Article 6(2)(c) of Parliament and Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions meant that an unfertilised human ovum whose division and further development had been stimulated by parthenogenesis did not constitute a “human embryo”, within the meaning of that provision, if, in the light of current scientific knowledge, it did not, in itself, have the inherent capacity of developing into a human being, that being a matter for the national court to determine.

The Court of Justice of the European Union so held on a reference by High Court, Chancery Division (Patents Court), United Kingdom, in proceedings between the applicant, International Stem Cell Corp (“ISCO”), and the Comptroller General of Patents, Designs and Trade Marks (“the Comptroller”) concerning the refusal to register national patents on the ground that the applications for registration, relating to parthenogenetic activation of oocytes, concerned the use of “human embryos”, within the meaning of Directive 98/44.

ISCO submitted two applications for registration of national patents at the United Kingdom Intellectual Property Office, for (a) “Parthenogenetic activation of oocytes for the production of human embryonic stem cells” and (b) “Synthetic cornea from retinal stem cells”. The office refused to register those applications, on the ground that the inventions related to unfertilised human ova whose division and further development had been stimulated by parthenogenesis and that such ova were “capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so”, within the meaning of Brüstle v Greenpeace eV (Case C‑34/10) EU:C:2011:669; [2011] ECR I-9821; [2012] Bus LR D73, para 36. Therefore, according to the office, those inventions constituted “uses of human embryos for industrial or commercial purposes”, within the meaning of national legislation implementing article 6(2)(c) of Directive 98/44, and, as a result, were excluded from patentability. ISCO appealed to the High Court, Chancery Division (Patents Court), claiming that, in Brüstle’s case, the Court of Justice had intended to exclude from patentability only organisms capable of commencing the process of development which led to a human being. However, organisms such as those which were the subject of the applications for registration could not undergo such a development process and consequently, they should be capable of being patented on the basis of Directive 98/44. The referring court stated that parthenogenesis consisted in the activation of an oocyte, in the absence of sperm, by a variety of chemical and electrical techniques and that that oocyte, referred to as a “parthenote”, was capable of dividing and further developing. However, according to current scientific knowledge, mammalian parthenotes could never develop to term because, in contrast to a fertilised ovum, they did not contain any paternal DNA, which was required for the development of extra-embryonic tissue.

THE COURT (Grand Chamber) said that it followed from Brüstle’s case that a non-fertilised human ovum had to be classified as a “human embryo”, within the meaning of article 6(2)(c) of Directive 98/44, in so far as that organism was “capable of commencing the process of development of a human being”. That term meant that, in order to be classified as a “human embryo”, a non-fertilised human ovum had to necessarily have the inherent capacity of developing into a human being. Consequently, where a non-fertilised human ovum did not fulfil that condition, the mere fact that that organism commenced a process of development was not sufficient for it to be regarded as a “human embryo”, within the meaning and for the purposes of the application of Directive 98/44. By contrast, where such an ovum did have the inherent capacity of developing into a human being, it should, in the light of article 6(2)(c), be treated in the same way as a fertilised human ovum, at all stages of its development. The instant case related solely to the classification, in the light of article 6(2)(c) of Directive 98/44, of a human parthenote in itself, and not of a parthenote which was the subject of additional manipulation falling within the scope of genetic engineering. It was for the referring court to determine whether or not, in the light of knowledge which was sufficiently tried and tested by international medical science, human parthenotes, such as those which were the subject of the applications for registration, had the inherent capacity of developing into a human being. If the referring court were to find that those parthenotes did not have such a capacity, it should infer from that that they did not constitute “human embryos”, within the meaning of article 6(2)(c) of Directive 98/44.