Abstract
Concerns have been voiced about the ethical implications of patenting practices in the field of biotechnology. Some of these have also been incorporated into regulation, such as the European Commission Directive 98/44 on the legal protection of biotechnological inventions. However, the incorporation of ethically based restrictions into patent legislation has not had the effect of satisfying all concerns. In this article, we will systematically compare the richness of ethical concerns surrounding biotech patenting, with the limited scope of ethical concerns actually addressed in the patent system. As sources of our analyses we will use literature and document studies and a survey with important stakeholders and experts related to Norwegian patenting in the aquacultural biotechnology sector. We will structure the analyses with an ethical matrix, developed for this purpose. Showing the misalignment of the discussions within and outside the patent system, we suggest that an important reason for the ethical controversy still surrounding patenting is that ethical questions keep being framed in a narrow way within the system. Until a richer set of ethical considerations is addressed head-on within the patent system, the patent system will continue to evoke academic and interest group criticism, potentially contributing to a legitimacy crisis of the whole system.
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Notes
After removal of duplicates. The search was carried out August 4 2016.
O’Sullivan (2012) discusses Rule 28 (c) specifically and shows that this has in some cases been interpreted more broadly, but does not suggest that this implies a general broadening of the interpretation of Article 53 (a).
Information by Christoph Then, coordinator of No Patents on Seeds! in a telephone interview August 2015, commenting on an opposition case regarding The European patent EP1330552, on selection for the breeding of dairy cows by marker DNA.
Note that Forsberg (2012) argues that the term ‘moral’ here is slightly misleading. She argues that this dimension of legitimacy (in Suchman’s definition) should rather be called ‘normative’ legitimacy, as it can refer to norms held by a certain community of people, but which nevertheless lack the universal character of most moral norms. In our case, however, when we discuss how the public views the moral legitimacy of the patent institution, the term ‘moral’ fits better as the normative evaluations here are not exclusive to certain groups’ norms, but represent general societal values.
Thambisetty (2017) offers an interesting account of how the EPO through instrumental use of textualisation and other strategies tries to repair some of the legitimacy lost or revoked by civil society organisations, while at the same time maintaining its legitimacy in the eyes of the patent community.
References
Adams, W. (2003). The myth of patent neutrality: Property, patents, animal rights and animal welfare in commissioner of patents V. President and fellows of Harvard College. Canada Business Law Journal, 39, 181.
Beauchamp, T., & Childress, J. (2012, 1979). The principles of biomedical ethics. Oxford and New York: Oxford University Press.
Beekman, V., De Bakker, E., Baranzke, H., Baune, Ø., Deblonde, M., Forsberg, E-M., et al. (2006). Ethical bio-technology assessment tools for agriculture and food production. 2006/2. http://estframe.net/ethical_bio_ta_tools_project/content_2/text_2c81d261-b7a8-43e8-8f1e-d724b43e2ba3/1346076907647/et1_final_report_binnenwerk_59p.pdf. Accessed 5 Jan 2016.
Beyleveld, D. (2000). Regulating morality through patent law. Critique of the EC Directive. Revista De Derecho Y Genoma Humano = Law And The Human Genome Review/Cátedra De Derecho Y Genoma Humano/Fundación BBV-Diputación Foral De Bizkaia, 12, 141–171.
Borrás, S., Koutalakis, C., & Wendler, F. (2007). European agencies and input legitimacy: EFSA, EMeA and EPO in the post-delegation phase. Journal of European Integration, 29(5), 583–600.
Cho, M. K., Illangasekare, S., Weaver, M. A., Leonard, D. G., & Merz, J. F. (2003). Effects of patents and licenses on the provision of clinical genetic testing services. The Journal of Molecular Diagnostics, 5(1), 3–8.
Ciliberti, R. (1993). Biotechnological patents and ethical aspects. Cancer Detection and Prevention, 17(2), 313–315.
Crespi, R. S. (1993). Ethical aspects of patenting in biotechnology. Cancer Detection and Prevention, 17(2), 323–327.
Crespi, R. S. (2000). An analysis of moral issues affecting patenting inventions in the life sciences: A European perspective. Science and Engineering Ethics, 6(2), 157–180.
Crespi, R. S. (2005). Ethico-legal issues in biomedicine patenting: A patent professional viewpoint. Science and Engineering Ethics, 11(1), 117–136.
Dickenson, D. (2004). Consent, commodification and benefit-sharing in genetic research. Developing World Bioethics, 4(2), 109–124.
Drahos, P. (1999). Biotechnology patents, markets and morality. European Intellectual Property Review, 21(9), 441–449.
