Abstract
This paper concerns the ideal of regulatory coherence, with particular reference to Europeanpatent law, and with the spotlight on the controversial decision of the CJEU in Oliver Brüstle v Greenpeace (interpreting Directive 98/44/EC on the Legal Protection of Biotechnological Inventions). The Brüstle decision invites the objection that it is incoherent, both formally (because the Court rules that the products of a permitted and innovative research activity are excluded from patentability) and substantively (because its strong protection of human embryos is not supported by the jurisprudence of the European Court of Human Rights). The thrust of the paper is that, while these particular objections can be answered, it is arguable that the decision of the CJEU is not the appropriate target for the critics; rather, if there is a serious incoherence in European patent law, it is in the 1998 Directive itself.
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- 1.
Rule (i) is supported by Foakes v Beer (1884) 9 App Cas 605; rule (ii) by Williams v Roffey Bros and Nicholls (Contractors) Ltd. [1991] 1 QB 1.
- 2.
Some of these questions are raised in R Brownsword, H-W Micklitz, L Niglia and S Weatherill (eds), The Foundations of European Private Law (Oxford, Hart, 2011).
- 3.
Case G 0002/06, November 25, 2008. Here, the Enlarged Board of Appeal at the EPO was asked by the Technical Board of Appeal (T 1374/04 ([2007] OJ EPO 313)) to rule on four questions of law – one of which was whether Article 6(2)(c), as incorporated in the EPC Rules, forbids the patenting of a human embryonic stem cell culture which, at the time of filing, could be prepared only by a method that necessarily involved the destruction of human embryos (even though the method in question is not part of the claim). Treating this as an exercise in the interpretation of a particular rule, rather than a more general essay in European morality, the EBA said (at para 18):
‘On its face, the provision (…) is straightforward and prohibits the patenting if a human embryo is used for industrial or commercial purposes. Such a reading is also in line with the concern of the legislator to prevent a misuse in the sense of a commodification of human embryos (…) and with one of the essential objectives of the whole Directive to protect human dignity.’
Rejecting the argument that human embryos were not actually being used for commercial or industrial purposes, the EBA held that, where the method of producing the claimed product necessarily involved the destruction of human embryos, then such destruction was ‘an integral and essential part of the industrial or commercial exploitation of the claimed invention’ (para 25); and, thus, the prohibition applied and precluded the patent.
- 4.
Case C-34/10 Oliver Brüstle v Greenpeace e.V. [2011] ECR I-9821.
- 5.
On the WARF case, see e.g. P Torremans, ‘The Construction of the Directive’s Moral Exclusions under the EPC’ in A Plomer and P Torremans (eds), Embryonic Stem Cell Patents (Oxford, Oxford University Press, 2009) 141. There is also the question of how coherently the WARF reading of the exclusion fits with other EC legal measures that license human embryonic stem cell research: see A Plomer, ‘Towards Systemic Legal Conflict: Article 6(2)(c) of the EU Directive on Biotechnological Inventions’ in Plomer and Torremans, Embryonic Stem Cell Patents, 173. Nevertheless, this broad interpretation was foreshadowed in EDINBURGH/Animal Transgenic Stem Cells (Patent App No 94 913 174.2, July 21, 2002, Opposition Division), on which see SHE Harmon, ‘From Engagement to Re-engagement: the Expression of Moral Values in European Patent Proceedings, Past and Future’ (2006) 31 EL Rev 642.
- 6.
Here, I use the term ‘dignitarian’ to capture a range of duty-based ethics, both secular and non-secular, that highlight the importance of not compromising human dignity. See, further, R Brownsword, ‘Bioethics Today, Bioethics Tomorrow: Stem Cell Research and the “Dignitarian Alliance”’ (2003) 17 University of Notre Dame Journal of Law, Ethics and Public Policy 15; id, ‘Stem Cells and Cloning: Where the Regulatory Consensus Fails’ (2005) 39 New England Law Review 535.
- 7.
However, Art 27(2) of the TRIPs Agreement permits members to exclude inventions from patentability on grounds of ordre public or morality. In other words, the international view is that provisions such as Art 53(a) of the EPC and Art 6 of Dir 98/44/EC are optional.
