On 18 December 2014, the CJEU ruled on the question referred to it by the High Court, in International Stem Cell Corporation v Comptroller General of Patents, Case C-364/13, an important case concerning the patentability of parthenotes, a cell type originating from unfertilised human ova. The CJEU decision has signiicantly expanded the scope of patentability of inventions in this area and is likely to provide a much needed boost for companies investing in embryonic research.
The question referred to the CJEU
‘Are 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, included in the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44 on the Legal Protection of Biotechnological Inventions?’
The Judgment of the Court (Grand Chamber)
In Oliver Brüstle v Greenpeace eV, C-34/10, the CJEU had previously ruled that parthenotes were human embryos capable of developing into a human being and, therefore, are excluded from patentability on moral grounds, under Article 6(2)(c) of the Biotechnology Directive. However, in this case, the CJEU, following the Advocate General’s opinion given in July, determined that the decision in Brüstle, to the extent that it equated unfertilised ova (which were incapable of developing into a human being unless genetically modiied) with fertilised ova, appeared to have been based on incorrect facts provided to the court. Applying the general principle laid down in that case, such organisms were not human embryos and not within the exclusion from patentability in Article 6(2)(c) of the Biotechnology Directive.
Significance of the Judgment
The decision in Brüstle was widely considered to have serious implications for the future progress of science in this important area, potentially discouraging biotechnology companies from further investment in stem cell research technologies due to the uncertainty of whether or not their inventions would be patentable. It is likely that, as in Brüstle, the EPO will declare that their practice will follow the CJEU’s decision. The decision and such a statement from the EPO is likely to be welcomed by companies and researchers active in this area, providing more certainty and potentially encouraging further investment.