The case against the patenting of genes
Dr. David King
Over the last 15 years patents on genes and living organisms have become a major political issue. The subject is so controversial that it took the EU 10 years to pass legislation on the subject, which included the European Parliament rejecting the directive on biotechnology patents in 1995, something almost unprecedented in the history of the EU. Around the world, indigenous peoples groups have reacted with outrage to the patenting of their genes and cell lines, and many environmental, farmer and consumer organisations have mounted sustained campaigns against patents. The idea of patenting genes and organisms is still not accepted by the majority of the world's governments.
This article does not attempt to discuss all the issues raised by patenting of genes and is mainly concerned with human genes. When I have discussed these issues with people from industry, I have often noted a sense of bafflement on their part about the vehemence of the opposition. It seems that many industry executives and scientists misunderstand the reasons behind the objections. For example, the statement that patents are nothing more than a legal mechanism to prevent third parties from stealing inventions misses the point. A company which owns a patent on a gene does not own that gene, we are told. But in fact the rights granted by a patent include the most significant practical aspects of ownership: the right to determine how an item is used and to reap profit from those uses. And unlike conventional property rights, intellectual property rights on genes and organisms confirm control over their use even after they have been sold. This is why farmers around the world object to patents on crops.
It is also sometimes said that there is no reason to object to patents, which are essentially neutral, and the opponents should confine their objections to the applications on biotechnology. While it is true that opposition to patents often comes from those who also criticise biotechnology, and who see patenting as part of the predatory practices of corporations, it is mistaken to ignore the deep concerns which underly the opposition to patenting itself. These stem from very fundamental philosophical issues which are at the root of the current crisis in western society.
Capitalism, nature and ethics
Since the 16th century, first mercantile and then industrial capitalism has been based upon the extraction of natural resources and the control of nature. The key philosopher of the Scientific Revolution, Francis Bacon, explicitly stated that the role of science was to dominate unruly nature in order to extract profit from it. This has been the central conception of western capitalist societies ever since. Of course, this approach has brought immeasurable benefits to humanity, such as improved health, sanitation and general standard of living. However, the environmental crisis of the late 20th-century has forced us to face the damage that is done through our attitudes and practices of domination of nature. Many people now question this ethic of domination, and this questioning sits naturally with an opposition to other forms of domination such as racism, sexism and class elitism.
In this context, biotechnology, with its ability to manipulate nature at a deeper level than previously possible, arouses anxieties. Although I am generally sceptical about much of the hype surrounding biotechnology, I think it is correct to say that biotechnology is a genuine industrial revolution, and as such is bound to bring with it its own regime of relations between humanity and nature. Many people feel that the idea of patenting living organisms, which is part of the regime of biotechnology, is in fact a radicalisation of the ethic of domination. Patenting goes a step beyond one entity (humanity) dominating another (nature): instead, we are now told that some humans are actually the intellectual originators, or inventors of naturally occurring entities (genes and organisms). Such a claim is, to most people, who still hold to the traditional conception that nature is something that exists independently of humanity, simply incomprehensible. When they begin to comprehend, it they often use the language of theology: they say that patenting genes is claiming to be God. Whether or not one believes in deities (I do not), this characterisation is surely correct, for it is only something outside and above nature that could possibly invent it.
Thus the objection that is often raised to patenting of genes, that these are only discoveries and not inventions and therefore are not patentable, is not just some technical complaint about abuse of patent law. It is an ethical objection that cannot be answered by technical-legal arguments. For the vast majority of people, the distinction between discovery and invention upon which the patent system is founded is based on a commonsense idea that humanity cannot invent nature, and the suggestion that it can is a deep offence to people's basic ethical ideas about the world. It is quite clear that a gene is a pre-existing part of nature and cannot be claimed as an invention even when isolated from the organism from which it came, since isolation and purification do not change the thing in itself. Patent lawyers' attempts to avoid these obvious facts, for example in the EU biotechnology patents directive, are profoundly unconvincing and for most people serve merely to confirm the sophistry of lawyers.
Genomics and greed
The distinction between discovery and invention is important in a practical as well as an ethical sense. In any other fields of research, the discovery of genes sequences would be absolutely pure, 'blue-skies' research. However, there is a peculiarity in genetics, which stems from the fact that the basic data is embodied in a chemical molecule. This gives a precedent for patenting basic information, rather than inventions. As many scientists have noted, to patent such basic data is analogous to patenting the Periodic Table of chemical elements. There is a good public policy reason for not allowing the patenting of basic discoveries, as opposed to inventions built upon them: basic discoveries give rise to a large variety of possible applications, which should not be monopolised by any one party. The discovery of a gene is capable of a range of applications, such as diagnostic tests, gene therapies and pharmaceutical products. A patent on a gene thus allows a company to control a very wide range of possibilities, and by getting in at the ground floor they constrain others' opportunities to build on their work.
