As the human genome is finally revealed, a THES survey reveals how genes are becoming an academic commodity. Steve Farrar reports on the new drive to exploit our DNA.
Julian Hopkin, professor of experimental medicine at the University of Wales, Swansea, would rather not patent. Like many other good scientists, he would prefer to disseminate his ideas on the genetics of asthma as widely as possible.
However, along with his scientific publications, Hopkin has two patents covering human genes. Exclusive rights are the price of securing the massive commercial investment needed to turn a good idea into a practical treatment. Yet he is uneasy. "I'm not sure that patenting is helping the asthma field," he says, referring to the need for global cooperation between different teams to beat the devilish complexity of the disease.
Hopkin's dilemma is increasingly common in the United Kingdom. A THES survey has found that 31 UK universities have full patents or applications covering 229 human genes and at least 1,116 genes from animals, plants and microbes. It is modest compared with the United States, where more lenient patent laws and a culture of commercialisation have led universities to embrace gene patenting. It is a different world from data-mining operations such as Genset in France and Ribozyme in the US, which have applications covering tens of thousands. But the trickle in the UK is gathering strength - genes are becoming an academic commodity. Compiled conservatively, this list is bound to be an underestimate - future editions will reveal greater totals.
A patent is a deal between the state and an inventor. In exchange for a 20-year monopoly on its commercial exploitation, an inventor makes public details of his or her invention for society's benefit. Researchers may replicate the work as long as it is not for profit.
Genes are simply DNA recipes for making proteins. The interaction of the 30,000 genes our genome is thought to contain, with each other and the environment, produces the almost unimaginable complexity of a human being. Their manipulation promises new cures, vaccines and therapies. To patent a gene, a scientist needs to isolate it from its natural state and identify a useful property that has not been previously disclosed. All of the patents in The THES survey are based around details of how particular functions of a gene or genetic sequences relating to a specific gene can be exploited, as well as the genetic sequences themselves.
Most universities see it as essential to protect the intellectual property generated by their research, from the stem-cell technology patents filed by scientists in Edinburgh and Sheffield universities and Imperial College, London, to such oddities as the University of Newcastle's vandal-proof gravestones.
The rewards can be high. Last year, the Royal Free campus of University College London was able to extend its medical laboratories and recruit more top academics thanks in part to revenue from its biomedical intellectual property. St Andrews University is fairly typical when it states: "The university court regards it as a specific responsibility of all staff to attempt to recognise and to report promptly any exploitable ideas or inventions arising from their research before any rights are lost through premature disclosure."
However, patenting is expensive. The initial filing may cost only a few thousand pounds, but full protection costs tens of thousands of pounds. UK universities seldom have the cash. Commercial partners or backing are needed.
In some cases, academics team up with industry from the start - Syngenta (formerly Zeneca and Novartis) has joint patents with Nottingham and Lancaster universities and Royal Holloway among others. Yet a wealthy supporter is no guarantee of success. Cardiff University recently dropped an application - concerning genetically modifying yeast so that more of the sugar turns to alcohol - after its commercial partner, the leisure company and former brewer Whitbread, decided there was little market for GM beer.
In 1990, Jeremy Dale, a microbiologist at Surrey University, filed a patent application on a DNA probe that could distinguish rapidly between different strains of the bug responsible for tuberculosis. Its potential as a diagnostic tool helped his team seal a deal with a US venture capital firm.
Johnjoe McFadden, who works in the same building as Dale, had similar hopes for his DNA probe for meningitis. However, his patent application was dropped as no commercial interest could be found for a disease that affects only a small number of people.
Dale's success has not made everything rosy. His patent has been challenged by a team from the Pasteur Institute in Paris, and Dale has found himself defending his work, with the support of his venture capitalist backers, against French counterparts with whom he has to rub shoulders in the small field of microbacteriology.
It is not enough for universities to gain a patent and then sit and wait for the rewards to roll in, warns Margaret Llewelyn, deputy director of the Sheffield Institute for Biotechnology, Law and Ethics. "Patents are worthless unless universities can protect them once the material is on the market. It is a question of who has the bottle and money to go to court."
Nevertheless, the patenting continues. Imperial College, London, has a malaria gene; the Royal Free genes linked to heart disease and multiple sclerosis; Queen Mary and Westfield College, London, one connected with eczema. Many, including Bristol, Glasgow and Dundee universities, have filed patents on genes connected with cancer. The THES survey has revealed two giant gene patent applications - one from Glasgow involving 902 non-human genes and a pair from Nottingham Trent covering 103 human genes connected with prostate cancer.
John Martin, professor of cardiovascular medicine at UCL, is almost evangelical about his support for patenting. He has taken an idea - involving the human VEGF gene that could help raise post-surgical success rates and even tackle heart disease - to the brink of clinical trials through his spin-off company, Ark Therapeutics, formerly Eurogene. He believes the wholesale commercial exploitation of research could make universities more independent and even boost funding for the arts and humanities. "All academics should be encouraged to do this, otherwise all of the commercial potential they generate is just wasted," he observes.
Geoffrey Goldspink, professor of anatomy and developmental biology and chairman of the basic medical sciences at the Royal Free, is less optimistic. His pioneering work on an ingenious gene therapy to help haemophiliacs has been patented in Europe and Japan, but it ran into a very broad patent filed by Baylor College of Medicine - a key centre of the Human Genome Project. As a result, he has had to concede the lucrative US market.
"British universities do not have the money to file worldwide patents. If a patent is breached, they do not have the resources to take on the big pharmaceutical companies," Goldspink says.
Although US universities protect intellectual property at every stage of the research process and are quick to resort to courts when they feel their rights have been violated, the culture in the UK is still very much rooted in cooperation and openness.
"It is a very different ethos from the one we have," Llewellyn says, "but perhaps not so different from the one we will have in the future."
- Where are UK academe's gene patents? Table of institutions
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