Patents & Stem Cell-Based Embryo Models in Europe: The Need for Nuanced Bioethics Scrutiny?

A range of ethical issues are currently being considered around the regulation of emerging ‘stem cell-based embryo models’ (SCBEM)  - the term ‘SCBEMs’ used here draws on the UK Parliament’s conception  as  models created using stem cells which mimic the development of the human embryo (or parts/stages of this) which includes different types of SCBEMs developed from adult stem cells and embryonic stem cells. Notably, scientific uncertainties remain around SCBEMs, at the time of writing, including their developmental potential. SCBEMs have a range of potential future applications, including facilitating deeper understanding of early stages of embryonic development, improving understandings of early pregnancy loss and IVF outcomes, investigating disease, and in drug discovery, although some uncertainties arise in such contexts.

 Alongside the broader ethical issues related to SCBEMs, questions arise around the patentability of SCBEMs, which this article argues warrants bioethical scrutiny. Some of the potential issues are sketched here to encourage greater consideration of these questions within the health law/bioethics communities. However, this article does not offer a comprehensive analysis of the complex issues at stake.

Patents

A patent is an intellectual property right which enables rightsholder(s) to exclude others from using the patentable ‘technology’ for the patent term, usually 20 years. Patents can be used to incentivise or encourage the development of technologies in certain contexts. This is because a patent enables rightsholders to develop an income stream from a technology, as permission to use a patented technology is granted by the rightsholders via a license, typically provided in exchange for monetary or other return. The extent to which patents are the most appropriate incentivisation tool is, however, contested. Moreover, patents enable rightsholders to hold a governance function by enabling rightsholders to control key aspects of how a patented technology is used and of the terms of access (including the price, and by whom that technology can be used by). Thus, rightsholders can act as gatekeepers whose decisions can shape development, delivery, access and use of patented technologies.

Bioethical Contestations – Patents & Human Embryo related Technologies in Europe

There are significant contestations in Europe over  the potential bioethical issues that arise in relation to patent grant/use over human embryo related ‘technologies’.  A range of differing issues have been discussed in literature, including:  1) the role of patents in (dis)incentivising the use of human embryos in research– this gives rise to complex questions, as the grant/refusal of a patent does not necessarily equate to limiting/encouraging use of a technology. Thus nuanced considerations are needed; 2) the role of patents in the commodification of the human body/life; and 3) the potential impact of patents on access to downstream technologies developed– an issue not unique to patents and embryonic related technologies. A myriad of differing perspectives arise. This article is not seeking to address the normative question of how these questions should be resolved. Instead, it sketches some of the ethical questions likely to emerge for patents and SCBEMs in Europe.

Patentability of Embryo Related Technologies in Europe – Legal Frameworks

There is no unified global patent system. The TRIPS Agreement which is applicable in World Trade Organisation States sets down minimum standards, however, regional/national jurisdictions may adopt further legal provisions. The European Patent Convention 1963, as amended (EPC) applies to 39 European Statesincluding all EU States and the UK. Whilst, the Biotechnology Directive 98/44EC (Directive) adopted in 1998 applies to the patentability of biotechnological inventions in EU States. The Directive was adopted as a supplementary means of interpretation for the EPC. A unitary European patent system was recently established for participating EU States, but is not considered in depth here.

Crucially, European patent law has tailored legal provisions to engage with ethical issues related patent law. These include: Art 53(a) EPC which states that patents shall not be granted for: “(a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality…;” Article 6(1), Directive largely replicates this general morality provision. Whilst Art 6(2) provides a non-exhaustive list of four inventions excluded from patentability under the general morality provision, including: “(c)uses of human embryos for industrial or commercial purposes...” These four listed exclusions were adopted within the Implementing Regulations for the EPC. Several of these provisions may be relevant to SCBEMs patentability, depending on how SCBEMs develop. However, due to space, this piece focuses on the general morality provision and Art 6(2)(c).

Patents & Embryo Models in Europe: Definitional Déjà vu?

The general morality provision can apply to any technology but is used rarely to deny patents. The European Patent Office (EPO) examination guidelines state that: “This provision is likely to be invoked only in rare and extreme cases…” Thus, whilst it is possible some SCBEM technologies could be denied patentability based on this, a high threshold is set. Furthermore, where this provision has been invoked in the EPO context, the depth of ethical analysis is often limited - it is questionable whether, the EPO is currently institutionally configured to engage in detailed ethical analysis. A range of other provisions in European patent law could also be applicable here, including provisions around the need to account for human dignity within patent law, and, Art. 5, Directive which excludes from patentability ‘[t]he human body, at the various stages of its formation and development..”  however, a narrow light touch approach to such provisions is often evident in practice.

Under Art 6(2)(c) Directive, given how the legal provision is framed, a definitional test has been applied, however, how the term ‘embryo’ is defined has led to considerable uncertainties due to scientific developments. In  WARF G2/06, (2008) the EPO held that technologies which involved the destruction of a human embryo at any stage in their development are excluded from patentability. Subsequently, in C-34/10 Brüstle (2011), the CJEU held that under Art 6(2)(c):  “[A]ny human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ … if that fertilisation is such as to commence the process of development of a human being.” However, in International Stem Cell Corporation v Comptroller General of Patents (2014) the CJEU held:  “…Article 6(2)(c) of Directive 98/44 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, that ovum does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.” This decision added some clarity around how the provision applied for parthenotes.

However, SCBEMs may again give rise to uncertainty in this context, and key considerations around Art 6(2)(c) and the patentability of SCBEMs are likely to include: whether SCBEMs can be defined as an ‘embryo’ for this purpose – including whether a SCBEM has an inherent capacity to develop into a human being; and/or whether the development of the SCBEM involved the use/destruction of human embryos at any stage. Moreover, given the range of different types of SCBEMs emerging, case-by-case approaches will likely be needed around such definitional questions.

Reflection – Need for bioethics scrutiny?

Arguably, however, this type of definitional task and more generally, the current approach to ethical issues in European patent law arguably lacks nuanced consideration of the bioethical Issues at stake, which are difficult to capture by definitional applications of specific legal exclusions. Whilst it is possible a deeper consideration of ethical issues could arise if questions are raised under the general morality provision, however, as noted, a light-touch approach has been evident to date. Moreover, such patent exclusions consider only patent grant/denial they do not engage with questions around how patents, if granted, can or should be used. For SCBEMs, arguably much greater scrutiny of the bioethical issues related to patentability is needed, including by the health law/bioethics communities, one which fully engages in a nuanced manner with the complexity of ethical issues that may arise at both patent grant and use stages.

Aisling McMahon, Professor of Law, Maynooth University

Email: aisling.mcmahon@mu.ie

Funding Acknowledgment: Funded by the European Union (ERC, PatentsInHumans, Project No. 101042147). Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union or the European Research Council Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.