Skip to main content
SpringerLink
Log in

Proliferating Patent Problems with Human Embryonic Stem Cell Research?

  • Published:
Journal of Bioethical Inquiry Aims and scope Submit manuscript

Abstract

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position of certain patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Notes

  1. ‘Patents’ or ‘patent rights’ are a form of ‘intellectual property’ or ‘intellectual property rights.’ In this article, the two terms are used interchangeably though intellectual property includes other things such as trade secrets, copyright and trademarks.

  2. This patent resulted from a subsidiary, or divisional, application made pursuant to another patent, U.S. Patent No. 5,843,780, issued to Thomson on December 1, 1998. Though this former patent pertains to all ‘primate’ embryonic stem cells, the divisional application (i.e., the U.S. Patent No. 6,200,806) specifically claims human embryonic stem cells as part of the invention. In this paper, the phrase “the WARF patents” is intended to refer to both the U.S. Patent Nos. 5,843,780 and 6,200,806. However, the U.S. Patent No. 6,200,806 is sometimes specifically referred to for greater precision.

  3. The reference to changes in U.S. policy is meant capture two particular statutes designed to enable and provide incentives for universities to transfer inventions produced with public funds to private entities: see the Bayh-Dole Act of 1980. Pub. L. No. 96–517, § 6(a), 94 Stat. 3015, 3019–28 (1980) (codified as amended at 35 U.S.C. §§ 200–212 (1994)); and the Stevenson-Wydler Technology Innovation Act of 1980. Pub. L. No. 96–480, § 2, 94 Stat. 2311–2320 (1980) (codified as amended at 15 U.S.C. §§ 3701–3714 (2000)).

References

  1. Annas, G. J., Andrews, L. B., & Isasi, R. M. (2003). Protecting the endangered human: Toward an international treaty prohibiting cloning and inheritable alterations. American Journal of Law & Medicine, 28, 151–178.

    Google Scholar 

  2. Bagley, M. A. (2003). Patent first, ask questions later: Morality and biotechnology in patent law. William and Mary Law Review, 45, 469–547.

    PubMed  Google Scholar 

  3. Benkler, Y. (2004). Commons-based strategies and the problems of patents. Science, 305, 1110–1111.

    Article  PubMed  CAS  Google Scholar 

  4. Brower, V. (1999). Human ES cells: Can you build a business around them? Nature Biotechnology, 17, 139–142.

    Article  PubMed  CAS  Google Scholar 

  5. Campbell, A., & Nycum, G. (2005). Harmonizing the international regulation of embryonic stem cell research: Possibilities, promises and potential pitfalls? Medical Law International, 7, 113–148.

    PubMed  Google Scholar 

  6. Caulfield, T. A. (2003). From human genes to stem cells: New challenges for patent law? TRENDS in Biotechnology, 21, 101–103.

    Article  PubMed  CAS  Google Scholar 

  7. Caulfield, T. A., Knowles, L., & Meslin, E. M. (2004). Law and policy in the era of reproductive genetics. Journal of Medical Ethics, 30, 414–417.

    Article  PubMed  CAS  Google Scholar 

  8. Cowan, C. A., Klimanskaya, I., McMahon, J., et al. (2004). Derivation of embryonic stem-cell lines from human blastocysts. The New England Journal of Medicine, 350, 1353–1356.

    Article  PubMed  CAS  Google Scholar 

  9. Daley, G. Q., Goodell, M. A., & Snyder, E. Y. (2003). Realistic prospects for stem cell therapeutics. Hematology, 398–418.

  10. Demaine, L. J., & Fellmeth, A. X. (2003). Natural substances and patentable inventions. Science, 300, 1375–1376.

    Article  PubMed  CAS  Google Scholar 

  11. Eisenberg, R. S. (2003). Patent swords and shields. Science, 299, 1018–1019.

    Article  PubMed  CAS  Google Scholar 

  12. Eisenberg, R. S. (1996). Public research and private development: Patents and technology transfer in government-sponsored research. Virginia Law Review, 82, 1663–1727.

