Patenting stem cells in Europe: The challenge of multiplicity in European Union Law

Common Market Law Review

Volumn 49, Issue 3, 2012, Pages 1007-1037

  Varju, Marton ^a   Sándor, Judit ^b  

^a UNIVERSITY OF HULL   (United Kingdom)

^b CENTRAL EUROPEAN UNIVERSITY   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84865537641     PISSN: 01650750     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (50)

1. Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions, O.J., L 213/13. 1998
2. EPO Enlarged board of appeal, decision G 2/06 of 25 Nov. 2008, OJ EPO, May 2009, 306; EPO boards of appeal, decision T 522/04 of 28 May 2009, nyr. 3. Judgment by the German federal patent court, AZ: 3 Ni 42/04 (5 Dec. (last visited 11 Jan. 2012) 2006), juris.bundespatentgericht.de/cgi-bin/rechtsprechung/document.py?Gericht=bpatg&Art=en& sid=061f0f9e4b6bfd679ba46c7b1fd93fcb&nr=1909&pos=0&anz=1&Blank=1.pdf.
3. Case C-34/10, Brüstle v. Greenpeace, judgment of 18 Oct., nyr. For a specific analysis, and proposing a somewhat different appraisal, see case note by Spranger, in this Review, 1197. 2011
4. 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.With a focus on the human rights limitations of biomedical research, it builds on the protection of human dignity and integrity and confirms the primacy of the human being over the interests of science and society (Arts. 1 and 2). Available through conventions.coe.int/.
5. See, inter alia, Harris, "Cloning and human dignity", 7 Cambridge Quarterly of Healthcare Ethics (1998), 163-167.
6. See, inter alia, Case 121/85, Conegate, ECR 1007 1986
7. Case C-275/92, Schindler, ECR I-1039 1994
8. Case C-268/99, Jany, ECR I-8615 2001
9. Case C-36/02, Omega Spielhallen, ECR I-9609. 2004
10. Rules 26-29 (ex Rules 23b-e) of the Implementing Regulations of the EPC.
11. Communication from the Commission, Life sciences and biotechnology - A strategy for Europe (23 Jan. 2002) COM 27 final. 2002
12. Favale and Plomer, "Fundamental disjunctions in the EU legal order on human tissues, cells and advanced regenerative therapies", 16 MJ (2009), 90.
13. Directive /23/EC of the Parliament and the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, O.J. 2004, L 102/48 and the related Directives. 2004
14. Regulation (EC) 1394/2007 of the Parliament and the Council of 13 Nov. 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Reg. (EC) No 726/2004, O.J., L 324/121. 2007
15. Rose, The Politics of Life Itself (Princeton Univ. Press, 2006), pp. 2-4.
16. In fact, opening an ethical perspective on European patent harmonization led the European Commission to realize that the regulatory divergence sought to be remedied by the Directive rested more in the regulation of the ethical aspects of biomedical advancement, Gold and Gallochat, "The European Biotech Directive: Past as prologue", 7 ELJ (2001), p. 337.
17. Wilkinson, Bodies for Sale (Routledge, 2003), pp. 44-45.
18. Beyleveld and Brownsword, Human Dignity in Bioethics and Biolaw (OUP, 2001), p. 11.
19. www.stemgen.org/mapworld.cfm (last visited 6 Nov. 2011) and Isasi and Knoppers, "Mind the gap: policy approaches to embryonic stem cells and cloning research in 50 countries", 13 European Journal of Health Law (2006), 9-26.
20. Brueggemann and Scheuten v. Germany 3 EHRR 244, (1981)
21. Paton V. UK, (1981) 3 EHRR 408; Open Door Counselling v. Ireland, (1993) 15 EHRR 244; Vo v. France, ECHR 2004-VIII; Evans v. UK, App. 6339/05, nyr; S.H. and Others v. Austria, App. 57813/00, nyr.
22. Opinion No. 15 (14 Nov. 2000) - Ethical Aspects of Human Stem Cell Research and Use, available at (last visited 4 Sept 2009). ec.europa.eu/european_group_ethics/docs/avis15_en.pdf
23. Plomer, The Law and Ethics of Medical Research (Routledge-Cavendish, 2005), p. 24.
24. For the origins of the "human ingenuity" argument see, Diamond v. Chakrabarty, 447 US 303 distinguishing between "products of nature" and "products of human ingenuity". 1980
