This case of the ECJ (C-364/13, issued on 18 December 2014) deals with the interpretation of the notion of “human embryos” of Article 6(2) (c), Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions [1].
Some years ago, the case of refusal of registration by the Comptroller General of Patents, Designs and Trade Marks (‘the Comptroller’) of a national patent deposed by International Stem Cell Corporation (‘ISCO’) was brought before the High Court of Justice (England & Wales), Chancery Division (Patents Court) (United Kingdom). The refusal in question was based on the prohibition of patents on “uses of human embryos for industrial or commercial purposes”, set by the Directive 98/44. Within this context, the High Court of Justice, submitted the following preliminary question to the Court of Justice:
“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 incapable of developing into human beings, included in the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44 ... ?”
Pursuant to article 6, para. 1 (d) and para. 2 (c) of the Directive 98/44/EC “d) Inventions shall be considered unpatentable where their commercial exploitation would be contrary to public order or morality” and in particular when they are related with “uses of human embryos for industrial or commercial purposes.
The Court considered that a “human embryo” does not fall under the scope of the exception of Article 6 paragraph 2 (c) if it does not, in itself, have the inherent capacity of developing into a human being. That being so, an unfertilized human ovum, whose division and further development have been stimulated by parthenogenesis, does not constitute a “human embryo” per se, unless it has the inherent capacity of developing into a human being.
The interpretation adopted by the Court narrows the scope of Article 6, para. 2 (c) of the Directive 94/88/EC. Consequently, according to the Court, the patentability of a human embryo is prohibited only under the following cumulative conditions:
- The human embryo is used for industrial or commercial purposes [2], and
- The human embryo in question has the inherent capacity of developing into a human being.
It should be mentioned that the present decision revises the previous judgment of the Court in Brüstle (case C‑34/10), according to which an unfertilized human ovum, whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being, just as an embryo created by fertilization of an ovum and, thus, it constitutes a “human embryo”, within the meaning of Article 6 para. 2 (c) of the Directive 94/88/EC.
Finally, it is worth noting that, even if the Court recognizes the necessity of a harmonized interpretation of the notion “human embryo” among Member-States, at the end it is up to national courts to determine whether a human ovum has the inherent capacity of developing into a human being. Consequently, in the present case British judges will have to examine according the current level of medical knowledge, whether, an unfertilized human ovum that forms the basis of the patent claim has the capacity to develop into a human being.
M. Katrakazi
[1] This Directive has been adapted to the Greek legislation with the Presidential Decree No. 321/2001 “Adaptation to Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions”. For an English translation see http://www.obi.gr/OBI/OBI_EN/Misc_EN/PresidentialDecree321_EN/tabid/361/Default.aspx
[2] On the contrary, inventions for therapeutic/ diagnostic purposes are allowed. It is worthwhile to remind that in previous drafts of the Directive, the human embryos were absolutely unpatentable, no matter the purpose underlying the invention. See in that sense A. Mikroulea, “Biotechnological inventions”, EEmpD, 2000, p. 262 ff.