Gene Patenting

In 2014 the Australian Federal Court upheld a 2013 decision (which had gone to appeal) to allow gene patenting.^{Footnote 5} The court found that biotechnology companies can hold patents in Australia on isolated biological material—in this instance, fragments of DNA that are defined as BRCA1 gene mutations (BRCA1 and BRCA2 gene mutations predispose women with a familial history to developing breast and ovarian cancer).

This was the final outcome of a suit brought by Genetic Technologies (which holds the Australian patent/franchise for the U.S. company Myriad Genetics) to enforce its rights in relation to the BRCA genes in Australia. The Senate Community Affairs Inquiry into Gene Patents in 2008 was prompted by Genetic Technologies’ initial threat to ban hospitals from using the BRCA tests.

In 2010, a private member’s bill—the Patent Amendment (Human Genes and Biological Materials) Bill 2010—was introduced into the Senate to prevent the patenting of human genes and biological materials existing in nature. The Senate Inquiry into Gene Patenting reported in 2010 and made 16 recommendations, none of which specifically aimed to ban gene patenting.

Further legal discussion involved the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, which advocated free access to patented inventions for regulatory approvals and research, before the 2013 verdict that Myriad Genetics may continue to hold its BRCA1 patent.^{Footnote 6} The case brought against Myriad by Yvonne D’Arcy—which concerned whether patents for gene sequences should be excluded from patentability—also found in favor of Myriad.^{Footnote 7}

There are several strands to the gene patenting debate familiar to those who have observed U.S. and European legislation. Several commentators have focused on the influence of big pharma—that is, when legislation appears to benefit corporation profits rather than public health. Lever, for example, has focused on the issues of “owning,” arguing that we “need to know what rights, values, powers and liberties justify these particular patents, or those legal, scientific, economic, and political practices that have made the patenting of human genes seem natural, justified, and inevitable”—and that we do not yet have the answers to such questions.^{Footnote 8}

Thus one question addresses whether patent law is sufficient to deal with the ethical issues raised by gene patenting; another asks whether or not patenting encourages innovative research and thus greater public benefit. The law firm Jones Day, which acted for Myriad in Australia, has adopted that approach, arguing that patents drive innovation: “Myriad invested hundreds of millions of dollars in research and development, patient and physician education, insurance reimbursement and operational excellence in laboratory operations which has resulted in a gold standard test, BRAC Analysis, for the testing of predisposition to hereditary breast and ovarian cancer risk at an affordable cost.”^{Footnote 9}

IP Australia, which has been granting patents for the last two decades, agreed with this argument. A further issue, however, is whether taking DNA—a public biological substance—and developing a test counts as invention, or whether it is simply creating a method. Here Australian legislation has taken the opposite approach to the northern hemisphere. When on September 5, 2014, it was determined that Myriad’s isolation of the human genes linked to breast and ovarian cancer was an invention under Australian patent law, this was the exact opposite of “the virtually identical case against Myriad in the US, where the US Supreme Court found in a unanimous nine-zero decision last year that human genes, whether isolated or not, are products of nature and as such are not patentable subject matter.”^{Footnote 10} The U.S. Supreme Court’s unanimous judgements in both the Myriad case and a prior case (Mayo and Prometheus) supported the decision by the U.S. government to overturn three decades of U.S. patent policy. This decision means that genetic materials isolated from the human body should never have been patented. Merely isolating biological materials (for the purposes of developing a test) is not enough for eligibility for a patent monopoly under U.S. patent law.

Whereas the Australian ruling appeared to argue that patenting inspires innovation, the U.S. judgment suggested that patenting would impede the flow of information that might spur invention. Americans are now free to use DNA to develop new products, while Australians are not. Which is the more desirable policy outcome?

The Australian Law Reform Commission (ALRC) noted that the Patents Act does not contain an explicit mechanism to allow patent examiners to take into account social and ethical considerations in assessing the patentability of a particular invention. The ALRC’s Genes and Ingenuity Inquiry—which reported in 2009 and undertook a comprehensive survey and analysis of IP law, policy, and practice in the area of genetic material and technologies—argued that the monopoly exploitation rights granted by a patent extend (with some limited exceptions) for only 20 years, meaning that the problems caused by patents granted on gene sequences are transient ones.^{Footnote 11}

Increases in the cost of BRCA testing attributable to patent rights have not occurred, because Genetic Technologies, despite an initial threat to do so, has not sought to enforce its patent rights against public sector laboratories. The company is able to offer BRCA testing conducted in its Melbourne laboratory for a lower price than that charged by Myriad in the United States, and it anticipates that investment in new robotic technology will further reduce future costs.^{Footnote 12}

This argument seems rather narrow. Given the pace of technological advancement in the field of genetics, it is insufficient to evaluate legal developments against what is currently possible.^{Footnote 13}

Assisted Suicide

A second interesting issue has been that of dying with dignity. This has become a media-central issue in Australia, partly in reaction to global changes such as the Belgian case of a prisoner who requested euthanasia and the same country’s landmark ruling on assisted death for minors. Global focus on this issue—such as Bishop Tutu’s full-page article in the U.K. newspaper the Observer on July, 13, 2014, in which he called the prolongation of the life of Nelson Mandela a “disgrace,” or the August debate by Canadian Medical Association members voting in support of physicians following their consciences when deciding to provide medical aid in dying—has been widespread, which has kept the topic in the headlines.

