Legal status and patentability of stem cells in Europe

Biotechnology Law Report

Volumn 21, Issue 2, 2002, Pages 105-112

  Spranger, Tade Matthias ^a  

^a UNIVERSITY OF BONN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 12244278533     PISSN: 0730031X     EISSN: None     Source Type: Journal    
DOI: 10.1089/07300310252962019     Document Type: Article

References (93)

1. Nuffield Council on Bioethics, Stem Cell Therapy: the ethical issues.
2. Capron, Stem Cells: Ethics, Law and Politics. [2001] 20 Biotechnology Law Report 678.
3. The Royal Society (Ed.), Stem cell research and therapeutic cloning, Doc. 12/00, November 2000; Nuffield Council on Bioethics, Stem Cell Therapy: the ethical issues; UK Department of Health (Ed.), Stem Cell Research: Medical Progress with Responsibility, June 2000, No. 2.8.
4. Handelsblatt, August 3/4, 2001.
5. The White House, Office of the Press Secretary, Remarks by The President on Stem Cell Research, August 9, 2001.
6. Cf. Capron, Stem Cells: Ethics, Law and Politics, [2001] 20 Biotechnology Law Report 678, 679 et seq.
7. Deutsche Forschungsgemeinschaft, Senate Commission on Genetic Research (Ed.), Genome Research-Perspectives and Consequences, Report 2, 2000, 87.
8. Cf. National Bioethics Advisory Commission (Ed.), Ethical Issues in Human Stem Cell Research, Vol. I, Report and Recommendations of the NBAC, 1999, 7.
9. National Bioethics Advisory Commission (Ed.), Ethical Issues in Human Stem Cell Research, Vol. I, Report and Recommendations of the NBAC, 1999, 9.
10. National Bioethics Advisory Commission (Ed.), Ethical Issues in Human Stem Cell Research, Vol. I, Report and Recommendations of the NBAC, 1999, 7.
11. Cf. Wiestler, Diskussionsveranstaltung zur Forschung an embryonalen Stammzellen (Fragen an die Fachgruppe Naturwissenschaften/ Medizin), in: Ministerium für Schule, Wissenschaft und Forschung des Landes Nordrhein-Westfalen (Hrsg.), Perspektiven der Stammzellenforschung, Wissenschaft und Forschung im Dialog, August 30, 2001.
12. Cf. Civin, Human Pluripotent Stem Cells: Science Fiction Poses No Immediate Dangers, [2000] 18 Stem Cells iv.
13. NIH Guide: Biology of Adult Stem Cells in Aging (RFA: RFA-AG-01-006), June 6, 2001.
14. See Palmer/Schwartz/Taupin/Kaspar/Stein/Gage, Progenitor cells from human brain after death, [May 3, 2001] 411 Nature 42.
15. NIH Guide: Biology of Adult Stem Cells in Aging (RFA: RFA-AG-01-006), June 6, 2001;
16. Capron, Stem Cells: Ethics, Law and Politics, [2001] 20 Biotechnology Law Report 678, 679.
17. Cf. Shihabuddin et al., Adult spinal cord stem cells generate neurons after transplantation in the adult dentate gyrus, [December 2000] 20 Journal of Neuroscience, 8727.
18. Wiestler, Diskussionsveranstaltung zur Forschung an embryonalen Stammzellen (Fragen an die Fachgruppe Naturwissenschaften/ Medizin), in: Ministerium für Schule, Wissenschaft und Forschung des Landes Nordrhein-Westfalen (Hrsg.), Perspektiven der Stammzellenforschung, Wissenschaft und Forschung im Dialog, August 30, 2001.
19. NIH Guide: Biology of Adult Stem Cells in Aging (RFA: RFA-AG-01-006), June 6, 2001.
20. The Royal Society (Ed.), Stem cell research and therapeutic cloning, Doc. 12/00, November 2000.
21. The Royal Society (Ed.), Stem cell research and therapeutic cloning, Doc. 12/00, November 2000.
22. Deutsche Forschungsgemeinschaft, Senate Commission on Genetic Research (Ed.), Genome Research-Perspectives and Consequences, Report 2, 2000, 73.
23. Nuffield Council on Bioethics, Stem Cell Therapy: the ethical issues.
24. UK Department of Health (Ed.), Stem Cell Research: Medical Progress with Responsibility, June 2000, No. 2.13;
25. NIH Guide: Biology of Adult Stem Cells in Aging (RFA: RFA-AG- 01-006), June 6, 2001.
26. Cf. Nuffield Council on Bioethics, Stem Cell Therapy: the ethical issues.
27. Capron, Stem Cells: Ethics, Law and Politics, [2001] 20 Biotechnology Law Report 678.
28. Deutsche Forschungsgemeinschaft, Senate Commission on Genetic Research (Ed.), Genome Research-Perspectives and Consequences, Report 2, 2000, 73.
29. The White House, Office of the Press Secretary, Remarks by The President on Stem Cell Research, August 9, 2001.
