On 23 December 2014, the Court of Justice of the European Union (CJEU) issued its opinion on the patentability of parthenotes. This opinion was given in response to a referral from the UK High Court in the case of International Stem Cell Corporation (ISCC) v Comptroller General of Patents (the UK Intellectual Property Office).
Parthenogenesis is a process that creates a parthenote which has many of the characteristics of an embryo in the early stages of division but, because it was created from an unfertilised ovum, cannot develop further to become a human being. The cells that form the early state of a human embryo are known as ‘totipotent’ and can go on to differentiate into any cell type, e.g. liver cells, heart cells, etc, whereas, the cells that form the parthenote are ‘pluripotent’ and cannot differentiate into the full range of cells required to create a foetus.
The referral by the High Court sought to clarify the meaning of the phrase ‘capable of commencing the process of development of a human’, as the parthenote is incapable of actually developing into a human being. In the prior case of 34/10 (Oliver Brüstle v Greenpeace), the CJEU ruled that inventions necessarily involving destruction of an embryo were not patentable, but left several question marks as to what constitutes “an embryo”. The CJEU stated that the concept of ‘human embryo’ within the meaning of Article 6(2)(c) of Biotechnology Directive 98/44/EC must be understood in a wide sense. Both fertilised human ova and stem cell lines made from human embryos that resulted in the destruction of the embryo were deemed to qualify as “human embryos” and therefore excluded from patentability.
In their judgement, the CJEU ruled that Article 6(2)(c) of Directive 98/44/EC must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’.
This judgement provides welcome news to those in the field of stem cell research and provides much needed clarity to what constitutes unpatentable subject matter in Europe after the 34/10 Brüstle decision.