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Embryonic Stem Cell Patents and Personalized Medicine in the European Union

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Personalized Medicine

Part of the book series: Europeanization and Globalization ((EAG,volume 2))

Abstract

This chapter scrutinizes the legal framework for research and patenting of inventions involving human embryonic stem cells in the European Union. Particular attention is given to the analysis of the relevant provisions of the Directive on Patents in Biotechnology and the two cases in which questions were referred to the CJEU, concerning provisions of the Directive that affect the patentability of human embryonic stem cell inventions. The close examination of Article 6 paragraph 2 items (a) and (c) reveals that the biggest problems in the uniform application of the provisions contained therein are caused by the lack of definitions of some very important terms and concepts, such as “human embryo” and “uses of human embryos.” It is suggested that it is not legally correct to define embryos as to include organisms created by somatic cell nuclear transfer and parthenogenesis for the purposes of the Directive because these organisms cannot complete the development of a human being, and the embryo is protected by the Directive primarily as an entity that has the capability to complete this process. Furthermore, it is put forward that the concept “uses of human embryo” should not encompass uses of human embryos in the stage of research, but it should prevent patentability only if human embryos are used when working the invention. Any wider interpretation would be in conflict with the wording of the general ordre public and morality clause from Article 6 paragraph 1 of the Directive.

Jasmina Mutabžija Ph.D., LL.M.; PAR Business School, Rijeka, Croatia.

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Notes

  1. 1.

    For more information on the basic science of embryonic stem cells and stem cells in general see e.g. DHHS (2001), NA (2006), and NIH (2009).

  2. 2.

    For more information on human cloning, see, e.g., UNESCO (2005).

  3. 3.

    For more information on parthenogenesis, see, e.g., Wilmut (2007).

  4. 4.

    For more information on the use of stem cells for research, see, e.g., DHHS (2001); Jones and Thomson (2000); Rathjen et al. (1998).

  5. 5.

    For more on the use of stem cells for drug testing, see, e.g., DHHS (2001), pp. 17–18.

  6. 6.

    See EGE (2000), p. 9.

  7. 7.

    For more on the use of stem cells for treatment, see DHHS (2001), pp. 17–18 and 59–93.

  8. 8.

    Rabesandratana (2014).

  9. 9.

    As of 9 June 2015, the Convention was signed and ratified by the following EU member states: Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Latvia, Lithuania, Portugal, Romania, Slovakia, Slovenia, and Spain; it was signed but not ratified by the following EU member states: Italy, Luxembourg, Netherlands, Poland, and Sweden; it was neither signed nor ratified by Austria, Belgium, Germany, Ireland, Malta, and the United Kingdom.

  10. 10.

    As of 9 June 2015, the Protocol was signed and ratified by the following EU member states: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Greece, Hungary, Latvia, Lithuania, Portugal, Romania, San Marino, Slovakia, Slovenia, and Spain; it was signed but not ratified by the following EU member states: Denmark, France, Italy, Luxembourg, Netherlands, Poland, Sweden; it was neither signed nor ratified by Austria, Belgium, Germany, Ireland, Malta, and the United Kingdom.

  11. 11.

    See EGE (1998).

  12. 12.

    See Council of Europe (1998), paras 16–20.

  13. 13.

    See Pattinson and Caulfield (2004).

  14. 14.

    See ECHR (2004).

  15. 15.

    For example, Finland, which has both signed and ratified the Convention, defines the human embryo as “a living group of cells resulting from fertilization not implanted in a woman’s body.” See Medical Research Act of Finland (1998).

  16. 16.

    See Council of Europe (1998), para. 6.

  17. 17.

    For information about the regulation of stem cell research in various European countries, see, e.g., EuroStemCell (2012).

  18. 18.

    For the history of the Directive, see Porter (2010).

  19. 19.

    See ECJ (2001). For the comment of the case, see, e.g., Scott (1999).

  20. 20.

