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

29 April 2013

By Antony Blackburn-Starza

Appeared in BioNews 702

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.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

12 January 2015 - by Antony Blackburn-Starza 
The European Court of Justice (CJEU) has cleared the way for the patenting of human parthenotes for industrial and commercial purposes, clarifying the definition of 'human embryo' excluded from patentability in European Law...
04 August 2014 - by Julian Hitchcock 
As BioNews 763 reported recently, Advocate General Cruz Villalón has advised the Court of Justice of the European Union (CJEU) that human parthenotes are not human embryos. The fact that he had to do so raises serious concerns about the ability of Europe's leading court to interpret bioethical legislation and challenges the authority of one of its most notorious cases....
21 July 2014 - by Antony Blackburn-Starza 
An advisor to the Court of Justice of the European Union (CJEU) has said that certain stem cells derived from unfertilised human eggs that have undergone parthenogenesis should not be excluded from patentability....
08 July 2013 - by Ari Haque 
Two US public interest groups have asked a federal appeals court to hear a challenge of a patent over human embryonic stem cells...
03 June 2013 - by BioNews 
A patent over a method for assessing cell-cycle data that can be used in IVF treatments to predict an embryo's future viability will make IVF treatments in the USA prohibitively expensive, a leading embryologist has said...

08 April 2013 - by Ruth Saunders 
A new study has reported that the entire human genome may be under patents held by commercial companies....
18 February 2013 - by Matthew Thomas 
A patent over a gene linked to hereditary breast and ovarian cancers is valid, an Australian federal court has ruled in a landmark case....
17 December 2012 - by Julian Hitchcock 
In November the case of Brüstle v Greenpeace was remitted to the German Federal High Court. How would a national court interpret the controversial ruling of the Court of Justice of the European Union which held that patent rights could not be granted in the EU for the use of any entity 'capable of commencing the process of development of a human being'?...
03 December 2012 - by Antony Blackburn-Starza 
The German Federal Court of Justice has ruled that a disputed patent held by Dr Oliver Brüstle, and the subject of a ruling by the European Court of Justice (ECJ) against the patentability of human embryonic stem cells, is valid in its revised form....

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