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Embedding Human Dignity Standards into Biotechnology Patents: The Role of Morality Clauses
Published online by Cambridge University Press: 18 October 2021
Abstract
This paper proposes an approach to the debate on how to reconcile international trade and human rights, explaining the minimum content of the ordre public and morality clauses (OPMCs) as the recognition of international human rights law (IHRL) standards in trade law and intellectual property law. Within the context of a multicultural and globalised society, in which trade and economic interests are protected worldwide and morality seems to be a culture-based concept, the primary considerations of IHRL embedded in these pivot clauses serve as a universal defence for human beings and a safeguard to the coherence of the human-centred international system. In particular, this study argues that the OPMCs allow for the enforcement of three standards derived from human dignity in the wider spectrum of biotechnology and scientific research, even constituting legitimate limits to the economic exploitation of biotechnological inventions.
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- Articles
- Information
- European Journal of Risk Regulation , Volume 12 , Issue 3: Special Issue on Biotechnology in International Economic Law and Human Rights , September 2021 , pp. 584 - 601
- Copyright
- © The Author(s), 2021. Published by Cambridge University Press
Footnotes
The authors thank Natalia Galindo and Johan Caldas for their contributions as research assistants while being Master’s students in the School of Law and Political Science at Universidad de La Sabana.
References
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2 H Ankum, “La Noción de Ius Publicum En Derecho Romano” (1983) 523 Anuario de historia del derecho español 534–36.
3 F De Castro, “Notas Sobre Las Limitaciones Intrínsecas de La Autonomía de La Voluntad” (1982) 987 Anuario de Derecho Civil 1017ff.
4 In countries with a common law system, it is usual to identify the notion of public policy with that of ordre public, characteristic of civil law: M Gebauer, “Ordre public (public policy)”, in Max Planck Encyclopedia of Public International Law (Oxford, Oxford University Press 2007); J Pila, “Adapting the ordre public and morality exclusion of European patent law to accommodate emerging technologies” (2020) 38 Nature Biotechnology 555.
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6 Ghodoosi, supra, note 5, 693.
7 Lowell v Lewis, 15 F Cas 1018 (CCCD Mass 1817).
8 J Crockett, “Morality: an important consideration at the patent office” (2020) 108 California Law Review 267, 276. Nevertheless, this doctrine ended in 1999 with the Juicy Whip, Inc. v. Orange Bang, Inc. case, in which the Federal Circuit reversed a decision of the District Court that considered that a deceptive invention was not useful.
9 L Bently etal, “WIPO Standing Committee on the Law of Patents – exclusions from patentability and exceptions and limitations to patentees’ rights” (2010) 13 <https://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3-annex1.pdf>.
10 ibid, 77–78.
11 Additional to the 2010 WIPO study: Brazil, Bhutan, Burundi, Denmark, Ethiopia, Gabon, Honduras, Hong Kong, Ivory Coast, Liberia, Madagascar, Mexico, Montenegro, New Zealand, Niger, Slovenia and Tonga.
12 Art 6quinquies, B(iii).
13 Convention on the Unification of Certain Points of Substantive Law on Patents for Invention (adopted 26 November 26 1963; entered into force 31 July 1980) ETS 47.
14 See Art 2.
15 Munich Convention on the Grant of European Patents (European Patent Convention) (EPC) (adopted on 5 October 1973) UNTS 1065.
16 Council Directive 98/44/EC of July 6 1998 on the legal protection of biotechnological inventions [1998] OJ L 213/13.
17 EPC, Art 53(a) and Council Directive 98/44 Art 6.1.
18 Harare Protocol on Patents and Industrial Designs (adopted 10 December 1982) ARIPO, Section 3(10)(j)(i).
19 Patent Regulations under the Eurasian Patent Convention (adopted 8 September 1994; entered into force 12 August 1995) EAPO, Rule 3(4).
20 Decision 486 (adopted 14 September 2000) Art 20.a.
21 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (15 April 1994) 1869 UNTS 299 33 ILM 1197 Art 27.2.
22 J Watal and A Taubman, The Making of the TRIPS Agreement: Personal Insights from the Uruguay Round Negotiations (Geneva, World Trade Organization 2015) p 174.
23 The Anell Draft: “1.4 The following [shall] [may] be excluded from patentability: Inventions, [the publication or use of which would be], contrary to public order, [law,] [generally accepted standards of] morality, [public health,] [or the basic principle of human dignity] [or human values]” in UNCTAD and ICTSD, “Resource Book on TRIPS and Development: An Authoritative and Practical Guide to the TRIPS Agreement”, 377 <https://unctad.org/system/files/official-document/ictsd2005d1_en.pdf>.
