Since 1984, the European Commission has provided funding for scientific research via framework programmes for research and innovation covering funding periods that span many years. When it comes to research funding for novel health technologies (such as hESC research), the Seventh Framework Programme (FP7) focused significantly on translational research, which pursues translating basic research into usable and marketable health technologies.41 Within FP7, the role of basic research was perceived as a driver of growth.42 Funding under FP7 has been confined by the principle of
“European added value”, which required discourse between researchers in the Member States to foster competitiveness in the health technology sector.43 Although research has
40 Warren-Jones, supra note 36, 85.
41 Bache, G., Flear M., Hervey, T.K. “The Defining Features of the European Union’s Approach to Regulating New Health Technologies” in Flear, M., Farrell, A-M., Hervey, T.A., and Murphy, T. (eds.), European Law and New Health Technologies. (Oxford: Oxford University), 2013, 21.
42 Op. cit., 22.
43 Ibid. More specifically, the European Commission claims that: “[o]ne key aspect of the European added value is the transnationality of many actions: research projects are carried out by consortia which include participants from different European (and other) countries; fellowships in FP7 require mobility over national borders. Indeed, many research challenges (e.g. fusion research, etc), are so complex that they
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been framed by the Lisbon Strategy that seeks to make Europe the most dynamic, competitive, knowledge based economy in the world, which is capable of sustaining economic growth, employment and social consistency,44 it should be noted that the European Commission has issued a Lisbon Strategy evaluation document in which it is reported that some of the endorsed ambitions, those related to fostering innovations, have not resulted in faster decision-making. Despite the importance of fostering innovations being highlighted by the European Council, including the case of “the need for a strong, affordable Community Patent”, the delivery of a solution has been rather slow.45 Subsequent to the FP7, Horizon 2020 has been the Research and Innovation Programme of the EU for 2014-2020.46 Horizon 2020 also emphasises the vital role of research and innovation for European Union economic growth and for attracting private investment, yet the European Commission does not finance research projects that involve destruction of embryos under its current Framework Programme for Research and Innovation Horizon 2020, which may adversely affect the commercialisation prospects of some hESC-based ATMPs, including downstream products.
Beyond issues of research funding, the Biotech Patent Directive constitutes another viable example of the importance of the internal market objectives as key drivers of regulation in the European health technology field.47 The Biotech Patent Directive in particular is justified by the idea that differences in the legal protection of biotechnology inventions in various Member States are conducive to imposing barriers on trade in the internal market.48 In Recital 7 of the Biotech Patent Directive, harmonisation of biotechnology patenting practices is justified by the need to foster the competitiveness of the internal market as “uncoordinated development of national laws on the legal protection of biotechnological inventions” in the EU risks causing additional “disincentives to trade, to the detriment of the industrial development of such inventions and impediments to the smooth operation of the internal market”.49
However, it has been noted in Research Article II that the implementation of the moral exclusions provision of the Biotech Patent Directive has been greatly disharmonised in the EU. The ethical controversies hampering the patentability prospects of hESC research are very complicated, multifaceted legal issues. Some commentators, such as
can only be addressed at European level.” European Commission. “What is FP7? The basics” Available at: https://ec.europa.eu/research/fp7/understanding/fp7inbrief/what-is_en.html. Accessed 21 June 2016.
44 Bache, et al., supra note 41, 22.
45 SEC(2010) 114 final European Commission. Commission Staff Working Document. Lisbon Strategy
evaluation document. Available at:
http://ec.europa.eu/archives/growthandjobs_2009/pdf/lisbon_strategy_evaluation_en.pdf. Accessed 21 June 2016.
46 See also European Commission, Communication on “Building the ERA of Knowledge for Growth” COM (2005) 118 final, 2. See also European Commission, Horizon 2020, Available at:
http://ec.europa.eu/programmes/horizon2020/en/what-horizon-2020. Accessed 21 June 2016.
