The spanner of “human dignity” in the wheels of modern medicine

22 April 2013 by

parthenote-stemcellInternational Stem Cell Corporation v Comptroller General of Patents 17 April 2013  [2013] EWHC 807 (Ch) – read judgment

The EU bans the patenting of human embryos for commercial purposes. This ban is implemented in national law via the 1977 Patents Act. But what precisely is a “human embryo” for the purposes of the Biotech Directive? Or, put another way, must the process involving embryonic stem cells be capable of developing into a human being, before the ban can bite?

Stem cells – not just the embryonic variety – are vital to current medical research. This is because they have the capacity to differentiate into almost any type of adult cell, thus opening the door to a wide variety of new therapies and other medical applications. In theory, stem cells can be grown in the lab and developed into healthy adult cells to correct cardiovascular disorders , diabetes and a range of degenerative brain diseases and spinal cord injuries. One of the first triumphs of stem cell therapy is the ability of retinal pigment epithelium cells, cultured from embryonic stem cells (ESCs), to reverse the effects of age related macular degeneration. Other potential applications include the treatment of burns, strokes, eye disease, spinal cord injuries and certain forms of cancer.

But the concept of ESCs  is fraught with emotion and controversy and scientists have worked, with varying degrees of success, at finding stem cells elsewhere, either in adult tissue, or by creating stem cells from non-viable embryos.

But even these achievements have run foul of the 1998 Biotech Directive . The problem is that the Directive is riven by competing aims. Two policy considerations lie flat against each other. The Recitals section proclaims, on the one hand, that research in the field of biotechnology is to be encouraged by means of the patent system. But on the other, it emphasises that patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; so that the human body, at any stage in its formation or development, cannot be patented. This may be of considerable interest and even charm to lawyers, but it amounts to nonsense in the lab, where whole entities such as “human embryos”  or “the human body” simply don’t exist.

The issues in this case

The case turned on whether parthenotes (illustrated above) are properly to be regarded as human embryos within Article 6(2)(c) of the Biotech Directive. The case law on this question is not acte clair in the light of the current state of the art.

There were two patent applications in issue. They both involved activation of the precursor-cells to human ova, called oocytes, without fertilisation by sperm. This process, parthenogenesis, produces clusters of embryonic stem cells which are incapable of reaching full term because of the lack of essential paternal genes.  Parthenogenetically-activated oocytes would seem to answer all the ethical and practical objections to “naturally” produced ECSs. That is why the biotechnology companies are competing so vigorously to come up with acceptable ways of producing them.  Both these patent claims involved the isolation of pluripotent stem cells from parthenogenetically-activated oocytes, and one of them was a product claim for synthetic cornea, also derived from these cells.

This question has already come up before the CJEU, in the context of neural stem cells. The court took the view in that case that, with its emphasis on human dignity, the Directive invited a wide interpretation of the concept of the “human embryo”, and that therefore it should also include

a non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis.(Case C-34/10 Oliver Brüstle v Greenpeace eV [2012] 1 CMLR 41)

Although the court acknowledged that those organisms had not, “strictly speaking”, been the object of fertilisation, it continued down this somewhat puzzling line of reasoning:

due to the effect of the technique used to obtain them they are … 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, by the same logic, any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis could be said to constitute a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive.

The claimant company argued that the only sensible way of interpreting Brüstle was to apply the “key” question to an organism, which is whether it is “capable of commencing the process of development of a human being”, and, that the only sane interpretation of that, in turn, was whether it is “capable of commencing the process of development which leads to a human being”. The alternative meaning – that an organism could be so defined even if it were capable only of commencing a process of development, but incapable of leading to a human being, would be nonsensical.

Unfortunately this submission implied ignorance on the part of the CJEU, which is that it considered such organisms activated by parthenogenesis to be capable of completing the process of development leading to a human being.

For his part, the Comptroller submitted that the CJEU meant that the “capable of commencing” test focussed only on the start of the process, and did not require completion of the process of development leading to the birth of a viable human being. The Comptroller also contended that this was an

 issue of “great delicacy”, on which different member states may have different views and that, given that the CJEU had clearly ruled that parthenotes are excluded from patentability as human embryos, it was not for the UK court to attempt to rewrite the ruling.

Well, quite clearly Henry Carr QC, sitting as Chancery judge, had no intention of “rewriting” Brüstle. But in determining that the issue is no longer acte claire – if it ever was, he has given a very strong indication of which way he thinks the CJEU should incline on this reference.  Cells from a parthenote are not like cells from a fertilised ovum. They do not have the ability to turn into any cell in the human body; they are pluripotent, not totipotent. A parthenote, containing as it does only maternal DNA, can never develop into a viable human being. The factual matrix is not only sufficiently different to that before the CJEU in Brüstle to justify a reference;  the Brüstle approach to patentability is incoherent and unworkable. Patent 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.

 

It is more akin to a total exclusion from patent protection of the fruits of stem cell research, to the detriment of European industry and public health.

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