Opaque CJEU clarifies human embryos in Brustle
Upon reviewing the much anticipated ruling, Beatriz San Martin questions if the CJEU has erred.
Under Article 6(2)(c) of the Directive on the Legal Protection of Biotechnological Inventions (98/44/EC) (the “Biotech Directive”), inventions whose commercial exploitation includes the use of human embryos for industrial or commercial purposes are considered unpatentable.
On 18 December 2014, in Case C-364/13 International Stem Cell Corporation v Comptroller General of Patents, the Court of Justice of the European Union (“CJEU”) ruled that in order not to be classified as a ‘human embryo’, a non-fertilised human ovum must not, in light of current scientific knowledge, have the inherent capacity of developing into a human being. The fact that a parthenogenetically- activated human ovum commences a process of development is not sufficient for it to be regarded as a ‘human embryo’.
In the September 2014 edition of Intellectual Property Magazine, Hannah Smith Willis and I commented on the opinion of Advocate General (AG) Cruz Villalón in this case and provided a general background.1 This article focuses on the decision of the CJEU.
By way of brief background, the preliminary reference was made by the UK High Court, following an appeal by International Stem Cell Corporation (ISC) to the UK Intellectual Property Office’s rejection of two patent applications concerning methods of producing pluripotent human embryonic stem cells from parthenogenetically-activated oocytes. Parthenogenesis in this context being the activation by chemical or electrical manipulation of unfertilised ova to initiate the process of cell division and development.
The CJEU effectively followed AG Villalón’s opinion although the court phrases its conclusion in slightly different terms: “An unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’… if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.” By analogy to the court’s earlier decision in Case C-157/99,2 “current scientific knowledge” is something that is “sufficiently tried and tested by international medical science”, although the only guidance provided in this earlier decision as to what is required is that scientific views prevailing in national medical circles and the views of one member state are unlikely to suffice.
The CJEU has been mindful to phrase its decision as a clarification to Brüstle, rather than admit that there was a technical error or that the court was misdirected or had misunderstood the science in Brüstle. Whether the use of unfertilised human ova stimulated by parthenogenesis might be objectionable on societal and ethical grounds and unpatentable under Article 6(1) of the Biotech Directive is an entirely separate question to whether such cells constitute a human embryo.
Did the CJEU also misunderstand the science or was it misdirected in relation to the creation of cells by somatic cell nuclear transfer? In this respect, it is notable that Brüstle makes no mention of the requirement to remove the nucleus from an unfertilised ovum before transplanting the nucleus from a mature human cell.
The carve-out in ISC with respect to parthenotes could equally apply to cells created by somatic cell nuclear transfer, as long as these do not have the inherent capacity to develop into a human being. Whether the law can be applied in this way would, however, inevitably require a further reference to the CJEU. It is a great pity that, given the importance of Brüstle to the cellular therapy and regenerative medicine industry, the court failed to provide clear guidance of general application.
The author does not know what submissions were made by the parties, member states and the European Commission in Brüstle, except for what is included in the AG opinion and in the CJEU decision itself. Unlike court proceedings before the Royal Courts of Justice in England, the court file is not made available for public inspection in proceedings before the CJEU.
Consequently, interested third parties are unable to gain access to any written observations or evidence relied upon from the CJEU Registry. The UK Freedom of Information Act 2000 can, in theory, be used to request copies of written observations submitted by the UK government but, surprisingly, such requests are not necessarily successful.
While the parties to the proceedings or their legal counsel can be approached directly, they are under no obligation to provide case material to third parties. In this author’s personal view, this lack of transparency in CJEU proceedings is an affront to a system of open justice which all governments should aspire to.
Footnotes 1. Ova but not out: a tale of patents and parthenotes. p.60-61 in Intellectual Property Magazine’s September 2014 issue. 2. BSM Geraets-Smits v Stichting Ziekenfonds VGZ and HTM Peerbooms v Stichting CZ Groep Zorgverzekeringen, ECLI:EU:2001:404.
Beatriz San Martin is a partner at Fieldfisher with a degree and PhD from the University of Cambridge, specialising in genetics, cellular and molecular biology.
This was first published in Intellectual Property Magazine in February 2015.