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Monday, 18 October 2010
Page: 524

Ms PARKE (8:37 PM) —I move:

That this House:

(1)   notes that:

(a)   on 6 September 2010 the ABC’s Four Corners program screened a story entitled ‘Body Corporate’, highlighting growing community and scientific concern regarding gene patents;

(b)   in particular, Four Corners discussed the case of five year old Liam who needed to have a genetic test to see if he had gene mutations to the SCN1A human gene linked to a specific form of epilepsy called Dravet Syndrome;

(c)   Bionomics, a South Australian company which had received a specific grant of around $1,000,000 from AusIndustry to develop a SCN1A gene test:

(i)   took out an Australian patent over the SCN1A human gene; and

(ii)   subsequently exclusively licensed the patent to Genetic Technologies, a Melbourne company that charges $2,000 for the SCN1A gene test in Australia;

(d)   Liam was being treated at the Westmead Hospital—a publicly funded institution that is part of NSW Health—which could not afford to pay Genetic Technologies $2,000 for each SCN1A gene test;

(e)   Liam’s doctors sent a sample of his DNA to be tested in Scotland where the charge was just one third of the price charged by Genetic Technologies; and

(f)   the option to send the DNA sample overseas for testing not only took more time, leaving the young boy and his family waiting in distress, but highlights how Australian taxpayers providing research funds to:

(i)   Australian universities to identify the SCN1A genetic mutations; and

(ii)   an Australian company to develop a genetic test have been deprived of the benefits of that very research;

(2)   notes that:

(a)   in July 2008, Genetic Technologies, as the exclusive licensee of Myriad Genetics, a United States company granted Australian patents over the BRCA 1 and 2 gene mutations linked to breast and ovarian cancers, demanded via a lawyer’s letter sent to all Australian hospitals and clinical laboratories (including the Peter MacCallum Cancer Centre) that they stop all testing for breast cancer, claiming such testing infringed Myriad Genetics’ Australian BRCA patents;

(b)   in 2009 in the United States, eleven plaintiffs, including Lisbeth Ceriani, a 43 year old single mother diagnosed with breast cancer, and professional medical and clinical associations such as the American Society for Clinical Pathology, launched a legal challenge to seven of Myriad Genetics’ United States BRCA patents, where: and

(i)   Ms Ceriani found that she was unable to get a second opinion on a positive genetic test for ovarian cancer because in the United States there is only one test, owned by only one company, Myriad Genetics, which charges over US$3,000 per test;

(ii)   in March 2010 a United States Federal Court agreed with the plaintiffs and declared all seven United States patents invalid on the ground that under United States patent law, patents can only be granted over inventions, not for the discovery of natural phenomena; and

(iii)   the Court so held because, first, despite being removed from the human body and thus ‘isolated’, the BRCA genes were ‘not markedly different from native DNA as it exists in nature’ and second, the analysis of these two human genes by way of a genetic test was ‘merely data gathering to obtain clinical data’;

(3)   notes that:

(a)   at the official commemoration of the decoding of the human genome in March 2000, United States President Bill Clinton and British Prime Minister Tony Blair said that ‘raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere’, yet by 2005, according to a survey published in Science, more than 20 per cent (probably now much higher) of the human genome was the subject of Untied States intellectual property;

(b)   President Clinton and Prime Minister Blair also said that ‘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 of all humankind.’;

(c)   unencumbered access to genetic information cannot be achieved when patents over human genes are being used to suppress competition, innovation, research and testing;

(d)   Professor Ian Frazer, the inventor of the cervical cancer vaccine, has joined other cancer researchers in calling for a revision of Australian patent law, stating that researchers need to be able to proceed with their work without having to consult the companies whose patents the work might infringe: ‘restricting the research use of a gene sequence could delay the development and testing of truly inventive and practical uses of the gene and its protein product for diagnosis and therapy.’; and

(e)   other groups opposed to the granting of gene patents include the Cancer Council Australia, the Breast Cancer Foundation of Australia, the Royal Australian College of Pathologists, the Human Genetics Society of Australia and the Australian Medical Association; and

(4)   calls for amendment of the Patents Act 1990 to ensure that patents cannot be granted over any biological materials which are identical or substantially identical to what exists in nature.

