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).

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Case Comment: Opinion of Advocate General Cruz Villalon in International Stem Cell Corporation (C-364/13)

Prof. Aurora Plomer

Three years after the landmark Brustle ruling, the CJEU is poised to revisit the scope of exclusion on industrial and commercial uses of “human embryos” in Article 6(2) (c) of the EU Directive on Biotechnological Inventions. This time, the referral is from a national court of first instance, the Chancery Division (Patents Court) of the UK High Court of Justice Court. In the Opinion of Advocate General Cruz Villalon, whilst the question raised by the UK court is “virtually identical” to the questions raised in the Brustle reference of the German Federal Court of Justice (BGH), the answer should be different.

One of the questions raised by the BGH in Brustle was whether the term ‘human embryo’ encompassed ‘unfertilised human ova whose division and further development have been stimulated by parthenogenesis’ (parthenotes). In Brustle, the Grand Chamber of the CJEU held that parthenotes fell within the scope of exclusion of Article 6(2) (c) because the term ‘human embryo’ had to be given an autonomous meaning in EU law and should be “be understood in a wide sense” to include any human ovum, as soon as fertilised “… since that fertilisation is such as to commence the process of development of a human being.” The criterion of whether an organism is “capable of commencing the process of development” (the ‘commencement’ test) was relied upon by the UK intellectual Property Office to reject two patent applications by International Stem Cell Corporation (ISC) relating to human embryonic stem cell lines produced by parthenogenesis activation of ova. In its appeal, ISC argued that the Brustle exclusion should not extend to parthenotes because such organisms are incapable of developing into human beings. In this light, the UK High Court raised the following question for a preliminary ruling: “Are unfertilised human ova whose division and further development has 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?”.

France, Sweden and the Commission submitted that, in the current state of science, parthenotes cannot be considered identical to embryos at any stage of their development and parthenogenesis cannot be regarded as a technique capable of commencing the process of development. Portugal expressed concern about the risks of further genetic manipulation and would have left the decision to national courts. The UK submitted that the critical factor was the capacity of the cell itself and not its capacities after genetic manipulation (para. 60). By contrast, Poland submitted that, even though parthenotes cannot develop into human beings according to current scientific understanding, nonetheless respect for human dignity requires that they should be treated as human embryos as they “initially undergo the same stages of development as a fertilised ovum (para. 60).

The analysis of Advocate General Cruz Villalon proposes to read into the Grand Chamber’s ‘commencement’ rule in Brustle a functional equivalence test, so that the decisive criterion which should be taken into account for determining whether an unfertilised ovum is a human embryo is “whether that unfertilised ovum has the inherent capacity of developing into a human being, i.e. whether it really constitutes the functional equivalent of a fertilised ovum.” (at para. 73). On this basis, the mere possibility that a parthenote could be genetically manipulated so that it can develop to term and into a human being does not change the fundamental character of the parthenote before manipulation. According to current scientific knowledge parthenotes do not have the capacity to develop into human beings but “where the parthenote is manipulated in such way that it actually obtains the respective capacity, it can no longer be considered a parthenote and it cannot be, consequently patented.” (at para. 77). Continue reading

Horizon 2020: EU funding of hESC research in the balance

Prof. Aurora Plomer

Stem cell research has the potential to bring important advances in our understanding and treatment of crippling diseases such as Parkinson’s, diabetes, stroke and heart disease. It has also attracted significant investment in a number of countries in Europe, notably the UK and Germany, which have established themselves as global market leaders in stem cell therapy and technology. The amount allocated to stem cell research under previous EU programmes has formed a relatively small portion of the overall budget but played a vital role in facilitating collaborations amongst EU researchers which would not have been possible through national funding alone.  Yet, the funding of embryonic stem cell research in Europe now lies in the balance.

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EU Accession to the ECHR – Latest Developments

Prof. Aurora Plomer

On Monday 30th of January I attended a conference organized by the European Academy of Law in Brussels on the latest developments on EU Accession to the ECHR. The meeting offered some illuminating insights into the contrasting perspectives of senior officials and judges from the CJEU and ECrtHR as well as members of the informal working group (CDDH-UE) charged with the drafting of the accession agreement. The final version of the draft legal instrument issued by the joint working group was released on 19th July 2011 for consideration and approval by EU and CoE institutions as well as Member States.

My overwhelming impression was that the process, particularly on the EU side, is unlikely to live up to the ‘rapid’ pace prescribed by Article 6 (2)(1) of the Lisbon Treaty. According to Luca de Matteis,  from the General Secretariat of the Council of the European Union, questions still open in relation to the draft accession instruments include the scope of EU’s accession and submission to ECtHR’s jurisdiction of violations deriving from EU’s Common foreign and security policy acts, “cases and conditions for unclenching the co-respondent mechanism” and voting arrangements for supervision of execution of judgments against the EU.

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EU Ban on Stem Cell Patents: Intended and Unintended Consequences

Prof. Aurora Plomer

The EU Court’s ban on embryonic stem cell patents and products derived therein continues to be the focus of attention and comments in scientific journals and newspapers, and will no doubt do so for a long time to come in the light of the unexpected and far-reaching scope of the ban. National patent offices in Europe and the European Patent Office have yet to analyze the implications of a judgment which requires the application of a uniform, judicially constructed definition of the human embryo across Europe, contrary to the existing diversity of legal definitions (see Asa Hellstadius, ‘A Comparative Analysis of the Implementation of the Directive’s Morality Clause’, in Plomer & Torremans, Embryonic Stem Cell Patents: European Law and Ethics, OUP, 2009) and the submissions of member States to the court.

Opponents of hESC research see the judgment as a ‘milestone’ and vindication of the rights of the embryo. But as legal definitions in this area have singularly been outstripped by the pace of scientific advance (see R v. SoS for Health ex parte Quintavalle),  the Court’s ruling is likely to invite future challenges and fuel the chronic legal uncertainty which has attended the interpretation of the scope of moral exclusions in the Directive. It is also possible that the ban may have unintended consequences and catch the work of scientists who have re-directed their research efforts to adult stem cells (including induced pluripotent cells or iPS cells) in the face of the persistent and powerful opposition of religious lobbies (see recent advances published in Nature only last month).

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