25. See also Sterckx and Cockbain, "Assessing the morality of inventions concerning uses of human embryos and the relevance of moral complicity: Comments on the EPO's WARF decision", 7 SCRIPTed (2010), 95-98.
26. See the interpretation provided by the EPO Board of Appeal, infra note 45.
27. Moufang, "Patenting of human genes, cells and parts of the body, the ethical dimensions of patent law", 25 International Review of Industrial Property and Copyright Law (1994), 504.
28. Defined as "market transactions in which products are traded for money or profit" and "direct, repetitive use of the human embryo as a raw material in a chemical, mechanical or technical process", in Plomer (project coordinator), Stem Cell Patents: European Patent Law and Ethics, Report EU FP6 "Life sciences, genomics and biotechnology for health", SSALSSB-CT-2004-005251 (2008), (last visited 12 Dec. 2011), pp. 74-75. www.nottingham.ac.uk/~llzwww/StemCellProject /project.report.pdf
29. At the time of the adoption of the Directive, human cloning was the dominant technology and the main concern for legislatures; hESC technology was still in its infancy.
30. Borrowed from Davis, "Patented embryonic stem cells: The quintessential 'essential facility'?", 94 Georgetown Law Journal (2005), 205.
31. See McKernan, McNeish and Smith, "Pharma's developing interest in stem cells", 6 Cell Stem Cell (2010), 517-520.
32. See Eisenberg and Rai, "Proprietary considerations", in Lanza et al. (Eds.), Handbook of Stem Cells. (Vol. 1) (Elsevier, 2004), pp. 793-798.
33. Pub. L. No. 96-517, 35 USC 200-211.
34. Schneider, "Can patent legislation make a difference?", in Hauns et al. (Eds.), Politics of Intellectual Property (Edward Elgar, 2009), p. 134.
35. See, inter alia, Kitch, "The nature and function of the patent system", 20 Journal of Law and Economics (1977), 266-267.
36. Rule 28© EPC/Art. 6(2)© of Directive.
37. The case concerning European Patent No. EP0695351, decided after oral hearings 22-24 July 2002.
38. Thomson et al., "Embryonic stem cell lines derived from human blastocysts", 282 Science (1998), 1145-1147 (US Patent No. 5,843.780 (1996), 6,200,806 (1998) and 7,029,913 (2001)).
39. Foundation for Taxpayer and Consumer Rights and Public Patent Foundation v.WARF, B.P.A.I. No. 2010-001854, 28 April 2010.
40. German patent number DE 197 56 864 (C1) and EPO patent number EP 1040185.
41. Taupitz, "The German stem cell Act", 11 German Law Journal (2010), 1373-1374.
42. www.gesetze-im-internet.de/bundesrecht/eschg/gesamt.pdf and www.gesetze-iminternet. de/bundesrecht/stzg/gesamt.pdf (last visited 8 May 2012).
43. The question from the referring court suggested that Art. 6(1) may play a role in determining the patentability of hES cells.
44. Its most recent revival: European Commission Proposal for a Regulation of the European Parliament and the Council implementing enhanced cooperation in the area of the creation of unitary patent protection, COM(2011)215/3.
45. Opinion 1/09 of the Court (Full Court) of 8 March, nyr 2011.
46. Arts. 36, 45 and 52 TFEU.
47. See Armstrong, "Mutual recognition", in Barnard and Scott, The Law of the Single European Market (Hart, 2005), 225.
48. See, inter alia, Galllini, "The economics of patents: Lessons from recent US patent reform (2002)", in Merges et al. (Eds.), Economics of Intellectual Property Law (Volume I) (Edward Elgar, 2007), 68-69, and specifically, Joly, "Clinical translation of stem cell therapies - Intellectual property and anticipatory governance", 7 SCRIPTed (2010), 268.
49. www.cirm.ca.gov/PressRelease_2011-11-14 (last visited 25 Jan. 2012).
50. In the form of iPS cells, pluripotent cells created by inducing somatic cells to redifferentiate. See, inter alia last visited 25 Jan., www.icems.kyoto-u.ac.jp/e/and www.wicell.org/index.php (2012).