Are human genes patentable? If so why? If they can be patented, what effect is this likely to have on the availability of, to those who need them, genetic tests for conditions such as breast cancer? If genes cannot be patented, what effect is this likely to have on the biomedicine industry? A recent article in the New York Review of Books sets out the issues - with respect to a forthcoming case in the United States - with admirable clarity.[1]
But first to things closer to home.
Australia’s Federal Court recently dismissed a challenge – from Cancer Voices Australia - to patents held by Myriad Genetics Inc over isolated DNA or RNA sequences. This was the first time an Australian court had considered the matter. The court held in favour of Myriad Genetic’s claim to hold a patent relating to the BRCA1 gene, the presence of which gene predisposes a woman to breast cancer and ovarian cancer.[2] The patent grants Myriad Genetics the right to exclude others from using this gene in medical research or health care.
In the next few months, the US Supreme Court will hear a similar case, this time involving Myriad Genetics Inc’s patents over two cancer-predisposing genes: BRCA1 and BRCA2.[3] In 2009, a lawsuit was filed in the Federal District Court of New York State to overturn the patents Myriad had on BRCA1 and BRCA2, patents which entitled Myriad to exclude others from using these genes in breast cancer research, diagnostics and treatment for the life of the patent (now twenty years).
The plaintiffs were not the usual parties in patent suits: competitors. They included the American Civil Liberties Union and the Public Patent Foundation as well as medical geneticists, pathologists, researchers, genetic counsellors, advocates for women’s health and several woman with breast cancer: all were opposed to Myriad’s patents allowing it to exercise monopolistic control over a biological substance as essential to medical research and health care as the DNA implicated in cancer.[4]
Interestingly, in American law, opponents of a public policy cannot ordinarily pursue their objections n the Federal Courts unless the policy causes an injury that gives them ‘standing’ to sue. The plaintiffs argued that they had suffered harms from Myriad’s enforcement of its BRCA patents: because of the ‘gravity’ of the issue for health and for science the judge granted them standing.
The matters in the forthcoming American case were first raised in 1990 when a geneticist at Berkeley announced that her laboratory had discovered that BRCA1 was located somewhere on chromosome number 17. In 1994 (after a race amongst several geneticists) its exact location was found, and in 1995 the exact location of BRCA2 was found (on chromosome 13). Myriad promptly applied for patents on both the isolated RNA that makes up the BRCA1 and BRCA2 genes and also on a set of diagnostic tests to detect their presence. The social utility of patents Three kinds of arguments are used to justify patents: natural rights arguments, distributive justice arguments and consequentialist arguments. Natural rights arguments go back to John Locke who held that persons have a right to property insofar as they have mixed their labour with it so long as they have appropriated natural things without exhausting them or taken more than their share. Distributive rights arguments hold that patents reward the initiative of inventors: without that reward, others would be able to compete unfairly. Consequentialist arguments relies on the idea that patents encourage innovation and the disclosure of knowledge.[5]
At the time of the American Revolution these ideas were much debated: Thomas Jefferson opposed the monopolies inherent in copyrights and patents, but James Madison persuaded him of their value as incentives to authors and inventors... so long as they were temporary. Thus the US Constitution contains what is now called the ‘progress clause’ which authorizes Congress to ‘promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries’.[6]
A statute of 1793 said that patents could be obtained for ‘any new and useful art’, and in 1953 the word ‘art’ was replaced with ‘process’. Jefferson’s language thus emphasized the requirement of newness or novelty, the necessity of an inventive step. It also implied that products of nature, which were held to be owned by everyone, were not to be removed from common possession. Why have patents been granted to genetic tests? It therefore may seem surprising that, since the 1980s, the US Patent and Trademark Office has issued patents on DNA: not however on DNA in the body but on different versions of DNA isolated from the body (‘complementary DNA’ or ‘cDNA’). These patents have been justified on the basis of two long-standing legal doctrines: the first, that products of nature can become eligible for patents if they have ‘markedly different characteristics from any found in nature’[7], the second, that having been extracted, purified and thus made useful, the [product of nature] became for every practical purpose a new thing commercially and therapeutically’.[8]
The idea is that, when cDNA is made by scientists outside the body, it differs markedly from DNA inside the body: it becomes a new composition of matter.
Against this it is argued that patents should never have been granted (either for the DNA or the tests on it). All that is involved in these genetic tests, it is said, is the comparison of the DNA taken from the patient with a version of the gene that it is known will dispose the person to cancer: this does not require a particular process, only the act of looking to see if one DNA sequence matches another! Some implications of patents on genetic tests Critics have criticized Myriad with charging prices for genetic tests that put them beyond the reach of some women, of preventing patients from obtaining a second diagnostic opinion from an independent laboratory, of causing the researchers who scrutinize a woman’s DNA to violate the ethical norms of medical practice because they are prohibited from telling the woman what they have found, of hampering research because women at risk of breast cancer are disinclined to participate if the results have to be kept from them.
Myriad has rejected these criticisms, declared that the company freely allows academic research on both genes and pointing out that more than eight thousand papers about the genes have been published around the world.[9]
In the recent Australian decision, the judge said: ‘The real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists. It is an especially difficult problem in the present case, not so much because the authorities provide no clear solution to it, but because the problem has an almost metaphysical dimension to it.’ [10]
The Australian decision may well be tested on appeal. It will most certainly be cited in the forthcoming case in the US Supreme Court. Postscript As a matter of justice, health care – in particular basic health needed by everyone - ought to be available according to need, and not on the basis of capacity to pay. Christians, and other people of good will, should be able to recognize the truth of that claim: Jesus’ attitude to sickness and disability was a world away from a conception of health care which portraits it as a consumer good and conceives of sick people as ‘consumers’ and doctors as ‘providers’. And his healing was available to all.
There is much that can be done to mitigate injustices in access to health, by biotech companies, by politicians, and (best) by collaboration between the two. At some cost to their shareholders, a biotech company could set licensing conditions which make the techniques more rather than less accessible to all whose health could benefit. At some cost to the community, politicians could prioritize the subsidizing of these tests in the design of health care budgets.
These matters raise complex ethical and social issues. But the ethical starting point is clear: that health care should be available on the basis of sheer need, that access to needed tests and treatments ought not to be limited by the operations of the market. Bernadette Tobin is director of the Plunkett Centre for Ethics, a joint centre of St Vincents & Mater Sydney and Australia Catholic University, in Sydney. This article has been reproduced with permission from Bioethics Outlook.  Notes