24 The EPO differentiates the two concepts in these terms: “It is generally accepted that the concept of ‘ordre public’ covers the protection of public security and the physical integrity of individuals as part of society. This concept encompasses also the protection of the environment … The concept of morality is related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture …” T 0356/93 (Plant cells) of 21.2.1995.
25 De Castro, supra, note 3, 1035–36.
26 For different approaches to “cross-fertilisation”, see: T Wongkaew, “The cross-fertilisation of international investment law and international humanitarian law: prospects and pitfalls” in KF Gómez, A Gourgourinis and C Titi (eds), International Investment Law and the Law of Armed Conflict (Cham, Springer 2019) pp 385–409.
27 Art 53 EPC. European patents shall not be granted in respect of:
(a) inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States.
28 T 0019/90 (Oncomouse) of 3 October 1990. The original patent application referred to mammals in general, but was adjusted in the process to meet the requirements of the test.
29 Guidelines for Examination in the European Patent Office, March 2021 Edition.
30 Ref: EP0439553A1, “Transgenic mice for the analysis of hair growth”. Application refused on 25 July 1993.
31 T 0315/03 (Transgenic animals/Harvard) of 6 July 2004.
32 This case also outlines what will later be known as the unacceptability test, when it states the following: “In the assessment of a “real“ Article 53(a) EPC objection, no single definition of morality based on e.g. economic or religious principles represents an accepted standard in European culture”.
33 T 1262/04 (Non-invasive localization/Leland Stanford) of 13 July 2012.
34 T 0356/93 (Plant cells) of 21 February 1995.
35 T 0272/95 (Relaxin/Howard Florey Institute) of 23 October 2002: “… an invention concerning a human gene was not an exception to patentability because it would not be universally regarded as outrageous …”. An antecedent of this abhorrent test can be found in T320/87 (Hybrid Plants/Lubrizol) of 10 November 1988.
36 “… no offence to human dignity had occurred as the woman who donated tissue was asked for her consent and her self-determination was not affected by the exploitation of the claimed molecules …”.
37 G 0002/06 (Use of embryos/WARF) of 25 November 2008.
38 “Given the purpose to protect human dignity and prevent the commercialization of embryos, the Enlarged Board can only presume that ‘embryo’ was not to be given any restrictive meaning in Rule 28 (formerly 23d) EPC, as to do so would undermine the intention of the legislator …”. Other EPO cases dealing with human embryo-related inventions and referring to the Brüstle case are: T 2221/10 (Culturing stem cells/Technion) of 4 February 2014 and T 1441/13 (Embryonic stem cells, disclaimer/Asterias) of 9 September 2014.
39 Case C-34/10 Brüstle v Greenpeace [2011] ECR I-09821.
40 Art 6 of Directive 98/44 is worded as follows:
“1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.
2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: …
(c) uses of human embryos for industrial or commercial purposes …”
41 Case C-364/13 International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks [2014].
42 “Article 6(2)(c) … must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine”. A comparative US and EU perspective is given in G Colangelo, “From Brüstle to Myriad Genetics: legal protection of biotechnological inventions in an EU/US comparative perspective” (2014) 22 The Digest – National Italian American Bar Association Journal 55.
43 See, among others, K Sideri, “Practical reasoning, impartiality and the European Patent Office: the legal regulation of biotechnology” (2012) 18 European Law Journal 821; J Straus, “Research, exploitation and patenting in the area of human embryonic stem cells in Europe – a case of concern causing inconsistency” (2017) 25 European Review 107.
44 For a summary of these positions, see Crockett, supra, note 8, 296–98. See also: D Jordaan, “Stem cell research, morality, and law: an analysis of Brüstle v Greenpeace from a South African perspective” (2017) 33 South African Journal on Human Rights 429; S Constand, “Patently a problem? Recent developments in human gene patenting and their wider ethical and practical implications” (2013) 13 QUT Law Review 100; C Staunton, “Brustle v Greenpeace, embryonic stem cell research and the European Court of Justice’s new found morality” (2013) 21 Medical Law Review 310.
45 E Bonadio, “Patents and morality in Europe” in I Calboli and S Ragavan (eds), Diversity in Intellectual Property: Identities, Interests, and Intersections (Cambridge, Cambridge University Press 2015) pp 152–53; V Prifti, “The limits of ‘ordre public’ and ‘morality’ for the patentability of human embryonic stem cell inventions” (2019) 22 Journal of World Intellectual Property 2.
