Whose rights are they anyway?

By Philip Cohen in San Francisco THE corporate merry-go-round as biotech companies are bought and sold may be stifling medical research because it leads to uncertainty over who owns the rights to patents on human genes. This has already forced some laboratories to put research into one disease on the back burner, suggests an American bioethicists’ report. Many conditions are either caused directly by faulty genes or can be influenced by genetic factors. Identifying them can give researchers crucial information about how to tackle the disease, and also allows the use of DNA tests to screen people who might be at risk. But the discovery of disease genes isn’t giving researchers the jump-start it should, says Jon Merz of the University of Pennsylvania Center for Bioethics in Philadelphia. Merz and his colleagues surveyed 112 genetic testing laboratories to see whether they performed a particular test for haemochromatosis, a hereditary condition that causes a build-up of iron which can lead to heart or liver failure. In the US, around 1 in 10 people carry the gene for the condition, but less than 2 per cent of those clinically affected are diagnosed. Merz says that the haemochromatosis test is a revealing example, because the patent for it has effectively been in limbo for the past year. Rights to the patent were bought this year by Bio-Rad Laboratories of Hercules, California, which licensed them exclusively to SmithKline Beecham Clinical Laboratories. But in February 1999, Quest Diagnostics of Teterboro, New Jersey, made an offer to buy SKB CL. Quest eventually acquired rights to the haemochromatosis test in August, when its bid succeeded. This uncertainty over who owned the patent forced five of the labs to halt testing for haemochromatosis. Twenty-one others said that they had decided not to offer the test for the same reason. This sort of confusion is “shutting down physicians and shutting down labs”, says Merz. Gary Samuels of Quest agrees that the changing ownership of the exclusive patent might have impeded research in the past. But the company is looking at ways to meet the demand for the test and the situation should soon improve,
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