- 8.
Notably the views associated with the Catholic Church (compare my remarks in n 6). But, for a view defending the ‘deontological’ approach of the CJEU against the general ‘consequentialism’ of patent courts, see J Giles, ‘The Brüstle and Eli Lilly Cases: Creation—God or Humankind’ (2012) 1 Oxford Journal of Law and Religion 518.
- 9.
See, most explicitly, Art 6 TEU. Generally, see S Douglas-Scott, ‘The European Union and Human Rights after the Treaty of Lisbon’ (2011) 11 Human Rights Law Review 645.
- 10.
For such a review, see D Beyleveld, R Brownsword and M Llewelyn ‘The Morality Clauses of the Directive on the Legal Protection of Biotechnological Inventions: Conflict, Compromise, and the Patent Community’ in R Goldberg and J Lonbay (eds), Pharmaceutical Medicine, Biotechnology and European Law (Cambridge, Cambridge University Press, 2000) 157.
- 11.
Case C-456/03 Commission v Italy [2005] ECR I-5335, para 78 ff. Interestingly, in para 82, the Court draws on the obscure proviso in Art 6(1), first, to underline the point that prohibition of commercial exploitation by law or regulation does not entail exclusion from patentability, and then to insist that any possible uncertainty is removed by legislating for the Art 6(2) exclusions. However, the first of these points invites clarification because, on the face of it, it is formally incoherent for a regulator to prohibit the commercial exploitation of x but, at the same time, to permit the patenting of x: that is, in the ordinary way of things, prohibition of commercial exploitation of x does entail exclusion of x from patentability. Nevertheless, there might be contextual factors that resolve the apparent contradiction—for example, if the prohibition is in the nature of a moratorium for a limited period, then, in the particular setting, regulatees might understand that the red prohibitory signal in conjunction with the green patentability signal actually amounts to an amber signal (to proceed cautiously).
- 12.
However, the Federal Court of Justice has subsequently ruled that Brüstle’s patent does not involve the destruction of human embryos and that, in an amended form, the patent is valid. See Bundesgerichtshof (BGH), 27/11/2012, 195 Entscheidungen des Bundesgerichtshofs in Zivilsachen 364; on which see A Blackburn-Starza, ‘German court upholds Brüstle patent as valid’ BioNews 684, www.bionews.org.uk/page_222080.asp.
- 13.
The Federal Court of Justice has now ruled that, on their own, human embryonic stem cells are not capable of developing into a born human and, thus, should not be treated as a ‘human embryo’, see Blackburn-Starza, ibid.
- 14.
Compare the seminal analysis in LL Fuller, The Morality of Law (New Haven, Yale University Press, 1969) (revised edition).
- 15.
For one such amber signal, in the context of a moratorium, see n 11. For further combinations that signal both prohibition and encouragement but the formal incoherence of which is more apparent than real, see M Schellekens and P Vantsiouri, ‘Patentability of Human Enhancements’ (2013) 5 Law, Innovation and Technology 190.
- 16.
Away from the law, whether contracts or patents, we can find common examples of regulators signalling that an action is permitted but not encouraged, or even that it is discouraged. Moreover, I suspect that liberal-minded parents often signal something rather similar to their teenage children.
- 17.
It is worth emphasising that this is subject to the various caveats in the text above and at n 15.
- 18.
The extent to which patent and other IP rights operate in the public interest is, of course, a moot point: compare the critique in J Boyle, The Public Domain (New Haven, Yale University Press, 2008).
- 19.
One of many problems with patents in practice is that a liberal policy on granting patents can lead to blockages for downstream researchers. Famously, see MA Heller and R Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280 Science 698.
- 20.
If the proprietary characteristics of post-grant patents are treated as focal, this can bear on the question of coherence. For example, A Plomer, ‘Patents, Human Dignity and Human Rights’ in C Geiger (ed), Research Handbook on Human Rights and Intellectual Property (Cheltenham, Edward Elgar, 2014 forthcoming) Ch 25 (on file with author) sets up the incoherence of Brüstle in the following terms:
‘A legal system cannot logically and consistently permit X and deny property rights over X on the grounds that X violates human rights/human dignity otherwise X could not be permissible. Thus, the supposed incompatibility of property rights or patents on X with human rights/human dignity have, in reality nothing to do with ownership of X but relate instead to the permissibility of X. (…) The glaring contradiction would not normally materialize within a national legal order because prohibitions on patents would normally be aligned to prohibitions on research reflecting the particular national moral and religious culture.’
