At stake is the multi-billion pound biotechnology industry, and future quality of health-care systems. If companies can patent the raw sequence of a gene, they can charge royalties from organisations which produce tests for the genes, and decide who is allowed to use the genes for scientific research. That will affect both patients and research.
Many of those who backed the new European Union directive, approved last month, thought it would only allow companies to patent a method of locating or testing for one of the 800,000-odd human genes - each an individual stretch of DNA. About 6,000 have been identified so far. But some people now realise that the eventual law could be more wide-ranging, allowing companies far more rights over genes - and hence what scientific work can be done with them - than was intended.
The possibility allowing for such "gene sequence" patenting, which would in effect give companies commercial control over the use of a naturally- occurring substance, is buried in a clause of the directive, which will be debated next month by patents specialists from EU member governments.
A specialist at the UK Patent Office told The Independent: "There is a clause which says that a gene `may be patentable'. It's not entirely clear if that allows it or not."
Alastair Kent, head of the Genetic Interest Group (GIG), representing millions of people with genetic diseases, who lobbied in favour of the new directive, accepted yesterday that the loophole exists. "This is one of those issues where there's clearly a need for further work," he said yesterday. "It's one of those things which probably will have to wait for case law."
GIG, which has about 120 member organisations including Mencap, the Huntingdon's Disease Association, the Cancer Research Campaign and the Muscular Dystrophy Group, lobbied strongly in favour of the new directive, which MEPs approved in its first reading last month.
When a similar directive came before the European Parliament in 1995, GIG - also headed then by Mr Kent - opposed it on the basis that it might allow gene sequence patenting.Reuse content