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.