Human embryos & beginning of life back at European Court

In our post Human Embryos, the beginning of life, and EU Citizens we reported on the “One of Us campaign, its use of the European Citizens’ Initiative and the underpinning judgement, Oliver Brüstle v Greenpeace e.V [2011] case c-34/10.  This case concerned the interpretation of Article 6(2)(c) of Directive 98/44/EC on the legal protection (i.e. patentability) of biotechnological inventions. Article 6 of the Directive states:

1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes.

In its judgement on Brüstle, the Court of Justice clarified:

  • the circumstances under which a human ovum falls within the definition of “human embryo” within the meaning of Article 6(2)(c) of the Directive in the context of patentable inventions;
  • that fertilization of the ovum “commences the process of development of a human being”.

However, this does not:

  • equate a fertilized human ovum with a human being;
  • suggest that a legal personality should be assigned to such a fertilized ovum.

The matter is set to return to the Europe following a reference by the High Court in International Stem Cell Corporation v Comptroller General of Patents [2013] EWHC 807 (Ch) (17 April 2013) in relation to an appeal by ISCC against a decision that the inventions disclosed in two of its patent applications relating to human stem cells were excluded from patentability. The issues raised by the appeal are summarized in paragraph 3 of the judgement, which states:

“… 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?

Henry Carr QC, sitting as a Deputy Judge of the High Court, suggested at paragraph 59 that subject to any further submissions from the parties, the question he intended to refer to the Court of Justice was:

“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/EC on the legal protection of biotechnological inventions?”

Comment

International Stem Cell Corporation turned on whether the term human embryos as defined in Article 6(2)(c) of the Directive on the legal protection of biotechnological inventions, 98/44/EC, encompasses activated oocytes [referred to as parthenotes [1] ].  Although the case was technically complex, there was common ground between the parties and the judgment of the Bundesgerichtshof in Brüstle regarding human embryogenesis, paragraphs 11 to 15, and parthenogenesis, paragraphs 16 to 20.

Brüstle gave some guidance on Article 6(2)(c), ruling that

any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitutes a ‘human embryo” within the meaning of Article 6(2)(c) due to it being capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so,” [emphasis added].

However, problems arose in the application of this guidance to the instant case in view of:

  • differences in the factual matrix: in the High Court, the Hearing Officer had made a finding of fact that the parthenotes produced by the methods of the invention are incapable of continued normal development, whereas the evidence presented to the CJEU was that parthenotes have the potential to create a human being.
  • uncertainty in the meaning of the test “commencing the process of development” which had been adopted not only in relation to parthenotes but also in relation to fertilised ova, non-fertilised ova subjected to somatic-cell nuclear transfer and stem cells obtained from human blastocysts;
  • uncertainty as to whether the test is to be applied to: the commencement of the process of development of a human being, whether or not the potential exists for the completion of the process; or to the commencement of a process which is capable of leading to the birth of a human being.

Referring to the (non-exhaustive) examples in recital 38 of the Directive [2] , the Deputy Judge concurred with the opinion of the Advocate General in Brüstle that totipotent cells should be excluded from patentability, whereas pluripotent cells should not.  Rosalind English notes that when the court considered neural stem cells in Brüstle, it took the view that, with its emphasis on human dignity, the Directive invited a wide interpretation of the concept of the “human embryo”, but concludes:

“[p]atent law has to strike a balance between the interests of encouraging research in biotechnology and the need to respect the principles safeguarding the integrity of the person. But to give too wide a role to “human dignity” by excluding processes of development which are incapable of leading to a human being does not strike a balance at all. This is particularly so in the case of parthenotes, which are not the same as fertilised ova at any stage. Excluding such important achievements from the protection of intellectual property, in the name of “human dignity”, achieves nothing.”

Not all would necessarily agree, and the judgment of the Court of Justice will be followed by both researchers and religious groups.


[1] Parthenogenesis refers to the initiation of embryogenesis without fertilisation by activation of an oocyte, [an unfertilised ovum], in the absence of sperm.  Such activation can be induced with a variety of chemical and electrical techniques.  The activated oocyte (referred to as a parthenote) contains a single or double set of maternally derived chromosomes but does not contain any paternal DNA, [para. 16];

A parthenote is capable of developing into a blastocyst-like structure comprising trophectoderm and an inner cell mass.  However it cannot develop to term because of the absence of any paternal DNA, [para.17].

In contrast to a fertilised ovum and its early stage descendants the cells of a parthenogenetically-activated oocyte are pluripotent, not totipotent, even in the first few cell divisions after activation. The same is true of the cells in a parthenogenetic blastocyst-like structure, [para.18].

[2]  . . . . . . . . whereas processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability, [Recital 38].

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