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Between Ethics and Innovation: Brüstle, International Stem Cell and the UK’s Post Brexit Options for a Balanced Biotechnology Framework

Feride Naz Kurtaran, LLM 2024-2025

1.   Introduction

Biotechnological advances hold great potential for developing new treatments, medicines, and applications that can improve human life. Inventions involving human embryonic stem cells have the potential to advance human health by contributing to the treatment of previously incurable neurodegenerative diseases and enabling the development of new drugs. At the same time, the use of human embryos raises serious ethical, religious, and moral debates over whether such inventions can be patented.

In the European Union (EU), Directive 98/44/EC of the European Parliament and Council of 6 July 1998 on the legal protection of biotechnological inventions (the Biotechnology Directive) sets out the rules governing the protection of biotechnological inventions.[1] However, Article 6(2) of the Directive, which prohibits the patenting of inventions contrary to ordre public or morality, has given rise to major debates and legal uncertainties.[2]

Furthermore, the ambiguity surrounding the definition of the term human embryo came to the forefront in two decisions of the Court of Justice of the European Union (CJEU): Brüstle v. Greenpeace (C-34/10) and International Stem Cell Corporation (C-364/13).[3] The inconsistency between these two rulings clearly highlights the uncertainties within the EU’s legal framework in this field.

This study examines how the CJEU’s two important judgments, Brüstle v. Greenpeace and International Stem Cell Corporation, have shaped the interpretation of the Biotechnology Directive in relation to inventions involving human embryonic stem cells. It also considers the post-Brexit United Kingdom, which is no longer bound by EU law and CJEU case law, and explores how the UK might design a patent system that both fosters scientific innovation and respects ethical boundaries.

Accordingly, the central research questions this study seeks to answer are:

How do the Brüstle and International Stem Cell Corporation decisions interpret the Biotechnology Directive?

What policy options are available to the United Kingdom after Brexit to develop a more balanced, innovation-oriented biotechnology patent system?

To broaden the analysis, the approaches of the United States (US) and Japan have also been examined. In this way, the study provides policy recommendations that may be useful for the UK’s post-Brexit patent framework.

2.   The Biotechnology Directive and European Patent Convention

Even if an invention fulfils the criteria of novelty, inventive step and industrial applicability, it cannot be patented if its  commercial exploitation is contrary to ordre public or morality under Article 53(a) of the EPC.[4] The ethical limitations introduced by this Article further clarified by Rule 28(1), which lists specific exclusions such as cloning of human beings or industrial uses of human embryos.[5] These exceptions are as follows:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c)uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to humans or animals, and also animals resulting from such processes.’[6]

Similarly, Article 6 of the Biotechnology Directive adopts the same ethical framework and provides nearly identical exclusions in paragraph 2. According to Article 6(2), the following inventions are explicitly unpatentable:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) 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’.[7]

For Rule 28 to be applicable, it is necessary to assess how terms such as cloning, human, germline genetic identity, use of human embryos and industrial or commercial purpose should be interpreted. However, the courts have not developed a detailed interpretation of these terms. The same terminology is used without further detail in Article 6(2) of the Directive, which perpetuates lack of legal clarity.

3.   The Concepts of Ordre Public and Morality

The notions of ordre public and morality are not universal fixed standards; rather, they are relative principles that vary according to time, place, social norms, and cultural values. Therefore, even within the same society, individuals may evaluate these standards differently depending on their age, past experiences, or personal beliefs. Similarly, patent examiners, legal experts, and judges may adopt different legal and ethical approaches regarding the moral aspects of biotechnological inventions. This lack of clarity raises questions about the consistency and predictability of patent law in a global context, shows that what is acceptable in one jurisdiction may be considered morally objectionable in another.

