BBC News | HUMAN GENOME | Who owns the genome?

The question of who should own the products of the human genome has caused more controversy than any other aspect of the mammoth endeavour.

The raw data, long strings of the four genetic letters, is not being patented. But patents are being granted on data which has been identified as a gene and for which the function is known to some extent.

Companies argue that patent protection is the only way that crucial investment in new genetic treatments can be obtained. But critics argue that many of the patents are too broad and speculative and amount to the privatisation of human biology.

Dr Sue Meyer, director of independent policy research group, Genewatch UK, says: "The really disturbing thing is that the human genome is falling increasingly into private hands.

"So the science is driven by private interests, aiming at maximising their shareholder value, rather than addressing public health issues."

Discovery and invention

Certainly, vast numbers of patents have been applied for on genetic information.

Estimates vary in this contentious area, but Incyte Genomics are widely believed to be the leading patent holders. Their website claims that they hold 513 full gene patents in the US and have filed over 50,000 applications for full or partial genes.

Many other companies are following suit, including Human Genome Sciences (112 patents, 7,500 applications) and Celera (6,500 applications).

Applications have been made in Europe too, though in thousands rather than tens of thousands.

Critics of patenting say that these companies have made discoveries, not created inventions, and should not be awarded the patents.

Patent contract

"The function of a gene is not an invention. That would be a gene test kit, or an actual gene therapy or a new drug," says Dr Meyer.

Broad, and sometimes speculative, patents which cover whole genes allow companies to charge royalties if other researchers want to work on those genes, even if they are pursuing a completely different line of study, the critics argue.

Gene prediction is as much art as science

Gerald Rubin, University of California Berkeley
Dr Donald Bruce, of the Church of Scotland's Society, Religion and Technology Project, has argued bitterly against such practices: "The patents are too broad - not focusing on one use of the gene. They should be open for someone else to find a different use for the gene, otherwise you are closing down areas of research."

Companies have already tried to charge royalties to groups working on a breast cancer gene and a gene important in HIV infection.

But Dr William Haseltine, chief executive of Human Genome Sciences, says patenting is essential.

"In order to invest in the development and testing of drugs, a patent is absolutely required. No-one would develop a gene-based drug without patent protection."

He notes that the awarding of a patent requires that the data is then made public.

"A patent is a contract between an inventor and society - the inventor teaches society his secret of the invention and he is rewarded by a limited period of exclusivity to make and sell products based on that invention."

The 'land-grab'

He also notes that critics do not question either the right of universities or public bodies to patent a gene, provided they have sufficient data on what it does and what its medical uses are.

The University of California has been awarded 219 gene patents and the US Department of Health has 183.

Since the "land-grab" has already occurred, the patent argument will now only move on when the bulk of the tens of thousands of applications begin to be ruled upon.

Many have considered the regime until now to have been quite favourable to the patent seekers, but public pressure could change that. And although the focus on the decisions of the patent-awarding bodies will become increasingly intense, this argument has many years to run.

A further complicating factor in the case of abnormal genes is the rights of the patients donating samples for research.

It is not uncommon for sufferers of relatively rare genetic disorders and their families to provide the impetus for research, raise the funding, and, crucially, donate their tissues.

However, when the study bears fruit in a commercially viable test or treatment, they receive nothing. So far, legal cases in the US have not awarded property rights to the people from whom tissue was taken.

By BBC News Online's Dr Damian Carrington


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