Patents on genes and other types of biomarkers have caused much controversy, but their importance to diagnostic innovation is in danger of being overlooked.
References
Nuffield Council on Bioethics. The ethics of patenting DNA (Nuffield Council on Bioethics, 2002).
Secretary's Advisory Committee on Genetics, Health, and Society. Gene patents and licensing practices and their impact on patient access to genetic tests (US Department of Health and Human Services, Washington, DC, 2010).
National Research Council. Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment (eds. Nass, S.J. & Moses, H.L.) (National Academies Press, Washington, DC, 2007).
Garrison, L.P. Jr. & Finley Austin, M.J. Health Aff. 25, 1281–1290 (2006).
National Endowment for Science, Technology and the Arts. The Innovation Gap, 24–26 (NESTA, London, 2006).
Cho, M.K. et al. J. Mol. Diagn. 5, 3–8 (2003).
Carbone, J. et al. Nat. Biotechnol. 28, 784–791 (2010).
Huys, I. et al. Nat. Biotechnol. 27, 903–909 (2009).
Association for Molecular Pathology v. USPTO et al., 669 F. Supp. 2d 365 - Dist. Court, SD New York (2009).
Stigilitz, J.E. BMJ 333, 1279–1280 (2006).
Association for Molecular Pathology v. Myriad Genetics, et al. 11–725 http://www.supremecourt.gov/orders/courtorders/032612zor.pdf
Decision of the Technical Board of Appeal 3.3.04, T 0080/05 (19 November 2008). http://www.epo.org/law-practice/case-law-appeals/pdf/t050080eu1.pdf
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 US ___ (2012).
Human Genetics Commission. Intellectual property and DNA diagnostics (Department of Health, London, 2011).
Gaisser, S. et al. Nature 458, 407–408 (2009).
Huys, I., Van Overwalle, G. & Matthijs, G. Eur. J. Hum. Genet. 19, 1104–1107 (2011).
The text of national legislation wherein these modifications can be found for France, Switzerland and Belgium can be found at the following sites, respectively: <http://www.legifrance.gouv.fr/affichCodeArticle.do;jsessionid=3011BE79C398F76D3F3C4286E5B42992.tpdjo10v_1?cidTexte=LEGITEXT000006069414&idArticle=LEGIARTI000006279493&dateTexte=20120402&categorieLien=id#LEGIARTI000006279493> <http://www.wipo.int/export/sites/www/tk/en/laws/pdf/switz_patent_law_2008.pdfhttp://www.wipo.int/wipolex/en/text.jsp?file_id=180969>
Matthijs, G. Br. Med. J. 329, 1358–1360 (2004).
Malik, N.N. Nat. Biotechnol. 29, 390–391 (2011).
Baker, M. Nat. Biotechnol. 24, 931–938 (2006).
Digene Corp. Annual Report (2003).
Hogarth, S., Hopkins, M. & Rodriguez, V. Sociol. Health Illn. 34, 234–250 (2012).
Hopkins. M.M. et al. Nat. Biotechnol. 24, 403–410 (2006).
Liddell, K., Hogarth, S., Melzer, D. & Zimmern, R. Intellect. Property Q. 3, 286–327 (2008).
Cornish, W.R., Llewelyn, M. & Adcock, M. Intellectual property rights (IPRs) and genetics (Public Health Genetics Unit, Cambridge, 2003).
Organisation for Economic Co-operation and Development. Guidelines for the licensing of genetic inventions (OECD, 2006).
Association of University Technology Managers. In the public interest: nine points to consider in licensing university technology (AUTM, 2007).
Thompson, M. et al. BMJ 342, d2973 (2011).
Acknowledgements
This article was prepared following a workshop on behalf of the UK's Human Genetics Commission (HGC). The article draws primarily on discussions held at the workshop. The authors are grateful to the workshop participants, HGC and the anonymous reviewers. The views expressed are those of the authors'.
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Hopkins, M., Hogarth, S. Biomarker patents for diagnostics: problem or solution?. Nat Biotechnol 30, 498–500 (2012). https://doi.org/10.1038/nbt.2257
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DOI: https://doi.org/10.1038/nbt.2257
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