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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

María Carmelina LONDOÑO-LÁZAROOpen the ORCID record for María Carmelina LONDOÑO-LÁZARO[Opens in a new window] and
Juan F. CÓRDOBA-MARENTESOpen the ORCID record for Juan F. CÓRDOBA-MARENTES[Opens in a new window]
María Carmelina LONDOÑO-LÁZARO
Affiliation:
Associate Professor in the International School of Economic and Administrative Sciences and the School of Law and Political Science, Universidad de La Sabana, Colombia; email: maria.londono1@unisabana.edu.co.
Juan F. CÓRDOBA-MARENTES
Affiliation:
Associate Professor and Dean, School of Law and Political Science, Universidad de La Sabana, Colombia; email: juanfc@unisabana.edu.co.
Rights & Permissions [Opens in a new window]

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.

Information

Type
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

I. Introduction

The controversies regarding the content and application of the ordre public and morality clauses (OPMCs) in the field of biotechnology patents are growing at the same pace as the bioethical concerns regarding the unconditional protection of human dignity in this realm. This study proposes an approach to the underlying debate on how to reconcile international trade and human rights (HRs), explaining the minimum content of the OPMCs as the recognition of international human rights law (IHRL) standards in trade law and intellectual property law (IPL). Within the context of a multicultural and globalised society, in which trade and economic interest are protected worldwide and morality seems to be a culture-based concept, the basic IHRL considerations 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.

With a systemic approach to international law (IL) – included in Article 31.3.c of the Vienna Convention on the Law of Treaties (VCLT) as a method of legal interpretation – this paper intends to justify the important legal role of the OPMCs on a national and global scale. Beyond the catalogue of patent regulations, 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 inventions.

The analysis will be developed in two parts. The first part is devoted to the historical and international legal background of the OPMCs, which frames current controversies. The second part proposes the recognition and justification of the OPMCs as legal mechanisms that embed human dignity standards into patentability assessments of biotechnological inventions.

II. Ordre public and morality clauses in intellectual property and international law

1. Historical background

Like other legal institutions, the concepts of public order and morality have their roots in Roman law. In this legal system, it was not possible to derogate from or modify ius publicum by private agreement.Footnote 1 The notion of ius publicum encompassed all matters related to public utility and morals, including the form and solemnities of legal acts and trials. In general, this concept denoted public rules of both positive law and morality, which were unbreakable: a Roman ordre public, which included ius sacrum, is summarised in the maxim “ius publicum cannot be altered by the agreements of private persons”. Footnote 2

Napoleon’s Civil Code brought and adapted the concept of ius publicum to modern law under the guise of ordre public and morality. The said Roman maxim was incorporated in Article 6: “Private agreements must not contravene the laws concerning ordre public and morality”. The inclusion of these concepts sought to temper the post-revolutionary trend that advocated absolute liberalism and unrestricted autonomy of the will.Footnote 3

In the common law tradition, the doctrine of public policyFootnote 4 was developed, since the fifteenth century, from the references to encounter commune ley: that is, that which was prejudicial to the community or communal values. Later, the courts interpreted principles contained in maxims such as ex dolo malo non oritur action or ex turpi causa non oritur actio to affirm that it is not possible to protect interests that have arisen from illegal or immoral grounds.Footnote 5 However, from the eighteenth century onwards, judges helped to shape a public policy doctrine that was also based on political considerations and not exclusively on immorality or illegality.Footnote 6

2. Introduction of ordre public and morality clauses in patent law

It was precisely in this context that the concepts of ordre public and morality were introduced in the earliest domestic patent laws. Thus, what is considered the first patent law in history, the Statute of Monopolies of 1623, referred to concepts such as “contrary to law”, “mischievous to the State” or “generally inconvenient” as grounds for patentability exclusions.