The DEPUTY SPEAKER (Ms S Bird)—Is the motion seconded?

Ms Saffin —I second the motion and reserve my right to speak.

Ms PARKE —I will try to set out at the outset what is involved in this issue. First, it is a fundamental principle of patent law that there must be an invention; however, it is clear that human genes are not inventions but naturally occurring phenomena. Second, in my opinion it is wrong from the point of view of public policy to allow genetic and biological material to be privately owned and controlled and for that control to be wielded in the interests of profit-making rather than in the interests of the public good. Lastly, when the companies that would be affected by the proposal to ban gene patents stir into the predictable frenzy of lobbying and public relations warfare to protect their interests, as is starting to happen right now, let us remember that their one argument—that is, that gene patents provide an incentive for companies to fund medical research—is both exaggerated and based on a false premise. The vast majority of research is publicly funded. Some of the 20th century’s greatest medical breakthroughs were not made in pursuit of a patent—penicillin and the polio vaccine, to mention just two. It is likely that banning gene patents will actually accelerate innovative competition in the biotechnology sector because the raw materials for new diagnostics treatments and medicines will be freely available and unencumbered.

I acknowledge the presence in the gallery tonight of Dr Luigi Palombi, who has dedicated much of his professional life and his passion to this issue. Since lodging my notice of motion about this issue a couple of weeks ago, I have been inundated with emails from around the country sent by people who cannot believe that we would permit genetic material to be controlled by patent. One of those emails was from a doctor at Westmead Hospital who each year cares for over 500 new families with a genetic history of breast and other cancers. On 30 September, Cancer Council Australia and the Clinical Oncological Society of Australia issued a press release welcoming my notice of motion. As I noted on 22 June 2009 in my last parliamentary speech on this issue, in 2008 a Melbourne company, Genetic Technologies, ordered Australian hospitals and clinical laboratories to stop testing for breast cancer, claiming it had the exclusive right to control access to the relevant gene under the licence it had obtained from US company Myriad Genetics.

In the US, public attention was drawn to the issue last year when two women, Genae Girard and Lisbeth Ciriani, who had sought second opinions on positive genetic tests for ovarian cancer, could not get those opinions because there is only one test, owned by only one company, Myriad Genetics. Ms Girard and Ms Ciriani, together with other patients and medical associations, participated in a legal challenge to Myriad’s US patents over the breast and ovarian cancer genes. In a landmark decision, the US Federal Court in New York held earlier this year that the patents were improperly granted to Myriad and were invalid under US patent law. In a subsequent article entitled The case against gene patents written for the Wall Street Journal in April by Nobel Prize winners Professor Joseph Stiglitz and Professor John Sulston, it was noted:

The court held that genes and human genetic sequences are naturally occurring things, not inventions. They are a part of all of our bodies and contain the most fundamental information about humanity—information that should be available to everyone. The researchers and private companies that applied for these gene patents did not invent the genes; they only identified what was already there.

Myriad is appealing the decision and it may take years for the matter to be definitively resolved in the US courts. In the meantime, Myriad has jacked up the price for its genetic test for ovarian and breast cancer from US$3,000 to $US4,000 per test. Americans cannot typically recover this cost under health insurance. A test case was launched by Cancer Voices Australia against Myriad’s Australian breast cancer gene patents in the Australian Federal Court earlier this year. Significantly, rather than having the principle determined by an Australian court, Myriad has chosen to surrender the entire patent in an attempt to avoid this happening.