Drahos, P. (2010). The global governance of knowledge. Patent offices and their clients. Cambridge: Cambridge University Press.
European Group on Ethics (EGE). Opinion no. 16: Ethical aspects of patenting inventions involving human stem cells (07/05/2002).
Falcone, A. (2009). Genetics and new fundamental rights: From international declarations to protection of the human genome and the innovation of national constitutions: Towards a global protection of the genetic heritage of humanity. Persona y Derecho, 60, 271–311.
Faunce, T. A., & Nasu, H. (2008). Three proposals for rewarding novel health technologies benefiting people living in poverty. A comparative analysis of prize funds, health impact funds and a cost-effectiveness/competitive tender treaty. Public Health Ethics, 1(2), 146–153. doi:10.1093/phe/phn013.
Forsberg, E.-M. (2007). A deliberative ethical matrix method—Justification of moral advice on genetic engineering in food production. Dr. Art. Dissertation. Oslo, Unipub.
Forsberg, E.-M. (2011). Inspiring respect for animals through the law? Current development in the Norwegian Animal Welfare Legislation. Journal of Agricultural and Environmental Ethics, 24, 351–366.
Forsberg, E.-M. (2012). Applying instruments for regional innovation—Generating projects or legitimacy? International Journal of Innovation and Regional Development, 4(5), 430–445.
Frati, L., Foà, R., & Frati, P. (1999). The patentability of living organisms between science, law and ethics. Forum, 9(3 Suppl 3), 8–14.
Gurry, F. (2005). The growing complexity of international policy in intellectual property. Science and Engineering Ethics, 11(1), 13–20.
Hettinger, N. (1995). Patenting life: Biotechnology, intellectual property, and environmental ethics. Boston College Environmental Affairs Law Review, 22(2), 267–305.
Hodgson, C. P. (1987). Social and legal issues of biotechnology: An educational perspective. The Ohio Journal of Science, 87(5), 148–153.
Kaiser, M., Millar, K., Thorstensen, E., & Tomkins, S. (2007). Developing the ethical matrix as a decision support framework: GM fish as a case study. Journal of Agricultural and Environmental Ethics, 20(1), 65–80.
Kluge, E. W. (2003). Patenting human genes: When economic interests trump logic and ethics. Health Care Analysis: HCA: Journal Of Health Philosophy And Policy, 11(2), 119–130.
Krikorian, G., & Kapczynski, A. (2010). Access to knowledge in the age of intellectual property. Zone Books. https://mitpress.mit.edu/sites/default/files/titles/free_download/9781890951962_Access_to_Knowledge_in_the_Age_of_Intellectual_Property.pdf.
Laurie, G. (2008). Ethical aspects of patenting. In Den etiske nemnda for patentsaker. Patentnmend uten portefølje? Publikasjon nr. 7. Oslo. https://www.etikkom.no/globalassets/documents/publikasjoner-som-pdf/patentnemnd-uten-portefolje-2008.pdf.
Llewelyn, M. (2002). European plant intellectual property. Journal of Herbs, Spices & Medicinal Plants, 9(4), 389.
Macer, D. R. J. (2002). Patent or perish? An ethical approach to patenting human genes and proteins. The Pharmacogenomics Journal, 2, 361–366.
Mangan, K. S. (1987). Institutions and scholars face ethical dilemmas over pursuit of research with commercial value. Chronicle of Higher Education, 33(46), 11–12.
Marturano, A. (2009). When speed truly matters, openness is the answer. Bioethics, 23(7), 385–393.
Mayer, S. (2006). Declaration of patent applications as financial interests: A survey of practice among authors of papers on molecular biology in Nature. Journal of Medical Ethics, 32(11), 658–661.
Mepham, T. B. (2000). A framework for the ethical analysis of novel foods: The ethical matrix. Journal of Agricultural and Environmental Ethics, 12, 165–176.
Mepham, T. B. (2005). Bioethics. An introduction for the biosciences. Oxford: Oxford University Press.
Milius, D., & Townend, D. (2008). Thoughts on the scope and operation of morality clauses in patent law. In Den etiske nemnda for patentsaker. Patentnmend uten portefølje? Publikasjon nr. 7. Oslo. https://www.etikkom.no/globalassets/documents/publikasjoner-som-pdf/patentnemnd-uten-portefolje-2008.pdf. Accessed February 5, 2016.
No Patents on Seeds! (2016). Patents on plants and animals—Time to act for European politicians. http://no-patents-on-seeds.org/sites/default/files/news/report_patents_on_seeds_time_to_act_2016.pdf Accessed March 7, 2017.
