The need for patents on medical genetic testing

20.24 Patent law creates an incentive to invest in the research and development of new products by providing a limited monopoly on the manufacture, use or sale of the patented invention. In the context of medical genetic testing, patent rights may be justified if they encourage investment in research that leads to the development of new, clinically useful, medical genetic tests.

20.25 Such an incentive may be required for the development of some medical genetic tests.[36] Even some of the most outspoken critics of gene patents concede that, in some cases, it may require significant effort to convert a known genetic sequence into a reliable and clinically useful medical genetic test. An empirical study in 2003 of medical biotechnology patenting by Nicol and Nielsen (Nicol–Nielsen Study) found that some individuals who work in public sector laboratories have a positive view of the impact of patents on medical genetic testing, depending on what the patents are and how they are exploited.[37]

20.26 It has been suggested that patent law incentives may not be as necessary to the development of genetic tests as they are to the development of other therapeutic goods, notably drugs. Professor Lori Andrews has argued that, while proponents of gene patents have tried to justify such patents by reference to arguments in favour of patenting drugs, drug patenting is not the appropriate analogy.[38] A study of clinical laboratories in the United States found that laboratories are able to translate published data into clinical tests quickly, without the incentive provided by patents.[39] The study suggested that patents are not critical to the development of genetic testing into a commercially viable service.[40]

20.27 Some submissions to the Inquiry doubted that patents are necessary to the development of new genetic tests.[41] The HGSA noted that many genetic tests are not expensive to develop and, for some tests, the costs involved in determining the gene sequence ‘are not the issue’. Instead, the real expense ‘relates to the cost of developing the platform that is used to perform the test eg sequencing or array technology or meeting regulatory requirements prior to marketing’.[42] Other submissions were clear about the importance of patents to genetic testing research and development, and focused on the role of patents in facilitating the development of research results into usable tests or therapeutics.[43]

[36] Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002), 51.

[37] D Nicol and J Nielsen, Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry (2003) Centre for Law and Genetics Occasional Paper No 6, 202.

[38] L Andrews, ‘The Gene Patent Dilemma: Balancing Commercial Incentives with Health Needs’ (2002) 2 Houston Journal of Health Law & Policy 65, 77–79.

[39] M Cho and others, ‘Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services’ (2003) 5 Journal of Molecular Diagnostics 3, 9. See also D Leonard, ‘Medical Practice and Gene Patents: A Personal Perspective’ (2002) 77 Academic Medicine 1388.

[40] M Cho and others, ‘Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services’ (2003) 5 Journal of Molecular Diagnostics 3, 9.

[41] Royal College of Pathologists of Australasia, Submission P26, 1 October 2003; Human Genetics Society of Australasia, Submission P31, 3 October 2003; G Suthers, Submission P30, 2 October 2003.

[42] Human Genetics Society of Australasia, Submission P31, 3 October 2003.

[43] GlaxoSmithKline, Submission P33, 10 October 2003; Department of Industry Tourism and Resources, Submission P36, 13 October 2003; Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003; Genetic Technologies Limited, Submission P45, 20 October 2003; A McBratney and others, Submission P47, 22 October 2003; Queensland Government, Submission P57, 5 January 2004; AusBiotech Ltd, Submission P58, 7 November 2003.