In Australia in 2014 the debate gathered momentum when voluntary euthanasia campaigner Dr. Rodney Syme, vice president of the proeuthanasia lobby Dying with Dignity, publicly confessed to having assisted the suicide of an “existentially suffering” patient in 2005.^{Footnote 14} Yet a brief overview of the Australasian Association of Bioethics and Health law Conference (October 2–4 at the University of Western Australia), arranged generally around the topic of “how we should decide” ethical issues, shows little focus on end-of-life issues, with only two papers on advance-care planning.^{Footnote 15}

The terminology used in the dying-with-dignity debate is useful here: “assisted death” is a model that includes both what has been called physician-assisted suicide and voluntary active euthanasia—the former involves the patient using lethal means provided by the physician; the latter, voluntary euthanasia, entails the physician taking an active role in carrying out the patient’s request.^{Footnote 16}

At the International Conference on End of Life: Law, Ethics, Policy and Practice (ICEL 2014), hosted by the Queensland University of Technology Australian Centre for Health Law Research on August 13–15, 2014, Professor Peter Singer, probably Australia’s best-known international bioethicist, waded into the debate again (Singer has long been notorious, according to some, for his advocacy of euthanasia). Singer’s utilitarianism suggests acting to maximize the satisfaction of the interests of the person affected, rather than relying on social mores, which in his view can be mistaken.^{Footnote 17} The socially prevalent idea that the life of human beings in the biological sense has intrinsic worth seems to him to ignore the issue of what life really is; life in its quality, its humanness, is determined by notions of consciousness, pleasure, pain, and so forth. Singer advocates voluntary euthanasia, definable as assisting a person’s rational and repeated wish to die (as opposed to nonvoluntary and involuntary euthanasia, which he sees as more complex). This is much the same as assisted suicide.

Singer is more famous and less notorious than Dr. Philip Nitschke, who is currently under investigation by Australian police for his role in suicides over the last 20 years. Dr. Nitschke, founder and director of the proeuthanasia group Exit International, faces expulsion by the Australian Medical Association in November 2014, after a move to suspend him the previous month failed after an error in the paperwork (he was suspended by the Medical Board of Australia in July 2014).^{Footnote 18} The November hearing, before a five-member panel, is shaping up to be a test case on the idea of rational suicide, whereby a person does not have to be severely depressed to make the decision to kill him- or herself. In response to the Belgian case of prisoner Frank van den Bleeken, who was granted the right to assisted death in Belgium, Nitschke has called for the same option to be granted to Australian life-term prisoners.^{Footnote 19}

The Australian Approach to Euthanasia, 1973–2014

Australia’s approach to the assisted suicide debate has vacillated between open and closed policies. The first voluntary euthanasia societies in Australia were formed in two of the six states that make up Australia’s federation (New South Wales and Victoria) in 1973.^{Footnote 20} Euthanasia was legalized in Australia’s Northern Territory (another of the six states) via the Rights of the Terminally Ill Act 1995. However, a repeal bill was brought before the Northern Territory Parliament a year later; although the bill was defeated, the law was voided by an amendment on the part of the Commonwealth to the Northern Territory (Self-Government) Act of 1978—the so-called Andrews Bill, named after Kevin Andrews, MP. Before the Commonwealth government made this amendment, three people had already died through physician-assisted suicide under the legislation, aided by Dr. Nitschke.

Several further attempts at a voluntary euthanasia bill then followed, in 1997, 2002, 2007, 2008, 2009, and 2012. Advance health directives are now accepted in some states, but there is some variation in the approach toward such directives.^{Footnote 21}

The Dying with Dignity Bill 2009 (Tasmania), defeated by the Tasmanian Parliament, gave an indication of how legislators tend toward the slippery-slope argument in legislating for assisted suicide. The criminal justice system often deals leniently with “mercy killing,” or assisted suicide, cases.^{Footnote 22} For example, in 2005 a Tasmanian nurse was convicted of assisting in the death of her elderly father, who had terminal cancer, and of trying to kill her mother, who was in the early stages of dementia. She was sentenced to two and a half years in jail, but the conviction was later suspended.^{Footnote 23}

Peter Singer, who has supported Nitschke publicly, has stated that he believes the legislation of voluntary euthanasia or assisted suicide is inevitable in Australia: “I think it will come as the population ages. . . . I think we’ll get voting pressure for it.”^{Footnote 24} Yet the recent call to investigate any assisted suicide in which Dr. Nitschke has been involved over the last 20 years suggests that such cases may be looked at more severely.^{Footnote 25}

In another of the Australian states, the Australian Capital Territory, a dying with dignity bill drafted by the Australian Green Party is currently under examination. The system described in the bill includes several important safeguards: that is, a patient who wishes to have the option of hastening his or her death requires the acquiescence of two independent doctors who agree on the patient’s prognosis and a psychiatrist who can attest that the person is not suffering from treatable clinical depression.^{Footnote 26}

The Senate inquiry into the bill received more than 663 submissions, with 57% opposed and 43% in support of the bill, which has now been referred to a senate committee that will report to parliament at the end of October, 2014. This may be another of Australia’s failed attempts to legalize euthanasia.

The final word in 2014, until the Nitschke and dignity issues are resolved, might as well go to Peter Short, a 57-year-old former executive with Wesfarmers/Coles, who was diagnosed with terminal esophageal cancer in January. He then wrote to every chairman, board member, and CEO of Australia’s top 300 public companies, urging them to promote discussion of euthanasia:

In Australia, as globally, the debate is not going away.