30. Japan already permits reproductive human cloning; cf. Spranger, The Japanese Approach to Human Cloning, [2001] 20 Biotechnology Law Report 700.
31. Cf. Normile, Japan to Allow Stem Cell Research, Academic Press, Daily inScight, 31 July, 2001 (http://www.academicpress. com/inscight(07312001/graphb. htm [12 September, 2001];
32. Japan set to embrace stem cell research, BBC News, 1 August, 2001 (http://news.bbc.co.uk/hi/english/sci/tech/newsid-1468000/1468518.stm [12 September, 2001]; Handelsblatt, August 3/4, 2001.
33. In general: Wolfrum/Zeller, Legal Aspects of Research with Human Pluripotent Stem Cells in Germany, [1999] 4 Biomedical Ethics 102.
34. Gesetz zum Schutz von Embryonen (Embryonenschutzgesetz) of 13 December 1990, entered into force on 1 January 1991, BGBl I, 2746.
35. See also: Bagness, Genetics, The Fetus and Our Future, 1998.
36. Art. 6 (1) of the German Embryo Protection Act.
37. See Spranger, Patentability of Human Stem Cell Procedures in Accordance with EC Law, [2002] 11 European Intellectual Property Review.
38. Similar rules were subsequently adopted by Sweden and Denmark; cf. Rogers, Prenatal issues: life before life? in: Rogers/Durand de Bousingen (Eds.), Bioethics in Europe, 1995, 55.
39. Capron, Stem Cells: Ethics, Law and Politics, [2001] 20 Biotechnology Law Report 678, 699 quotes a limit of 15 days.
40. Nuffield Council on Bioethics, Stem Cell Therapy: the ethical issues.
41. 2001 No. 188, Human Fertilisation and Embryology, The Human Fertilisation and Embryology (Research Purposes) Regulations 2001 (made 24th January 2001; coming into force 31st January 2001).
42. See also: Civin, Stem Cell Research: Back to the Future, [2001] 19 Stem Cells 356.
43. Of 19 November 1996, ETS No. 164.
44. Council of Europe, Directorate of Legal Affairs (Ed.), Explanatory Report to the 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, 1997, No. 115.
45. Council of Europe, Directorate of Legal Affairs (Ed.), Explanatory Report to the 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, 1997, No. 116.
46. Of 6 November 1997, ETS No. 168 5 [1997] 36 ILM 1415.
47. In general: Spranger, What is wrong about Reproductive Human Cloning?-A Legal Perspective [2001] 11 Eubios Journal of Asian and International Bioethics 101 et seq.
48. See Spranger, The Japanese Approach to Human Cloning, [2001] 20 Biotechnology Law Report 700.
49. Kitagawa, The Law of "Life Units" as a New Legal Order, in: Fujiki/Macer (Eds.), Bioethics in Asia, 1998, 56, 57.
50. Schatz, in: Singer/Stauder (Eds.), Europäisches Patentü bereinkommen, 2. Aufl. 2000, Art. 53 No. 7.
51. See also Newiss, The patenting of genetically modified foods, [1998] 9 Trends in Food Science and Technology 368, 370.
52. Grubb, Patents for Chemicals, Pharmaceuticals and Biotechnology, 3rd Ed. 1999, 14.
53. In-depth: Bostyn, Enabling Biotechnological Inventions in Europe and the United States, 2001, 27 et seq.
54. The EU-U.S. Biotechnology Consultative Forum, Final Report, December 2000, 20.
55. OJ. L 213/13 30.7.98.
56. Recital 5 of the Directive.
57. Recital 7 of the Directive.
58. Recital 8 of the Directive.
59. Cf. Herdegen/Spranger, in: Herdegen (Ed.), Internationale Praxis Gentechnikrecht, EC-Law/Comment, Directive 98/44/ EC, No. 4;
60. Louët, French refuse to implement biotech patent directive, [2000] 18 Nature Biotechnology 820.
61. Opinion of Advocate General Jacobs delivered on 14 June 2001, Case C-377/98, Kingdom of the Netherlands v. European Parliament and Council of the European Union.
62. Bermann/Goebel/Davey/Fox, European Community Law, 1993, 72.
63. Case C-377/98, Kingdom of the Netherlands v. European Parliament and Council of the European Union (decision unpublished so far); cf. Spranger, Urteilsanmerkung, [2001] Gewerblicher Rechtsschutz und Urheberrecht Internationaler Teil 1047.
64. Grubb, Patents for Chemicals, Pharmaceuticals and Biotechnology, 3rd Ed. 1999, 26.
65. See also Baldock/Kingsbury, Where Did It Come from and Where Is It Going ? The Biotechnology Directive and Its Relation to the EPC, [2000] 19 Biotechnology Law Report 7.
