Patents involving DNA sequences should be the exception rather than the rule, according to a paper published today (23 July 2002) by the Nuffield Council on Bioethics. The Discussion Paper, The ethics of patenting DNA, recommends a number of significant changes to the way that patents are granted involving DNA sequences.
The Discussion Paper, prepared by an international group of experts, proposes an ethical framework for gene patenting with recommendations aimed at policy-makers, courts, patent lawyers and patent offices. “We are concerned that, for patents involving DNA, the patent system is in danger of not achieving its main goal – to stimulate innovation for the public good. We believe that the Council’s recommendations would safeguard against this situation,” comments Dr Sandy Thomas, Director of the Nuffield Council on Bioethics.
“It is important to question whether patents involving genes could adversely affect healthcare and research,” continues Dr Thomas. Diagnostic tests and medicines could become unaffordable or unavailable, the development of new ones might be slowed down, and research could be inhibited. The Paper aims to address these concerns. “The Council calls on patent offices worldwide to work together to examine ways to ensure that the patent system is fairly, but rigorously applied in the case of DNA.”
Currently, the patent system considers DNA sequences as eligible for patenting, once isolated from their natural environment. “But even if DNA is, in principle, eligible for patenting, it does not mean that each and every application for a patent should be granted” explains Dr. Thomas. At present each application must also satisfy three legal tests: it must be novel, inventive and useful. When applied to DNA sequences, the Nuffield Council argues that these three tests are increasingly problematic.
“It is vital that the tests of inventiveness and usefulness should be more rigorously applied,” insists Martin Bobrow, Professor of Medical Genetics and one of the authors of the paper. “If this happens, it should substantially reduce the number of patents granted involving DNA sequences.”
The process of isolating a gene has changed dramatically in the past ten years. It is now possible, for example, to identify a gene simply by using a database made by others. The Paper concludes that the identification of DNA sequences through the use of such computational techniques should not be regarded as ‘inventive’.
Several types of patents involving DNA would be unlikely to be granted if the test of ‘inventiveness’ were stringently applied. When a gene is associated with a disease, the DNA sequence can be used as a diagnostic test, for example for breast cancer, or as a target for gene therapy, for example to treat haemophilia. But should that DNA sequence itself be patentable? “We feel that once the link between gene and disease is identified, the use of the gene, for diagnosis or therapy is obvious. It therefore does not fulfil the inventive (or ‘non-obvious’) test. Patents involving a DNA sequence as a diagnostic test or for gene therapy should rarely be granted,” continues Professor Bobrow. “In the case of a diagnostic test, a patent on the use of the sequence may be acceptable, but the patent should be restricted to the particular test specified”.
This test should also be rigorously applied. Some medicines, or therapeutic proteins, can be produced directly from a DNA sequence, for example insulin. “In such cases, we accept that the test for usefulness is fully met, and a patent on the DNA sequence itself, to produce a specific protein, is justifiable,” says Professor Bobrow. However, some patents are filed for DNA sequences that do not have any immediate therapeutic use but which may be important for research. The Paper recommends that granting patents involving DNA sequences which are to be used as research tools should be discouraged.
The Paper recognises that the patent system should reward people for useful new ideas and inventions but argues that, in the case of DNA sequences, the balance is currently too firmly in favour of the claimant. “One specific problem which we considered is the fact that one gene often gives rise to more than one product. This means that it is quite common to find an entirely new use for a DNA sequence after it has been patented. If a patent protects all the uses of a sequence, this can give extensive, and in our view unjustified, rewards to the original researcher,” comments Dr Thomas. The Paper notes that some patents that have already been granted are of doubtful validity and makes a number of recommendations to limit the possible adverse effects of these patents.