The Court of Justice of the EU has confirmed its interpretation of the term “human embryo”. In a new case concerning the patentability of processes covering the use of parthenogenetically-activated human ova, the High Court of Justice for England and Wales submitted a preliminary question to the CJEU, asking whether the concept of “human embryo”, as interpreted in the judgment in the case of Brüstle v. Greenpeace, is limited to organisms capable of commencing the process of development which leads to a human being. In that regard, the High Court of Justice explained that, according to current scientific knowledge, organisms such as those which are the subject of the applications for patent registration are not capable of developing into a human being. Human embryos are excluded from patentability under Article 6 of Directive 98/44/EC on the legal protection of biotechnological inventions.
In today’s judgment, the CJEU holds that, in order to be classified as a “human embryo”, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being. Consequently, the mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a “human embryo”.
By contrast, where such an ovum does have the inherent capacity of developing into a human being, it should be treated in the same way as a fertilised human ovum, at all stages of its development. In that regard, the High Court of Justice must still determine whether or not, in the light of knowledge which is sufficiently tried and tested by international medical science, the organisms which are the subject of the pending patent application have the inherent capacity of developing into a human being.
(“Inherent capacity” relates to the question whether the organism has at all the potential of developing into a human being, not to whether or not the current state of technology makes it possible to trigger such a development, nor to whether the applicants or any future users have any intention of doing so.)