While it is right to suggest that no legal system could rationally permit X where it judges that X violates human rights or human dignity, care needs to be taken that there is no shift in the reference of X. For example, it might be perfectly rational to permit the research and development of a life-saving diagnostic test and treatment (X1), and yet to exclude the patentability of the test or treatment on the grounds that the commercial exploitation of such a life-saving invention (X2) is not compatible with human rights or human dignity. At all events, none of this affects the claim that formal coherence allows for permitting X while denying patentability of X.
- 21.
See the range of criticisms of the Wisconsin Alumni Research Foundation case in Plomer and Torremans (eds), Embryonic Stem Cell Patents.
- 22.
Brüstle (n 4) para 40.
- 23.
Compare the reading of moral exclusions in D Beyleveld and R Brownsword, Mice, Morality and Patents (London, Common Law Institute of Intellectual Property, 1993).
- 24.
Evans v United Kingdom (Application no 6339/05) Grand Chamber, 10/4/2007; Vo v France (Application no 53924/00) Grand Chamber, 8/7/2004.
- 25.
Art 18(1) provides that ‘Where the law allows research on [human] embryos in vitro, it shall ensure adequate protection of the embryo’; and Art 18(2) prohibits the ‘creation of human embryos for research purposes’.
- 26.
A Plomer, ‘After Brüstle: EU Accession to the ECHR and the Future of European Patent Law’ (2012) 2 Queen Mary Journal of Intellectual Property 110, 132.
- 27.
For an argument tapping into Art 1 of the 2001 Protocol to the Convention, which concerns the protection of property (and, by implication, intellectual property) rights, see Plomer, ‘After Brüstle’, 130 f.
- 28.
Compare D Beyleveld and R Brownsword, ‘Emerging Technologies, Extreme Uncertainty, and the Principle of Rational Precautionary Reasoning’ (2012) 4 Law Innovation and Technology 35.
- 29.
Similar arguments might be offered for the protection of non-human animals: see P Carruthers, The Animals Issue (Cambridge, Cambridge University Press, 1992). And, for a succinct expression of the concern, see S Turkle, Alone Together (New York, Basic Books, 2011) 47: ‘This is, of course, how we now train people for war. First we learn to kill the virtual. Then, desensitized, we are sent to kill the real.’
- 30.
Case C-36/02 Omega Spielhallen- und Automatenaufstellungs-GmbH v Oberbürgermeisterin der Bundesstadt Bonn [2004] ECR 1-9609.
- 31.
Similarly, two accounts might be given of the decision of the ECJ in Omega Spielhallen (n 30).
- 32.
In support of such a liberal rights-driven interpretation, I would rely on arguments derived from A Gewirth, Reason and Morality (Chicago, University of Chicago Press, 1978).
- 33.
Compare the defence of appellate court judges against the accusation that they act inappropriately as ‘legislators’ in ‘hard cases’; seminally, see R Dworkin, Taking Rights Seriously (revised ed) (London, Duckworth, 1978).
- 34.
For a case in point, see S and Marper v United Kingdom [2008] ECHR 1581.
- 35.
Fully aware of the many different views as to both the meaning of a human embryo and the degree to which such embryos should be protected. Advocate General Bot insists that the legal position as settled by the Directive is actually perfectly clear. Within the terms of the Directive, the concept of a human embryo must be taken as applying from ‘the fertilisation stage to the initial totipotent cells and to the entire ensuing process of the development and formation of the human body’ (para 115). In themselves, isolated pluripotent stem cells would not fall within this definition of a human embryo (because they could not go on to form a whole human body). See AG Bot, Case C-34/10, Oliver Brüstle v Greenpeace e.V. [2011] ECR I-9821.
- 36.