47 Bache, et al., supra note 41, 22-23.
48 The Biotech Patent Directive, Recitals 5, 6 and 7.
49 Op. cit., Recital 7.
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Hellstadius, along with Van Overwalle, have even described the role of ethics as a
“distraction” in patent law.50
The current European legislative framework for patents involves a very fragmented, but co-operative relationship between many institutions, expressed in numerous regulatory instruments and practices. It also wields an indirect regulatory effect on hESC-based inventions, partly via the basic requirements for patentability of inventions (e.g., novelty, the inventive step, and industrial application) and in part via moral exclusions from patentability.51 Generally speaking, there are two types of motives for excluding hESC inventions from patentability; economic and political.52 The main economic reason is the perception of patents for unethical inventions as a waste of social resources,53 whereas the political reasons relate to the public perception of the nature of a hESC patent. As patents constitute incentives for innovation, the refutation of patent protection simultaneously constitutes the removal of the incentive, and hence discourages R&D on certain types of technology. Patents are needed to attract private investment and accelerate the growth of university spin-offs (as described in Section 7.2). The significant difficulty in accommodating the moral aspects of hESCs into the traditional patentable subject matter scope has been addressed.54 The difficulty of aligning the ethical notion of human dignity with patent protection of inventions of embryonic origin has been recognised by the EPO55 and the ECJ56 alike in their stem cell decisions. Patent proceedings have become a forum for other stakeholders (such as prolife activists) for participation via opposition proceedings.57 In the late 1980s, the introduction of the first draft of the Biotech Patent Directive had already provoked public opposition by various stakeholders, discussions which have intensified in the course of advancements in stem cell science.
50 Van Overwalle, G. “Biotechnology patents in Europe: from law to ethics” in Sterckx, S. (ed.), Biotechnology, Patents and Morality, (Surrey: Ashgate), 1997, 139. Van Overwalle has described that particular relation as “die grosse Störung”, a big distraction. See also Hellstadius, Å. A quest for clarity.
Reconstructing Standards for the Patent Law Morality Exclusion. LL.D Dissertation distributed by Stockholm University, (Malmö: Holmbergs), 2015, 90.
51 See e.g. Odell-West, A. “Exclusions in Patent Law as Regulation for NHTs” in Flear, M., Farrell, A-M., Hervey, T.A. and Murphy, T. (eds.), European Law and New Health Technologies. (Oxford: Oxford University Press), 2013, 148-171.
52 Hellstadius, supra note 50, 29.
53 To illustrate the social dimension, Hellstadius refers to the Minutes of the Round Table organised by the European Group on Ethics in Science and New Technologies on 20 November 2001 in Brussels, World Intellectual Property Organization (WIPO) Secretariat at the Roundtable on the ethical aspects of patenting inventions involving human stem cells.
54 Agovic, A. Patents, Ethics and Stem Cell Research. The Case of hESC Innovation in Australia, Europe and the United States. (Sarajevo: BEMUST Printing House), 2011,27-32, 35-36. Plomer, A. Constitutional Limits on Moral Exemption to European Biotech Patents. Available at:
http://www.law.dept.shef.ac.uk/cms/staffprofiles/ap/Plomerfetschthrift.pdf. Accessed 21 June 2016. See also Levin, M. Stamceller och patent: omfattningen av undantaget om goda seder och allmän ordning. NIR 2006;(5):405-415.
55 See Enlarged Board of Appeal, WARF, G02/06 and Decision of the Opposition Division of 21 July 2003 on European patent no. EP0695351 (University of Edinburgh).
56 See Oliver Brüstle v. Greenpeace, EU:C:2011:669 and International Stem Cell Corporation v.
Comptroller General of Patents, EU:C:2014:2451.
57 Hellstadius, supra note 50, 90.
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When it comes to the current forum for the expression of values in patent law ethics, the EPO has been seen to operate in its own domain in the absence of guidance from regulatory law integrating ethical concerns, since the existing regulatory legislation is currently not used by the patent offices and courts in the application of the morality exclusion.58 According to Hellstadius however, ethical considerations appear to have a superseding role in the sense that the application of the morality clause cannot be undermined by any technical criteria being fulfilled. Plomer has advocated that as a starting-point the scope of moral exemptions in patent law should be in line with the constitutional limits set out by the background legal framework of the European Union and Treaties, which suggest “respect for the diversity of national cultural moral traditions in a pluralistic and democratic Europe”.59 Consequently, a wide margin of appreciation must by granted to the Member States in respecting the differing moral traditions in ethically sensitive questions in Plomer’s view of the interpretation of the moral provisions in the EU law.60 It seems however very problematic that the margin of appreciation exercised by the ECJ and the European Court of human rights (ECtHR) apparently differs in the case of the legal status granted to an embryo.