In the USA, although there was no legal provision excluding inventions that violated ordre public or morality from patentability, case law built a similar doctrine (moral utility) by interpreting the word “useful” employed in its Patent Act of 1790. The landmark case was Lowell v Lewis. Footnote 7 Lower courts continued to use this doctrine during the nineteenth and twentieth centuries, especially in cases related to gambling devices. Footnote 8

Other intellectual property (IP) statutes issued during the nineteenth century included concepts related to ordre public and morality as grounds for patentability exclusions. For example, the Austrian Law of 1852 excluded from patentability inventions “which cannot be worked for reasons of public health, morals, or safety …”, and the Italian Patent Law of 1864 included a very similar exclusion. Using a different expression, the Canadian Law of 1872 excluded from patentability inventions “having an illicit object in view”. Footnote 9

The timid initial inclusion of OPMCs in national patent laws in the nineteenth century expanded considerably in the following century. In a study submitted to the World Intellectual Property Organization (WIPO) in 2010, it was found that eighty-four countries in the Americas, Europe, Africa and Asia excluded from patentability inventions contrary to law, public order, public policy, public interest and morality. In addition, countries such as France and Panama had expressly excluded from patentability those inventions that violated human dignity. Footnote 10 In a new review of patent laws, we observed that other jurisdictions, as of September 2020, expressly include concepts related to ordre public and morality in their patent laws, completing more than a hundred countries with OPMCs.Footnote 11

3. The ordre public and morality clauses in international intellectual property law

The first multilateral treaty on industrial property, the Paris Convention of 1883, did not expressly include the concepts of morality and ordre public concerning patents, although it did so to exclude the registration of certain trademarks.Footnote 12 However, some European international instruments did include OPMCs in the regulations for the granting of patents. In particular, the Strasbourg Patent ConventionFootnote 13 contains OPMCs with a wording that allows a margin of appreciation for each member to exclude patentability.Footnote 14 Nevertheless, subsequent European international instruments such as the European Patent Convention (EPC)Footnote 15 and the Directive on the legal protection of biotechnological inventionsFootnote 16 declare, in a mandatory way, that patents shall not be granted to inventions that are contrary to ordre public or morality.Footnote 17 This phrasing is also used in European national laws, with some variations to refer to “morality”. Other regional economic integration organisations also provide OPMCs with similar wording, as is the case of the African Intellectual Property Organisation,Footnote 18 the Eurasian Patent OrganisationFootnote 19 and the Andean Community.Footnote 20

Nonetheless, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is the most important international instrument that provides OPMCs, albeit in a way that allows a margin of appreciation to each of the Member States. The TRIPS Agreement allows members to exclude from patentability “inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality … provided that such exclusion is not made merely because the exploitation is prohibited by their law”.Footnote 21 Some consider that the wording of this article is based on the said EPC,Footnote 22 although the initial draft explicitly included other elements that should be considered, such as human dignity.Footnote 23

4. Characterisation of ordre public and morality clauses and related controversies

The OPMCs are characterised by using open terms that can be interpreted in different ways, depending on the local context in which they apply. They can be categorised as general clauses (Generalklauseln) due to their lack of fixity and their adaptation to different circumstances. There is a close relationship between the ordre public and morality concepts. Since their inclusion in the French Civil Code, the two concepts have usually been used together. They have both been used to delimit the scope of the autonomy of the will. It can be said that ordre public and morality are differentiableFootnote 24 but, at the same time, inseparable concepts.Footnote 25 Furthermore, from the historical background, it can be inferred that OPMCs are expressions of cross-fertilisation.Footnote 26 They amalgamate civil law concepts such as ordre public and morality (bonnes mœurs) with others that are representative of common law: reasonability, utility and exploitation. In other words, OPMCs help to temper a purely utilitarian approach to the patent system.

Paradoxically, this utilitarian approach has influenced the application of OPMCs in specific cases decided in the European Patent Office (EPO). Concerning an invention related to animals genetically modified with cancer genes, the EPO, when interpreting the scope of Article 53(a) of the EPC,Footnote 27 considered that patenting such an invention “would seem to depend mainly on a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other”.Footnote 28 In applying this balancing test, the EPO finally concluded that the benefits obtained from the invention were more significant than the suffering of the animals modified for this purpose and eventually granted the Oncomouse patent. This test would later lead to Rule 23 (currently Rule 28) of the EPO’s guidelines for patent examiners that exempts from patentability “processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes”.Footnote 29

The utilitarian approach in the Oncomouse balancing test was reaffirmed in the Upjohn patent application process for a transgenic mouse created to experiment with possible cures for baldness.Footnote 30 The EPO refused the application because it found that the cost (the mouse’s suffering) was higher than the possible final benefit for humankind. With different outputs, the balancing test was used in other cases related to animal experimentation, particularly in that of Transgenic animals/Harvard and Leland Stanford. In the first case,Footnote 31 the patent was granted after applying the test created in the Oncomouse case and identifying a clear benefit for humanity.Footnote 32 In the Leland Stanford case, in addition to applying the abhorrent test (to which we will refer later), the cost/benefit analysis of the invention was carried out, and it concluded that the “medical benefit was readily apparent”, so that the patent was finally granted.Footnote 33

