Beatriz San Martin

Dr Beatriz San Martín

Last week the BIA submitted comments to the UK Intellectual Property Office on case C-364/13, the International Stem Cell Corporation (ISC) preliminary reference to the Court of Justice of the European Union (CJEU) requesting clarification of what is meant by the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, commonly referred to as the Biotech Directive. In particular, whether artificially stimulated ova that are incapable of developing into viable human beings should nevertheless be classified as human embryos. Dr Beatriz San Martín, Partner at Field Fisher Waterhouse LLP and member of our Intellectual Property Advisory Committee (IPAC), outlines the background to the case and the BIA’s position on this issue.

ISC applied to the UK Intellectual Property Office (UK IPO) for two patents comprising a new method for activating an oocyte in the absence of sperm through parthenogenesis (the initiation of embryonic cell development without fertilisation) using a variety of chemical and electrical techniques. Such ova contain only pluripotent cells and cannot develop to full term due to the absence of paternal chromosomes, typically only reaching the blastocyst stage (about five days after activation).

The UK IPO refused ISC’s patent applications on the grounds that the inventions disclosed in the patent applications were excluded from patentability as Article 6(2)(c) of the Biotech Directive specifically excludes from patentability ‘uses of human embryos for industrial and commercial purposes’. This was based on the CJEU’s previous decision in the Brüstle case where, the Court concluded (emphasis added):

That classification [of a ‘human embryo’] must also apply to … a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis. Although those organisms have not, strictly speaking, been the object of fertilisation, due to the effect of the technique used to obtain them they are, as is apparent from the written observations presented to the Court, capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.’

ISC appealed the decision to the High Court arguing that the only sensible way of interpreting Brüstle was to question what is meant by ‘capable of commencing the process of development of a human being’. According to ISC, clarification is needed on whether an organism must:

(a)   be capable of commencing the process of development which leads to a human being; or

(b)   be capable of commencing the process of development even if that process is incapable of leading to a human being.

ISC’s position is that the test adopted by the CJEU was directed at the first alternative because a parthenote is not totipotent and, whilst it can commence the process of development, it can never actually lead to a viable human being, therefore it should not fall within the patent exclusion for a ‘human embryo’. The High Court ruled in April this year that the issue was not ‘acte clair’ and referred the matter to the CJEU for determination.

Comment

Capturing commercial value from stem cell research would be far easier under a narrower definition of what constitutes a ‘human embryo’ in terms of patentability. Nonetheless, the law has to strike a balance between encouraging the investment of those in biotechnology and the need to respect the principles safeguarding the integrity of the person. In considering the Biotech Directive and the potential for stem cell technologies to transform medicine, the High Court emphasised that excluding processes which are incapable of leading to a human being would not strike a balance at all and was ‘more akin to a total exclusion from patent protection of the fruits of stem cell research, to the detriment of European industry and public health’.

The BIA was assisted in its submission by two of its advisory committees: the Cell Therapy and Regenerative Medicine Advisory Committee (CTRMAC) and IPAC. A copy of the BIA submission can be found here, which concludes that unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, are not human embryos under the Biotech Directive.

Through its experts on the IPAC and CTRMAC committees the BIA will continue to monitor developments in this case; please contact Antonis Papasolomotos with comments. Whilst an Advocate General opinion has been common in the past, the CJEU is increasingly bypassing this step. There is also no guarantee that there will be an oral hearing, such that the next we hear of this case could be the ruling from the CJEU.