High stakes battle is joined in deciding who owns our genes

The race is on to decode 'God's software', but the debate rages over who should benefit from the results
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The Independent Online

By June, perhaps July, Craig Venter reckons he will complete a task described by some as "decoding God's software" - unravelling the 3.5 billion base pairs of DNA that contain the 100,000 or so human genes.

It will be a momentous achievement, given that it has been done virtually from a standing start in May 1998 when he left his prestigious job at the Institute for Genomic Research in Rockville, Maryland (where he was doing much the same thing, but in the public sector) to set up Celera Genomics, aided by the Perkin-Elmer company. Since then Celera, aided by state-of-the-art DNA decoding machines, has been whirling through the genome.

The stakes are high. According to most experts, gene sequencing might lead to medical breakthroughs for a whole range of illnesses - not only the ones we now think of as gene-based (such as cystic fibrosis, caused by faults in a single gene), but eventually also disorders caused by faults in more than one gene, such as Alzheimer's disease, heart diseases and asthma.

Diana Garnham of the Association of Medical Research Charities (AMRC) said: "Everyone now tends towards the thinking that genetics can tell us something, in some way, about the cause or treatment of diseases. That has been quite a radical change in the past few years."

Biotech stocks around the world fell on Tuesday after stern pronouncements by Tony Blair and Bill Clinton that "to realise the full promise of this research, raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere".

Public and charitably-funded research organisations such as the Wellcome Trust in the UK - part of the multinational Human Genome Project (HGP), which expects to complete its fine-grained decoding of the genome by 2003 - already do so. Dr Venter, by contrast, does not plan to - at least, not immediately.

The sell-off in biotech shares was blamed on the knock-on effect if companies that presently make money by selling databases of gene sequences are undercut by publicly-funded rivals, or forced to make their data public by law.

For example, shares in Genset, a French biotech company that studies the function of human genes and sells its findings to pharmaceutical companies, fell by almost 27 per cent on Tuesday. "It's a disaster for Genset if they have to make their research freely available," said a biotech analyst. "They will not be able to make a single euro of turnover from their investments."

The White House insisted yesterday that the intention of the statement was to "make raw data available so private companies can innovate, create new medicine and treatment and make a profit", and to "foster competition".

Dr Venter, who has been blamed for prompting the leaders' joint statement, also lost out: Celera shares fell by more than 25 per cent. He was pinpointed as the man at fault after the breakdown, amid some acrimony, of talks with the Human Genome Project about sharing genome data. Celera had demanded to retain exclusive commercial rights of distribution of any merged products.

As it happens, Celera (like other biotech companies) cannot patent pure DNA sequences, nor even the genes within those sequences, even if it manages to map them first. The US and European patent offices have long since declared that such sequences do not fit the three criteria of patentability - that something is new, contains an inventive step that would not be obvious to an expert in the relevant field, and has an industrial application.

For instance, it would not be possible to patent the string of DNA that forms the breast cancer gene called BRCA1. Nor can you patent the comparatively few base pairs of DNA in that string that actually generate the BRCA1 protein.

However, you can patent a method for testing for the presence of defects in that string of DNA that could lead to cancer. That is what Myriad Genetics, an American company, has done after winning an international race to be first to publish its findings with Britain's Cancer Research Campaign.

It now intends to capitalise on that by marketing tests to health providers. These tests will cost money - but arguably, for those worried that they may have the cancer-promoting gene, the price is worth paying.

Celera, similarly, may be able to patent genes for which it can establish an application. Critics say Dr Venter's sequencing method is a scattergun one. Whereas the HGP aims to map the genome very precisely - like creating a map at the highest possible resolution - Celera is sequencing almost at random, like mapping cities but ignoring the surrounding countryside.

Dr Venter says his data will be published in a peer-reviewed scientific journal once he has sequenced the genome. And would he patent any genes, or applications involving them? "We definitely will not be patenting the human genome. We think that's a violation that should not happen. We don't think random [DNA] sequences should be patented - we think only those things that lead immediately to a new therapeutic should be." This is a clear hint that Celera is looking for applications to genes, in a market whose value can only be guessed at.

If this is all Celera intends to do, then Mr Blair and Mr Clinton are not against it, making the fall in biotech stocks seem odd. Their joint statement also said: "Intellectual property protection for gene-based inventions will play an important role in stimulating the development of important health care projects."

At Britain's Biotech Industry Association, Andrew Sheard, a patent attorney who chairs its intellectual property (IP) committee, says: "We don't think this affects things very much at all. The release of raw data doesn't affect the IP issue, because they're simply releasing the DNA code sequence from the gels, with the function of that code unascribed. And 95 per cent of the genome is not thought to have any direct function."

So is it a lot of fuss about nothing? At the AMRC, Ms Garnham thinks there might be some fallout, but the effects are hard to gauge. "If you don't involve commercial entities early on, and the information is in the public domain and used by the public sector, does that delay the bringing of therapies to the market?

"And if the UK and Europe make this genome information available without a sharing agreement with the US, have we created a potential problem where the US could charge us back by patenting something from data we sent them? Myriad got the BRCA1 patent, and we don't know if that's going to be a good or bad thing. But it worries people." The debate is set to run and run.

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