On 17 July 2014, Advocate General Cruz Villalón delivered his Opinion concluding that unfertilised human ova whose division and further development have been stimulated by parthenogenesis should be excluded from the term 'human embryos' in Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (the "Directive"), as long as those parthenotes are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity (Case C-364/13).
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 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.
As noted by A-G Cruz Villalón, the question referred was almost identical to one answered by the CJEU in Brüstle (Case C-34/10). Cruz Villalón analysed Brüstle and in his view, in defining a 'human embryo', the CJEU established a functional equivalence between fertilised ova, non-fertilised ova subjected to somatic-cell nuclear transfer and parthenotes. This meant the Court treated all three as being capable of commencing the process of development of a human being. Crucially the CJEU had not been provided with any technical information to the contrary evidencing the fact that, in fact, parthenotes cannot develop into human beings.
The decisive criterion in A-G Cruz Villalón's Opinion was whether the unfertilized ovum had the inherent capacity of developing into a human being. Parthenotes do not have such a capacity and the AG proposed that the CJEU exclude them from the definition of human embryos. However, in light of successful genetic manipulations conducted on non-human mammalian parthenotes (namely mice), this should only apply to those parthenotes that have not been genetically manipulated to become capable of developing into a human being.
In addition, in the A-G's Opinion, Article 5(1) of the Directive did not apply because a parthenote was neither a human body at a stage of its formation and development, nor one of its elements. This was based on the fact that parthenotes were produced by means of a technical process.
AG Cruz Villalón also analysed the ordre public and morality provisions of the Directive. In his Opinion, while these provisions established a core 'no-go' zone in terms of what was unpatentable, the Directive did not prevent a Member State from excluding parthenotes from patentability on the grounds of ethical and moral considerations under Article 6(1) (see paragraphs 37 to 49). This would therefore provide for Member States to extend the prohibition of patentability from the perspective of ordre public or morality based on social and cultural context.
It will be interesting to see if the CJEU adopts the Opinion of A-G Cruz Villalón based on new technical information, in what has historically been a controversial topic.
This article is part of the International Life Sciences Update for October 2014