    Article  Google Scholar 

  13. Eisenberg, R. S. (2001). Patenting research tools and the law. In: Intellectual Property Rights and Research Tools in Molecular Biology [book chapter on the Internet]. Washington: National Academy Press [cited 2005 June 1]. Available from: http://stills.nap.edu/html/property/2.html#2.

  14. European Group on Ethics in Science and New Technologies. Opinion No. 16, Ethical aspects of patenting inventions involving human stem cells. [released 2002 May 7; cited 2005 May 30]. Available from: http://europa.eu.int/comm/european_group_ ethics/docs/avis16_en.pdf.

  15. Farnley, S., Morey-Nase, P., & Sternfeld, D. (2004). Biotechnology – A challenge to the patent system. Current Opinion in Biotechnology, 15, 254–257.

    Article  PubMed  CAS  Google Scholar 

  16. Ferance, S. J. (2003). The experimental use defence to patent infringement. Canadian Intellectual Property Review, 20, 1–50.

    Google Scholar 

  17. Fins, J. J., & Schachter, M. (2002). Patently controversial: Markets, morals, and the president's proposal for embryonic stem cell research. Kennedy Institute of Ethics Journal, 12, 265–278.

    PubMed  Google Scholar 

  18. Flattmann, G. J., & Kaplan, J. M. (2002). Licensing research tool patents. Nature Biotechnology, 20, 945–947.

    Article  PubMed  CAS  Google Scholar 

  19. Fox, J. L. (2004). California votes for embryonic stem cell research. Nature Biotechnology, 22, 1485–1486.

    Article  PubMed  CAS  Google Scholar 

  20. Gearhart, J. (2004). New human embryonic stem-cell lines – More is better. The New England Journal of Medicine, 350, 1275–1276.

    Article  PubMed  CAS  Google Scholar 

  21. Germinario, C. (2004). The value of life: Are human embryonic stem cells patentable. Patent World, 63, 16–18.

    Google Scholar 

  22. Gold, E. R., Adams, W., Castle, D., et al. (2004). The unexamined assumptions of intellectual property: Adopting an evaluative approach to patenting biotechnological innovation. Public Affairs Quaterly, 18, 299–344.

    Google Scholar 

  23. Golden, J. M. (2001). Biotechnology, technology policy, and patentability: Natural products and invention in the American patent system. Emory Law Journal, 50, 101–191.

    Google Scholar 

  24. Heller, M. A., & Eisenberg, R. S. (1998). Can patents deter innovation? The anticommons in biomedical research. Science, 280, 698–701.

    Article  PubMed  CAS  Google Scholar 

  25. Herder, M. (2002) In (or out of) the marketplace of ideas: WARF v. Geron and lessons for Canada. Dalhousie Journal of Legal Studies, 11, 196–216.

    Google Scholar 

  26. Hettinger, E. C. (1989). Justifying intellectual property. Philosophy and Public Affairs, 18, 31–52.

    Google Scholar 

  27. Hoffman, D. C. (2003–2004). A modest proposal: Toward improved access to biotechnology research tools by implementing a broad experimental use exception. Cornell Law Review, 89, 993–1043.

    Google Scholar 

  28. Holden, C. (2001). HHS inks cell deal; NAS calls for more lines. Science, 293, 1966–1967.

    CAS  Google Scholar 

  29. Holden, C., & Vogel, G. (2002). ‘Show us the cells,’ U.S. researchers say. Science, 297, 923–925.

    Article  PubMed  CAS  Google Scholar 

  30. Howard, K. (2004). Global biotech expansion taking cues from Bayh-Dole. Nature Biotechnology, 22, 919–920.

    Article  PubMed  CAS  Google Scholar 

  31. Hughes, S. S. (2001). Making dollars out of DNA: The first major patent in biotechnology and the commercialization of molecular biology, 1974–1980. Isis, 92, 541–575.