O’Sullivan, E. (2012). Is Article 53 (a) EPC still of narrow interpretation? Journal of Intellectual Property Law & Practice, 7(9), 680–690.
Oberthür, S., & Rosendal, G. K. (2014). Global governance of genetic resources: Access and benefit sharing after the Nagoya Protocol. New York and London: Routledge.
Parthasarathy, S. (2015). Co-producing knowledge and political legitimacy. In S. Hilgartner, C. Miller, & R. Hagendijk (Eds.), Science and democracy: Making knowledge and making power in the biosciences and beyond (pp. 74–93). London: Routledge.
Radder, H. (2004). Exploiting abstract possibilities: A critique of the concept and practice of product patenting. Journal of Agricultural and Environmental Ethics, 17(3), 275–291.
Reiss, M. J. (2003). The ethics of patenting DNA. Journal of Commercial Biotechnology, 9(3), 192–198.
Resnik, D. B. (2001). DNA patents and human dignity. Journal of Law, Medicine and Ethics, 29, 152–165.
Rigaud, N. (2008). Biotechnology: Ethical and social debates. http://www.oecd.org/futures/long-termtechnologicalsocietalchallenges/40926844.pdf. Accessed June 13, 2016.
Ross, D. (1930). The right and the good. Oxford: Clarendon Press (2002).
Santoro, M. A., & Gorrie, T. M. (2005). Ethics and the pharmaceutical industry. Cambridge: Cambridge University Press.
Schneider, I. (2012). To be or not IP? Exploring limits within patent law for the constitutionalization of intellectual property rights and the governance of synthetic biology in human health. Revista De Derecho Y Genoma Humano = Law And The Human Genome Review/Cátedra De Derecho Y Genoma Humano/Fundación BBV-Diputación Foral De Bizkaia, 37, 193–233.
Schofield, P. N., Bubela, T., Weaver, T., Portilla, L., Brown, S. D., Hancock, J. M., et al. (2009). CASIMIR Rome Meeting participants. Post-publication sharing of data and tools. Nature, 461, 171–173.
Smith, R. D., Thorsteinsdottir, H., Daar, A. S., Gold, E. R., & Singer, P. A. (2004). Genomics knowledge and equity: A global public goods perspective of the patent system. Bulletin of the World Health Organization, 82(5), 385–389.
Soini, S., Aymé, S., & Matthijs, G. (2008). Patenting and licensing in genetic testing: Ethical, legal and social issues. European Journal of Human Genetics, 16, 510–550.
Staff Representatives, EPO. (2007). Governance of the EPO: A staff perspective, CA/93/07. http://www.suepo.org/public/ec07093.pdf. Accessed September 20, 2015.
Sterckx, S., & Cockbain, J. (2012). Exclusions from patentability. How far has the European Patent Office eroded boundaries?. Cambridge: Cambridge University Press.
Suchman, M. C. (1995). Managing legitimacy: Strategic and institutional approaches. Academy of Management Review, 20(3), 571–610.
Terragni, F. (1993). Biotechnology patents and ethical aspects. Cancer Detection and Prevention, 17(2), 317–321.
Thambisetty, S. (2017). The construction of legitimacy in European patent law. Intellectual Property Quarterly, 3. ISSN 1364-906X (In Press).
Toronto International Data Release Workshop Authors. (2009). Prepublication data sharing. Nature, 461, 168–170. doi:10.1038/461168a.
Van der Burg, W., & Brom, F. W. A. (2000). Legislation on ethical issues: Towards an interactive paradigm. Ethical Theory and Moral Practice, 3, 57–75.
Warren-Jones, A. (2004). Patenting DNA: A lot of controversy over a little intangibility. Medical Law Review, 12(1), 97–124.
Zimmer, F., & Sethmann, S. (2005). The immoral gene: Does it really exist? Science and Engineering Ethics, 11(1), 97–104.
Acknowledgements
This work has been funded by the Research Council of Norway’s ELSA program, Grant No 220609/O70. We are grateful for all the discussions we have had with our good colleagues Morten Walløe Tvedt and Nico Groenendijk in the Patent Ethics project, and we appreciate the useful feedback we received in the publication process.
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Forsberg, EM., Hanssen, A.B., Nielsen, H.M. et al. Patent Ethics: The Misalignment of Views Between the Patent System and the Wider Society. Sci Eng Ethics 24, 1551–1576 (2018). https://doi.org/10.1007/s11948-017-9956-5
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DOI: https://doi.org/10.1007/s11948-017-9956-5