Endorsing the European consensus criteria, the EPO proposed another complementary test to identify when an invention is contrary to morality. In the Plant Cells caseFootnote 34 – in which the EPO defined the scope of the concepts ordre public and morality – it ruled that “inventions the exploitation of which is not in conformity with the conventionally-accepted standards of conduct pertaining to [European] culture are to be excluded from patentability as being contrary to morality”. This unacceptability test seems to establish a lower level of compliance than the balancing test since it leaves aside the cost/benefit analysis to focus on those values that are conventional and generally accepted by the public in European society.

The difficulty of applying the previous tests led the EPO to propose another, apparently more straightforward test to interpret the OPMCs. According to this test, first put into practice in the Relaxin case, OPMCs should only be invoked in rare and extreme cases. To determine whether the application is admissible, the examiner should consider whether the invention is so abhorrent, so offensive to the general public that it would be inconceivable to grant it a patent.Footnote 35

In addition to applying the abhorrent test, the Relaxin case is also crucial because, in its decision, the EPO makes one of the first explicit references to human dignity, although to affirm that it had not been affected in the invention process.Footnote 36 Later, in the Use of embryo/WARF case,Footnote 37 the EPO justified the exclusion from patentability of an invention – which involved destroying human embryos – in the apparent purpose of European legislation to protect human dignity.Footnote 38

In the same line, landmark decisions of the Court of Justice of the European Union (CJEU) must be referenced to ensure a complete overview of the interpretation of OPMCs within the European context. Of paramount importance, the decision in Brüstle Footnote 39 highlights the nuclear role of human dignity in the judicial test for assessing the patentability of biotech inventions. In the interpretation of Article 6(2)(c) of the Biotech Directive,Footnote 40 which represents an OPMC, the CJEU placed the concept of dignity – endorsed in the Directive preamble – as the core legal principle that justifies the broadest understanding of “human embryo” to exclude the patentability of products or procedures that imply uses of such human embryos for industrial or commercial purposes, even purposes of scientific research. This radical protection of human embryos is explained since fertilisation constitutes the beginning of a human being’s development. As a corollary of this case, protecting human life from its very beginning is a requirement of human dignity. Although with a different legal issue at stake, the International Stem Cell Corporation caseFootnote 41 confirms Brüstle as regards the scope and limits of Article 6(2)(c) for its intrinsic relation to human dignity. However, it proposes an adjusted interpretation of such an article when it specifies that stem cells obtained through the destruction of human embryos that cannot develop into a final human being can be patented.Footnote 42 From our perspective, Brüstle in particular reinforces our hypothesis regarding the enforceability of human dignity standards through OPMCs, beyond culture-based approaches. As we will argue in the next section, three imperative prohibitions derived from the primacy of human dignity in IHRL (instrumentalisation, discrimination and economic quantification of human beings) are suitable for enforcement through OPMCs, facilitating a systematic and harmonic interpretation of IPL and IHRL within the current international legal order.

A review of these cases and the corresponding comments shows that OPMCs are not without controversy.Footnote 43 For some, they are unnecessary, since patent law is very technical. Patent office examiners are either not capable or are not required to make decisions based on ethical or moral criteria, which are quite relative in each society. Their role should be limited to the application of technical criteria. Ethical issues should be left to the judgment of policymakers, judges or legislators, but not to these officials. In summary, patent law should be ethically and morally neutral.Footnote 44

For others, OPMCs are necessary and justified for different reasons. First, they are requirements of international patent law to guarantee universal ethical conditions in scientific research, Footnote 45 as patent law has a clear and close relationship with ethics.Footnote 46 In addition, these clauses make it possible to prevent the exploitation of inventions that could endanger the most important values and assets of international society or of a State.

Our purpose is that the following considerations can help us to understand the ethical–legal basis of OPMCs for their application in future cases.