    Article  PubMed  CAS  Google Scholar 

  32. Kesselheim, A. S., & Avorn, J. (2005). University-based science and biotechnology products: Defining the boundaries of intellectual property. Journal of the American Medical Association, 293, 850–854.

    Article  PubMed  CAS  Google Scholar 

  33. Kevles, D. J. (2002). Of mice & money: The story of the world's first animal patent. Daedalus, 131, 78–88.

    Google Scholar 

  34. Klimanskaya, I., Chung, Y., Meisner, L., et al. (2005). Human embryonic stem cells derived without feeder cells. Lancet, 365(9471), 1636–1641.

    Article  PubMed  CAS  Google Scholar 

  35. Kunin, S. G., Nagumo, M., Therkorn, L. S., & Walsh, S. (2001–2002). Reach-through claims in the age of biotechnology. American University Law Review, 51, 609–638.

    Google Scholar 

  36. Laurie, G. (2004). Patenting stem cells of human origin. European Intellectual Property Review, 2, 59–66.

    Google Scholar 

  37. Lebacqz, K. (2001). Who ‘owns’ cells and tissues? Health Care Analysis, 9, 353–368.

    Article  PubMed  CAS  Google Scholar 

  38. Lee, J. B., Kim, J. M., Kim, S. J., et al. (2005). Comparative characteristics of three human embryonic stem cell lines. Molecules and Cells, 19, 31–38.

    PubMed  CAS  Google Scholar 

  39. Lo, K. C., Chuang, W. W., & Lamb, D. J. (2003). Stem cell research: The facts, the myths and the promises. Journal of Urology, 170, 2453–2458.

    Article  PubMed  Google Scholar 

  40. Marshall, E. (2000). The business of stem cells. Science, 287, 1419–1421.

    Article  PubMed  CAS  Google Scholar 

  41. Mitchell, P. (2004). UK opens stem cell bank. Nature Biotechnology, 22, 795.

    Article  Google Scholar 

  42. Mowery, D. C., Nelson, R. R., Sampat, B. N., & Ziedonis, A. A. (2001). The growth of patenting and licensing by U.S. universities: An assessment of the effects of Bayh-Dole act of 1980. Research Policy, 30, 99–119.

    Article  Google Scholar 

  43. Mueller, J. M. (2001). No “dilettante affair”: Rethinking the experimental use exemption to patent infringement for biomedical research tools. Washington Law Review, 76, 1–66.

    Google Scholar 

  44. Ponsaerts, P., van Tendeloo, V. F., Jorens, P. G., et al. (2004). Current challenges in human embryonic stem cell research: Directed differentiation and transplantation tolerance. Journal of Biological Regulators and Homeostatic Agents, 18, 347–351.

    PubMed  CAS  Google Scholar 

  45. Rabin, S. (2005). The gatekeepers of hES cell products. Nature Biotechnology, 23, 817–819.

    Article  PubMed  CAS  Google Scholar 

  46. Rai, A. K., & Eisenberg, R. S. (2003). Bayh-Dole reform and the progress of biomedicine. Law and Contemporary Problems, 66, 289–314.

    Google Scholar 

  47. Report from the Commission to the Council and the European Parliament. Development and implications of patent law in the field of biotechnology and genetic engineering. [released 2005 July 14; cited 2005 September 18]. Available from: http://www.europa.eu.int/comm/internal_market/en/indprop/invent/com_2005_312final_en.pdf.

  48. Resnik, D. B. (2002). The commercialization of human stem cells: Ethical and policy issues. Health Care Analysis, 10, 127–154.

    Article  PubMed  Google Scholar 

  49. Resnik, D. B. (2003). A pluralistic account of intellectual property. Journal of Business Ethics, 46, 319–335.

    Article  Google Scholar 

  50. Rimmer, M. (2003). The attack of the clones: Patent law and stem cell research. Journal of Law and Medicine, 10, 488–505.

