape for researchers and those that want to produce new diagnostic treatments and medicines. Indeed, the evidence is to the effect that gene patents are having a chilling effect on research and testing as scientists and clinicians fear being sued by large corporations with deep pockets for infringement of patents.

It is helpful to look at some examples of how this has occurred in the Australian context. The US corporation Myriad holds the patents over the breast and ovarian cancer susceptibility genes. The Australian licence holder is Genetic Technologies. In 2008 Genetic Technologies ordered all Australian public laboratories to stop testing for breast cancer, claiming it had the sole right to do so under the patent. In 2010 the Peter MacCallum Cancer Centre gave evidence to a Senate committee inquiry that its research into breast and ovarian cancer had been delayed two years and ended up costing three times as much because Myriad and Genetic Technologies refused it permission to use the breast and ovarian cancer genes in its research. Myriad's patents are currently under challenge in the US and here in the Federal Court of Australia by breast cancer patient Yvonne D'Arcy and Cancer Voices Australia. They are only able to do this because the law firm Maurice Blackburn as well as David Catterns QC and Professor Peter Cashman have taken this on as a pro bono case. It is shameful that cancer patients have been forced into this action because of the facilitation of gene patents by IP Australia and inaction by successive governments.

It is not only cancer research and treatment being impacted by these patents. Chiron Corporation held the patent over the hepatitis C virus and aggressively defended this patent through legal action, thereby preventing the development of better alternative tests for hepatitis C for 10 years, despite its own test being largely ineffective. Professor Baruch Blumberg of the Fox Chase Cancer Centre in Pennsylvania was awarded the Nobel Prize in medicine and physiology in 1976 for his work on the hepatitis B virus. During the course of patent litigation between Chiron Corporation and Murex Diagnostics Australia Pty Ltd, Professor Blumberg gave the following testimony:

I have reviewed Chiron Australia's Australian patent No. 624105 for the purposes of these proceedings.

…    …   …

Based on the unusually broad nature of the patent, if I were a research director for anti-virals and had the option of working on several viruses, the existence of this patent would weigh against my deciding to undertake HCV research. A company, or even an academic laboratory, might well be deterred from conducting research on HCV because the patent is, in effect, intimidating. With the patent as it stands, any investigator, particularly in commercial laboratories (where much of the work on hepatitis has been done) would have to seriously consider that Chiron would bring an action against them if they attempted any commercialization of anything related to HCV.

There is also the matter of doctors at Westmead Hospital sending children's samples to Scotland for epilepsy testing rather than pay the exorbitant fees demanded by Genetic Technologies. What makes this even more preposterous is the fact that much of the work that went into identifying the epilepsy gene was done at publicly funded research institutions in Adelaide, and the diagnostic test for epilepsy was developed with the help of a $1 million AusIndustry grant from the Australian taxpayer.

The fact is that knowledge about human genes should belong to everyone. That is why, when the human genome was decoded 12 years ago, US President Clinton and UK Prime Minister Blair issued a joint statement which said:

… raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere. Unencumbered access to this information will promote discoveries that will reduce the burden of disease, improve health around the world, and enhance the quality of life for all humankind.

This has been recognised in an extremely significant legal case in the United States. The US Supreme Court, in the case of Prometheus v Mayo Clinic, made a unanimous 9-0 decision two months ago affirming the long-held legal principle that natural phenomena are not patentable. They noted that Einstein could not have patented E=MC2 and nor could Newton have patented gravity. The Prometheus case was not about a patent on genes but about a patent on the measurement of naturally occurring metabolite levels in the blood, but the legal issue was the same: can you patent natural phenomena? The court's definitive and emphatic response to that question was no.

The Supreme Court has now ordered the US federal court to look again at the validity of Myriad's patents over the breast and ovarian cancer genes, in the light of its decision in Prometheus. The US Supreme Court's judgment supports the recent decision by the US government to overturn decades of US patent policy. The US government policy is now that genes isolated from the human body are not patentable, in the same way that coal extracted from the earth and cotton extracted from cotton seeds are also not patentable. In the course of its judgment in Prometheus, the Supreme Court made the important point that 'monopolisation of natural phenomena through the grant of a patent might tend to impede innovation more than it would tend to promote it', and this is the key reason why we must challenge the claim by the biotechnology industry that a ban on gene patents would mean the end of investment in genetic research.

As Nobel laureates for economics and medicine Professors Joseph Stiglitz and John Sulston have written in the Wall Street Journal, in an article entitled 'The Case Against Gene Patents':

Proponents of gene patents argue that private companies will not engage in genetic research unless they have the economic incentives created by the patent system. We believe that a deeper understanding of the economics and science of innovation leads to exactly the opposite conclusion.

Patents such as those in this case not only prevent the use of knowledge in ways that would most benefit society, they may even impede scientific progress. Every scientific advance is built on those that came before it. There is still a great deal to learn about our genes, particularly how they contribute to disease. Gene patents inhibit access to the most basic information.

I want to make it clear that there is no objection to corporations getting patents over genuine inventions like treatments, vaccines and medicines that use genetic materials in them. The objection is to the patenting of the genes themselves, as these are the building blocks of the human body. The fact is that it is immoral, and contrary to both legal principle and good public policy, to continue to allow the creeping privatisation of the human body through gene patents, and there is, in my view, an urgent need for the Patents Act to be amended to address the issue of patentable subject matter, which was not dealt with in the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 that recently went through this parliament. When I spoke on that bill, I looked at the research exemption that is raised by industry as the answer to the problems created by gene patents. The research exemption is a step in the right direction, but, as Professor Ian Olver, CEO of the Cancer Council of Australia, has noted, the research exemption is simply too narrow to be of any practical use to researchers and it is of no use to clinicians at all.

I come back to the basic point: that no-one should be getting a patent over something that they did not invent in the first place. As the Cancer Council of Australia noted in its submission to the Senate inquiry into gene patents:

… excluding genes from patentable subject matter would be the most efficient way to ensure medical research and resultant public health outcomes are not compromised by the current anachronistic patent arrangements.

I know that there are many parliamentarians inside the Labor caucus and across the political spectrum who would like to see reform in this area, and I will be continuing to work within the government, the caucus and the parliament to see this wrong righted. When you have the Cancer Council of Australia, the National Breast Cancer Foundation, the Royal Australian College of Pathologists, the Royal Australasian College of Surgeons, the Clinical Oncological Society and the Human Genetic Society, among many others, all saying there is something seriously wrong here, we should listen to that. We as lawmakers have a duty to listen to that and to do something.