66. Cf. Herdegen/Spranger, in: Herdegen (Ed.), Internationale Praxis Gentechnikrecht, EC-Law/Comment, Directive 98/44/EC, No. 10.
67. Schrell, Funktionsgebundener Stoffschutz für biotechnologische Erfindungen, [2001] 103 Gewerblicher Rechtsschutz und Urheberrecht 782, 783.
68. See Recital 16 of the Directive. In general: Bostyn, The Patentability of Genetic Information Carriers, [1999] 1 Intellectual Property Quarterly 1, 2 et seq.
69. Recital 21 of the Directive.
70. Recital 17 of the Directive.
71. In general: Moufang, Patenting of Human Genes, Cells and Parts of the Body ?-The Ethical Dimensions of Patent Law, [1994] 25 International Review of Industrial Property and Copyright Law 487;
72. Ford, The Morality of Biotech Patents: Differing Legal Obligations in Europe ?, [1997] 6 European Intellectual Property Review 315;
73. Sherman/Bently, The Question of Patenting Life, in: Bently/Maniatis (Eds.), Intellectual Property and Ethics, 1998, 109;
74. Vandergheynst, La notion dî ordre public et des bonnes moeurs dans la proposition de directive européenne relative à la protection juridique des inventions biotechnologies, in: van Overwalle (Ed.), Patent Law, Ethics and Biotechnology, 1998, 79;
75. Sterckx (Ed.), Biotechnology, Patents and Morality, 2nd ed., 2000;
76. Spranger, Ethical Aspects of Patenting Human Genotypes According to EC Biotechnology Directive, [2000] 31 International Review of Industrial Property and Copyright Law 373.
77. Cf.: Spranger, Ethical Aspects of Patenting Human Genotypes According to EC Biotechnology Directive, [2000] 31 International Review of Industrial Property and Copyright Law 373;
78. Opinion of Advocate General Jacobs delivered on 14 June 2001, Case C-377/98, Kingdom of the Netherlands v. European Parliament and Council of the European Union, No. 95: "I would note at the outset that the concepts of ordre public and morality have a long and distinguished history as criteria for the lawfulness of the grant or exercise of intellectual property rights." Dissenting opinion: Klitzsch/Stockmair, The Protection of Technical Innovations and Designs in Germany, 2nd ed. 2001, 11.
79. Herdegen/Spranger, in: Herdegen (Ed.), Internationale Praxis Gentechnikrecht, EC-Law/Comment, Directive 98/44/EC, No. 32.
80. However, protection for living organisms was already being granted under patent law in the century before last-for the first time on July 24, 1843;
81. cf. Spranger, Ethical Aspects of Patenting Human Genotypes According to EC Biotechnology Directive, [2000] 31 International Review of Industrial Property and Copyright Law 373, 376;
82. Spranger, Patente auf Leben ? Die sogenannte Biotechnikrichtlinie und die Patentierbarkeit von Genen, [2000] 10 Sozialrecht und Praxis 170, 171.
83. Cf. Herdegen/Spranger, in: Herdegen (Ed.), Internationale Praxis Gentechnikrecht, International Law/Comment, Convention on Human Rights and Biomedicine, No. 58 et seq. In addition, some scholars state that it is allowed to use cloning techniques within the period of two weeks of embryonic development;
84. see Bostyn, One Patent a Day Keeps the Doctor Away ?, [2000] 7 European Journal of Health Law 229, 244.
85. On the other hand, Flammer, Biotechnologische Erfindungen im Patentrecht, 1999, 148, recommends a total ban on each kind of cloning techniques.
86. See above sub II.
87. Baldock/Kingsbury, Where Did It Come from and Where Is It Going ? The Biotechnology Directive and Its Relation to the EPC, [2000] 19 Biotechnology Law Report 7, 14.
88. Sub III.
89. Spranger, Patentability of Human Stem Cell Procedures in Accordance with EC Law, [2002] 11 European Intellectual Property Review.
90. National Bioethics Advisory Commission (Ed.), Ethical Issues in Human Stem Cell Research, Vol. I, Report and Recommendations of the NBAC, 1999, 45.
91. Cf. Art. 21 of the Convention.
92. Council of Europe, Directorate of Legal Affairs (Ed.), Explanatory Report to the 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, 1997, No. 134.
93. Council of Europe, Directorate of Legal Affairs (Ed.), Explanatory Report to the 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, 1997, No. 134.