III. Human dignity, ordre public and morality clauses and biotechnology

This article proposes that, beyond the outlined controversies, OPMCs are mechanisms that allow for scrutiny of the morality of inventions in accordance with the ethical–legal framework adopted by the international community, based on the primacy of human dignity as a founding principle of the current international system. In this way, they play a fundamental role in the defence of human beings and in providing coherence to that complex system.Footnote 47

The systemic approach adopted is based upon Article 31.3.c of the Vienna Convention on the Law of Treaties (VCLT),Footnote 48 and it is partially inspired by the idea embraced by the International Law Commission’s Fragmentation Report, according to which IL also pursues the common good of humankind and not merely the good of any particular institution or regime, stressing the function of law to protect rights and enforce obligations that have a backing in general public interest. Footnote 49

This second part explains the minimum content of OPMCs and the main legal reasons to justify them, based on such a systemic approach, according to which it is necessary to read IP regulations within the framework of current IL and IHRL.Footnote 50 In our opinion, the OPMCs allow for the integration of fundamental legal requirements of IHRL in international trade law through patent law; hence, they can be understood as pivot clauses for the articulation of international regimes. When fulfilling this function, OPMCs ensure a certain effectiveness of HRs, strengthening their transversality within the international legal system. Footnote 51

1. Human dignity: a basic morality standard

While it is true that the morality criteria are highly relative depending on the historical, cultural, social and religious context,Footnote 52 it is also a fact that the international community, after World War II, has been re-established on the grounds of an ethical framework translated into fundamental legal requirements derived from the recognition of human dignity and the inalienable rights of every human being.Footnote 53 This is the sense adopted by the Charter of the United Nations (UN Charter), the new constitution of the international community, founded upon the “faith in fundamental human rights, in the dignity and worth of the human person, in the equal rights of men and women”,Footnote 54 and expressly committed to “promoting and encouraging respect for human rights and for fundamental freedoms for all without distinction …”.Footnote 55

Hence, attending to the spirit and words of said “constitution”,Footnote 56 the concept of dignity is a founding principle of the international legal system.Footnote 57 In fact, dignity, in addition to being an ethical or moral criterion, adopts a legal nature.Footnote 58 Such a legal dimension has been widely developed in a set of international instruments that complement the UN Charter, particularly the so-called “Bill of Human Rights”.Footnote 59

This legal foundational framework adopted by most nations of the worldFootnote 60 sets the threshold of coherence to IL where numerous actors and subfields coexist.Footnote 61 In this light, dignity is an enforceable principle rather than a rhetorical concept. This explains, for instance, the universal condemnation of genocide, slavery or torture as serious attacks against human dignity.Footnote 62 This study attempts to contribute to this perspective, according to which human dignity entails certain specific requirements.Footnote 63 In our opinion, the ethical–legal grounds of the international system, represented in the principle of human dignity, also become a universal criterion for the moral scrutiny of inventions,Footnote 64 to the extent that it is a regulated matter by international trade law. Notwithstanding that at the national level new morality criteria may be incorporated based on the context, the argument proposed is that inventions, just like in any other matter of international legal regulation, are subject to minimum requirements derived from human dignity as one of the bases of the international system.

2. Legal requirements of ordre public and morality clauses according to international human rights law

The perspective that we offer in this section gives an understanding of some of the minimum requirements derived from the principle of human dignity in the field of biotechnology to the extent relevant for patent law. The intention is to shed light on the decisions of judges and examiners evaluating the patentability of inventions in order to contribute to the defence of the dignity of every human being and, consequently, to reinforce the coherence of IL.

To the extent that human dignity takes the form of a legal principle,Footnote 65 it fulfils a dual function in the field of biotechnology. On the one hand, it provides minimum requirements for the respect and protection of any human being, even setting limits or conditions for biotechnological developments. On the other hand, within its hermeneutical role, dignity defines benchmarks for evaluating the morality of inventions.

With regard to the first function, we present a threefold argument in this section: first, human dignity as a founding principle of IHRL; second, the structural role of human dignity in the relevant IL regulating biotechnology; and finally, the human dignity threshold set in three standards.

a. The principle of human dignity as a foundational principle of international human rights law

IHRL is founded upon the Universal Declaration of Human Rights (UDHR) and the main universal HRs covenants, all of which recognise expressly the structural role of human dignity. The wording of the UN Charter coincides with that of the UDHR, reaffirming the vital status of human dignity in IL. Following the preamble – recognising the inherent dignity of all members of the human family – this foundational pillar was reinforced in Article 1 with legal emphasis: “All human beings are born free and equal in dignity and rights”.

