What constitutes a human embryo? - CJEU to revisit controversial issue
On 17 April the UK High Court has made a reference to the Court of Justice of the European Union (“CJEU”), requesting that the term “human embryos” in Article 6(2) of the Directive 98/44/EC, commonly referred to as the Biotech Directive, be clarified. The referral focuses on whether artificially stimulated ova that are incapable of developing to term should nevertheless be classified as human embryos.
International Stem Cell Corporation (ISCC) applied to patent a new method for activating an oocyte in the absence of sperm through parthenogenesis, the initiation of embryonic cell development without fertilisation, using instead a variety of chemical and electrical techniques. The technique is viewed as a vital method for producing human embryonic stem cells for research purposes.
An ovum activated in such a way is known as a parthenote and contains half the amount of genetic material found in fertilised cells; they contain a set of maternally derived chromosomes but cannot develop to full term due to the absence of paternal chromosomes. Development can occur to different stages after activation but typically parthenotes only reach the blastocyst stage, about five days after activation and develop no further.
In contrast to fertilised cells, parthenotes are not considered as totipotent, in that they do not have the capacity to produce a complete human being. They are instead considered as pluripotent being only capable of differentiating into embryonic tissues, such as those for the lungs, bones or nervous system, but not extra-embryonic tissues, such as the placenta.
ISCC was appealing to the High Court following the decision of the IPO to refuse two UK patent applications in the name of ISCC, both relating to stem cell research. The refusal was made on the basis that paragraph 3(d) of schedule A2 of the Patents Act 1977 (implementing the Biotech Directive) specifically excludes from patentability ‘uses of human embryos for industrial and commercial purposes’.
The CJEU considered parthenogenesis before in Brüstle where, in the context of the Biotech Directive, a wide interpretation was given to what constitutes a “human embryo”. The Court concluded that (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."
On addressing this point, ISCC said 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 ISCC, 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.
ISCC argued that the test adopted by the CJEU was directed at the first alternative because a parthenote is not totipotent and therefore whilst it can commence the process of development it can never actually lead to the full development of a human being, therefore it should not fall within the patent exclusion for a 'human embryo'. The High Court ruled that the issue was not ‘acte clair’ and referred the matter to the CJEU for determination. In expressing his own view, Henry Carr QC, sitting as Chancery judge, said he felt that parthenotes were not the same as fertilised ova at any stage and that if the process of development was incapable of leading to a human being, then it should not be excluded from patentability.
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. Despite stem cells having the potential to revolutionise the treatment of human conditions, including cancer, heart disease, and spinal injuries, the current caution from the pharma industry and reluctance from venture capital houses mean that research is underfunded and yet to reach its full potential.
The field is laden with controversy but the law has to strike a balance between the 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 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”.
Beatriz San Martin is a Partner and Hannah Smith-Willis is a Trainee Solicitor in the IP protection and enforcement group at Fieldfisher.