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POSTER NO: 254 Patenting the genome
Sandy Thomas The application of patents to human DNA sequences has long been controversial. Many researchers, clinicians, non-governmental organisations and religious groups have been opposed to the concept that a human DNA sequence can constitute part of an invention and therefore be claimed as property by the patent owner. However in helping to develop many discoveries into clinically useful products, the patent system has been a force for good. However, following the complete sequencing of the human genome, it is by no means certain that this positive influence on the patent system can be maintained in the future. The expansion and data mining of genome databases is likely to lead to greatly increased patenting activity as researchers gain more insight into gene function. The issue of how and when to assign patent rights to all manner of DNA sequences threatens to throw the patent system into disarray. Human genes have been patented for a variety of uses. An expressed gene may produce a protein drug such as erythropoetin for the treatment of anaemia, clearly a tangible product for which a distinctive therapeutic use has been identified. A gene might also be used directly for clinical diagnosis in the form of a gene-based diagnostic kit. However the majority will fall into the broad category of scientific findings which have no immediate commercial use but which have been dubbed 'research tools' since they can like any other scientific information, guide the design of future research. Some of these are single genes that could speculatively be thought to be in some way implicated with specific diseases. Key questions to be addressed in the talk include: - To what extent is it reasonable that 'gambles', such as a 'best guess' of utility for an extremely important cell receptor, based on database homologies, be rewarded? Should the established principle that a patent applies even to an unanticipated utility be applicable to genes, where the effort of isolation is low? - Should groundbreaking research be rewarded with broad patents, for example patents conferring the exclusive use of gene sequences in diagnostics? - Should inventors be able to use their patents on genes to prohibit low cost tests of this kind which are much more cost effective for public health systems, even if they detect fewer mutations? Using three cases (BRCA2, CCR5 and hepatitis C), this talk will discuss the key issues surrounding the patenting of human genes in the context of human genome databases. It will draw on the recent conclusions of the Nuffield Council on Bioethics. |