BILLS › Intellectual Property Laws Amendment Bill 2014
Mr PERRETT (Moreton) (20:04): I thank the member for Fremantle for her contribution. She has been a strong advocate in this area of law for a long time. I congratulate her on being elected seven years ago today, in fact; and I look forward to catching up with her later. The Intellectual Property Laws Amendment Bill 2014 is substantially similar to the Intellectual Property Laws Amendment Bill 2013 introduced by Labor last year. Labor supports the measures that are contained in the current bill before the House, although I do note the contribution of the member for Fremantle and some of the concerns she raised. However, it is what the government has excluded from this 2014 bill that is concerning. The bill that the government is seeking to have passed leaves out important protections that were contained in schedule 1 of the 2013 bill. Schedule 1 of the 2013 bill set out to clarify the Crown use of patents. It contained important protections for public access to patented innovations—in particular, it clarified the scope of Crown use in relation to health care. The healthcare system is Australia is complex, particularly in an ageing society. Funding is split between different levels of government, and the provision of services is split between public and private sectors. There are many funders, many healthcare providers and many challenges that come with the myriad service providers. Currently, Crown use only applies where the invention is exploited for the services of the Commonwealth or a state or territory. The amendment that the Labor government proposed in 2013 was to ensure that Crown use would include services where the Australian, state or territory governments have the primary responsibility for funding, regardless of the actual provider of the services. This was an amendment recommended by the Productivity Commission in its report entitled Compulsory Licensing of Patents released in March 2013. There was an example given in the text of the Labor government 2013 bill to illustrate the intended use, which states: The Commonwealth and the States primarily fund the provision of health services, including genetic tests covered by patents. Under this Chapter, a relevant authority can authorise a third party (an authorised person) to exploit such a patent. Any exploitation of the patent by the third party conducting the test on an individual is not an infringement under this Chapter. This is an important safeguard to the utilisation of advances in health care, and the public benefit is obvious. It is interesting that the example given relates to genetic testin I refer again to the contribution of the member for Fremantle. The full Federal Court has recently brought down a judgement in D'Arcy v Myriad Genetics Inc., a case referred to by the member for Fremantle, and that case confirmed that companies can patent gene sequences—that is, a corporation owns the intellectual property over naturally occurring phenomena. Many women will know that the BRCA1 gene is commonly called the 'breast cancer gene'. This gene was the subject of the proceedings in the Federal Court. It is worthwhile explaining the court proceedings in some detail. In 1995 an American company called Myriad Genetics Inc. filed a patent application with IP Australia. They claimed their 'invention' related to 'methods and materials used to isolate and detect a human breast and ovarian cancer predisposing gene'. They faced no opposition, and the patent was sealed in June, 1998. Myriad entered into a licence arrangement with Gene Technology Ltd in Australia to provide BRCA1 testing for Australian women. A very brave cancer survivor, Yvonne D'Arcy, together with a cancer support organisation, Cancer Voices Australia, commenced proceedings in the Federal Court of Australia to challenge the validity of Myriad's patent. At the same time similar proceedings were occurring in the United States challenging the patent that Myriad had already obtained there. On 5 September this year the full Federal Court in Australia handed down their decision. The joint judgement, in upholding the lower court decision to allow the patent, said: In Australia, there is no statutory or jurisprudential limitation of patentability to exclude 'products of nature'. To the contrary, the High Court has specifically rejected such an approach. The court judgement made it very clear that if for 'policy or moral or social reasons', patents for gene sequences should be excluded from patentability, then that is a matter for parliament to decide. In contrast, the proceedings in the United States, another common law jurisdiction, ruled that the patent there was invalid. The danger of such patents being allowed is that the owners of the patent are in complete control of access to the naturally occurring gene sequence. Delays in research and inflated costs for people requiring the testing may follow. This is the very situation that Schedule 1 of Labor's 2013 bill was intended to correct. Women who have this gene have an 87 per cent risk of breast cancer and a 44 per cent risk of ovarian cancer. When the die are loaded like this, parliamentary intervention is a delicate balancing act. Detection of the gene will allow women carrying it to monitor their health or take preventative measures, such as the actor and UN advocate Angelina Jolie chose to do. In light of the recent decision of the full Federal Court and without Schedule 1 of the 2013 bill, Australian women have no guarantee that there will be ready access to this lifesaving testing. The Cancer Council, commenting on Schedule 1 in the Labor bill of 2013, said: New safeguards announced by the Federal Government will help to protect consumers from commercial monopolies over vital services such as genetic testing for cancer risk. In the same media release Cancer Council Australia CEO Professor Ian Olver said that he welcomed a bill that would clarify the application of Crown use provisions. He gave an example: Back in 2008, the commercial licensee for patents on the BRCA1 and BRCA2 breast and ovarian cancer genes sought to enforce its patent claims over the state and territory laboratories that were providing those tests as a public service. While the company eventually withdrew its claim, there was uncertainty at the time over Crown use provisions or any other legal mechanism that might have been able to protect Australian women from a potential monopoly over the genes and the tests. It is chilling that an attempt has already been made to limit the availability of this lifesaving testing to Australian women. I understand that private research must be funded via product sales, but this strategy is drifting into very dangerous territory. The Cancer Council is not a lone voice in raising concerns about the patenting of genes. Specialist cancer support services, such as the Peter MacCallum Centre, have said their research into BRCA1 and BRCA2 diagnostics has been delayed by more than two years and the cost has increased by 300 per cent because of patents over the BRCA1 and BRCA2 genes. How many lives were lost because of that delay? Nobel laureate Professor Sir John Sulston, the director of the UK's Human Genome Project, has said that patents on human genes would restrict access to treatments and inhibit research. In 2009 Professor Ian Frazer, the inventor of the cervical cancer vaccine, wrote an article in The Australian. He argued that: … if we allow patenting of genes we're allowing patenting of ourselves. He said then that 'it is crucial we address this issue now'. Mary-Claire King, the geneticist responsible for isolating the BRCA1 gene, says she is delighted by the US Supreme Court ruling that makes it illegal to patent it. Nevertheless, the schedule missing in this coalition legislation screams a missed opportunity. It is clear that the government is not listening to the Cancer Council, the specialist cancer support services or the scientists who develop this lifesaving technology. Who is the government listening to? Sadly, the government is once again putting the profits of big business ahead of the health of everyday, ordinary Australians. As a lawyer, I am particularly concerned that these vital protections have not been included in the current bill, especially with the current state of patent laws in Australia. As a husband, father, son and brother, I am deeply concerned that Australians, and especially Australian women, will be unable to access lifesaving testing procedures necessary to make crucial decisions about their health. As I said at the start, Labor does support the current bill and the measures that it does contain are important ones—actually proposed by Labor in 2013. Proposing an amendment now to address the Crown use concerns would delay the balance of the bill and the value it delivers to Australian people. While I am deeply concerned by the government's neglect, I am hopeful that the Senate will address this issue and save this government from its own incompetence yet again—and ain't that a full-time job for the current Australian Senate in the 44th Parliament.