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Biopatenting: “Angst” v. European Harmonization – The ECJ Decision on Stem Cell Patents
Published online by Cambridge University Press: 20 January 2017
Abstract
Case C-34/10 Brüstle v. Greenpeace
1. Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:
– any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;
– it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.
2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.
3. Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.
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References
1 Para. 24 et sqq.
2 Para. 32 et sqq.
3 Para. 47 et sqq.
4 Plomer, Aurora, “Towards Systemic Legal Conflict: Art. 6 (2) (c) of the EU Directive on biotechnological Inventions”, in Plomer, Aurora and Torremans, Paul (eds.), Embryonic Stem Cell Patents – European Law and Ethics (Oxford: Oxford University Press, 2009), pp. 173 et sqq., at p. 196Google Scholar; in Sweden according to the country's opinion para. 29 three patents were granted.
5 Furthermore, leaving patent owners with at least partially invalid patents also puts them at considerable risk of invalidity proceedings, e.g. revocation procedures in the UK, based on the grounds of ordre public and morality, with the owner having to bear the costs of the proceedings.
6 While taking a clear stand on most of the issues at question the Court did not decide on this completely undisputed point, but leaves this to the national courts to determine. By doing so, the Court puts the applicant of the Directive down with unnecessary uncertainty. Adding to this confusion, the concept of the “human embryo” as defined by the Court has no end point. By only defining the term human embryo with regard to its starting point, it is not determined which later stages of development are included. Therefore e.g. foetal cell lines today widely used e.g. in pharmaceutical screening applications, might be excluded from patentability by Article 6(2) (c).
7 Observations of UK, para. 79, Sweden, para. 57 et sqq., Portugal, para. 38 and oral observation of Ireland as well as observation of the European Commission, para. 51 et sqq.
8 Straus, Joseph, „Comment on the Decision”, 60 GRUR Int. (2011), pp. 1048 et sqq., at p. 1049Google Scholar.
9 For a detailed discussion of the legislative history see Straus, Joseph, „Zur Patentierung Humaner Embryonaler Stammzellen in Europa”, 59 GRUR Int. (2010), p. 911 et sqq., at p. 917 et sqq Google Scholar.
10 For a discussion of the benefits and problems of patenting in biomedical research see Heller, Michael A. and Eisenberg, Rebecca S., “Can patents deter innovation? The Anticommons in Biomedical Research”, 280 Science (1998) p. 698 et sqq.CrossRefGoogle Scholar; for a comparison of the WARF cases in the US and Europe and in favor of a fostering effect of a harmonized legal landscape, Plomer, Aurora, Taymor, Kenneth and Scott, Christopher, “Challenges to Human Embryonic Stem Cell Patents”, 2 Cell Stem Cell (2008), p. 13 et. sqq.CrossRefGoogle Scholar ; for a critical discussion of the WARF decision of the EPO see Straus, Joseph, “Zur Patentierung humaner embryonaler Stammzellen in Europa”, 59 GRUR Int. (2010), p. 911 et sqq.Google Scholar; arguing that the developments around WARF's stem cell patents in the US might be viewed as a positive demonstration of how a robust patent system can support private sector investment and innovation and at the same time showing the tensions regarding follow-on research and their mitigation, Golden, John M., “WARF’s Stem Cell Patents and the Tensions between Public and Private Sector Approaches to Research”, 38 J.L. Med. & Ethics (2010), p. 314 et sqq CrossRefGoogle Scholar.
11 See Smith, Austin, “‘No’ to ban on stem-cell patents”, 418 Nature (2011), p. 472 Google Scholar.
12 Expecting a move of researches and research projects out of Europe to Asia and the Americas, ALLEA Standing Committee on Intellectual Property Rights, “Patenting Inventions Involving Human Embryonic Pluripotent Stem Cells in Europe”, para. III.
13 Although the necessary adaptations of the ECHR are already in place (ratification of the 14. additional protocol in force since June 1, 2010) after Russia's long outstanding ratification on January 15, 2010, there are significant procedural hurdles according to Article 218 Treaty on the Functioning of the EU; for a detailed description of the difficulties expected see Eckard Pache and Franziska Rösch, Die neue Grundrechtsordnung der EU nach dem Vertrag von Lissabon, 44 EuR (2009), pp. 769 et sqq., at p. 782 et sqq.
14 Para. 62 of the FCJ's reference decision.
15 Even suggesting that the Court did not finish reading the FCJ reference judgement, to explain the lack of discussion of this issue in the ruling see Straus, Joseph, “Comment on the Judgement”, 60 GRUR Int. (2011), pp. 1048 et. sqq., at p. 1049Google Scholar.
16 ENStem-ATM Human Neural Progenitor Expansion Kit, Millipore catalogue number: SCR055.
17 This is only partly due to the fact that the US Patent Act lacks any explicit morality requirement comparable to the European legal system, for other reasons like a reluctance of the stem cell community to argue that patenting is morally suspect, Golden, John M., “WARF's Stem Cell Patents and the Tensions between Public and Private Sector Approaches to Research”, 38 J.L. Med. & Ethics (2010), pp. 314 et sqq.CrossRefGoogle Scholar; for the US WARF cases see e.g. Loring, Jeanne F. and Cambell, Catherine, “Intellectual Property and Human Embryonic Stem Cell Research”, 311 Science (2006), pp. 1716 et sqq CrossRefGoogle ScholarPubMed. or US and EU comparative Plomer, Aurora, Taymor, Kenneth S. and Scott, Christopher Thomas, “Challenges to Human Embryonic Stem Cell Patents”, 2 Cell Stem Cell (2008), pp.13 et. sqq CrossRefGoogle ScholarPubMed.
18 Kaiser, Jocelyn, “NIH Wins in Appeals Court, But Legal Battle Continues”, 322 Science (2011), p. 651 CrossRefGoogle Scholar.
19 With California being the first in 2002 to proclaim its support for hESC research at least a half dozen others have followed suit in the meanwhile, see Korobkin, Russel, Stem Cell Century, (New Haven, CT: Yale University Press, 2007), at p. 53Google Scholar for an overview of the states legislation. The decentralized approach on hESC research in the US leading to maximum diversity between the states has been seen as a hindrance to competitiveness and scientific progress, see Schlecher, Jody, “Promoting Human Embryonic Stem Cell Research: a Comparison of Policies in the United States and the United Kingdom and Factors Encouraging Advancement”, 45 Tex. Int’l L.J (2010), pp. 603 et sqq Google Scholar.
20 Steven D. Schwartz, Jean-Pierre Hubschman, Gad Heilwell et al., “Embryonic stem cell trials for macular degeneration: a preliminary report”, The Lancet, published online 23 January 2012, available on the Internet at <http://download.thelancet.com/flatcontentassets/pdfs/S0140673612600282.pdf> (last accessed 25 January 2012).
21 Aurora Plomer, “EU ban on stem cell patens is a threat to both science and the rule of law”, The Guardian Blog posted 12 December 2011, available on the Internet at <http://www.guardian.co.uk/science/blog/2011/dec/12/eu-ban-stem-cell-patents2011> (last accessed 25 January 2012).