An organism which is incapable of developing into a human being does not constitute a human embryo within the meaning of the Biotech Directive. This is an important decision for the biotech industry, as it creates more room for patenting of stem cell related inventions in the EU.

The background

International Stem Cell Corporation (ISCC) applied for two UK patents relating to stem cells derived from unfertilised human ova which have been parthenogenetically activated to stimulate cell division (“parthenotes”).

In the course of the application procedure, an objection was raised that the inventions disclosed constitute uses of human embryos which are not patentable under the standard established by the Court of Justice (C‑34/10, EU:C:2011:669).

Indeed, the Court has held that the concept of a ‘human embryo’ includes unfertilised human ova whose division and further development have been stimulated by parthenogenesis, since such ova are, just like embryos created through the fertilisation of an ovum, capable of commencing the process of development into a human being.

ISCC argued that this case law was inapplicable, as the inventions in question concern parthenogenetically activated oocytes which are not "capable of commencing the process of development of a human being" (unlike an embryo created through fertilisation of an ovum).

The question referred to the Court of Justice was therefore whether an organism which is incapable of developing into a human being constitutes a human embryo within the meaning of the Biotech Directive (Directive 98/44/EC).

The decision

In today’s judgment, the Court held that in order to be considered a human embryo, an unfertilised human ovum must have the inherent capacity of developing into a human being. Consequently, the mere fact that a parthenogenetically activated human ovum can commence a process of development is insufficient for it to be regarded as a human embryo.

It is now up to the referring court (the High Court of Justice) to determine whether, in light of knowledge which has been sufficiently tried and tested by international medical science, the organisms which form the object of the patents applications have the inherent capacity to develop into a human being.