There is no objection to corporations that have invested in research to develop a new diagnostic test or vaccine or medicine being granted patents. However, there is a very large objection to corporations being granted patents over the underlying biological materials—that is, genes and proteins—because, although the biological materials have not been invented, by having the patent on them corporations prevent others from carrying out clinical tests or undertaking research using those biological materials. In the Wall Street Journal article I referred to earlier, Professors Stiglitz and Sulston wrote:

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 … 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.

This motion calls for an amendment to Australia’s patent law to impose a ban on patents over biological materials such as human genes. Genetics technology companies argue that such a change will mean the end of medical research—the end of discovery. In fact, the exact opposite will happen. By liberating these naturally occurring materials from patents, the process of discovery and invention will be improved significantly. Everyone knows that human genes are not inventions but products of nature. They belong to everyone. This is why, when the human genome was decoded 10 years ago, US President Clinton and British Prime Minister Blair issued a joint statement which said that to ‘realise the full promise of this research, raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere’. Why did they say that? Because they believed that:

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.

How are scientists supposed to make new discoveries and inventions to cure cancer if they have to seek permission and pay thousands if not millions of dollars to companies like Myriad who own patents over human genes? Publicly funded R&D is crucial, and these kinds of patents cause unnecessary delay and make research much more costly. During the Senate’s inquiry into gene patents, Australian scientists at the Peter MacCallum Cancer Centre told of how their research into breast and ovarian cancer was delayed by two years and ended up costing three times as much as it otherwise might have because Genetic Technologies refused to grant permission to use the patented genes.

Let us remember that nearly all of the primary research which has led to the discovery of human genes which are linked to cancers and diseases has been publicly funded by taxpayers or by philanthropic organisations. Is it right that Myriad should own patents over the BRCA 1 gene mutations which cause breast and ovarian cancers, when it was Professor Mary-Claire King, a publicly funded researcher at the University of California who, after spending 16 years looking for the BRCA 1 gene, found it on human chromosome 17q? That Myriad’s scientists were able to see a little further and sequence the BRCA 1 gene is only because they stood, borrowing the words of Sir Isaac Newton, on the shoulders of Professor King, a true scientific giant.

Is it right that Australian taxpayers, who have provided research funds to universities to identify the epilepsy gene and have provided a $l million AusIndustry grant to the Bionomics company to develop a genetic test for epilepsy, have now been deprived of the benefits of that funding and research to the point where doctors at Westmead Hospital are sending children’s DNA samples to Scotland rather than pay the fees and royalties demanded by Genetic Technologies? We now know that we are merely at the beginning of a long and complex story about how genes work. To grant patents to those that make the initial link will impede the necessary work which must be done in order to turn science fiction into science fact.

As Professor Bowtell from the Peter MacCallum Cancer Centre said to the Senate inquiry:

We are coming into an era where lots of genes are actually being identified that work in concert to actually cause an outcome, like the risk of developing breast cancer, diabetes, stroke … If the patents for each of those genes are held by different companies then it is going to be extremely difficult to assemble a practical test to test for a particular condition.

Finally, a bedrock principle of the patent system which has stood for more than 500 years is that there must be an invention. Without an invention there is no reward. The proposed ban on gene patents will not prevent Myriad and other companies from seeking patents for new and inventive diagnostics, treatments, medicines and cures which make use of human genes. After all, that is what the patent system is about, rewarding those who invent such things. But the gene itself is not something that anyone has invented.

Professor Ian Frazer, inventor of the cervical cancer vaccine, President of Cancer Council Australia and former Australian of the Year, has said:

… there is no more invention in isolating and characterising biological materials that exist in our bodies … than in collecting and arranging a set of postage stamps.

Further, he said that ‘if we allow patenting of genes we’re allowing patenting of ourselves’. These are some of the reasons the Cancer Council of Australia, the National Breast Cancer Foundation, the Royal College of Pathologists of Australasia, the Royal Australasian College of Surgeons, the Clinical Oncological Society, the Human Genetics Society and many ordinary Australians are calling for an amendment to the Patents Act to ban gene patents.