International Stem Cell Corporation v Comptroller General of Patents (CJEU, C-364/13, 2014)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the High Court (Patents Court), the Grand Chamber refined the definition of human embryo laid down in Brüstle. An unfertilised human ovum whose division and further development have been stimulated by parthenogenesis is not a « human embryo » within Article 6(2)(c) of Directive 98/44 if, in the light of current scientific knowledge, it does not in itself have the inherent capacity of developing into a human being, which is for the national court to determine. The decisive test becomes the capacity to develop into a human being, not the mere ability to commence a process of development; inventions based on human parthenotes lacking that capacity thus fall outside the exclusion.

Facts and procedure

International Stem Cell Corporation (ISCO) had filed two UK patent applications, one claiming methods of producing pluripotent human stem cell lines from parthenogenetically activated oocytes and the resulting lines, the other methods of producing synthetic cornea involving the isolation of such cells and the resulting cornea (paras 9 and 10). By decision of 16 August 2012, the Intellectual Property Office refused both applications: following Brüstle, the ova concerned were capable of commencing the process of development of a human being, so the inventions were uses of human embryos for industrial or commercial purposes (paras 11 to 13). On appeal, the High Court noted that mammalian parthenotes can never develop to term because they lack paternal DNA; ISCO amended its applications to exclude any additional genetic manipulation aimed at overcoming that limit (paras 17 and 18). Taking the view that excluding parthenotes did not strike a proper balance between biotechnological research and respect for human dignity (para 19), it made a reference (para 20).

The applicable law

Article 6(2)(c) of Directive 98/44, implemented in the United Kingdom by paragraph 3(d) of Schedule A2 to the Patents Act 1977, excludes from patentability uses of human embryos for industrial or commercial purposes. The Court recalled that the directive does not regulate the use of embryos in scientific research but only patentability (para 22), and that « human embryo » is an autonomous concept to be understood in a wide sense (paras 23 and 24).

Question

Is an unfertilised human ovum stimulated by parthenogenesis, which contains only pluripotent cells and cannot develop into a human being, a « human embryo » within Article 6(2)(c) (para 20)?

Decision

The Court restated Brüstle, under which a non-fertilised ovum falls within the concept of human embryo where it is capable of commencing the process of development of a human being (paras 25 to 27). It clarified that this expression means that the ovum must necessarily have the inherent capacity of developing into a human being (para 28). The mere fact that it commences a process of development is not sufficient (para 29); if it has that capacity, by contrast, it must be treated like a fertilised ovum at all stages of its development (para 30). In Brüstle, the observations before the Court indicated that parthenogenetically stimulated ova had that capacity (paras 31 and 32). Here, the referring court and all the interested parties accepted that, on current scientific knowledge, a human parthenote is not, as such, capable of commencing the process of development which leads to a human being (para 33). The question concerns only the parthenote as such, not one subjected to additional genetic manipulation (paras 34 and 35). It is for the national court to determine, in the light of sufficiently tried and tested medical knowledge, whether the parthenotes at issue have that inherent capacity; if not, they are not human embryos (paras 36 and 37).

Key points for practice

• The test for a human embryo is the inherent capacity of developing into a human being; commencing a process of development is not enough (paras 28 and 29).
• The assessment rests on current scientific knowledge and lies with the national court, so it may evolve (paras 36 and 38).
• The ruling covers only the parthenote as such; additional genetic manipulation would call for a different analysis (para 35).
• Practical point: applications directed to human parthenotes are best drafted to exclude expressly any genetic manipulation aimed at conferring a capacity for full development, as ISCO did (paras 18 and 34).

Provisions applied

Directive 98/44/EC

Art. 6(2)(c)

National law

Patents Act 1977 (United Kingdom), Schedule A2, paragraph 3(d)

Case law cited

Brüstle (C-34/10); Smits and Peerbooms (C-157/99)

Related decisions

• Brüstle v Greenpeace, 18 October 2011, the judgment whose definition of human embryo is refined here.

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.