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Advocate General paves the way for 'stem cell patents'

21 July 2014
Appeared in BioNews 763

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.

The Opinion was published by Advocate General Pedro Cruz Villalón in a case involving a US company, International Stem Cell Corporation (ISSC), which is appealing the rejection of two patent applications by the UK's Intellectual Property Office (IPO) over a method of producing stem cells from parthenogenetically-activated oocytes and the cell lines produced, as well as corneal tissue produced by these methods.

The IPO rejected ISCC's applications on the grounds that the CJEU in 2011 had excluded from patentability any process that involved the destruction of human embryos, which the Court defined as anything capable of commencing the process of development of a human being, including, on the face of it, parthenotes (see BioNews 630).

ISCC argued, however, that the CJEU's 2011 ruling does not apply to its stem cells derived from eggs it said could not develop into a human being without paternal DNA. The UK High Court subsequently asked the CJEU to clarify if parthenotes of such qualities fall under its definition of a human embryo (see BioNews 702).

Villalón agreed, proposing that such material should be excluded from the definition of human embryo under European Law for the purposes of patentability. He explained that upon his interpretation of the 2011 decision, 'the decisive criterion that should be taken into account for determining whether an unfertilised ovum is a human embryo hence is whether that unfertilised ovum has the inherent capacity of developing into a human being'.

He continued: 'It now appears that a parthenote does not, per se, have the required inherent capacity of developing into a human being and hence as such does not constitute a "human embryo"'.

Villalón went on to point out that if a parthenote is genetically altered so that it becomes capable of becoming a human being then it would cease to be patentable. He also said that EU member states are not prevented from introducing laws to exclude such material from patentability on ethical or moral grounds.

The Opinion is not binding on the Court, which will give its judgment at a later date.

EU Court Adviser Backs Stem Cell Patenting
Wall Street Journal |  17 July 2014
International Stem Cell Should Win EU Case, Adviser Says
Bloomberg Businessweek |  17 July 2014
Opinion of Advocate General Cruz Villalon - Case C‑364/13
CURIA |  17 July 2014
Top EU lawyer clears way to stem-cell patent ruling
Yahoo! News (AFP) |  17 July 2014
12 January 2015 - by Antony Starza-Allen 
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...
4 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....
2 June 2014 - by Patricia Cassidy 
The European Commission has rejected a petition requesting a stop to the funding of research involving the 'presupposed destruction' of human embryos....
29 April 2013 - by Antony Starza-Allen 
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 for the purposes of patentability...
3 December 2012 - by Antony Starza-Allen 
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....
24 October 2011 - by Antony Starza-Allen 
The European Court of Justice (ECJ) has ruled that stem cell processes which require the prior destruction of human embryos or are based upon the use of human embryos are not patentable. The decision may have wide implications for scientists engaged in embryonic stem cell research....
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