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  • DNA patents need tighter restrictions


A ban on patenting genome sequences would be both impractical and unrealistic. But much tighter rules, both national and international, are needed on the conditions under which such patents are granted.

One of the most commonly heard refrains from those critical of the private sector's control over biotechnology is that no patents should be granted on DNA sequences. Outlawing such patents, it is argued, is particularly important for those strips of DNA that code for specific proteins — in other words for genes.

The logic is both straightforward and appealing. On practical grounds, it is argued that such stretches of DNA are 'natural', and therefore cannot qualify as inventions (which is what the patent system was set up to protect). On ethical grounds, an equally strong argument can be made that if the human genome — and all its contents — belongs to anyone, it should be commonly owned by all mankind. Staking claims to the sequences that make up individual genes, even if previously unknown, is portrayed as the ultimate form of biopiracy.

Unfortunately, perhaps, such a viewpoint appears somewhat utopian. We live in a world where society, through its patent laws, has already agreed that certain kinds of products can be patented (even if they exist in a 'natural' form) and that, under certain circumstances, this can include a gene. A likely candidate, for example, would be a gene sequence that forms an essential element of a novel diagnostic test for a disease. Reversing 25 years of legal precedents, particularly when so much is at stake for biotechnology companies, is not a reasonable expectation.

Need for action

But that does not mean that nothing can — or should — be done about DNA patents. A discussion paper published last week by the Nuffield Council on Bioethics, the closest that Britain has to a national bioethics advisory committee, points to a number of urgent priorities (See Gene patenting rules 'must be stricter). The ethics of patenting DNA argues, for example, that the criteria of 'utility' applied by patent offices around the world to applications for patents on DNA is often interpreted much too broadly. One knock-on effect is to deter research by others in whole fields of discovery.

In future, the paper suggests, a patent should only be granted on a gene if the social benefit likely to emerge from knowing the genetic code for that gene can be clearly defined. Patents on gene sequences should no longer cover all possible uses of that sequence, some of which may be unknown. As the Nuffield panel concludes, DNA patents should be "the exception rather than the rule".

Similarly, the Nuffield panel's report is highly critical of the way that private companies are able to exploit the results of research that has been publicly financed. The prime example here is the US company Myriad, which has been able to patent a diagnostic test for breast cancer based on work carried out — and openly published — by researchers in Britain, and is now charging $2,400 for anyone wishing to take the test (about twice what British researchers claim they would need). At present, however, Myriad's tactics are entirely legal, as the UK research was published in the open literature.

Challenge for reformers

The challenge to those seeking to introduce greater social equity into the international patent system is how to introduce changes that — while remaining true to the spirit of the system, as well as to its central role in the modern knowledge economy — can prevent the actions and activities of individual companies that are widely perceived as excessive, if not unethical.

Researchers in developing countries have a major stake in this debate. There is no direct mention of the interests of developing countries in the Nuffield report. But one of the characteristics of the global knowledge economy is that, for those engaged in it (which include a growing number of developing countries) the issue of the public versus private control of knowledge is becoming just as important as whether such ownership originates in a rich or a poor country.

It is understandably tempting for researchers to ignore such controversies. On the basis of "if you can't beat them, join them", many developing country scientists engaged in research that could produce patentable genomic sequences appear as eager as their colleagues in the developed world to obtained the widest possible patent protection. Indeed, there is an argument that one of the most effective ways of supporting such scientists is providing them with the advice and resources to do precisely that.

Yet in the long run, this will only compound the problem. The issue, as stated above, is not rich versus poor; it is private interest versus the public good, in developed and developing countries alike.

Future actions

Even as it stands, therefore, the Nuffield report raises important issues that should concern all those in the international community. For example, it is not only in the North that the existence of a complex labyrinth of patents in an important area of, say, medical research can act as a powerful deterrent to researchers even entering the field.

Two avenues for action need to be explored. The first, on which some progress has already been achieved, is that to ensure that the deterrence effect of patenting is minimised in the most pressing areas of social need. This has already been promised, for example, by some of the companies engaged in sequencing the rice genome, who have made results freely and publicly available.

But others have not been so altruistic. Some way therefore needs to be found to formalise this procedure and reach a common understanding by which such genomes should be deliberately kept outside the patent system — a challenge that could be profitably taken up at the World Summit on Sustainable Development, which opens in Johannesburg next month.

The case for special treatment

The second need is for ways to provide special treatment for genome patents within international patent legislation, for example by insisting on narrow interpretations of the concept of utility. Patents lawyers are likely to call foul, arguing that all patent applications should be judged by identical criteria. And the crafting of 'special exemption' wording would be a major challenge for international negotiators, as has already become clear in attempts to make the Trade Related Intellectual Property (TRIPS) clauses of the World Trade Organisation compatible with government commitments under the Convention on Biological Diversity.

But this challenge would be minor compared to re-writing the patent laws from scratch to take concerns about biotechnology patents into account. And as long as protestors continue to gather increasing support for their demands for 'no patents on life', the pressure for a compromise solution remains. No-one is likely to be totally satisfied. But equally, no-one could then complain that their point of view on this important topic had been ignored.

Link to The ethics of patenting DNA

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