In addition, the division of competences between the European patent system and the pharmaceutical regulatory system and its impact on the application of the patent morality clause has raised some significant debate.61 It has been also noted that despite the EPO having to some extent sought common European values and ethical standards, the impact of existing pharmaceutical regulatory legislation on the interpretation of the morality clause appears very infrequently in the case law of the EPO. As mentioned in Research Article II, the ECJ established in the Brüstle case,62 that certain types of
58 Hellstadius, op. cit., 91. It has been pointed out that such a tie is reinforced in some of the contracting states of the EPC, where the morality clause related to existing research regulation is substantiated by direct references in the legislation. Please refer to Hellstadius, Å. “A Comparative Analysis of the National Implementation of the Directive’s Morality Clause”, in Plomer, A., Torremans, P. (eds.), Embryonic Stem Cell Patents European Law and Ethics. (Oxford: Oxford University Press), 2009, 117-141.
59 Plomer, supra note 54, 489.
60 Plomer, A. After Brüstle: EU accession to the ECHR and the future of European patent law. Queen Mary Journal of Intellectual Property, 2012: 2(2):110–135.
61 Hellstadius, supra note 50, 408-410. Hellstadius argues that the EPO should take the existing values and norms expressed in the national (non-patent) regulatory legislation in force into account to a greater extent in interpreting the morality clause. According to Hellstadius, the actual mandate of patent authorities is more fitted to questions relating to other patentability criteria such as novelty, the inventive step, and commercial exploitation of inventions. She further asks: if risk assessment is not the primary function of the EPO or even its duty, for what purpose is the EPO as a patent office trying to evaluate risks involved with a specific technology? Secondly, does the EPO have the required expertise for conducting such a risk assessment in connection with its standard patent examination process? (p.286). Whilst Amanda Warren-Jones has suggested that by means of the moral provision in patent law, the patent system should merely act as a filter against undesirable inventions. Hence, it complements the sanctioning function of other regulatory organs. Warren-Jones, A. Vital parameters for patent morality – a question of form’, Journal of Intellectual Property Law & Practice, 2007;(2)12; 832-846. Hence, the division of competences appears to be problematic if the purpose of the morality provision is to identify inventions contrary to public order or morality, and patent authorities end up conducting risk assessments, which is already ultimately a duty of the regulatory authorities.
62 Oliver Brüstle v. Greenpeace, EU:C:2011:669.
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hESC-based inventions (i.e., those necessitating destruction of human embryos) are ineligible for patent protection, despite the fact that the subject matter of the invention could be commercialised in a number of the EU Member States. It should also be noted that the EUCTDs and the ATMP Regulation have both implemented a permissive default approach to commercialisation of stem cell research.63
From the perspective of coherence of the legal system, it is undesirable that this kind of obvious discrepancy arises in a situation in which patentability is denied on moral grounds despite the permissive regulatory approach. It has been reasonably argued that the EPO’s competence in risk assessment seems questionable as it is not its primary function or even its duty. However, despite concerns about the scope of the EPO’s mandate, the Boards and Divisions of the EPO are currently conducting risk assessments that could be more aptly done by the pharmaceutical regulatory authorities.64 Therefore, it seems reasonable to argue that the scope of assessment of the patent morality clause should be kept strictly within the limits of the patent system, namely, commercial exploitation.65 Given the complex nature of ATMPs and possible risk-adjusted approaches to be used in GMP manufacture and trials, it is evident that risk assessments pertaining to the ATMPs require much specialised expertise. As shown in Section 7.6.3 of this study, the risk-proportionate approach to clinical trials and GMP are indeed subject to comprehensive stakeholder consultations that aim at establishing common acceptable standards and principles to deal with risks associated with advanced therapies.
Since patent authorities are by no means vested with adequate competence and resources to assess whether a product may constitute a public health risk, it is reasonable to argue that to improve the regulatory coherence of the EPO they should take the decisions of competent regulatory authorities into consideration as supplementary (regulatory) material in the assessment of the morality exclusion.
Pursuant to the idea of reflexive law (that will be further clarified in Section 3.4.2 of this study) this approach could improve coherence between the pharmaceutical regulatory system and the patent system, and allow significant adaptation and flexibility in present-day conditions over time and place.
63 Plomer, supra note 60, 127.
64 Hellstadius, supra note 50, 408-410. Hellstadius finds it especially problematic that the Boards of Appeal of the EPO have addressed the question of risk assessment as part of their mandate under Article 53(a) EPC, despite it is not their duty. See for instance, PSG, T 356/93. See also Hellstadius, op. cit., 286.
65 Hellstadius, op. cit., 408-410. See also for a general overview of the drafting history of the Biotech Patent Directive Porter, G. “The Drafting History of the European Biotechnology Directive” in Plomer, A., Torremans, P. (eds.), Embryonic Stem Cell Patents: European Law and Ethics. (Oxford: Oxford University Press), 2009, 3–26.
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