ECJ decision removes threat to stem cell research
The Court of Justice of the European Union has issued a decision in a patent case brought by a US corporation which gives a fresh interpretation to restrictions laid down in 2011 on the patentability of human embryos for industrial or commercial purposes.
The Court of Justice of the European Union has issued a decision in a patent case brought by a US corporation which gives a fresh interpretation to restrictions laid down in 2011 on the patentability of human embryos for industrial or commercial purposes.
Announced on 18 December, the decision upholds the opinion of Advocate General Cruz Villalón in July 2014 who said that ovum which have been stimulated without fertilisation — a process known as parthenogenesis — do not fall under the restrictions on patentability laid down by the court in 2011 in the case Brüstle v Greenpeace.
The latest decision will remove a threat to biotech research in Europe, which had been imperilled following the Brüstle v Greenpeace decision.
The case was brought by the International Stem Cell Corporation of Carlsbad, California which applied for two patents in the UK for technology enabling the production of pluripotent stem cells from parthenogenetically-activated oocytes. The UK patent office rejected the applications on the grounds that they contravened the Brüstle judgment which was handed down in October 2011. The Brüstle judgment is an interpretation of the EU Biotech Directive which says that the use of human embryos for industrial or commercial purposes is unpatentable.
In the Brüstle case, the court took a very broad view of the definition of ‘human embryo,’ considering it to be any human ovum that has been fertilised and any non-fertilised human ovum whose division has been stimulated by parthenogenesis.
Taking a somewhat different stance, AG Cruz Villalón said that parthenotes, or organisms resulting from parthenogenesis, should be excluded from the definition of human embryo.
This interpretation has now been endorsed by the ECJ which said that in order to be classified as a human embryo, a non-fertilised human ovum “must necessarily have the inherent capacity of developing into a human being. Consequently, the mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regard as a human embryo”.
The case now goes back to the UK court to determine whether or not the International Stem Cell Corporation’s work is patentable.
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