Advertisement

Patenting of Human Stem Cell-Based Inventions: Ethical Issues Including and Beyond the Morality Clause

  • Göran Hermerén
Part of the Stem Cell Biology and Regenerative Medicine book series (STEMCELL)

Abstract

Using the goals of patent law as a starting point, controversies over patent applications are put in a wider ethical and societal context. I argue that ethical aspects are relevant in three phases: (1) before the patent application is granted, when the conditions of patentability are applied to concrete cases; (2) in the patent law, especially in interpretation and application of the so-called ”morality clause” in the European Patent Convention; (3) but also after patents have been granted. Differences between different patent systems are mentioned briefly, and the choice between more liberal and more restrictive policies is obviously not ethically neutral.

After a brief discussion of the relations between patents, economy and politics, some current criticisms of patent and patent law are discussed. Internal criticism, more or less accepting the premises of the system and trying to improve it, is distinguished from more radical, external criticism, which challenges one or several of the premises of the current patent system. This paves the way for a discussion of future relations between ethics and patent law. Some problems of definition and interpretation, again highlighting the role of values in the controversies over patents, are indicated, and the chapter concludes with a discussion of the present and future relations between EGE (European Group on Ethics) and EPO (European Patent Office).

Keywords

Ethics Patents Stem cells Morality clause Biotech directive 

References

  1. 1.
    European Parliament and Council Directive 98/44/EC on the legal protection of biotechnological inventions. Official Journal of the European Communities, 1998, L 213.Google Scholar
  2. 2.
    Bioethics and Patent Law. The case of Myriad genetics. WIPO Magazine, August 2006. Can be downloaded via www.wipo.int/wipo_magazine/en/2006/04/article_0003.html
  3. 3.
    Schneider I. Governing the patent system in Europe: the EPO’s supranational autonomy and its need for a regulatory perspective. Sci Public Policy 2009; 36:619–29.CrossRefGoogle Scholar
  4. 4.
    Cyranoski D. Arsenic patent keeps drugs for rare cancer out of reach of many. Nat Med 2007; 13:1005. Epub 2007 Aug 31.PubMedCrossRefGoogle Scholar
  5. 5.
    Warrell RP. Reply to “Arsenic patent keeps drugs for rare cancer out of reach of many.” Nat Med 2007; 13:1278.PubMedCrossRefGoogle Scholar
  6. 6.
    Van Overwalle G. Gene patents and collaborative licensing mechanisms. Patent pools, clearing houses, open source models and liability regimes. Cambridge: Cambridge University Press, 2009.CrossRefGoogle Scholar
  7. 7.
    Pogge T. Freedom from poverty as a human right: who owes what to the very poor? Oxford: Oxford University Press, 2007.Google Scholar
  8. 8.
    Pogge T. World poverty and human rights: cosmopolitan responsibilities and reforms. 2nd expanded edition. Cambridge: Polity Press, 2008.Google Scholar
  9. 9.
    Bentham J. An introduction to the principles of morals and legislation. Oxford: Clarendon, 1996.Google Scholar
  10. 10.
    Singer P. Practical ethics. Cambridge: Cambridge University Press, 1993.Google Scholar
  11. 11.
    Gewirth A. Reason and morality. Chicago: University of Chicago Press, 1978.Google Scholar
  12. 12.
    Gewirth A. The community of rights. Chicago: University of Chicago Press, 1996.Google Scholar
  13. 13.
    Beyleveld D, Brownsword R. Human Dignity in Bioethics and Biolaw. Oxford and New York: Oxford University Press, 2002.Google Scholar
  14. 14.
    Brownsword R. Human dignity, ethical pluralism, and the regulation of modern biotechnologies. In: T. Murphy ed., New technologies and human rights. Oxford: Oxford University Press, 2009, pp. 19–84.CrossRefGoogle Scholar
  15. 15.
    Council of Europe. 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. European Treaty Series – No. 164. Council of Europe, Oviedo, 4 IV, 1997.Google Scholar
  16. 16.
    Crisp R, Slote M (eds.). Virtue ethics. Oxford: Oxford University Press, 1997.Google Scholar
  17. 17.
    Chappell T (ed.). Values and virtues. Oxford: Oxford University Press, 2006.Google Scholar
  18. 18.
    Urbach A, Bar-Nur O, Daley GQ, Benvenisty N. Differential modeling of Fragile X syndrome by human embryonic stem cells and induced pluripotent stem cells. Cell Stem Cell 2010; 6:407–11.PubMedCrossRefGoogle Scholar
  19. 19.
    US Patent, Patent Number 4,736,866. Filed Jun 22, 1984, date of Patent April 12, 1988. Inventors: Leder et al.Google Scholar
  20. 20.
    European Patent Office. Board of appeal decision T 315/03 of July 6, 2004.Google Scholar
  21. 21.
    Ching LL. Canada’s supreme court rules out patents on higher life forms. ISIS, 30 Jan 03; downloadable from www.mindfully.org/GE/2003/Canada-Patents-Life30jan03.htm.
  22. 22.
    European Group on Ethics EGE, Opinion on the ethical aspects of patenting inventions involving human stem cells. Opinion N° 16. Brussels, Belgium: 7 May 2002.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Göran Hermerén
    • 1
  1. 1.Department of Medical EthicsLund University Biomedical CentreLundSweden

Personalised recommendations