46 E Siew-Kuan, “Immoral inventions – interaction between ethics and biotechnology patent law” (2010) 22 Singapore Academy of Law Journal 931; MW Tvedt and EM Forsberg, “The room for ethical considerations in patent law applied to biotechnology” (2017) 20 Journal of World Intellectual Property 160; S Thambisetty, “The learning needs of the patent system: implications from institutionalism for emerging technologies like synthetic biology” (The London School of Economics and Political Science Working Papers 2013) 18.
47 Complexity is linked to fragmentation, the process and the result of the proliferation of special treaty-regimes, normative overlaps and the discussed hierarchy among international legal sources in a pluralistic international community. ILC, “Report on the fragmentation of international law: difficulties arising from the diversification and expansion of international law”, finalised by M Koskenniemi (13 April 2006) UN Doc A/CN4/L682.
48 Vienna Convention on the Law of Treaties (adopted 23 May 1969, entered into force 27 January 1980) 1155 UNTS 331 (VCLT). For further analysis, see: ME Villiger, Commentary on the 1969 Vienna Convention on the Law of Treaties (The Hague, Brill | Nijhoff 2009) pp 432–34.
49 ILC, supra, note 47, 480.
50 Accordingly, the International Court of Justice (ICJ) has stated: “the Court must take into consideration the changes which have occurred in the supervening half-century, and its interpretation cannot remain unaffected by the subsequent development of law, through the Charter of the United Nations and by way of customary law. Moreover, an international instrument has to be interpreted and applied within the framework of the entire legal system prevailing at the time of the interpretation”. Legal Consequences for States of the Continued Presence of South Africa in Namibia (South West Africa) notwithstanding Security Council Resolution 276 (1970) (Advisory Opinion) [1971] ICJ Rep 71, 53.
51 Regarding the transversality of HRs, see: T Meron, “International law in the age of human rights: general course on public international law”, in Recueil des Cours, Collected Courses, Volume 301 (2007) (The Hague, Martinus Nijhoff 2010); AAC Trindade, International Law for Humankind (The Hague, Brill | Nijhoff 2020).
52 Vienna Declaration and Programme of Action (adopted 25 June 1993 World Conference on Human Rights); Bently etal, supra note 9.
53 MA Glendon, Un Mundo Nuevo: Eleanor Roosevelt y La Declaración Universal de Derechos Humanos (P Pallares trans., 1st edn, Mexico City, Fondo de Cultura Económica 2011) p 252ff; P Carozza, “Human dignity” in D Shelton (ed.), The Oxford Handbook of International Human Rights Law (Oxford, Oxford University Press 2013) p 345.
54 Universal Declaration of Human Rights (adopted 10 December 1948) UNGA Res 217 A(III) (UDHR) Preamble.
55 UDHR Art 1(3). In the same sense, UDHR Art 2; International Covenant on Civil and Political Rights (adopted 16 December 1966 UNGA Res 2200A (XXI) (ICCPR) Art 2; International Covenant on Economic, Social and Cultural Rights (adopted 16 December 1966 UNGA 2200A (XXI) (ICESCR) Art 2.
56 Weeramantry considers that the UN Charter “is a world constitution such as no other document in world history has ever been. It commands universal acceptance … It binds the entire international community not only to an adherence to the structure of the United Nations, but also to the fundamental principles of international law”. CG Weeramantry, Universalising International Law (The Hague, Brill | Nijhoff 2004) p 77.
57 A Addis, “The role of human dignity in a world of plural values and ethical commitments” (2014) 31 Netherlands Quarterly of Human Rights 403, 410; MA Glendon, “Foundations of human rights: the unfinished business” (1999) 44 The American Journal of Jurisprudence 1; G Le Moli, “The principle of human dignity in international law” in M Andenas etal (eds), General Principles and the Coherence of International Law (The Hague, Brill 2019) pp 356–58.
58 For Habermas, dignity is “the portal through which the egalitarian and universal substrate of morality is transferred to the field of law and comes, this way, to fulfill a ‘catalyst function’ in the construction of human rights”: J Habermas, “El concepto de dignidad humana y la utopía realista de los derechos humanos” (2010) LV Diánoia 3. In the same vein, Adorno submits that human dignity serves as “bridge” between morality and law: R Andorno, “La Dignidad Humana Como Principio Biojurídico y Como Estándar Moral de La Relación Médico-Paciente” (2019) 195 Arbor 501.
59 The Bill of Human Rights is composed of the UDHR, the ICCPR and the ICESCR. See Carozza, supra, note 53, 350; M Goodman, “Human dignity in supreme court constitutional jurisprudence” (2005) 84 Nebraska Law Review 750.
