The European Court of Justice recently ruled in International Stem Cell Corporation that parthenogenetically activated non-fertilised human ova are not human embryos in the sense of Article 6(2) of the Biotech Directive if they do not have the inherent capacity of developing into human beings. This means that the use of such cells is not excluded from patentability under Article 6(2). This judgment refines the ECJ's ruling in Brüstle and is important for stem cell technologies. However, it remains unclear whether subject matter as included in International Stem Cell Corporation's patent application can withstand the more general test of Article 6(1) of the same directive.
In International Stem Cell Corporation (ISCO), the European Court of Justice further delineated the words 'human embryos' in Article 6(2)(c) of the Biotech Directive. This article excludes the use of human embryos for industrial or commercial purposes from patentability.
The ECJ had already explained the meaning of 'human embryo' in Brüstle v Greenpeace, ruling that both fertilised and non-fertilised human ova are capable of commencing the process of development into a human being and should thus be regarded as a 'human embryo' in the sense of Article 6(2). The referring court's question in ISCO was whether non-fertilised human ova where the division and development to a certain stage have been stimulated by parthenogenesis (parthenotes) qualify as human embryos even when they do not have the inherent capacity of developing into a human being.
The ECJ followed the opinion of Advocate General Cruz Villalón – see our previous In context article – by holding that a non-fertilised human ovum stimulated by parthenogenesis does not constitute a 'human embryo' within the meaning of the directive if that ovum does not have the inherent capacity of developing into a human being.
The ECJ pointed out that 'human embryo' is an autonomous concept of EU law and must be widely construed, as respect for human dignity is involved. Taking into account the AG's reasoning and the decision in Brüstle, the ECJ then considered that the decisive test should be whether an unfertilised ovum has the inherent capacity of developing into a human being. The ECJ held that "the mere fact that that organism commences a process of development is not sufficient for it to be regarded as a 'human embryo', within the meaning and for the purposes of the Directive." This means that the ECJ has now qualified its previous decision with respect to non-fertilised ova in Brüstle.
It is a matter for the national courts to determine whether or not, in light of current scientific knowledge, a non-fertilised human ovum has the inherent capacity of developing into a human being. However, this does not necessarily mean that parthenotes will now be patentable. The AG observed that Article 6(2) is non-exhaustive and merely stipulates the "no-go zone" in Europe: specific cases in which patentability is automatically excluded. But Article 6(1) of the Biotech Directive is a more general provision, stating that inventions where the commercial exploitation would be contrary to the ordre public or morality, are excluded from patentability. The AG specifically refers to this potential role of Article 6(1). A relevant example in this respect – given by the AG – is provided by a case in Switzerland. In line with Article 6(1), Switzerland has incorporated an exclusion of patentability regarding parthenotes in national law.
In comparison with the Brüstle decision, the ECJ has given a further, more nuanced explanation of the term 'human embryos' in this recent ISCO decision. Subject matter relating to parthenotes, such as in ISCO, should not be automatically excluded from patentability on the basis of Article 6(2) of the directive. This is for the national courts to determine based on the criterion held out in ISCO. Furthermore, it remains to be seen what role Article 6(1) of the directive can play on a national level. These considerations should be taken into account when taking commercial steps in this field of technology.
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