With decision dated December 18, 2014 in the proceeding no. C-364/13, the Court of Justice of the European Union (hereafter, “Court of Justice”) has returned on the patentability of unfertilised human ovums.
The case originated from the refusal of the United Kingdom patent office to grant the International Stem Cell Corporation (hereinafter, “ISCC”) patents for inventions involving the production of pluripotent human stem cell lines from non-fertilised oocytes that had been activated parthenogenetically, so called “parthenotes”. The British office’s refusal was grounded on the Court of Justice decision in the proceeding no. C-34/10 “Brüstle-Greenpeace”. This decision interpreted the notion of “human embryo” under EU law on patents for biotech inventions in a wide sense, also excluding from patentability any non-fertilised human ovum whose division and further development, by any means, had made it capable of commencing the process of development into a human being.
ISCC had appealed the Britain office decision before the High Court of Justice, claiming that the Court of Justice in the case “Brüstle-Greenpeace” had intended to exclude from patentability only organisms capable of commencing the process of development which leads to a human being. Therefore, the organisms such as those, which are the subject of the applications for patent registration, cannot undergo such a development process and consequently they should be capable of being patented on the basis of Directive 98/44/CE on the legal protection of biotechnological inventions.
Then the High Court decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling on if “Are unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incarable of developing into human beings, included in the term <human embryos> in Art. 6, paragraph 2, letter c), of Directive 98/44”.
With the above mentioned decision, the Court of Justice stated that, according to Art. 6, paragraph 2, letter c), of Directive 98/44, an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis (that consists in the activation of an oocyte, in the absence of sperm, by a variety of chemical and electrical techniques), does not constitute a human embryo, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being.
Consequently, where an unfertilised human ovum does not fulfil that condition, the mere fact that the organism commences a process of development is not sufficient for it to be regarded as a “human embryo”, within the meaning and for the purposes of the application of Directive 98/44, and therefore it can be patentable.