According To Advocate General Cruz Villalon, An Ovum Whose Development Has Been Stimulated Without Fertilisation And Which Is Not Capable Of Becoming A Human Being Cannot Be Considered A Human Embryo
BRUSSELS, July 17 -- The European Union'sCourt of Justice issued the following news release:
The Biotechnology Directive1 sets out the rules regarding the patentability of biotechnological inventions. According to the Directive, the human body in any stage of its development cannot constitute a patentable invention. However, an element isolated from the human body or otherwise produced by means of a technical process may be subject to patent protection.
Nevertheless, inventions whose commercial exploitation is contrary to ordre public or morality are excluded from patentability. In this context, uses of human embryos for industrial or commercial purposes are not patentable.
International Stem Cell Corporation (ISC), a biotechnology company, applied to the UK Intellectual Property Office for two national patents for a technology that produces pluripotent stem cells2 from parthenogenetically-activated3 oocytes. The Office rejected both applications on the grounds that the inventions in question entail uses and even the destruction of human embryos and are therefore not patentable under the Brustle4 judgment of the Court of Justice. In this judgment the Court stated that any non-fertilised human ovum whose development has been stimulated by parthenogenesis and which is capable of commencing the process of development of a human being constitutes a "human embryo".
ISC appealed the decision of the Office to the UK courts. It claims that as the activated oocyte, in the absence of paternal DNA, is not capable of becoming a human being, the restrictions on patentability resulting from the Brustle judgment do not apply to its technology.
The High Court of Justice, hearing the case, has asked the Court of Justice whether unfertilised human ova whose development has been stimulated by parthenogenesis and which are not capable of becoming human beings should be considered as human embryos.
In his Opinion today, Advocate General Pedro Cruz Villalon considers that, when assessing if an unfertilised ovum should be regarded as a human embryo, the decisive criterion to be taken into consideration is whether it has the inherent capacity of developing into a human being. By contrast, the mere fact that an unfertilised ovum is capable of engaging in a process of cell division and differentiation similar to that of a fertilised ovum does not suffice in itself to consider it as a human embryo. The observations submitted by the parties as well as the explanations given by the High Court of Justice suggesting that the parthenotes, organisms resulting from parthenogenesis, do not as such have the inherent capacity of developing into a human being, the Advocate General proposes to the Court to exclude them from the definition of human embryos.
However, in the light of successful genetic manipulations conducted on mice, Mr Cruz Villalon cannot exclude the possibility that, in the future, human parthenotes can be altered genetically in such a way that they can develop to term and thus into a human being. For this reason, the Advocate General makes it clear that parthenotes can only be excluded from the concept of "embryos" to the extent that they have not been genetically manipulated to become capable of developing into a human being.
Finally, the Advocate General emphasises that, in his view, even if human parthenotes are to be excluded from the concept of human embryos, the Directive does not prevent a Member State from excluding parthenotes from patentability on the grounds of ethical and moral considerations. He is of the view that, by excluding human embryos from patentability, the Directive only expresses a minimum, EU-wide prohibition, whilst allowing the Member States to extend the prohibition of patentability to other organisms on the basis of ethical and moral considerations.
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