On 18 December 2014, the Court of Justice of the European Union (CJEU) handed down its judgment holding that an organism that was incapable of developing into a human being did not constitute a human embryo within the meaning of Directive 98/44/EC (Case C-364/13).  The CJEU observed that the purpose of the Directive was to regulate patentability of biotechnological inventions and not to regulate research and use of human embryos. It was a matter for the English Court to determine if human parthenotes had the inherent capacity to develop into a human being but if they did not, then they would not be a human embryo within the meaning of the Directive. Any such an organism used for industrial or commercial purposes would in principle be capable of being patented. This Judgment adopted the Opinion delivered by Advocate General Cruz Villalón on 17 July 2014 (previously reported in the October 2014 edition of the Life Sciences Newsletter).
In April 2013, the English High Court referred a question to the CJEU on the interpretation of Article 6(2)(c) of the Directive (reported in the May 2013 edition of the Life Sciences Newsletter). The question asked whether a parthenote, which only contained pluripotent and not totipotent cells and was therefore incapable of developing into a human being, was included in the term “human embryo” under Article 6(2)(c) of the Directive. This arose from the application by International Stem Cell Corporation ("ISC") for a patent claiming methods of producing pluripotent human stem cells from parthenogenetically-activated oocytes and stem cell lines produced according to the methods and another patent claiming methods of producing synthetic corneal or corneal tissue from such pluripotent stem cells. ISC argued that the parthenotes were unable to develop into a human embryo because of genomic imprinting, although ISC acknowledged that this might be possible through extensive genetic manipulation and had amended the claims to exclude such a possibility.
In Brüstle (Case C-34/10) the CJEU held that a ‘human embryo’ included "non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis" as they were "capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so". The CJEU noted that whereas in Brüstle, written observations presented to the Court stated that parthenotes did have the capacity to develop into a human being, none of the interested parties (which included a number of observations from Member States) in this case disputed that this was not correct according to current scientific knowledge.
The CJEU agreed with A-G Cruz Villalón's Opinion 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". Therefore, if an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis did not, in itself, have the inherent capacity of developing into a human being, it would not constitute a 'human embryo' under the Directive.
The case will now come back before the English High Court who will consider the application of the CJEU's Judgment to ISC's patent applications.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ 1998 L 213, p. 13).