You may think that your body is your own. But at least one in 20 of the people reading this article possesses a gene that a team of North American scientists is claiming as its own. And they've got the papers to prove it. The researchers spent much time and effort isolating the gene, which lurks harmlessly in the cells of a significant proportion of the population. But for a child who inherits two copies of the gene one from each parent it means cystic fibrosis (CF), the most common genetic disease in white Europeans. Few of those afflicted survive beyond their thirtieth birthday. But the gene that causes CF could prove a real money-spinner. New diagnostic kits or even CF treatments are a possibility and the paymasters of the scientists who uncovered the gene want to patent it. This claim that discovery of the CF gene leads to ownership has led to a genetic goldrush in which companies are staking their claim to parts of human DNA the molecule from which our genes are made. This week a largely unremarked new law, allowing patents on biotechnological inventions, makes its way to the European Parliament. Opponents believe it will usher in market values for our genes. The influential legal advisors to the Parliament decide today whether to recommend it. Traditionally, patents have been granted for inventions usually bits of machinery, not living things. The biotechnology industry sees no distinction, arguing that its products are biological machines. Without patent protection, they argue, industry will not invest the money needed to diagnose and treat the 4,000 diseases with a genetic root. Those who object believe laws designed for physical devices have no place in the quest to understand human genes. Patents mean commercial exploitation at the expense of medical progress. If the biotechnology industry wins the debate, the genes for disorders such as Huntington's chorea and Tay-Sachs disease (both fatal), for more common conditions such as diabetes and obesity, and perhaps one day even the genes for longevity, could become the property of small firms in California or multinational drugs companies. If a member of your family requires a genetic test, clinics will have to add to the cost a royalty payment to whoever owns the gene, just as the price of compact discs in the shops includes a royalty payment to Philips and Sony, joint owners of the patent on CD technology. Research scientists will have to pay fees to work on genes they do not own. But commercial pressure to implement the new law is intense. Companies are queuing up to file patents on a variety of pieces of human DNA, even for fragments with no obvious use. The American-Canadian research team that applied for the CF patent was one of the first in the queue. If the application succeeds, every CF test conducted in the European Community will have to include royalties to the University of Michigan and the Toronto Hospital for Sick Children whose researchers located the CF gene in 1989. Cellmark, a subsidiary of ICI, makes a kit to identify the CF gene. It is already negotiating a licence fee with the patentees, and has said it will recover this fee by increasing the cost of the test. The fear is that demands for royalties could price genetic tests out of the reach of ordinary people. The two institutes have also tried to charge British doctors royalty fees in return for permission to investigate the gene. They have sent out at least 30 requests for payments. St Mary's Hospital in Manchester, for instance, has received a demand for almost 4,000 a year. So far the British have not paid up. Peter Goodfellow, Professor of Genetics at Cambridge University, has condemned attempts to patent DNA as stamp collecting on a mass scale. He opposes unchecked patenting for economic reasons, not because of ethical squeamishness. Professor Goodfellow is a co-founder of Sequana, a Californian biotechnology start-up company. He said: In my view this should not be an ethical debate, but a debate about trade . . . If you allow the Americans to gain patents that cover vast stretches of the entire human genome, the economic consequences could be disastrous. I work on sex determination. There is a group in the US that has applied for a patent on the whole Y chromosome, so if I were to try to claim anything I would be subject to their ownership. That is an economic and political act to try and stop other people working in the area. Patents are granted only if their subject matter is novel. So scientists will become increasingly tight-lipped about their work if speaking at conferences or casual conversation with peers means putting a patent application at risk.
It is this that most concerns representatives of patients and families affected by genetic disease. Alastair Kent, director of the Genetic Interest Group, which represents charities concerned with gene-based disorders, said the secrecy involved in patenting will slow down the translation of research into treatments.
The group is not opposed to patenting of technologies associated with gene sequences, but to patenting of those sequences themselves. Mr Kent explained: If you think of a heart transplant, you need a bag to carry the heart from donor to recipient. The bag could be patented, but the heart could not. The same is true in genetics. To carry genes from one place to another you need some technology. That technology should be patentable but not the gene itself. There have been earlier disputes over patents on bits of humans. These have centred on the use of cells taken from people and nurtured in the laboratory to produce useful drugs. One example involved a leukaemia sufferer called John Moore. He won limited financial compensation after a lengthy legal battle with the University of California but the university has retained patent rights to cells it took from his spleen. The rush to patent DNA itself began in earnest when the US government's National Institutes of Health (NIH) applied for patents on more than 2,000 genes in the human brain three years ago. The genes were discovered by Craig Venter, a molecular biologist. They provide basic instructions for development, so play a key role in memory, intelligence and body control. Promising medical possibilities beckoned. But the patent application provoked international outcry. Some researchers echoed religious objections that to patent anything from humans was unethical. Companies objected, too, being unwilling to pay a fee for use of genes. The main objection was that the genes did not fulfil the criterion that an invention must have some proven utility before it can be patented. The inventors argued that they had satisfied the two other key criteria for patentability that the invention should be novel and non-obvious because their applications refer to genes that are, technically, artificial copies of natural genes. Britain's Medical Research Council retaliated in 1992 by applying for patents of its own on more than 1,000 fragments of DNA. The council said it felt bound to file defensive patent applications to protect the interests of its researchers and of British molecular biology in general. This brought the issue to a head, and precipitated several months of scientific diplomacy. In mid-February this year, both sides withdrew their claims. In a statement, the NIH director, Harold Varmus, said: I do not believe that patenting at this stage promotes technology development, and it may impede important research collaborations here and internationally. The fragments are primarily useful as research tools rather than as commercial products. But the problem has not gone away. Professor Ventner has since set up his own company, Human Genome Sciences, which is uncovering new genes by the thousand. In recent weeks, a similar row has broken out over a database at a private research foundation in France that holds DNA fragments from more than 5,000 diabetics. Scientists at the Centre for the Study of Human Polymorphisms (Ceph) hope to find a common genetic link. A few months ago, the director of the centre, Daniel Cohen, joined an American biotechnology company, called Millennium, and started negotiations on the company's behalf to buy the DNA databank for dollars 1m. Scientists working at the foundation were outraged, and the French government has since blocked the sale while an inquiry decides who owns the DNA held in the databank the families who gave their genes, the research foundation, the scientists, or the state. And while the row rumbles on, little science is getting done.