More MS news articles for September 2002

Gene patenting—diagnosing the problem

01 September 2002
Lancet Neurology, Volume 1, Number 5

On July 16, 2002, the UK Human Genetics Commission (HGC) launched a 3 month consultation exercise asking whether genetic tests should be sold direct to the public, or only be available through a doctor. Currently, there are no specific legal requirements in the UK about who may supply genetic tests or how the results of such tests should be given to people. The paternalistic attitude that pervaded medicine in the past is slowly changing, but is it really in the public's interest to be able to buy a genetic test over the internet to be used, unsupported, at home?

Most neurologists would agree that testing for a fatal genetic condition, such as Huntington's disease, should only be done in a clinical setting. Counselling is essential in such a situation, for the patient as well as for family members. But not all conditions are as serious as Huntington's disease and many people would argue that they have the right to diagnose themselves without a doctor's help. Whatever the outcome of the HGC consultation process, one thing is certain, however. As our knowledge of the genetic basis of disease increases, more and more diagnostic tests will appear on the market.

Indeed, Athena Diagnostics, a Massachusetts subsidiary of Ireland's Elan Pharmaceuticals, currently offers tests for a large number of neurological conditions, after buying exclusive patent rights to several diagnostic tests. The company has asked university labs, who used to routinely perform these tests, to stop offering some of them because the company wants to be the exclusive provider. Interestingly, universities can be just as ruthless, as testified by John Merz, a bioethicist from the University of Pennsylvania, in his chapter from the book “Who owns life?”, which is due to be published shortly. He describes how the Miami Children's Hospital Research Institute patented the Canavan disease gene, commercialised the diagnostic test, and then aggressively enforced the patent. Perhaps the most disturbing aspect of this case is that the Ashkenazi Jewish community, which altruistically provided the tissue samples that allowed the gene to be sequenced, was later exploited commercially. As the US law stands, patents only reward those who have made financial or intellectual investments, and not those who provide the genetic information.

The ethical issues surrounding DNA patenting are comprehensively covered in a discussion paper that was published on July 23 by the Nuffield Council on Bioethics. One of the main findings of the report is that far too many genes are being patented by a system that is failing to apply the rules strictly enough. The paper's authors recognise that the patent system should reward people for useful ideas and inventions but argue that in the case of DNA sequences the balance is currently too firmly in favour of the claimant. In particular, the paper proposes that the criterion of inventiveness should be “stringently applied for ‘product’ patents which assert, inter alia, rights over DNA sequences for use in diagnosis”. The granting of product patents for diagnostic tests should become the rare exception, rather than the norm, the paper concludes. Diagnostic tests could be protected, however, by “use” patents, which cover the use of a DNA sequence for a specific purpose. This could, on the one hand, provide sufficient incentive for the company to develop the test, and on the other, result in the development and marketing of a number of different tests for the same gene.

Importantly, most of the report's recommendations do not require new laws—they could be achieved simply by applying the existing criteria more stringently. This needs to be done, and soon. The US Patent and Trademark Office currently has over 20 000 applications that are awaiting action or in active prosecution, and another 30 000 that are being claimed or disclosed in provisional applications. Reducing the number of successful patent applications is essential, otherwise the question “Who owns life?” will become increasingly difficult to answer.

© 2002, The Lancet Neurology