    The Directive on Patents in Biotechnology came into force on 30 June 1998, whereas the EU member states had the obligation to harmonize their national legislation with its contents until 30 June 2000. However, in 2003, the European Commission had to submit claims against the seven EU member state before the European Court of Justice, namely, Sweden in case C-518/03, the Netherlands in case C-395/03, France in case C-448/03, Luxembourg in case C-450/03, and Belgium in case C-454/03, because they failed to implement the Directive in time. Subsequently, the Directive was implemented by all EU member states, the last one to do so being Luxembourg on 23 April 2006.

  21. 21.

    This could be concluded from recital 16 of the Directive on Patents in Biotechnology, which reads: “Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells […] cannot be patented.”

  22. 22.

    See recital 16 of the Directive on Patents in Biotechnology: “Whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells […] cannot be patented.”

  23. 23.

    See, e.g., Denker (2006).

  24. 24.

    But see Denker (2008), who claims that patenting is barred whenever cells have the potential to renew the embryo even if such potential is shown exclusively with significant human intervention. However, if that reasoning would be applied, one could also say that the nucleus of every cell in the body is totipotent since it supports embryo development if transferred to an unfertilized egg cell by means of somatic cell nucleus transfer.

  25. 25.

    See Eisenberg (2000).

  26. 26.

    This provision is related to Article 3 paragraph 2 of the Directive, which reads: “Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.”

  27. 27.

    See recital no. 20 of the Directive on Patents in Biotechnology.

  28. 28.

    See recital no. 20 of the Directive on Patents in Biotechnology.

  29. 29.

    Recital 34 of the Directive, however, prescribes that the Directive shall be without prejudice to concepts of invention and discovery, as developed by national, European, or international patent law. About the theories concerning the distinction between inventions and discoveries in the field of human biotechnology, see Mutabžija (2014), pp. 31–41.

  30. 30.

    See recitals 17 and 18 of the Directive on Patents in Biotechnology.

  31. 31.

    See, e.g., Denker (2008).

  32. 32.

    See Triller Vrtovec and Vrtovec Vrtovec (2007). Similarly also Webber (2005), pp. 242–243.

  33. 33.

    See the last part of the sentence in Article 5 paragraph 1 in the English language: “cannot constitute patentable inventions,“ in the French language: “ne peuvent constituer des inventions brevetables,” and in the German language: “können keine patentierbaren Erfindungen darstellen.”

  34. 34.

    See the last part of the sentence in Article 5 paragraph 2 in the English language: “may constitute a patentable invention,” in the French language: “peut constituer une invention brevetable,” and in the German language: “kann eine patentierbare Erfindung sein.”

  35. 35.

    Herdegen, for example, is of the opinion that this provision relates exclusively to reproductive cloning. See Herdegen (2002), p. 154. However, certain documents related to the history of the Directive on Patents in Biotechnology point to the conclusion that the intention of its drafters was to exclude from patentability not only reproductive but also therapeutic cloning. For instance, in drafting Article 6 paragraph 2 item (a) of the Directive, the formulation “processes for reproductive cloning of human beings” was replaced with the formulation “processes for cloning human beings” because the adjective “reproductive” was considered too restrictive. In addition, the European Group on Ethics in Science and New Technologies to the European Commission considers the patentability of processes for creating human embryos by cloning with the objective of isolating stem cells ethically unacceptable and calls for their unpatentability. See Saunders and Mutabžija (2004), p. 22.

  36. 36.

    For example, United Kingdom, Belgium, Sweden, and Spain.

  37. 37.

    For example, Denmark, Germany, Poland, and France.

  38. 38.

    For example, Romania, and Bulgaria.

  39. 39.

