Case C-364/13 – Patentability of embryonic stem cells and parthenotes: Inherently Uncertain?

plomerAurora Plomer

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’) [2013] 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).

The Grand Chamber followed the Opinion of Advocate General Cruz-Villalon (para. 73) 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  (para. 28).  Accordingly, an organism which commences a process of development and lacks the inherent capacity to develop  into a human being is not to be regarded as a ‘human embryo’, within the meaning and for the purposes of the application of  Directive 98/44 (para. 29). The Grand Chamber distinguished its judgment in Brüstle where “it was apparent from the written observations presented to the Court that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being.” (para 31) and left it to the referring court to determine, whether  in the light of scientific knowledge and advance,  parthenotes, such as those which are the subject of the applications for registration in the case in the main proceedings, have the inherent capacity of developing into a human being.” (para. 36).

The Grand Chamber’s judgement is noteworthy in three respects. First, the Grand Chamber refrained from providing a more extensive legal definition of the ‘commencement’ test as contemplated in AG Cruz-Villalon’s  Opinion. Although invited by the English High Court  to approach the referral question as raising important questions of principle, the Grand Chamber  reasoned instead that the issues at stake are essentially questions of fact which national courts should answer by reference to the state of scientific knowledge at the time. This is a welcome development which will enable national patent offices and courts to adjust the interpretation of moral exclusions in the Directive to the pace of scientific advances. On the other hand, the judgment arguably introduces  a new test relating to the “inherent capacities” of an organism for which there is no legal definition in the Biotech Directive or in the national laws of member states potentially opening new areas of uncertainty. In what sense precisely does a stored frozen human embryo have the inherent capacity to become a human being if it is never going to be implanted? And why should different moral considerations apply to such an embryo from an embryo created by somatic cell reprogramming – from which induced pluripotent cells (iPS cells) are derived? The ‘inherent capacities’ test gives no clear legal (or moral) answer to these questions, whilst  the broad exclusionary principles established in Brüstle remain untouched. Thus,  ISCO, a California based company, will be able to exploit patents circumventing the Brüstle ruling in Europe, whilst similar promising cell therapies to treat incurable eye diseases developed by European researchers, and others based on decades of research  funded under EU Framework programmes, will have to fall back on commercial secrecy. This continues to be a worrying prospect for the commercialization of European research on health and innovation and  ultimately for patients in Europe as well as scientists whose research in full compliance with national laws, EU laws and European human rights law has been challenged as ‘immoral’ on the back of the Brustle ruling.

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