Opaque CJEU Clarifies Human Embryos In Brustle

Upon reviewing the much anticipated ruling, Beatriz San Martin questions if the CJEU has erred.

Under Article 6(2)(c) of the Directive on the Legal Protection of Biotechnological Inventions (98/44/EC) (the "Biotech Directive"), inventions whose commercial exploitation includes the use of human embryos for industrial or commercial purposes are considered unpatentable.

On 18 December 2014, in Case C-364/13 International Stem Cell Corporation v Comptroller General of Patents, the Court of Justice of the European Union ("CJEU") ruled that in order not to be classified as a 'human embryo', a non-fertilised human ovum must not, in light of current scientific knowledge, have the inherent capacity of developing into a human being. The fact that a parthenogenetically- activated human ovum commences a process of development is not sufficient for it to be regarded as a 'human embryo'.

Background

In the September 2014 edition of Intellectual Property Magazine, Hannah Smith Willis and I commented on the opinion of Advocate General (AG) Cruz Villalón in this case and provided a general background.1. This article focuses on the decision of the CJEU.

By way of brief background, the preliminary reference was made by the UK High Court, following an appeal by International Stem Cell Corporation (ISC) to the UK Intellectual Property Office's rejection of two patent applications concerning methods of producing pluripotent human embryonic stem cells from parthenogenetically-activated oocytes. Parthenogenesis in this context being the activation by chemical or electrical manipulation of unfertilised ova to initiate the process of cell division and development.

CJEU decision

The CJEU effectively followed AG Villalón's opinion although the court phrases its conclusion in slightly different terms: "An unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a 'human embryo'... if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine." By analogy to the court's earlier decision in Case C-157/99,2 "current scientific knowledge" is something that is "sufficiently tried and tested by international medical science", although the only guidance provided in this earlier decision as to what is required is that scientific views prevailing in national medical circles and the views...