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FEATURE: Geoff Watts The locked code BMJ 2007; 334: 1032-1033 [Full text]

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Implications of gene patents for healthcare

Naomi L Hawkins   (4 June 2007)

Implications of gene patents for healthcare 4 June 2007
Naomi L Hawkins, Doctoral research student The Ethox Centre, University of Oxford, Gibson Bld, Radcliffe Infirmary Woodstock Rd, Oxford OX2 6HA Send response to journal: Re: Implications of gene patents for healthcare	Although the discussion of human gene patenting by Geoff Watts published on 19 May 2007 highlights an area of importance for the future of genomic medicine, it does not discuss the implications of gene patents for research and access to health care. Whilst debate continues as to the legitimacy of patents on human genes, it is important to consider the implications for healthcare of the patents which do in fact exist. Some of the more important issues are highlighted below. Empirical research reassuringly indicates that patents on genes have a minimal impact on basic biomedical research. 1 2 However, this appears to be largely because patents are ignored by researchers, and not because the law deals with this matter appropriately. Whilst much basic research in the UK is covered by a research exemption (in section 60(5)(b) of the Patents Act UK), the activities allowed under this exemption are narrow in scope, while at the same time being poorly defined. This lack of clarity in the law is likely to be problematic in the area of translational research where products are taken from the research laboratory into clinical (and commercial) use. In the area of genetic diagnostics, the division between research and clinical use is often not clear cut, particularly as many tests for more complex diseases require extensive validation. This research which crosses the boundary between the laboratory and the clinic is unlikely to be exempt from liability for patent infringement. Where a single gene is the subject of many patents, and also where a single test requires the examination of many genes, all or some of which are patented, the patent landscape can become complicated. Thus a major concern arising from gene patents is associated with these overlapping sets of patent rights (or ‘patent thickets’)3 and the associated stacked royalties, with possible increases in the costs of healthcare as a result. These problems will potentially become more widespread as more genetic diagnostics for complex diseases enter clinical use, where multiple mutations in multiple genes will need to be examined. Despite the one high-profile example of Myriad’s attempts to corner the market for breast cancer genetic testing, which is discussed in the article, there have been few similar cases of gene patents controversy.4 However, it may be that the full implications of gene patents for healthcare are not yet clear, as many genetic diagnostics and treatments are still in the pipeline. As more genetic tests reach the clinic and genomic medicines are developed, these issues will become more important. Intellectual property rights should not be a barrier to translational research but rather just another consideration that can be navigated with appropriate support. If dealt with appropriately, patents may provide the means for collaborations between academia and industry, with increased access to genetic innovations. Institutions engaging in translational research should have policies and practices in place to deal with issues associated with patents appropriately. In this way, care can be taken that patent rights do not restrict patient access to innovations arising from basic biomedical research. 1. Nicol D, Nielsen J. Patents and medical biotechnology: An empirical analysis of issues facing the Australian industry - Occasional Paper No. 6. Hobart: Centre for Law and Genetics, Faculty of Law, University of Tasmania, 2003. 2. Walsh JP, Cho C, Cohen WM. Science and law. View from the bench: patents and material transfers. Science 2005;309(5743):2002-3. 3. Jensen K, Murray F. Intellectual property landscape of the human genome. Science 2005;310(5746):239-40. 4. Caulfield T, Cook-Deegan RM, Kieff FS, Walsh JP. Evidence and anecdotes: an analysis of human gene patenting controversies. Nat Biotechnol 2006;24(9):1091-4. Competing interests: None declared