Royalties demand threatens research into cystic fibrosis

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The Independent Online
Research and treatment of cystic fibrosis could be hamstrung because researchers are facing demands for royalty payments following the patenting of the human gene responsible for the disease.

The decision by the institutions which found the genetic defect to ask for royalties from any scientist making use of their discovery has reopened the question of allowing the patenting of human genes.

St Mary's Hospital Manchester has received a demand for dollars 6,000 ( pounds 3,900) a year from the University of Michigan and the Toronto Hospital for Sick Children. In 1989, a joint team of researchers at the two institutions located and analysed the gene responsible for cystic fibrosis.

The discovery was a breakthrough in understanding the most common genetic defect - more than 4,000 such human genetic defects are known - to afflict Caucasians. However, while the researchers, led by Dr Francis Collins at Michigan and Dr Lap- Chee Tsui at Toronto, published the details of the genetic defect as is customary, the institutions patented the discovery.

Now they have sent out about 30 requests for payment of royalties, according to the journal Bio/ Technology. The bills have prompted some researchers to question the grounds of the patent: a gene is something there to be discovered; it is not an invention and only inventions can be patented.

Martin Scott, of the Cystic Fibrosis Trust, said that such a development was not unexpected. In America, commercial organisations conduct genetic tests to see if people are at risk of having children suffering from the disease, whereas in the UK such work is carried out by non-profit making Regional Genetics Services.

If the royalties were set too high, he added, it could prevent the UK from having a national screening programme to identify those at risk.

Dr Andrew Read, of the medical genetics department of St Mary's Manchester, confirmed that his department had received a request for payment. Dr Read, who is also chairman of the Clinical Molecular Genetics Society, warned of the precedent being set. There are many disease-related genes, he said. 'The whole work of laboratories like ours depends on knowing the function of lots of genes and this has been treated as part of public knowledge.

'If they win this one, everyone who clones a gene will patent it,' Dr Read said. It would mean that researchers might have to pay extensive royalties to use knowledge about genes. 'It's a mess.'

Dr Read said that charities funded most of the research into cystic fibrosis and questioned whether they would benefit from the royalties.

He added that it was unfair for Toronto and Michigan to have the patents when other laboratories provided essential intermediate research crucial to the final location of the gene.

ICI's subsidiary Cellmark makes a diagnostic kit to identify the cystic fibrosis gene and is negotiating a licence fee with Toronto and Michigan, according to an ICI spokeswoman. The fee 'will be built into the cost of the test', she said.

One in twenty of the population carries the gene and one in 2,500 suffers from the disease. It causes the lungs of sufferers to clog with thick mucus which provides a breeding ground for bacterial infections, even when the lungs are cleared by regular physiotherapy.

Ducts in the pancreas are also blocked, causing severe digestive troubles. Until recently, few sufferers survived childhood, but modern techniques mean there are now many in their thirties.

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