Travaux préparatoires and in-depth studies of the UDHR show that, from its origins, the concept of human dignity that inspired this instrument raises a new logic that goes beyond the foundation of rights either in classical individualism or in collectivism.Footnote 66 For the purposes of this paper, we should underline some characteristics of this conception of dignity. In the first place, the UDHR opts for a holistic reading of rights and duties; therefore, it is necessary to read Articles 1, 2 and 29(1) in an articulated manner. Second, the UDHR promotes a perspective on interdependent, universal and inalienable HRs. In this sense, the rights catalogue responds to principles and values common to the many traditions represented in the drafters’ profiles. Footnote 67 Hence, HRs represent a universal recognition of the human condition and its fundamental requirements. At the same time, they were recognised with sufficient flexibility to preserve the principle of subsidiarity; therefore, there was no need to promote homogeneity for their implementation. Footnote 68 Additionally, the condition of interdependence excludes an antagonistic view between rights, which requires preferring systemic and harmonising hermeneutical formulae to reconcile their interpretation in specific cases. This logic proposed by the UDHR is carried over the two main HRs covenants.

In summary, the new paradigm that founds IHRL recognises human dignity as a moral concept prior to any international or national legal system,Footnote 69 according to which every human being has an intrinsic value derived from their condition or human nature.Footnote 70 Once this reality is acknowledged by law, specific legal forms are adopted towards its enforceability. This is how HRs represent the legal recognition of the ontological dignity that accompanies every human being.Footnote 71 Since the version of dignity that characterises IHRL is not that of a rhetorical abstraction but of a human condition specified in the form of rights, it can well be said that this dignity is protected by the legal system through legal positions that human beings face before the law. This is the meaning we can understand from Waldron’s “condition status” theory.Footnote 72

Thus, beyond the many expressions of dignity according to the HRs catalogue,Footnote 73 this principle entails minimum universal standards that are above the State or any legal system. On these basic grounds, IL has developed the law ruling biotechnology in connection with bioethics.

b. Human dignity and human rights in the international corpus iuris of biotechnology

The global impact of the debates related to bioethics in biotechnology justifies the need for IL to provide a legal framework guiding these topics.Footnote 74 While bioethics is a discipline concerned with studying and resolving biomedical problems and challenges within life sciencesFootnote 75 and biotechnology relates to any technological application that uses biological systems or living organisms,Footnote 76 the clear intersection between those fields and HRs allows for integrating the relevant instruments ruling the matter into the system of IHRL.Footnote 77

Such an international corpus iuris is composed of the following most representative instruments: Universal Declaration on the Human Genome and Human Rights (UDHGHR)Footnote 78 ; Universal Declaration on Bioethics and Human Rights (UDBHR)Footnote 79 ; and Convention on Human Rights and Biomedicine – Oviedo Convention.Footnote 80 Even if the legal nature of the Declarations is different from the Convention, their unanimous adoption by all state members of the United Nations Educational, Scientific and Cultural Organization (UNESCO) cannot be underestimated, reinforcing their legal meaning. Thus, considering the purposes of this paper, we have summarised the shared features of the three instruments with the intention of illustrating the common grounds underlying the concept of human dignity as foundational for this field, in consistency with IHRL.

First, the number of times that the principle of human dignity is appealed to clears up any doubt about its radical importance, its universal character and the sense of practical orientation in all of the texts.Footnote 81 Accordingly, human dignity stands out as the basis for the rights, conditions and limitations for research impacting human life, as well as the criterion for the interpretation and integration of all of those instruments’ provisions.Footnote 82 Clearly, the instruments are intended to guide State actions, policies and lawsFootnote 83 ; therefore, the agreed guidelines should be endorsed in the national and international legal systems, in a coherent and harmonic manner.

Second, the express recognition of some particularly relevant HRs in the field of biotechnology resorts to a conception of dignity founded on three assumptions that must be read in an integrated and non-exclusive mode: personal autonomy; the ontological equality of all human beings; and the non-disposable character of human life. In other words, the holistic vision of human dignity, HRs and fundamental freedoms proposed by these international instruments – consistent with the original vision of the UDHR – promotes a version of dignity reconciling different traditions. One of the practical consequences of this enriched version of dignity is the necessity to always privilege the interpretation that provides the widest protection to the human being within the realm of a specific case.Footnote 84

Finally, the provisions of the three instruments coincide in highlighting some imperative prohibitions in the field of scientific research, which turn out to be direct expressions of the primacy of human dignity. In our view, these prohibitions can be grouped into three sets, each inspired by a practical manifestation of dignity. The first set refers to prohibitions against the instrumentalisation of human beings. The second refers to prohibitions against discrimination or ignorance of the essential equality of every human being. The third prohibits the economic quantification of human beings.

