As the Guardian announces that British women now have a one in nine chance of getting breast cancer, HELENA PAUL of EcoNexus reports on attempts to monopolise gene testing worldwide.

'Patents on genes connected with breast cancer? That's outrageous!'

That is what many people said when they first heard about it, yet that is exactly what the European Patent Office has quietly granted to a US company.

Between 1988-98, there was a long and bitter struggle in Europe over whether to extend patents to cover living organisms, their cells and genes. Groups from all over Europe, and from around the world, produced a great deal of evidence to show that patents on life would promote corporate monopolies and damage research, as well as violate one of the basic rules of patenting in Europe, that only inventions, not discoveries can be patented.

A major case against patenting genes cited by the opposition was that of the patents on the breast cancer gene BRCA 1; granted in the US to Myriad Genetics of Salt Lake City, Utah. Opponents such as the 'No Patents on Life Coalition' pointed out that the breadth of these patents meant that Myriad could block further research on the gene, which had been discovered through scientists and affected families sharing information internationally in the interests of promoting research. Myriad had benefited from that research and gained the patents simply because it had the technical capacity to sequence the genes before anyone else. Opponents also pointed out that the patents would enable Myriad to exclude national health services from carrying out diagnostic tests. This monopoly would further enable Myriad to increase the price of tests. Opponents also noted that, while these genes play a part in breast cancer, there are many other factors involved; the issue can never be reduced to a simple equation between a gene and an illness. In Europe, MEPs, researchers, the public and the press responded strongly to the story.

However, in 1998, the European Directive on the Legal Protection of Biotechnological Inventions (98/44/EC) was finally adopted after the biggest corporate lobby of the European Parliament ever seen, certainly up to that time. Children in wheelchairs were brought into the Parliament with the message that MEPs would be depriving them of cures for their disabling illnesses if they did not vote for the directive. The Dutch Government, with the support of the Italian and Norwegian Governments, afterwards challenged the directive at the European Court of Justice, but their appeal was rejected.

Then, during 2001, the European Patent Office granted three patents related to BRCA1 and a second gene, BRCA2 to Myriad Genetics. This second gene owed its discovery largely to British scientists at the Sanger Centre and the Institute of Cancer Research, but Myriad filed for the patent just hours before they were able to publish their findings. The patent numbers are: EP 705902, EP 705903 and EP 699754. Collectively, these patents are extremely broad, covering diagnosis, diagnostic kits and therapeutic uses, even though these last cannot yet be described as should be required of a patent application.

As if to demonstrate even more clearly the dangers of commercial domination of the genes, during 2002, Myriad launched an advertising campaign in the US to persuade women to ask their physician for a test, while simultaneously contacting some 200,000 US physicians in order to promote them. Comparisons of test costs at that time showed that charges in the US were roughly twice those of the UK. Furthermore, it remains the case that Myriad could potentially claim damages against the National Health Service for using the genes in its own tests, if the patents were to be granted in the UK itself.

Opposition to the patents in Europe has been led by French medical organisations since 2001: the Institut Curie and Institut Gustave Roussy, with support from the Dutch and Austrian health ministries and research organisations from across Europe, including the UK. The case is likely to take several more years. However, it can be fought only on the legal issues, even though concerns about the patents reach far wider. The reduction of key issues of the public good in human health and research to the level of obscure battles between patent lawyers in an arena where the corporations have all the advantages, is a serious and growing problem - which the EPO and the European Commission both appear to consider as beyond their competence.

Useful sources of information
"Patents and public health: European institutions are challenging Myriad Genetics's patent monopoly on the brca1 gene" by Aude Lecrubier, 1120 EMBO reports vol. 3 | no. 12 | 2002 (c) 2002 European Molecular Biology Organization, Found at www.nature.com
For the sequence of events: www.curie.fr/upload/presse/keydates.pdf and you will also find further info re the challenge on the Curie website.

"Patenting Genes - Stifling Research and Jeopardising Healthcare"
Briefing (including the BRCA1 and 2 case) printed and published by EcoNexus and GeneWatch UK, April 2001

Gene Patenting: A BMA Discussion Paper: British Medical Association, July 200: Useful for further information about the directive and the general impacts.