This is the meaning of William Haseltine's notorious statement that, 'Any company that wants to be in the business of using genes, proteins, or antibodies as drugs has a very high probability of running afoul of our patents. From a commercial point of view, they are severely constrained - and far more than they realize (1).' A whole industry, the genomics industry, has been built on this morally illegitimate way of doing business. These companies, armed with DNA sequencing machines, have been set up with the primary purpose of patenting genes. In most cases, the companies do not even have a clear idea of the functions of the genes that they are patenting. Companies like Haseltine's Human Genome Sciences and Incyte already own hundreds of patents and have submitted thousands more. Their strategy is to hold the rest of the world, including the rest of the pharmaceutical and biotechnology industries, to ransom. The root of this problem is the patenting of discoveries.
Such a situation would be bad enough in any industry, but in the area of health and food it is disastrous. The possession by a small number of companies of a large number of inappropriately broad patents threatens to give those companies a frightening degree of control over the future of medicine. (The fact that the public now has access to the sequence data through the work of the Human Genome Project does not help the situation greatly, because if anyone wishes to develop products based on human gene sequence information they will still find themselves at the mercy of the genomics companies.) An example of the way that patents on genes give companies too much control is the Amgen versus Transkaryotic Therapies (TKT) dispute: Amgen claims that its patent on the EPO gene should prevent TKT from making EPO, even though TKT's method does not involve use of the gene. It is hard to avoid the conclusion that an illegitimate monopoly is being used to prevent the marketing of a cheaper product. There have already been many reports of companies using their patent monopolies to close down genetic testing programmes conducted by charitable or public sector laboratories. This is one of the reasons that many scientific organisations have taken positions against the patenting of genes.
In their defence, biotechnology and pharmaceutical companies generally claim that gene patents are necessary to justify their investment in research. However, they have never presented any evidence that such broad patents, based upon discoveries rather than inventions are necessary. Companies wishing to market products such as diagnostic tests and therapeutic proteins can, like those in other industries, patent the products themselves. If biotechnology companies want to avoid a reputation for unnecessary greed they should abandon their insistence on patenting genes.
Secrecy and public science
A major reason that many scientific organisations and patients' groups, such as the National Organisation for Rare Disorders in the USA have criticised gene patenting is that it inhibits free sharing of data and materials amongst academic scientists. Such exchanges, and the convention of rapid publication of research results have traditionally been the basis of scientific progress, but in the field of genetics it is now widely acknowledged that commercial sponsorship of research have greatly eroded this ethic. It is true that patents are not solely to blame for this problem, but they do impose delays in publication whilst a patent application is being prepared.
A common response to this argument is that patents encourage openness: if they were not permitted, companies argue, they would simply keep research results secret. In a field which has been so distorted as genetics has, so that companies are doing basic discovery work, this has some force. However in general, it is the basic discovery work, which should be done by the public or charitable sectors that is of most value to society, and which really needs to be kept in the public domain. Such work by its nature should be unpatentable.
Commodification of the body
The other key ethical objection raised to the patenting of genes is that it turns into a commodity something which should not be one. In the case of crop genes, the objection is usually because these are seen as the common heritage of humanity, a shared resource which should be available to all. UNESCO's declaration on The Human Genome and Human Rights extends this argument to human genes. The argument is a reflection of a common hostility to the privatisation of common resources and the exploitation which generally accompanies this.
We have already seen many examples of such exploitation such as the many patents on cell lines taken from indigenous peoples, without consent, and in contradiction to their basic values. The overall commercialisation of human tissues and genes that is most apparent in the USA is already leading to a backlash, which threatens to severely damage medical research. People who see doctors and companies reaping profit from tissue samples that they have donated freely are beginning to ask, 'If they are going to make money out of my body, why shouldn't I have a share too?' Is this the route we want to go down? It is the inevitable consequence of the biotechnology industry's insistence on patents.
In the case of human genes the argument against commercial exploitation acquires extra moral force because of the important value that is based upon the human body and our revulsion at the idea that people should sell bits of themselves. The continuing international scandals over trade in human organs have sharpened people's awareness of this issue, and have hardened resistance to the commercialisation of blood and gamete donation. As Andrew Kimbrell, author of The Human Body Shop notes, 'Don't we degrade these things by selling them? If you earn a medal in war, through courage, that has some value. If you can buy it, it loses its value. If you become a priest, for example, through your work that's one thing: if you could buy priesthoods, wouldn't that terribly devalue it? Well if we turn our blood, our organs, motherhood itself, our genes, into just one more commodity, won't the integrity of our persons suffer the is same kind of devaluing? And what happens to our concepts of inherent rights, much less this image of God that most religious traditions give us?'
It is time that the pharmaceutical and biotechnology industries faced up to the fact that the patenting of genes and organisms is morally unacceptable and damaging to society. Unless this happens the opposition will not go away. Just because one is used to doing business in particular way does not mean that it is right or necessary to do so.
David King is the editor of GenEthics News (email@example.com), a newsletter on the ethical and social issues raised by genetics.
1. Fisher, Lawrence. "The Race to Cash in on the Genetic Code," New York Times, August 29, 1999.