    Although the grant of a patent does not convey to the patent holder the right to implement the invention but only the right to exclude others from exploiting the invention, the historical function of patents is to reward inventors and encourage further innovations. This reward and incentive consist of the monopoly that the patent holder will enjoy in relation to the invention for a limited period of time, in which he can use the invention in any way allowed by law, including commercial exploitation or generating profits from the invention. All other motives of filing patent applications claimed by the applicants are not relevant because patent law does not envisage the possibility to limit the use of an invention in the process of granting a patent, and its holder is allowed to use it for any purpose that is not prohibited by law, including those industrial or commercial purposes. A patent holder might truly have the invention to use the patented invention for a noble purpose, which does not have to be industrial or commercial, but once the patent is granted, patent law has no means to prevent the patent holder to actually use the invention in industrial or commercial purposes. That the intention to commercially exploit an invention is necessarily connected with filing patent claims is also the position of Moufang (1994), p. 504, and Sterckx and Cockbain (2010), p. 91. See also CJEU (2011), para. 41.

  40. 40.

    See Porter (2010), p. 20.

  41. 41.

    See Council of the European Union (1998), para. 37.

  42. 42.

    Similarly Torremans (2010) and Piirman (2011).

  43. 43.

    This was also the position of the United Kingdom Patent Office before the CJEU’s decision in Oliver Brüstle and the EPO’s decision in G 02/06. See Porter et al. (2006), p. 654.

  44. 44.

    CJEU (2011).

  45. 45.

    See CJEU (2011), para. 38.

  46. 46.

    See CJEU (2011), para. 36.

  47. 47.

    See CJEU (2011), para. 37. In its decision that followed the CJEU’s judgement, the referring court—the Bundesgerichtshof—stated that human embryonic stem cells are patentable because they cannot lead to the development of a human being according to the state of the art, provided that a fertilized ovum was not destroyed for producing the embryonic stem cells. See Dombrowski (2012). Such a decision was expected because there aren’t any available scientific studies proving that human embryonic stem cells are capable of commencing the process of the development of a human being. Therefore, for now, they should not be considered embryos, even under the broad CJEU’s definition.

  48. 48.

    See Article 5 of the Directive and recitals 16 and 38 of the Directive.

  49. 49.

    See, e.g., EGE (2002), p. 13.

  50. 50.

    See CJEU (2011), para. 43.

  51. 51.

    See CJEU (2011), para. 52.

  52. 52.

    See CJEU (2011), para. 49.

  53. 53.

    See CJEU (2011), para. 50.

  54. 54.

    See EBA (2008), paras 2–11.

  55. 55.

    See Mutabžija (2014), pp. 150–157.

  56. 56.

    See Mutabžija (2014), pp. 145–164. See also Minssen and Nordberg (2015).

  57. 57.

    See CJEU (2014), para. 10.

  58. 58.

    See CJEU (2014), paras 11 and 12.

  59. 59.

    See CJEU (2014), paras 14 and 15.

  60. 60.

    See CJEU (2014), para. 16.

  61. 61.

    See CJEU (2014), paras 31, 32, and 33.

  62. 62.

    See CJEU (2014), para. 38.

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Authors and Affiliations

  1. PAR Business School, Rijeka, Croatia

    Jasmina Mutabžija Ph.D., LL.M.

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Correspondence to Jasmina Mutabžija Ph.D., LL.M. .

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Editors and Affiliations

  1. Jean Monnet Department of European Public Law, University of Rijeka, Rijeka, Croatia

    Nada Bodiroga-Vukobrat

  2. Croatian Academy of Sciences and Arts, Rijeka, Croatia

    Daniel Rukavina

  3. Department of Biotechnology, University of Rijeka , Rijeka, Croatia

    Krešimir Pavelić

  4. University of Applied Sciences, Hochschule für öffentliche Verwaltung und Finanzen Ludwigsburg, Ludwigsburg, Germany

    Gerald G. Sander

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Mutabžija, J. (2016). Embryonic Stem Cell Patents and Personalized Medicine in the European Union. In: Bodiroga-Vukobrat, N., Rukavina, D., Pavelić, K., Sander, G. (eds) Personalized Medicine. Europeanization and Globalization, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-319-39349-0_4

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