Court of Justice of the European Union (CJEU) Rules on the Extent to which Parthenotes Fall within the Patentability Exclusion in Article 6(2)(c) of Directive 98/44/EC (C-364/13)

23 December 2014

Article 6(2)(c) of the European Union's Directive 98/44/EC on the Legal Protection of Biotechnological Inventions states that uses of human embryos for industrial or commercial purposes shall be considered unpatentable. This is reflected in Rule 28(c) of the European Patent Convention (EPC) and Section 76A and Schedule A2 of the UK Patents Act 1977 (as amended).

Henry Carr QC (sitting as Deputy Judge of the High Court) in International Stem Cell Corporation v Comptroller General of Patents referred the following question to the CJEU:

"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 on the Legal Protection of Biotechnological Inventions?"

Parthenogenesis is an artificial method by which unfertilised human eggs (ova) can be stimulated to develop further without fertilisation. It forms the basis of asexual reproduction in many species, such insects and amphibians, but does not occur naturally in humans and other mammals.

In Decision C-364/13 issued on 18 December 2014, the CJEU answered as follows:

"Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis 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, this being a matter for the national court to determine."

The full judgement of the Court can be found here.

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