4.   Summary of the Findings

4.1.      Brüstle v Greenpeace

The Brüstle decision interpreted the notion of human embryo too broadly and this approach contradicts scientific data by classifying structures that do not have the full potential for human development as embryos. The court failed to consider the biological difference between totipotent and pluripotent cells from a legal perspective, thereby applying the same legal consequences to cells with different developmental potentials and excessively broadening the scope of the law. Furthermore, the court's classification of the use of embryonic stem cells in scientific research as falling under industrial or commercial purposes could potentially  discourage scientific progress. The court  left the question of whether cells at the blastocyst stage fall under the definition of an embryo to national courts. This approach weakens legal harmonisation across the EU and leads to different outcomes in different countries. Moreover, even if embryos are not directly used in patent applications, the decision to deny patent protection in cases where embryos were destroyed in previous research presents a practical contradiction when compared to in vitro fertilisation (IVF) procedures. Surplus embryos not used in IVF treatments are generally destroyed. However, as stated in the Brüstle decision, any invention that was in any way connected to the destruction of the embryo in the past has been excluded from patentability. At this point, while the procedure undertaken by couples paying for IVF treatment is not considered commercialisation, it does not appear consistent for the CJEU to prohibit the granting of a patent even if the embryos were previously destroyed and the destruction is not mentioned in the description of the invention.

4.2.      International Stem Cell Corporation

The International Stem Cell decision can be considered a positive development in that it narrows the definition of human embryo, contrary to the broad interpretation in Brüstle, and introduces the inherent capacity test. The Court's acceptance that parthenogenetic ova without paternal DNA cannot become human beings through natural means reflects a more scientifically sound approach that takes into account the biological difference between totipotent and pluripotent cells. In this respect, the decision partially strengthens the scientific basis that was lacking in Brüstle. However, some problems remain, as in the Brüstle decision. The CJEU has set current scientific knowledge as an assessment criterion, but has given national courts the power to decide whether this condition is met. Leaving the application of the current scientific knowledge criterion to national courts continues to pose a problem of legal harmonisation at the EU level. Furthermore, while scientific research was broadly assessed as falling within the scope of industrial or commercial use in the Brüstle decision, the International Stem Cell decision did not directly revisit this issue. This leaves uncertain whether scientific research conducted within the framework of ethical rules will still be assessed under the patent prohibition.

5.     Embryonic Stem Cell Patents under US Law

The US has granted patents in the field of stem cells that encompass not only induced pluripotent stem cells (iPSCs) and regenerated tissues, but also human embryonic stem cells. At this point, the fact that moral considerations are not taken into account in determining whether a subject matter is eligible for patent protection is one of the important features that distinguishes US patent law from other regions. This approach differs from the European framework, where morality and ordre public play a central role in deciding whether biotechnological inventions, especially those involving human embryonic stem cells, can be patented. In the US approach, technical criteria are taken into account when evaluating patents, whereas in the European system, both technical criteria and ethical and moral considerations are taken into account. At this point, Europe's approach remains more rigid and conservative. On the other hand, from the US perspective, the complete removal of moral considerations from patent law may also cause certain problems. Focusing solely on technical criteria, particularly in sensitive areas such as human embryonic stem cells, may lead to outcomes that conflict with the ethical values of society.

5.1.      Embryonic Stem Cell Patents under Japanese Law

Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT) set out ethical rules for research involving human embryonic stem cells. These rules acknowledge the moral concerns raised by embryo destruction and make ethics committee approval a prerequisite for any derivation plan. However, as long as donors are informed that their embryos will be destroyed, the guidelines do not ban the procedure outright. The JPO, represents this flexible stance, patent claims are only rejected on morality grounds if they explicitly include the step of embryo destruction. As a result, inventions derived from embryonic stem cells are generally not rejected on ethical grounds, provided that the destruction of embryos is not explicitly claimed in the patent application.

As examined in detail in the Brüstle case, while patent applications have been rejected in Europe even if embryo destruction occurred in the past, Japan only rejects applications that explicitly involve embryo destruction, which is an important distinction between the two systems. Another important distinction between the two systems lies in the fact that, unlike the European approach, Japan permits research that may involve the destruction of embryos, provided that such research is approved by an ethics committee and informed consent has been obtained from the donors. This situation also shows that Japan is pursuing a more balanced policy in order to remain competitive in the field of biotechnology, while at the same time developing protective mechanisms for issues that are sensitive within society.

6    Post-Brexit Regulatory Options for the UK

Patent law in EU law is regulated to a more limited extent than other areas of intellectual property and this means that patent law will be one of the areas in which the UK will gain the least independence after Brexit. The main reason for this is that the EPC, which forms the basis of the patent system in Europe, was established outside the EU within a much broader international framework. Not only EU members but also non-EU countries such as Turkiye, Switzerland and Iceland are parties to the EPC. Under this system, the EPO, based in Munich, evaluates and registers patent applications. The EPO functions in accordance with the EPC, and since the UK continues to be a member of the EPC, it will remain integrated within this framework.

