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From the Patentability of Living Matter to the Ethics of Biotechnological Innovation: the Person-Body Relationship

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Biotech Innovations and Fundamental Rights

Abstract

Recent biotechnological advancements in molecular genomics are contributing to shape a market in health care where legal and moral quandaries arise in connection with the patenting of living matter. This is a problem to approach which I propose an ethic of biotechnological innovation that views the human body and its parts as an entity protected under the principle of personal biological identity and inviolability: I argue that we need to consolidate a legal-bioethical perspective accompanying the new rights and freedoms asserted with respect to the body, where the body is at once a source and an object of claims. More to the point, it seems important to consolidate a principle recognizing a bodily or biological identity alongside our personal reality, in such a way as to expand the current ownership model, on which the body is conceived as property.

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Notes

  1. 1.

    For a discussion, see L. B. Andrews, D. Nelkin, Body Bazaar: The Market for Human Tissue in the Biotechnology Age, New York, 2001, at 243.

  2. 2.

    N. Rose, The Politics of Life Itself: Biomedicine, Power and Subjectivity in the Twenty-First Century, Princeton, 2007, at 11.

  3. 3.

    K. Sunder Rajan, Biocapital. The Constitution of Postgenomic Life, Dhuram and London, 2006, at 434.

  4. 4.

    It would be remiss here not to mention the 1980 case Diamond v. Chakrabarty, where the U.S. Supreme Court held that a genetically modified micro-organism is patentable subject matter. This ruling — which locates the criterion for patentability in the distinction between human intervention and the work of nature -has become a reference point in all subsequent discussion on the patentability of living matter in Europe and the United States alike. Indeed, the effect of this ruling has been to make widely accepted on both sides of the Atlantic Chief Justice Burger’s remark that patentable subject matter can be made to “include anything under the sun that is made by man.”

  5. 5.

    More on this topic, see D. B. Resnik, The Ethics of Science: An Introduction, London and New York, 1998, at 221.

  6. 6.

    European Patent Convention (1973), an updated version available at 〈http://www.epo.org/lawpractice/legal-texts/epc.html〉 (April 15, 2011).

  7. 7.

    Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, available at 〈http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:213:0013:0021:EN:PDF〉 (April 12, 2011).

  8. 8.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4 April 1997, available at 〈http://conventions.coe.int/Treaty/en/Treaties/html/164.htm〉 (March 4, 2011).

  9. 9.

    The charter was signed and proclaimed in Nice on 7 December 2000. However, not until the Treaty of Lisbon came into force, on 13 December 2007, was the charter given binding legal effect equal to the treaties.

  10. 10.

    The EGE has found that “the patentability of embryonic cell lines is morally acceptable so long as these lines are genetically modified and aimed at the production of specific stem cells.” EGE, Ethical aspects of patenting inventions involving human stem cells, Opinion n. 16, 7th May, 2002. For a discussion see D. B. Resnik, “DNA Patents and Human Dignity,” Journal of Law, Medicine & Ethics, 2001 (29), at 152–165.

  11. 11.

    The EU directive expressly prohibits the patenting of human embryos for commercial use. It is unclear, however, whether this prohibition is to be broadly construed as ruling out en bloc any research on human embryonic stem cells, or whether it should more restrictively be interpreted to mean that there can be no patenting of inventions involving the destruction of human embryos. The moral reasons for the proscription are therefore not unambiguous: its interpretation winds up being entrusted to the political process, where the application of broad, and hence open-ended, moral principles is worked out by way of compromise solutions.

  12. 12.

    On the protection of genetic identity and on a right to genetic integrity, see C. Faralli, S. Zullo, “Terapia genica e diritti della persona”, Trattato di biodiritto, vol. II, diretto da S. Rodotà — P. Zatti, Milano, 2011, at 511–529.

  13. 13.

    T. Caulfield, R. Brownsword, “Human dignity: a guide to policy making in the biotechnology era?”, Nature Review Genetics, 2006–7 (7), at 72–76.

  14. 14.

    John Moore was a cured leukemia patient whose spleen was removed in 1976 by physicians at the University of California at Los Angeles (UCLA) Medical Center. In the next years, the Medical Cenetr granted US patent on the cell line of John Moore. So that Mr. Moore claimed an ownership interest in the patent which generated substantial revenue through commercial arrangements. Mr. Moore was not informed about the research work or the potential of the cell line. On appeal, the Supreme Court of California rejected Mr. Moore’s claim to ownership interest in the patent: he was not one of the inventors. But the Court claimed that a physician has a “duty” to inform a patient of any economic or personal interest in using or studying his tissues.

  15. 15.

    M. Marzano, La philosophie du corps, Paris, 2007, at 127.

  16. 16.

    J. H. Fujimura, “Postgenomic futures: translations across the machine-nature border in systems biology”, New Genetic and Society, 2005, (2), at 195–226; F. Kamm, “Moral Status and Personal Identity: Clones, Embryos, and Future Generations”, Social Philosophy and Policy, 2005 (2), at 283–307.

  17. 17.

    The Moore case posed the problem of who is to be recognized as the rightful owner of a body part (here a specific cell sequence). The only right Moore was recognized as having vis-à-vis the parts extracted from his body — the right to confidentiality and human dignity — can be alienated by informed consent. The case cannot be reduced to an economic conflict between the parties: we can appreciate this because, especially in light of the subsequent bioethical debate on the issue, the case called the proprietary model into play, greatly expanding the concepts of use, exploitation, appropriation, and identity.

  18. 18.

    J. Locke, Two Treatises of Government, Cambridge, 1960; J. S. Mill, On Liberty, New York, 1956.

  19. 19.

    M. Merleau-Ponty, Phenomenology of Perception, New York, 1962; P. Ricoeur, Oneself as Another, Chicago, 1992.

  20. 20.

    P. Zatti, “Principi e forme del governo del corpo”, in Trattato di biodiritto, ed. S. Rodotà and P. Zatti, vol. 2, chap. 5, Milano, 2011, at 57–86.

  21. 21.

    R. Esposito, Terza persona: Politica della vita e filosofia dell’impersonale, Torino, 2007.

  22. 22.

    K. Sunder Rajian, “Genomic Capital: Public Cultures and Market Logics of Corporate Biotechnology.” Science as Culture, 2003, (1), at 87–121.

  23. 23.

    M. Tallacchini, “Habeas corpus? Il corpo umano tra non commerciabilità e brevettabilità.” Bioetica, 1998, (4) at 531–52.

References

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  2. N. Rose, The Politics of Life Itself: Biomedicine, Power and Subjectivity in the Twenty-First Century, Princeton, 2007, at 11.

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  4. D. B. Resnik, The Ethics of Science: An Introduction, London and New York, 1998, at 221.

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  6. M. Marzano, La philosophie du corps , Paris, 2007, at 127.

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  8. J. Locke, Two Treatises of Government, Cambridge, 1960; J. S. Mill, On Liberty, New York, 1956.

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    Google Scholar 

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Zullo, S. (2012). From the Patentability of Living Matter to the Ethics of Biotechnological Innovation: the Person-Body Relationship. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_7

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