Not since the enclosures of common land has there been such a conflict over the boundary between public and private property. Who owns the genome?
Deciphering the genetic code is one of the biggest steps in biology since Vesalius published the first human anatomy in 1543, and the first milestone has just been passed: researchers at the Wellcome Trust's Sanger Centre, near Cambridge, have decoded an entire human chromosome (number 22). By the end of the year, the Sanger scientists will announce that they have sequenced one third of all human DNA. A rough draft of the genome-three billion letters long-will be available next spring. In these letters is a new version of human anatomy: not in bones and blood vessels like Vesalius's atlas, but a blueprint in biochemistry: the genome is the recipe book for all the proteins which make up the human body.
The world's biotechnology companies have been quick to recognise the potential for drug discovery of this genetic knowledge. Since 1945, drug companies have used only 400 or so "targets" for drug development: proteins (such as insulin) or the receptors on which the proteins act. There are thought to be at least 100,000 human genes, each of which could supply several targets for drug development. Small wonder that some companies have been rushing to patent every gene sequence to which they could lay claim.
More than 1,000 patent claims have now been made for genes or gene fragments. For example, two genes appear to be associated with inherited breast and ovarian cancer (fewer than 5 per cent of all breast cancers are inherited), and both have been patented.
However, in a deal brokered three years ago in Bermuda by the Wellcome Trust, the US National Institutes of Health and its counterparts in Britain, France, Germany and Japan, committed themselves to dumping every piece of sequence data on the worldwide web as soon as it became available. In Europe, at least, prior publication makes patenting impossible, so the agreement represented a commitment by all the big publicly-funded players that the human genome should remain accessible to all. What the agreement did not allow for was the possibility that privately financed sequencing efforts might outstrip the public ones, and file for patents before publication on the web. Last year, Craig Venter, an American researcher, announced that he would lead a privately financed consortium to do just this.
The issue has become serious politics. Tony Blair and Bill Clinton are expected to extend the Bermuda agreement with a public declaration later this year that the genome should not be patentable as such. Michael Morgan, chief executive of the Trust's Genome Campus (which runs the Sanger Centre), welcomes the interest. "A declaration that the genome should not be patentable would be helpful to patent offices," he said. He stressed that the Trust was not opposed to patenting at the appropriate point in the innovation chain. But it was, he said, arrogant to assume that any one company had the resources or the interest to exploit all this information.
The Wellcome Trust is already applying its open approach to the stage beyond sequencing the genome. What will be produced in draft next spring-and to an accuracy of 99.99 per cent by the year 2003-will be a "reference" genome. To draw the analogy again with anatomy: no one's skeleton is exactly like that of the anatomical drawings; we all differ from each other in subtle ways. Similarly, we all differ in the anatomy of our DNA-at the level of about 0.1 per cent, according to Morgan: "There are 3m differences between each of us."
Once the reference sequence has been established, the next step is to find the sites along the double-helix strands of human DNA where such differences commonly occur. The Trust is now working with a consortium of pharmaceutical companies to map out the locations of at least 150,000 sites of common difference. In the argot of the trade, these are called single nucleotide polymorphisms ("snips"). Different patterns of snips are associated with different diseases, and so provide landmarks for researchers trying to find genes associated with those diseases.
Bizarrely, in order to keep this information in the public domain, and to ensure that rival biotechnology companies who have not contributed to the consortium do not patent the snips, the consortium will patent them and then not enforce the patent leaving the information available for anyone to use.
The consortium has grown out of a realisation among some companies that it was pointless to map out separately the same landmarks in DNA. Although the issue of patenting gene sequences is far from settled-hence the Blair-Clinton interest-a new pattern of relations between commercial and non-commercial funders of research is emerging. It is a shift away from the commercial free-for-all towards a new model which respects both the interests of shareholders and the wider, public interest, in ensuring that the genome remains public property.