60 Glendon, supra, note 53, 252.
61 Regarding the role of dignity in the coherence of IL, see, among others: Le Moli, supra, note 57, 367.
62 Weeramantry, supra, note 56, 57; G Robertson, Crímenes contra la humanidad. La lucha por una justicia global (A Resines trans., 1st edn, Mexico City, Siglo XXI 2008); Addis, supra, note 57, 35.
63 For similar proposals, see: DP Sulmasy, “Dignity and bioethics: history, theory, and selected applications”, in Human Dignity and Bioethics (Hoboken, NJ, Wiley 2009); O Schachter, “Human dignity as a normative concept” (1983) 77 American Journal of International Law 848; S Joseph, Blame It on the WTO?: A Human Rights Critique (Oxford, Oxford University Press 2011) pp 91–141.
64 This statement is corroborated by the role of “human dignity” in the negotiation of Art 27.2 of the TRIPS Agreement as recounted by a direct participant: “Thus, the concept of ‘human dignity’, which would discourage the creation of chimeras or human clones, might be encompassed in the concept of ordre public or morality. Animal dignity, a very hot issue in Switzerland, was discussed too. But like ordre public, morality is subject to the perception of the people living in a country or region”. T-LT Wasescha in Watal and Taubman, supra, note 22, 175.
65 Le Moli also highlights three features of dignity: “(i) structural element and necessary foundational of the international legal system; (ii) possesses a legal substance …; (iii) obligation-creating principle”. Le Moli, supra, note 57, 360.
66 Glendon, supra, note 53, 21.
67 Weeramantry, supra, note 56, 14.
68 Glendon, supra, note 53, 311–28.
69 J Waldron, “Is dignity the foundation of human rights?” in R Cruft, SM Liao and M Renzo (eds), Philosophical Foundations of Human Rights (Oxford, Oxford University Press 2015) pp 117–37.
70 The word “nature” was removed from Art 1 UDHR, precisely to avoid misunderstandings of nature as biology, leading to reductionist approaches to human life. P Pallares-Yabur, Un Acuerdo En Las Raíces. Los Fundamentos de La Declaración Universal de Derechos Humanos. De Jacques Maritain a Charles Malik (Pamplona, Universidad de Navarra 2020) pp 240–47.
71 Glendon, supra, note 57; Pallares-Yabur, supra, note 70, 383.
72 J Waldron, Dignity, Rank and Rights (Oxford, Oxford University Press 2012) pp 57–61.
73 The UDHR recognises twenty-one rights, the ICCPR recognises twenty-three rights and the ICESCR recognises nine rights.
74 C Weeramantry, Human Rights and Scientific and Technological Development: Studies on the Affirmative Use of Science and Technology for the Furtherance of Human Rights (Tokyo, United Nations University Press 1990); A Bagheri, JD Moreno and S Semplici (eds), Global Bioethics: The Impact of the UNESCO International Bioethics Committee, vol. 5 (Cham, Springer 2016).
75 F Molnár-Gábor, “Bioethics” (2015) Max Planck Encyclopedia of International Law (Oxford, Oxford University Press 2007).
76 Convention on Biological Diversity (5 June 1992) 1760 UNTS 69.
77 Universal Declaration on Bioethics and Human Rights (adopted 19 October 2005 UNESCO’s General Conference), Preamble and Art 2(c). In the same vein, see, among others: R Andorno, Biomedicina y derecho internacional: en busca de un consenso global (Geneva, WHO Bulletin 2002) p 959.
78 UDHGHR (unanimously adopted 11 November 1997 UNESCO’s 29th General Conference), endorsed by the UNGA, Resolution AIRES/53/152 on 9 December 1998, 53rd session. For further analysis, see: RE Ávila and ME Samar, “Medicina Genómica Aspectos éticos, legales y sociales del Genoma Humano” (2011) 11 Revista Latinoamericana de Bioética 18.
79 UDBHR (unanimously adopted 19 October 2005 UNESCO’s General Conference). For further analysis, see: HT Have and S Bahri, “Introducción a la declaración universal sobre bioética y derechos humanos” (R Lang trans.) in M Casado (ed.), Sobre la dignidad y los principios. Análisis de la Declaración Universal sobre Bioética y Derechos Humanos de la UNESCO (London, Civitas 2009) pp 25–26.
80 Oviedo Convention (entered into force 1 December 1999) ETS 164.
81 The concept of human dignity is present fifteen times in the UDHGHR, twelve times in the UDBHR and five times in the Oviedo Convention, significantly, including the same title.
82 UDHGHR, Preamble and Arts 1, 2, 6, 10–12, 15, 21, 24 and 25. UDBHR, Preamble and Arts 2, 3, 10–12 and 28. Oviedo Convention, Preamble and Arts 1, 2, 15, 18 and 21. See also Andorno, supra, note 58.
