Patenting parthenotes: High Court asks if parthenotes are 'human embryos' under the Biotech Directive

The UK's High Court has asked the Court of Justice of the European Union (CJEU) to clarify if human parthenotes fall under the definition of a human embryo under the Biotechnology Directive for the purposes of patentability .

The case concerns an appeal brought by International Stem Cell Corporation (ISCC) against a decision made by the UK's Intellectual Patent Office (IPO) in 2012 to reject two patent applications over a method for inducing pluripotent stem cells from human eggs that have undergone parthenogenesis.

The IPO's decision said: 'A parthenogenetically-stimulated human oocyte is considered, on the basis of the Brüstle judgment to be capable of commencing the process of development even if it is not able to complete this development'.

In October 2011 the CJEU ruled that processes which require the prior destruction of human embryos are not patentable. In its judgment the court defined a 'human embryo' under European law as 'any [fertilised] human ovum [...] if that  fertilisation is such as to commence the process of development of a human being'.

It further said that this definition includes 'a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis'.

ISCC argued that the key question was what the CJEU meant by 'capable of commencing the process of development of a human being'. It was unclear whether this referred to an entity that could in fact develop into a human being or something that could start the process of becoming a human being but was unable to complete that process.

A parthenote is capable of developing into a blastocyst-like structure but cannot develop into a human being because it lacks paternal DNA. There was, however, no consensus on the scientific evidence as to the developmental potential of parthenotes put before the CJEU.

Henry Carr QC, sitting in as Deputy Judge of the High Court, said that, in his opinion, if a parthenote is not capable of developing into a human being then it should not be excluded from patentability.

'The recitals to the Biotech Directive show that a part of its purpose is encourage research in the field of biotechnology by means of the patent system', he said. 'The balance between [this objective] and the need to respect the fundamental principles safeguarding the dignity and integrity of the person may properly be struck by excluding from patentability processes of development which are capable of leading to a human being'.

'However, to exclude processes of development which are incapable of leading to a human being does not, in my view, strike a balance at all', he said.

Commenting on the decision, Rosalind English of One Crown Office Row, said: 'Excluding such important achievements from the protection of intellectual property, in the name of "human dignity", achieves nothing'.

The judge highlighted the importance of supporting stem cell research. 'Stem cells have the potential to revolutionise the treatment of human disease', he said, adding that their potential may 'open the door to a wide variety of new therapies and other medical applications'.

The reference made by the High Court may now return the issue to the CJEU.