    PubMed  Google Scholar 

  51. Rodriguez, V. (2005). Material transfer agreements: Open science vs. proprietary claims. Nature Biotechnology, 23, 489–491.

    Article  PubMed  CAS  Google Scholar 

  52. Scheinfeld, R. C., & Bagley, P. H. (2001). The current state of embryonic stem cell patents. New York Law Journal, 226, 3.

    Google Scholar 

  53. Siepmann, T. J. (2004–2005). The global exportation of the U.S. Bayh-Dole Act. Dayton Law Review, 30, 209–244.

    Google Scholar 

  54. Spar, D. (2004). The business of stem cells. New England Journal of Medicine, 351, 211–213.

    Article  PubMed  CAS  Google Scholar 

  55. Thomson, J. A., Itskovitz-Eldor, J., Shapiro, S. S., et al. (1998). Embryonic stem cell lines derived from human blastocysts. Science, 282, 1145–1147.

    Article  PubMed  CAS  Google Scholar 

  56. Trilateral Project B3b. Mutual understanding in search and examination, report on comparative study on biotechnology patent practices, theme: Comparative study on “reach-through claims.” [released 2001 November; cited 2005 May 25]. Available from: http://www.uspto.gov/web/tws/B3b_reachthrough.pdf.

  57. van Overwalle, G. Patentability of human stem cells and cell lines. In: Danish Council of Ethics, The ethics of patenting human genes and stem cells. [released 2004 September 28; cited 2005 September 18]. Available from: http://www1.etiskraad.dk/graphics/03_udgivelser/engelske_publikationer/patenting_human_ genes/patents_konf_04/index.htm.

  58. Vogel, G. (2003). Stem cells lose market luster. Science, 299, 1830–1831.

    Article  PubMed  CAS  Google Scholar 

  59. Vogel, G. (2004). Stem cell claims face legal hurdles. Science, 305, 1887.

    Article  PubMed  CAS  Google Scholar 

  60. Vogel, G. (2005). Korean team speeds up creation of cloned human stem cells. Science, 308, 1096–1097.

    Article  PubMed  CAS  Google Scholar 

  61. Voorhees, M. Cellular Divide. American Lawyer Media's Law.com [website on the Internet]. [released 2003 February 11; cited 2005 May 25]. Available from: http://www.law.com/jsp/article.jsp?id=1044059452918.

  62. Webber, P. M. Patentability of human embryonic cells under the EPC. [released 2005 June 28; cited 2005 September 14, 2005]. Available from: http://pharmalicensing.com/features/disp/1119630334_42bc33fe14906.

  63. White House, Office of the Press Secretary. Remarks by the President on stem cell research. [released 2001 August 9; cited 2005 June 2]. Available from: http://www.whitehouse.gov/news/releases/2001/08/print/20010809-2.html.

  64. Wobus, A. M., & Boheler, K. R. (2005). Embryonic stem cells: Prospects for developmental biology and cell therapy. Physiological Reviews, 85, 635–678.

    Article  PubMed  CAS  Google Scholar 

  65. Yamamoto, K. R. (2004). Bankrolling stem-cell research with California dollars. The New England Journal of Medicine, 351, 1711–1713.

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgements

The author acknowledges support from the Stem Cell Network and would like to thank the members of the Novel Tech Ethics research team, based at Dalhousie University, for their helpful feedback.

Author information

Authors and Affiliations

  1. Department of Bioethics, Dalhousie University, Room C315, 5849 University Ave., Halifax, Nova Scotia, B3H 4H7, Canada

    Matthew Herder

Authors
  1. Matthew Herder
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Matthew Herder.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Herder, M. Proliferating Patent Problems with Human Embryonic Stem Cell Research?. Bioethical Inquiry 3, 69–79 (2006). https://doi.org/10.1007/s11673-006-9005-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11673-006-9005-6

Keywords

Search

Navigation