Sir: Alastair Kent (letter, 15 July) states that the EU directive on gene patenting "is a significant clarification over the present position". The tabled directive, although stating in paragraph one that the simple discovery of a gene is not patentable, also states that technical processes that isolate the gene may constitute a patentable invention. This amounts to the fact that genes are patentable.
Actual genes or gene sequences in isolation will probably never be used in therapy. However, work with identified genes will lead to the design and production of new small molecules which will be useful therapies. These in themselves would be patentable. If a gene is to be delivered to the body, a delivery system or vector needs to be developed. As these also would be patentable inventions, why patent the gene itself?
If a biotech company creates a new molecule it does not gain any reward from it until it can demonstrate a use for it. There is, therefore, real incentive to develop a treatment, as the molecule itself has no value without it. A gene, however, can be tested for, and as such the discovery of a gene immediately gives it a value. If a company can earn money from a discovery, is there a real incentive to develop a therapy?
As things stand in the directive, licence fees and royalties will have to be paid on all patented genes. In the future genetic tests for heart disease and breast cancer may involve the testing of 15 or more genes each. This will mean 15 separate royalties to be paid, and thus make genetic testing much more expensive and inaccessible. The economic and patient benefits of targeting preventive and screening strategies on those really at high risk will be less attainable. The NHS will also have to pay out for the administrative costs of negotiating a separate deal with every gene patent holder, as well as the legal costs of any patent challenge.
Biomedical companies do need to be encouraged to invest in genetic research, but let us get the directive right. We don't need a broadly interpretable patent directive which will allow effective monopoly of research on particular genes and cost the NHS unnecessary money. Why not get the wording right to mean that companies can benefit from gene discoveries only if they make a truly inventive step such as the development of a therapy (which will incur real development costs). Let us hope that MEPs vote for amendments which really tighten up the interpretation of this directive.
Dr GARETH EVANS
Consultant in Medical Genetics
Central Manchester Healthcare NHS TrustReuse content