Since one of the objectives of our research is to specify the minimum requirements derived from the principle of human dignity as a universal ethical–legal criterion in order to justify the basic content and importance of the OPMCs, we will dedicate the following subsection to specifying the three groups of prohibitions applicable to the field of biotechnology.

c. The minimum threshold of morality clauses: limits of biotechnology

To avoid criticism against the concept of dignity as vague,Footnote 85 it is necessary to point out its practical legal implications based on the understanding that every human being possesses dignity and its recognition is a basic requirement of justice.Footnote 86

As we have demonstrated, from a legal and ethical viewpoint, the concept of human dignity illuminates the entire field of biotechnology, but there is no doubt that the greatest risks of disregarding its requirements are in the area of decisions about the beginning and end of human life.Footnote 87 This study does not intend to provide specific arguments about the protection of life in those extremes. However, it is evident that an interpretation of the legal and ethical limits of biotechnology, consistent with the equal dignity of every person, Footnote 88 can hardly justify a lower or non-existent standard of protection in the case of the most vulnerable human beings, precisely located in those extremes.Footnote 89 Therefore, we claim that the following strict prohibitions, derived from the international corpus iuris ruling HRs and biotechnology, apply to every human being.

  1. (1) Prohibition against the instrumentalisation of the human being. This maxim, based on the Kantian approach to dignity, demands respect for the intrinsic worth of every person, in a sense that deters against anyone being used as a means or object for whatever purpose – even a noble one.Footnote 90 The prohibition cannot be understood only as a requirement for personal autonomy to decide, since those who have very limited or no autonomy are also recognised as having intrinsic dignity.Footnote 91

    Accordingly, the UDHGHR has stated, “No research … should prevail over respect for the human rights, fundamental freedoms and human dignity” (Article 10); “Practices which are contrary to human dignity … shall not be permitted” (Article 11). In the same sense, the UDBHR establishes, “Human dignity, human rights and fundamental freedoms are to be fully respected. The interests and welfare of the individual should have priority over the sole interest of science or society” (Article 3). Finally, the Oviedo Convention reiterates the primacy of the human being (Article 2), defines specific conditions for the protection of persons undergoing research (Article 16) and prohibits the creation of human embryos for research purposesFootnote 92 (Article 18).

  2. (2) Prohibitions against discrimination to any human being. The principle of non-discrimination – considered to have the status of a ius cogens normFootnote 93 – endorses the equal ontological value of every human being, reaffirming its intrinsic worth as the expression of human dignity. Footnote 94

    This is the sense of the provisions of the UDHGHR, which affirm that “Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics” (Article 2); and “No one shall be subjected to discrimination based on genetic characteristics” (Article 6). In the same vein, the UDBHR states, “Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected” (Article 8); “The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably” (Article 10); and “No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity” (Article 11). Accordingly, the Oviedo Convention prescribes, “Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights …” (Article 1); and “Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited” (Article 11).

  3. (3) Prohibitions against the economic quantification of human beings. This expression of dignity demands the recognition of the equal and priceless worth of every human being, in such a way that they cannot be reduced to a commercial value or price. This prescription prevents the denigration of human beings as exchangeable objects in the economic market, a real risk associated with utilitarian ethics.Footnote 95

    The UDHGHR endorses this ban with the following wording: “The human genome in its natural state shall not give rise to financial gains” (Article 4); the UDBHR warns that “Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries … Benefits should not constitute improper inducements to participate in research” (Article 15). Finally, the Oviedo Convention prescribes that “The human body and its parts shall not, as such, give rise to financial gain” (Article 21).

On these grounds, we can conclude that even if there is a lack of global consensus on the patentability of biotechnology-related creations that are immoral or contrary to ordre public, Footnote 96 the previous expressions of human dignity should be considered when examiners evaluate patentability as essential criteria to qualify the morality – which turns into the legality – of inventions. In the final section, we will justify the role of OPMCs as tools for embedding those IHRL minimum standards into the broad field of international trade dynamised by biotechnology.

