The Court of Justice of the European Union (CJEU) ruled today that unfertilised human ova whose division and further development have been stimulated by parthenogenesis (known as “parthenotes”) are not human embryos. The decision will mean that parthenotes can be patented in Europe. Its full ruling is available on Curia (the CJEU's website).
Parthenotes are cells that are not fertilised but are stimulated to divide and grow like human fertilised eggs, although they cannot develop completely to a human being. They are often seen as an ethical source of stem cells, because they can be cultured without destruction of a fertilised egg, and so many take the view that these are not human embryos and should be patentable. Stem cell research is a burgeoning area which has huge medical potential. Stem cell therapy is already being trialled in a number of medical conditions, including heart diseases, ALS (motor neurone disease) and Parkinson’s disease. Patenting stem cell research is highly contentious area where ethics and the law meet, giving rise to many different voices and opinions.
The case was referred to the CJEU by the UK High Court after the UK Intellectual Property Office (UK IPO) refused a patent application from the International Stem Cell Corporation for parthenotes on the basis that they were human embryos. In Article 6(2)(c) of Directive 98/44/EC1 on the Legal Protection of Biotechnological Inventions, human embryos are excluded from patent protection. Today’s decision means that the International Stem Cell Corporation will likely be granted a patent on parthenotes.
The present case has relied on the 2011 Brüstle case in which the CJEU held that a human embryo was broadly any human egg cell, from fertilisation onwards. That case focused on a patent application for embryonic stem cells. In the present case, the CJEU ruled that parthenotes differ from human embryos in that they do not have the capacity of completing the process of development into a human being, and they have not been genetically manipulated to acquire such a capacity.