The EU’s Biotechnology Directive provides that uses of human embryos for industrial or commercial purposes are excluded from patentability.
In Decision C-364/13 (International Stem Cell Corporation), the CJEU has recently ruled that in order to be classified as a ‘human embryo’ as specified under the Biotechnology Directive, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being.
There has been uncertainty as to patentability in the field of stem cells derived from human egg cells following a 2011 CJEU ruling (C-34/10, Oliver Brüstle v Greenpeace) that the concept of a “human embryo” should be defined broadly and included “any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis”, on the basis that such an ovum is capable of commencing the process of development of a human being, just as an embryo created by fertilisation can.
In DecisionC-364/13, the Court stated “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, that ovum does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine”.
The Decision follows a reference from the UK High Court (International Stem Cell Corporation v Comptroller General of Patents) which considered patentability of claims directed to methods of producing pluripotent human ESC lines from parthenogenetically-activated oocytes (GB0621068.6) and methods of isolating pluripotent human ESC lines from parthenogenetically-activated oocytes (GB0621069.4). ISCC presented scientific evidence demonstrating that parthenogenetically-activated ESC are pluripotent and therefore incapable of developing into human beings. All parties agreed that the evidence showed that unfertilised human ova whose division and further development were stimulated by parthenogenesis and which, in contrast to fertilised ova, contain only pluripotent cells are incapable of developing into human beings.
This decision, providing that uses of parthenotes for industrial or commercial purposes may be patentable, is welcome news to the Biotech sector.
A copy of the press release announcing the CJEU's decision can be found here.