As the UK remains a party to the EPC, it will be obliged to comply with the provisions of the EPC in patent applications filed through the EPO. However, Brexit is providing the UK with the capacity for change, and this presents a strategic opportunity for  the country. The UK can adopt a more flexible patent regime for embryonic stem cell research than the rest of Europe, based on its domestic law and value system. This will encourage researchers to file for patents in the UK instead of elsewhere in Europe, thereby making the UK an attractive centre for embryonic stem cell research.

6.1.      Clarifying the Definition of Human Embryo to Enhance Legal Certainty

The CJEU’s broad interpretation of the concept of human embryo in the Brüstle decision, followed by the narrowing of this interpretation in the International Stem Cell decision, has created uncertainty regarding patentability. Now that the UK is no longer bound by these precedents, it has the chance to define the term human embryo in its national law in a more consistent manner based on scientific criteria. By adopting an approach based on the developmental potential of cells, it is possible to restrict totipotent cells due to ethical concerns, while excluding pluripotent cells from this scope. This distinction in national legislation will make the process more predictable for both researchers and applicants.

6.2.      Past Embryo Use Should Not Determine Patentability

The UK remains a party to EPC and keeps its relationship with the EPO. However, following Brexit, the UK is not required to follow the case law of the CJEU and is therefore not obliged to apply the strict logic adopted in the Brüstle decision. For this reason, the UK may depart from the European approach, which deems inventions unpatentable solely because the embryo material was destroyed at an earlier stage, even if the final product does not involve such a destruction process. Instead, a more flexible interpretation may be adopted in UKIPO’s application practice under the Patents Act. In this respect, the Japanese model could provide a valuable example for the UK. This approach will, to some extent , eliminate the contradiction created by IVF. In this way, while the destruction of surplus embryos in IVF treatment continues, at least not taking into account the past destruction of the embryo in patent applications will create a more consistent system.

6.3.      Clear Distinction Can Be Made Between Scientific and Therapeutic use and  Unethical Commercial Use

EU legislation and CJEU rulings have deemed the use of human embryos for industrial or commercial purposes unpatentable, with this concept being broadly interpreted to include scientific research, particularly in the Brüstle ruling. By excluding medical or therapeutic research from patent protection, this situation might risk slowing scientific advancement. Although ethical approval is already required for human embryonic stem cell research in the UK, the scope of unethical commercial use in patent law remains ambiguous. The UK's autonomy after Brexit could be a step towards addressing this situation differently. In this context, the UK patent law could be explicitly amended to exclude inventions for scientific or therapeutic purposes from the concept of unethical commercial use, provided that the use of embryos remains within ethical boundaries. This would both safeguard ethical principles and encourage scientific progress.

7.     Conclusion

In general, these recommendations could lay the groundwork for establishing a balanced system that addresses science, law and social values. The contribution of this study is to connect doctrinal analysis of EU case law with concrete policy options for the UK, a link that has not been fully developed in existing scholarship. The post-Brexit process for the UK presents an opportunity to define its own path among these three different approaches.

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[1] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions [1998] OJ L213/13 (Biotechnology Directive) <https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0044:EN:HTML#:~:text=The%20protection%20conferred%20by%20a,contained%20and%20performs%20its%20function> accessed 2 July 2025.

[2] ibid art. 6(2).

[3] Brüstle v Greenpeace eV (C-34/10) EU:C:2011:669; International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks (C-364/13) EU:C:2014:2451.

[4] Convention on the Grant of European Patents (European Patent Convention, EPC) (5 October 1973, as revised 17 December 1991 and 29 November 2000) art. 53(a) <https://www.epo.org/en/legal/epc/2020/a53.html> accessed 4 July 2025.

[5] Implementing Regulations to the European Patent Convention (EPC Implementing Regulations) reg. 28(1)  <https://www.epo.org/en/legal/epc/2020/regulations.html> accessed 5 July 2025.

[6] EPC Implementing Regulations, reg 28(1) (n 5).

[7] Biotechnology Directive (n 1) art. 6(2).