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Stem Cell Lines and Destruction of Human Embryos: the EPO Shares the Perspective of the Court of Justice

Published online by Cambridge University Press:  20 January 2017

Stefano Barazza
Stefano Barazza*
Affiliation:
Studio Legale Barazza, email: [email protected].
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Extract

The Technical Board of Appeal of the European Patent Office, in case T 2221/10, held that Article 53(a) and Rule 28(c) of the European Patent Convention do not merely exclude the patentability of biotechnological inventions that make use of human embryonic stem cells obtained by de novo destruction of human embryos, but also apply to inventions which employ publicly available cell lines which were initially derived by a process resulting in the destruction of human embryos. The decision relies on the judgment of the Enlarged Board of Appeal in theWARF case, falling in line with the perspective endorsed by the Court of Justice of the European Union in Oliver Brüstle v Greenpeace.

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 5 , Issue 2 , June 2014 , pp. 273 - 277
Copyright
Copyright © Cambridge University Press 2014

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References

1 Case T 2221/10, Culturing stem cells/TECHNION, decision of the Technical Board of Appeal of the European Patent Office, 4 February 2014

2 Case G 2/06, Use of embryos/WARF, decision of the Enlarged Board of Appeal, 25 November 2008, OJ EPO 2009, 306. See Bostyn, Sven, “Patenting human embryonic stem cells in peril: the decision of the Enlarged Board of Appeal in G 2/06”, BioScience Law Review (2009), pp. 13 et sqq. Google Scholar, and Nettleton, Ewan, “EPO’s Enlarged Board rules on patenting stem cell inventions’, 4(5) Journal of Intellectual Property Law & Practice (2009), pp. 306 et sqq.CrossRefGoogle Scholar

3 See also the decision of the EPO in Greenpeace Deutschland e.V. v The University of Edinburgh, 24 July 2012, where the Opposition Division held that Rule 23d(c) EPC - now Rule 28(c) – ‘has to be interpreted broadly to encompass not only the industrial or commercial use of human embryos but also the human ES cells retrieved therefrom by the destruction of human embryos’. For an overview of the decision, see Rimmer, Matthew, Intellectual Property and Biotechnology: Biological Inventions (Edward Elgar Publishing 2007), at pp. 266 et sqq.Google Scholar

4 WARF, supra note 2, para. 22.

5 TECHNION, supra note 1, para. 15.

6 The Board noted that, for some of the cell lines allegedly available from the United States National Institute of Health, there was no evidence that they were obtained by methods not involving the destruction of a human embryo (ibid., para. 22).

7 Ibid., para. 16.

8 WARF, supra note 2, para. 23.

9 TECHNION, supra note 1, para. 26.

10 [2011] ECR I-09821. See, inter alia, Bonadio, Enrico, “Stem Cells Industry and Beyond: What is the Aftermath of Brüstle?”, 1 EJRR (2012), pp. 93 et sqq.Google Scholar, and Schuster, Martina Ines, “The Court of Justice of the European Union's Ruling on the Patentability of Human Embryonic Stem-Cell-Related Inventions (Case C-34/10)”, 43 International Review of Intellectual Property and Competition Law (2012), pp. 626 et sqq.Google Scholar

11 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ 1998 L213/13.

12 BRUSTLE, supra note 10, para. 51.

13 Ibid., para 49.

14 WARF, supra note 2, paragraphs 2–11.

15 TECHNION, supra note 1, para. 39.

16 As recognized by the EPO in a Notice of 1 July 1999, concerning the amendment of the Implementing Regulations to the European Patent Convention, OJ EPO 1999, p. 573.

17 Case G 5/83, Second medical indication, decision of the Enlarged Board of Appeal of the EPO, 5 December 1984.

18 Ibid., para. 6.

19 Case G 2/02, Priorities from India/ASTRAZENECA, decision of the Enlarged Board of Appeal of the EPO, 26 April 2004.

20 Case T 197/10, Wasch- oder Reinigungsmittel mit wasserlöslichem Buildersystem/HENKEL AG & Co., decision of the Technical Board of Appeal of the EPO, 28 October 2011.

21 TECHNION, supra note 1, para. 33.

22 WARF, supra note 2, para. 29.

23 For an overview of the morality questions surrounding stem cell research, see Cheney, Kenneth C., “Patentability of Stem Cell Research under TRIPS: Can Morality-Based Exclusions be Better Defined by Emerging Customary International Law?”, 29 Loyola of L.A. International and Comparative Law Review (2007), pp. 503 et sqq Google Scholar. Relevant case law and legislation on the matter is examined by Agovic, Amina, “Stem cell patents on a knife edge”, 3(11) Journal of Intellectual Property Law & Practice (2008), pp. 718 et sqq.CrossRefGoogle Scholar

24 Wright, S., “Minutes of EPO/epi Meeting on 15 November 2010”, 3 epi Information (2011), p. 91.Google Scholar

25 See Klimanskaya, I., Chung, Y., Becker, S., Lu, S.J., Lanza, R., “Human embryonic stem cell lines derived from single blastomeres”, 444 Nature (2006), pp. 481 et sqq. CrossRefGoogle ScholarPubMed, first published online on 23 August 2006.