On 18th December 2014, the Grand Chamber of the CJEU revisited the scope of the moral exclusion on industrial and commercial uses of “human embryos” in Article 6(2) (c) in Directive 98/44/EC on the legal protection of biotechnological inventions (Biotech Directive) and held that the exclusion does not cover unfertilized human eggs produced by parthenogenesis (parthenotes).
The referral followed the refusal of the UKIPO to grant two national patents to International Stem Cell Corporation (‘ISCO’)  EWHC 807 (Ch) on the ground that the patents fell within the definition of the term ‘human embryo’ adopted by the Grand Chamber in Brüstle (EU:C:2011:669) . The first patent, GB0621068.6, entitled “Parthenogenetic activation of oocytes for the production of human embryonic stem cells” covered both the methods for producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and the stem cell lines themselves. The second application GB0621069.4 , entitled “Synthetic cornea from retinal stem cells” similarly included claims to methods and ‘product-by-process’. The UKIPO applied the Grand Chamber’s reasoning in Brustle that parthenotes were ‘capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so’ and therefore fell within the meaning of paragraph 36 of the judgment in Brüstle (C‑34/10, EU:C:2011:669). ISCO appealed on the grounds that, according to current scientific knowledge, mammalian parthenotes can never develop to term because, in contrast to a fertilised ovum they do not contain any paternal DNA, which is required for the development of extra-embryonic tissue (para 17). In this light, the High Court of Justice (England & Wales), Chancery Division (Patents Court), decided that the appeal “raised a question of considerable importance. What is meant by the term “human embryos” in Article 6(2)(c) of the Biotech Directive? In particular, what was meant by the CJEU in Brüstle by the expression “capable of commencing the process of development of a human being”? Does that contemplate the commencement of a process which must be capable of leading to a human being? Or does it contemplate the commencement of a process of development, even though the process cannot be completed, so that it is incapable of leading to a human being?” (At para. 3).