3. The ordre public and morality clauses as pivot clauses

As the OPMCs allow the exclusion of patentability based on the necessity of protecting, among others, human beings, the basic threshold of OPMCs defined in IHRL does not overshadow the considerations of convenience or national policy that States may include in their internal regulations.Footnote 97 In any case, provided that granting patents requires assessing the different interests at stake (public order, morals, private economic interests, scientific research incentives, among others), examiners are called to harmonise morality reasons with other principles and rules underlying trade law and IPL. This is the specific function of OPMCs and the reason we advocate to qualify them as pivot clauses.

The pivot expression intends to reveal the capacity of these clauses to harmonise or articulate different legal subsystems, as in the cases of IHRL, trade law and IPL. In other words, OPMCs embed human dignity standards in the wide spectrum of trade law through patent law regulations. This role should be underlined in IL as it contributes to the coherence of a legal system based on the centrality of the human being.

As a matter of fact, the advancement of biotechnological research has proliferated the ethical debates, and within this framework OPMCs are used as legal tools to incorporate the ethical considerations necessary to decide the boundaries of biotechnological inventions. Due to the wide range of moral debates in biotechnological research, we argue that OPMCs are essential tools to legally decide at least two different types of moral dilemma.Footnote 98

In the first place, OPMCs introduce the minimum requirements of humanity into the scientific field in order to protect human beings at the most basic level (the three prohibitions). In the second place, morality clauses provide legal and ethical arguments considering social justice claims, when tensions between economic rights protected by patents and social rights arise.Footnote 99 This second level also relies on respect for human dignity, but it gives a wider room of appreciation to the decision-makers, based on specific contexts.Footnote 100 Debates regarding the restrictions that patents impose on developing countries or vulnerable groups to access medicines are good examples for illustrating the role of these clauses beyond the basic level.

As they are usually drafted, OPMCs imply the application of a necessity test.Footnote 101 They are designed for those cases in which it is “necessary to protect ordre public or morality” by excluding patentability. This is the language of the TRIPS Agreement and most of the national laws that have followed this model. Although this test has not been interpreted by the World Trade Organization panels, one can resort to the interpretation of Article XX of the General Agreement on Tariffs and Trade (GATT), which has a similar wording and has been applied in a significant number of cases. Accordingly, a measure is necessary “only if no reasonable alternative is available to a Member which is not inconsistent, or at least less inconsistent, with the GATT”.Footnote 102

The result of the application of the test will be the exclusion of patentability: that is, lawmakers “may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality”. This consequence is different from that resulting from the application of the proportionality testFootnote 103 in the case of exceptions and limitations on patents. Unlike what happens with the necessity test of the OPMCs, the proportionality test is applied to a granted patent whenever it is required to limit its exploitation for the reasons provided by law. In summary, the protection of morality and public order, in the terms explained in this paper, is of considerable importance, such that the application of the test will imply a complete exclusion of the requested right and not a mere restriction on its exploitation as in the case of exceptions and limitations.

Based on the explained consequences, among the various benefits, we believe that the economic impacts of the application of OPMCs may have a persuasive effect on biotechnological developers to engage in respect for human dignity.

IV. Final remarks

Facing the unpredictable race of biotechnological developments, the only legal defence for human beings is the unconditional enforcement of human dignity standards at a global level. This paper argues for the recognition of the vital role of OPMCs for that purpose. In our view, OPMCs entail the benefits of harmonising subsystems, reinforcing the coherence of the international system and ensuring a certain degree of uniformity and predictability in relation to the minimum ethical–legal standards that, today, guide scientific work in the field of biotechnology.

The rationale behind a universal application of human dignity essentials through OPMCs reinforces the fact that the entirety of humanity has an interest in the regulation of biotechnological developments due to their potential worldwide impacts (benefits and risks) beyond national borders, as the current pandemic evidences. Undoubtedly, regulations and decisions of patent law that may limit or condition the economic exploitation of biotechnological inventions have the potential to be persuasive for a real commitment to human dignity.

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.

1 G Mousourakis, The Historical and Institutional Context of Roman Law (Abingdon-on-Thames, Routledge 2017), p 29.

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.

5 F Ghodoosi, “The concept of public policy in law: revisiting the role of the public policy doctrine in the enforcement of private legal arrangements” (2016) 94 Nebraska Law Review 685, 691–93, 726–27; K Murphy, “The traditional view of public policy and ordre public in private international law” (2015) 11 Georgia Journal of International & Comparative Law 591, 592.

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 Footnote 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).

ibid