Three years after the landmark Brustle ruling, the CJEU is poised to revisit the scope of exclusion on industrial and commercial uses of “human embryos” in Article 6(2) (c) of the EU Directive on Biotechnological Inventions. This time, the referral is from a national court of first instance, the Chancery Division (Patents Court) of the UK High Court of Justice Court. In the Opinion of Advocate General Cruz Villalon, whilst the question raised by the UK court is “virtually identical” to the questions raised in the Brustle reference of the German Federal Court of Justice (BGH), the answer should be different.
One of the questions raised by the BGH in Brustle was whether the term ‘human embryo’ encompassed ‘unfertilised human ova whose division and further development have been stimulated by parthenogenesis’ (parthenotes). In Brustle, the Grand Chamber of the CJEU held that parthenotes fell within the scope of exclusion of Article 6(2) (c) because the term ‘human embryo’ had to be given an autonomous meaning in EU law and should be “be understood in a wide sense” to include any human ovum, as soon as fertilised “… since that fertilisation is such as to commence the process of development of a human being.” The criterion of whether an organism is “capable of commencing the process of development” (the ‘commencement’ test) was relied upon by the UK intellectual Property Office to reject two patent applications by International Stem Cell Corporation (ISC) relating to human embryonic stem cell lines produced by parthenogenesis activation of ova. In its appeal, ISC argued that the Brustle exclusion should not extend to parthenotes because such organisms are incapable of developing into human beings. In this light, the UK High Court raised the following question for a preliminary ruling: “Are unfertilised human ova whose division and further development has been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, included in the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44 on the Legal Protection of Biotechnological Inventions?”.
France, Sweden and the Commission submitted that, in the current state of science, parthenotes cannot be considered identical to embryos at any stage of their development and parthenogenesis cannot be regarded as a technique capable of commencing the process of development. Portugal expressed concern about the risks of further genetic manipulation and would have left the decision to national courts. The UK submitted that the critical factor was the capacity of the cell itself and not its capacities after genetic manipulation (para. 60). By contrast, Poland submitted that, even though parthenotes cannot develop into human beings according to current scientific understanding, nonetheless respect for human dignity requires that they should be treated as human embryos as they “initially undergo the same stages of development as a fertilised ovum (para. 60).
The analysis of Advocate General Cruz Villalon proposes to read into the Grand Chamber’s ‘commencement’ rule in Brustle a functional equivalence test, so that the decisive criterion which should be taken into account for determining whether an unfertilised ovum is a human embryo is “whether that unfertilised ovum has the inherent capacity of developing into a human being, i.e. whether it really constitutes the functional equivalent of a fertilised ovum.” (at para. 73). On this basis, the mere possibility that a parthenote could be genetically manipulated so that it can develop to term and into a human being does not change the fundamental character of the parthenote before manipulation. According to current scientific knowledge parthenotes do not have the capacity to develop into human beings but “where the parthenote is manipulated in such way that it actually obtains the respective capacity, it can no longer be considered a parthenote and it cannot be, consequently patented.” (at para. 77). Continue reading