The patenting of inventions relating to human embryonic stem cells remains a controversial topic in Europe. At the forefront of this debate is the need to balance fundamental human rights with a patent system that encourages scientific research in areas having the potential to revolutionise the treatment of human disease.
The Biotech Directive, which was implemented in an attempt to harmonise laws governing patents in this sector, excludes from patentability: “uses of human embryos for industrial or commercial purposes”. The Court of Justice of the European Union (CJEU) has already provided guidance on interpretation of this provision in Case C-34/10 Oliver Brüstle v Greenpeace (the Brüstle case). However, the High Court of England and Wales has now made a further Referral to the CJEU, in particular to seek clarification of comments made in this earlier decision. The question referred by Henry Carr QC, sitting in as Deputy Judge of the High Court, is:
“Are unfertilised human ova whose division and further development have been stimulated by parthogenesis, 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/EC on the legal protection of biotechnological inventions?”
– Henry Carr QC
Facts of the present case – ISCC v Comptroller General of Patents
The case leading to the current Referral is an Appeal brought by International Stem Cell Corporation (ISCC) against a decision made by the UK Intellectual Property Office (UK IPO) to refuse two patent applications. ISCC’s applications relate to methods involving the isolation of stem cells from human “parthenotes”. Mammalian parthenotes are activated oocytes induced to undergo embryogenesis in a manner analogous to that of a fertilised ova, but in the absence of fertilization.
ISCC’s applications were refused by the UK IPO based on the reasoning set forth by the CJEU in the Brüstle decision. However, ISCC believe that parthenotes should not fall within the test for a “human embryo” as set out in Brüstle, because these structures, unlike fertilized ova, cannot develop into a viable human being. This inability of parthenotes to ever develop to term is a consequence of the lack of any paternal DNA, and the fact that the cells of the parthogenetically-activated oocyte are only pluripotent, therefore lacking some of the essential elements for development of a human being.
Background to the Referral – the Brüstle case
In the Brüstle case, the CJEU considered a number of questions relating to the interpretation of the term “human embryo” as it appears in Article 6(2)(c) of the Biotech Directive. Pertinent to the present case was the issue of whether or not the term was broad enough to encompass “unfertilised ova whose division and further development have been stimulated by parthogenesis”.
In the Judgement, the CJEU concluded that the classification of “human embryo” should also apply to a parthogenetically-activated oocyte for the reason that it was “capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.”
The CJEU’s comments have come under scrutiny in the present case because it is unclear whether the test that the Court had in mind turned on merely commencing the process of development of a human being (irrespective of the potential for completion of the process) or commencing a process capable of leading to the birth of a viable human being. This is perhaps unsurprising given that in the Brüstle case, the CJEU did not have evidence before it clearly establishing that cells from a parthenote are pluripotent only, and that parthenotes can never complete the developmental process leading to a human being. This new Referral reflects the need to clarify the CJEU’s position given the facts of the present case.
Henry Carr QC has stated as his preliminary view that if, as in the case of parthogenesis, the process of development is incapable of leading to a human being, then it should not be excluded from patentability. He noted in particular, that if parthenotes were to be excluded, it would be 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. In setting forth his opinion, Carr has agreed with the view expressed by the Advocate General in the Brüstle decision, namely that totipotent cells should be excluded from patentability, whereas pluripotent cells should not. Hopefully, the CJEU will take the opportunity to comment on this important distinction, and provide greater certainty for those seeking patent protection in this important area of research.
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