83 UDHGHR, Preamble and Artis: 11, 15, 20 and 21. UDBHR, Preamble and Arts 2, 18 and 21. Oviedo Convention, Preamble and Arts 1, 23 and 30.
84 The pro homine principle in IL demands the prevalence of the interpretation most favourable to the human being. See UDHR, Arts 29 and 30; ICCPR, Art 5; ICESCR, Art 5. Among others, see: AA Cançado, “Current state and perspectives of the Inter-American System of Human Rights Protection at the dawn of the new century” (2000) 8 Tulane Journal of International & Comparative Law 5; V de Oliveira Mazzuoli and D Ribeiro, “The pro homine principle as a fundamental aspect of international human rights law” (2016) 17 Meridiano 47 1.
85 R Macklin, “Dignity is a useless concept” (2003) 327 BMJ 1419, 1420.
86 J Rawls, A Theory of Justice (Cambridge, MA, Harvard University Press,1971) p 2; P Lee and RP George, “The nature and basis of human dignity”, in Human Dignity and Bioethics, vol. 21 (Hoboken, NJ, Wiley 2009).
87 LR Kass, “Defending human dignity” in The President’s Council on Bioethics (ed.), Human Dignity and Bioethics (Washington, DC, The President’s Council on Bioethics 2008) pp 297, 304.
88 Lee and George, supra, note 86.
89 See Sulmasy, supra, note 63, 490–98.
90 I Kant, Groundwork of the Metaphysics of Morals (HJ Paton trans. New York, Harper & Row 1964) p 96; N Kurata, “What is ‘human dignity’?: biotechnology and human dignity” (2006) 118 The Annual Report on Cultural Science 35, 39.
91 Andorno, supra, note 58; Schachter, supra, note 63.
92 I Schneider, “Patent governance, ethics and democracy: how transparency and accountability norms are challenged by patents on stem cells, gametes and genome editing (CRISPR) in Europe”, in TC Berg and R Cholij (eds), Patents on Life (Cambridge, Cambridge University Press 2019) pp 263–88.
93 Juridical Condition and Rights of the Undocumented Migrants, Advisory Opinion OC-18/03, Inter-American Court of Human Rights Series A No 18 (17 September 2003) 101.
94 Currently, concerns about equality are particularly relevant due to resurgent racism and xenophobia. See R Andorno etal, “Geneva statement on heritable human genome editing: the need for course correction” (2020) 38 Trends in Biotechnology 351.
95 Le Moli, supra, note 57, 358.
96 Crockett, supra, note 8, referencing Prof R Merges, 297; J Field, “The patentability of human embryonic stem cell-based inventions in the European Union” (2015) 5 Aberdeen Student Law Review 1; JH Tudor and J Tudor, “Stem cell and biotechnological patentability and research in the European Union: an interdisciplinary approach” (2018) 87 University of Cincinnati Law Review 977; Constand, supra, note 44; S Donnelly, “The patentability of human embryonic stem cells” (2011) 20 Dalhousie Journal of Legal Studies 7; MA Bagley, “Patent first, ask questions later: morality and biotechnology in patent law” (2003) 45 William and Mary Law Review 469.
97 Thus, for example, in Colombia the examiner must bear in mind that inventions contrary to public order or morality are not patentable (eg those that incite crime), propaganda that supports racial, religious or other similar discrimination and obscene or rude material (SIC, Manual para Examinadores, 2014). For restricting the granting of invention patents “the expression ‘good customs’ can be assimilated to the construction that the Colombian Constitutional Court has made around the criterion of ‘social morality’ or ‘public morality’” (C-234/2019).
98 Similarly, see Andorno, supra, note 58, 5.
99 See, among others, A Stazi, “Biotechnological inventions and limits of patentability between recent evolutions in the US case law and the EU perspective of fundamental rights: moving toward a common ‘Western approach’?” (2014) 5 Comparative Law Review 1; P Cullet, “Human rights and intellectual property protection in the TRIPS era” (2007) 29 Human Rights Quarterly 403.
100 “While the market decides how ‘useful’ an invention is, the patent system should decide which inventions to incentivize”: Crockett, supra, note 8, 267; Prifti, supra, note 45.
101 D Matthews, “Access to CRISPR genome editing technologies: patents, human rights and the public interest” (2020) Queen Mary School of Law Legal Studies Research Paper No. 332/2020.
102 UNCTAD and ICTSD, supra, note 23, 378.
103 C Bernal-Pulido, El Principio de Proporcionalidad y Los Derechos Fundamentales (Bogotá, Universidad Externado de Colombia 2014).