10 September 2014

Advocate General: the use of unfertilised human ova is patentable

In International Stem Cell Corporation, the Advocate General of the European Court of Justice recently opined that parthenogenetically activated unfertilised human ova are not human embryos if they are incapable of developing into human beings. The use of those cells is thus not excluded from patentability in the Biotech Directive. If followed by the ECJ, this would nuance its previous ruling in Brüstle v Greenpeace and have important consequences for stem cell technologies.

In International Stem Cell Corporation (ISCC), Advocate General Cruz Villalón opined on the meaning of the words ‘human embryos’ in the Biotech Directive, stating that the use of human embryos for industrial or commercial purposes is excluded from patentability in Article 6(2)(c). The ECJ had already explained the meaning of ‘human embryo’ in Brüstle v Greenpeace. In that case, it ruled that both fertilised and non-fertilised human ova can constitute a ‘human embryo’, as long as those organisms are capable of commencing the process of development into a human being. According to the ECJ, this applies when a cell nucleus from a mature human cell has been transplanted into a non-fertilised human ovum or when further development of a non-fertilised human ovum has been stimulated by parthenogenesis.

In ISCC, the referring court’s question was whether parthenogenetically activated unfertilised human ova qualify as a human embryo even when they only contain pluripotent cells and are therefore incapable of developing into human beings (even though they can commence that process). The Advocate General’s concluded that this is not the case. When taking into account the ECJ’s reasoning in Brüstle, the decisive criterion should be whether an unfertilised ovum has the inherent capacity of developing into a human being. The Advocate General observed that – unlike at the time of Brüstle – it is now apparent that parthenotes cannot develop into human beings and therefore do not, per se, have the required capacity of developing into a human being. Accordingly – as long as they do not obtain that capacity or have been genetically manipulated to acquire such a capacity – those organisms cannot be included in the term ‘human embryos’. Thus the use of such cells is not excluded from patentability.

This conclusion seems logical. If followed by the ECJ, this would considerably nuance Brüstle and could be important for the patentability of (the results of) stem cell research and technologies.