In Washington DC, Dr James Watson is arguing for his great discovery, the double helix structure of DNA, to be freed from its restrictive bonds. Not the sugar and phosphate bonds that form the backbone of our genetic code but from bonds of different, but equally intricate, kind: patent monopolies.
In Sydney, Yvonne D’arcy, a woman with breast cancer, has her day in court. Five days in fact, signifying the importance of her case. D’arcy, along with Cancer Voices Australia, is challenging not only a particular patent monopoly but the decades-old practice of Australia’s patent office, IP Australia, to award patent monopolies over isolated human genes.
Connecting these two cases is the right of individuals to access their genetic information and the democratic diffusion of knowledge about what makes us… us.
On 26 June 2000, US president Bill Clinton and UK prime minister Tony Blair announced that the Human Genome Project had completed its first draft map of the human genome. Clinton also said that because the genome had been published it could never be patented.
Despite Clinton’s assertion, possibly 20 per cent of the human genome is under a patent today. One patent (Australian Patent 686,004), held by Myriad Genetics Inc., restricts access to the BRCA1 and BRCA2 genes. Women with mutations in either the BRCA1 or BRCA2 genes have a 60 per cent chance of developing breast cancer during their lives, five times the rate of women in the general population. Mutations in BRCA1 or BRCA2 also increase the lifetime risk of developing ovarian cancer, from 1.4 per cent to 15-40 per cent.
Because it has enforced its monopoly "rights" in the United States, Myriad is able to charge between $300-$3000 ($3000 gets you a comprehensive result) for its test and faces no competition, because it can stop new tests coming onto the market. In Australia, Genetic Technology Ltd (GTL) — the exclusive licensee of Myriad’s BRCA patents — in 2003 and 2008 sent "cease-and-desist" letters to Westmead Hospital and the Peter MacCallum Cancer Institute in Victoria, telling them to stop testing for the BRCA1 and 2 genes.
Public outcry led to GTL withdrawing its threats but Myriad continues to enforce its monopoly rights in the US. And GTL could, legally, commence action against any Australia hospital or clinic that tests for these mutations.
No alternative tests means higher costs for treatments and tests. It also means, in the case of the BRCA patents, that women are denied the chance for a second opinion before making potentially life-changing decisions, such as having both breasts removed to reduce their risk of developing breast cancer (so-called "prophylactic mastectomies"). In the words of the Royal College of Pathologists of Australasia these patents "restrict a doctor’s freedom to make a diagnosis" — in other words, they chill both research and speech.
More fundamentally, these patents privatise our genetic information (DNA, RNA and proteins), information the members of the United Nation’s Education, Scientific and Cultural Organisation (UNESCO) unanimously declared was the "heritage of humanity". Gene patents constitute an unethical monetisation of our very essence and it is a practice our patent agency, IP Australia, has engaged in for more than two decades. It is a practice our Parliament must address and reconsider.
Gene patents undermine international treaties that promote the right to health and the Universal Declaration on the Human Genome and Human Rights which, unambiguously, states: "The human genome in its natural state shall not give rise to financial gains."
While pharmaceutical companies claim they need investment certainty, this should not come at the expense of equitable access to healthcare. Indeed, it is often forgotten that patents are a social contract between inventors and the State with benefits to ultimately flow to the community. The UK Statute of Monopolies (passed in 1624), from where we get our definition of "invention", originally held that patents should not be granted if they were "contrary to the law … mischievous to the state by raising prices of commodities at home, or hurt of trade, or [be]generally inconvenient."
Gene patents show all these inconveniences, raising the price of healthcare and undermining ethical norms that hold the human genome as something worthy of special protection. Of course, inventions that build upon the naturally occurring genetic information, such as new vaccines, medicines and diagnostic tests, should remain patentable — provided they offer something "new".
However, Civil liberties groups in Australia and in the US oppose patents over naturally occurring genetic information, because patents have a chilling effect on "speech" (which includes the freedom for researchers to research, and for doctors to diagnose and treat a patient).
Patents also restrict the rights of individuals to access their own genetic information and they involve the privatisation and monetization of genetic information that was never "invented" but rather discovered and published by public laboratories.
While James Watson and Yvonne D’Arcy fight their personal battles in court, the Australian Parliament and various governments have been struggling to resolve the gene patents issue. A series of inquiries and private members bills have failed to resolve the uneasiness felt by parliamentarians and the public over the patenting of genes. Government appointed commissions, while not recommending changes to the Patents Act, have conceded that arguments against gene patenting were "attractive".
While we wait to see if the US Federal Court of Appeals (and/or Supreme Court) or Australia’s Federal Court throw out Myriad’s gene patents, Federal Labor MP Melissa Parke is proposing another Bill to reform the Patents Act 1990. Time will tell if this Bill can address the concerns of many that our genes are hostage to the "whims" of patent holders.
DNA is scientifically and culturally unique from other chemical compounds. It has a special place in our lives and its commercialisation raises challenging ethical questions. But one thing is clear: you are not aspirin or any simple compound, and you shouldn’t be patented as such.
Disclosure: Civil Liberties Australia is supporting Melissa Parke’s new Bill.
Timeline: Banning Gene Patents in Australia
- 2003: Genetic Technology Ltd (GTL) attempts to enforce BRCA gene patents. Relents in face of public pressure.
- 2004: Australian Law Reform Commission (ALRC) report (Genes and Ingenuity) recommends against the introduction of a specific patent exemption for genetic material or technologies, although the ALRC concedes that arguments in favour of a ban are "attractive".
- 2008: GTL attempts again to enforce patent. Backs away again and agrees to "gift" its BRCA patents to the Australian Community.
- 2010: Senate Community Affairs Reference Committee inquiry into Gene Patents. Divided Committee does not support a ban but rejects IP Australia’s justification for patenting genetic information.
- 2010: Several claims in Myriad’s BRCA patents held "invalid" in US by District Court — appeal is ongoing. In June, Cancer Voices Australia and Yvonne D’Arcy file an action in the Federal Court to challenge Myriad’s Australian patents.
- 2010: Senator Bill Heffernan introduces a Bill to ban the patenting of genetic and biological materials, supported by the Greens, Family First and the independents; and in the lower house by Liberals, Nationals and cross-benchers.
- 2011: A Senate Committee rejects Heffernan’s Bill after fierce lobbying by the pharmaceutical industry. Department of Health and Ageing presented evidence at inquiry, supporting the "intention" of the Bill.
- 2011: US Federal Circuit Court of Appeals overturns District Court’s decision an reinstates Myriad’s US Patents. Appeal lodged to Supreme Court.
- 2012: US Supreme Court reaffirms 9-0 in a different case that natural phenomena and products of nature are not patentable. The Court orders the US Court of Appeal to review its decision in the Myriad appeal in light of this decision.
- 2012: ABC Lateline story about another move to ban gene patents, this time led by Labor MP Melissa Parke, with support from Bill Heffernan.
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