Examples include the earlier Directives on doorstep selling (85/577/EEC), consumer credit (87/102/EEC), package holidays (90/314/EEC), unfair terms (93/13/EEC), and distance selling (97/7/EC).
- 37.
For evidence, see S Vogenauer and S Weatherill, ‘The European Community’s Competence to Pursue the Harmonisation of Contract Law – An Empirical Contribution to the Debate’ in S Vogenauer and S Weatherill (eds), The Harmonisation of European Contract Law (Oxford, Hart, 2006) 105; and the supporting case for a proposed Regulation on a Common European Sales Law, COM(2011) 635 final.
- 38.
Per Commissioner Kuneva, giving a public lecture on ‘Transformation of European Consumer Policy’ at Humboldt University, Berlin, 28/3/2008.
- 39.
See R Brownsword, ‘Regulating Transactions: Good Faith and Fair Dealing’ in G Howells and R Schulze (eds), Modernising and Harmonising Consumer Contract Law (Munich, Sellier, 2009) 87.
- 40.
For one such example, see C Twigg-Flesner, A Cross-Border-Only Regulation for Consumer Transactions in the EU: A Fresh Approach to EU Consumer Law (Berlin, Springer, 2011).
- 41.
Commission v Italy, para 58.
- 42.
See R Brownsword, Rights, Regulation and the Technological Revolution (Oxford, Oxford University Press, 2008).
- 43.
407 US 1 (1972).
- 44.
Ibid, 9.
- 45.
Generally, see R Brownsword, Contract Law: Themes for the Twenty-First Century (Oxford, Oxford University Press, 2006).
- 46.
See, eg, Plant Cells/PLANT GENETIC SYSTEMS Case T 0356/93; and E Armitage and I Davis, Patents and Morality in Perspective (London, Common Law Institute of Intellectual Property, 1994).
- 47.
This is drawn out very clearly in H Collins, Regulating Contracts (Oxford, Oxford University Press, 2002) 8: ‘The trajectory of legal evolution alters from the private law discourse of seeking the better coherence for its scheme of principles to one of learning about the need for fresh regulation by observations of the consequences of present regulation.’
- 48.
For an extensive jurisprudence, see R Whish and D Bailey, Competition Law, 7th ed (Oxford University Press, 2012) ch 19.
- 49.
For an excellent case-study, albeit in a very different context, see A Murray, ‘The Reclassification of Extreme Pornographic Images’ (2009) 72 MLR 73.
- 50.
See, eg, recitals (20) and (21), and Art 5(2).
- 51.
See, eg, recitals (37), (38) and (42).
- 52.
Compare, S Leader, ‘Collateralism’ in R Brownsword (ed), Human Rights (Oxford, Hart, 2004) 53.
- 53.
See R Brownsword, ‘Human Dignity, Human Rights, and Simply Trying to Do the Right Thing’ in C McCrudden (ed), Understanding Human Dignity (Oxford, Oxford University Press, 2013) 470.
- 54.
D Beyleveld and R Brownsword, Human Dignity in Bioethics and Biolaw (Oxford, Oxford University Press, 2001).
- 55.
For an even more worrying example, see the judgment of the Grand Chamber at the European Court of Human Rights in the case of SH v Austria (application no 57813/00) 3/11/2011. There, the Court seems to permit Austria to rely on conservative dignitarian values to justify its restrictive IVF laws (prohibiting third-party donation of gametes).
- 56.
For the implications of the difference between ‘open’ and ‘closed’ value pluralism, see R Brownsword, ‘Regulating the Life Sciences, Pluralism, and the Limits of Deliberative Democracy’ (2010) 22 Singapore Academy of Law Journal 80; id, ‘Framers and Problematisers: Getting to Grips with Global Governance’ (2010) 1 Transnational Legal Theory 287.
- 57.
Explicitly so in Art 2 TEU, according to which the Union is founded on ‘the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities.’ Art 2 continues by emphasising that these ‘values are common to the Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail.’
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Brownsword, R. (2014). Regulatory Coherence—A European Challenge. In: Purnhagen, K., Rott, P. (eds) Varieties of European Economic Law and Regulation. Studies in European Economic Law and Regulation, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-319-04903-8_12
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