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Friday, 19 April 2013

Brief from the AdvoKat: Parthenotes from a small island - stem cells back at the Court of Justice

The Advokat
She sells stem cells on the sea shore. If you repeat this tongue twister quickly enough, you may find yourself saying “Have we seen this all before?”.

Following WARF and Brüstle, here comes International Stem Cell Corporation v Comptroller General of Patents [2013] EWHC 807 (Ch), the Judgment of Henry Carr QC and the patentability of parthenotes. Is their commercial exploitation contrary to ordre public or morality (Article 6(1) of the Biotech Directive 98/44/EC), and, in particular, are they human embryos under Article 6(2)? This was, the Judge said, “a question of considerable importance”.

Parthenotes, for those who have not already looked it up on Wikipedia, are activated unfertilised oocytes. They are incapable of continued normal development into a human being due to the absence of paternal DNA. On the evidence before the Court, human parthenoteswere shown to develop to the blastocyst stage, over about five days, but after that period the requirement for paternal genes became acute and the oocyte did not develop further, and never to term.

No doubt in an attempt to give exhaustive guidance on when commercial exploitation of any stem cell technology would be contrary to ordre public [Merpel: is this the Great European Public?] or morality [Merpel: but whose morality?], the CJEU dealt with the question of parthenotes in Brüstle(C-34/10), even if that case on the facts concerned the quite different neuronal progenitor cells derived from embryonic stem cells. The Court said:

35.  Accordingly, any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ within the meaning and for the purposes of the application of Article 6(2)(c) of the Directive, since that fertilisation is such as to commence the process of development of a human being.

36.  That classification must also apply to 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. Although those organisms have not, strictly speaking, been the object of fertilisation, due to the effect of the technique used to obtain them they are, as is apparent from the written observations presented to the Court, capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.
Said the Applicant in this case, it seems that the CJEU found that parthenotes are capable of commencing a process which leads to a human being. Therefore, it was wrong on the facts - parthenotes are not totipotent, and its application should be allowed. The Comptroller was not so sure, and urged the Court to make a further reference to clarify the Brüstle ruling.

Merpel suspects that the CJEU knew fully well what parthenotesare, and that they cannot develop into a human being. However, in an attempt to protect the morals of the Great European Public, it decided to draw the exclusion around them on the basis that they at least appeared to commence the process of development into a human. On the other hand, the Judge was clear that a line should be drawn between inventions with totipotent and pluripotent cells, the latter being patentable, the former not. This distinction was supported by the Advocate General’s opinion in Brüstle (see [91], although it was not clear to the A-G whether in fact parthenotes could generate cells which were totipotent), by the reference to totipotent cells in recital 38 of the Biotech Directive (and the implicit exclusion from that list of pluripotent cells), the immense potential for stem cell therapies to treat disease, and the recited aim of the Biotech Directive to encourage European biotechnology research. In the words of the Judge at [58]:
“The balance between this objective and the need to respect the fundamental principles safeguarding the dignity and integrity of the person may properly be struck by excluding from patentability processes of development which are capable of leading to a human being. However, to exclude processes of development which are incapable of leading to a human being does not, in my view, 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. 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.”
Therefore, the Judge found, the law was not acte clair, and so there shall be another reference to the CJEU on patentability of stem cells, specifically on the patentability of unfertilised human ova.

Merpel has the feeling that the CJEU is rather entrenched on this issue, but hopes the Court will take this opportunity to revisit its interpretation of the legal morality standard to be applied, and move closer to that envisaged by the optional exclusion of the Strasbourg Convention of 1963, the EPO Guidelines for Examination (especially the “abhorrent” standard in the earlier versions), case law of the EPO (see for example Leland Stanford/Modified Animals[2002] EPOR 2 at [51]),and the views of the European Group on Ethics, amongst other sources.

If there is still a balance to be struck on the policy of the Directive, the way is open for the fertile minds at the totipotent Court of Justice to give our scientists their reward.

From the AdvoKats at 3 New Square

5 comments:

Anonymous said...

Everyone is very hooked on this question of pluripotent versus totipotent, and the UKIPO in particular seemed to have made it a central part of determining what is patentable and what is not. However cells which are pluripotent today using today's technology will tomorrow become totipotent using tomorrow's technology. I think the CJEU's Brustle decision sort of hinted at that, and was trying to say please leave us out of these incredibly complex emotive issues and just take a decision based on the facts (at that time) in national courts/patent offices. Unfortunately Mr Carr has not taken the hint and so we're pushing the CJEU back into making a decision on this issue. Had decision-making stopped at the WARF case at the EPO things would have been so much simpler, where everything after a certain date was simply patentable. But alas that did not happen.

Tim Roberts said...

“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.”

This is overstated. More accurately, it would read “.. the fruits of human embryonic stem cell research”. There are few objections to research on adult stem cells. Further, this research leads to effective treatments – which HESC research has yet to do. For purely utilitarian reasons, it could be better to concentrate on the former.

But the referral is reasonable. Given that parthenotes cannot develop into adult humans, it may be easy to decide that they do not fall under the Brüstle ruling. There remains a more general question as to whether this work is contrary to 'morality' (98/44 Art 6.1). This is not to be answered solely by indignant cries about 'the right to do research' and speculative claims about the cures that could result.

Anonymous said...

"For purely utilitarian reasons, it could be better to concentrate on the former" (adult stem cells)

What if the person has a genetic defect? What about telomeres?

Parthenotes form homozygous chromosome pairs, which will HLA match people, something adult stem cell zealots conveniently ignore.

Anonymous said...

"For purely utilitarian reasons, it could be better to concentrate on the former" (adult stem cells)

What if the person has a genetic defect? What about telomeres?

Parthenotes form homozygous chromosome pairs, which will HLA match people, something adult stem cell zealots conveniently ignore.

Anonymous said...


http://curia.europa.eu/juris/document/document.jsf?text=&docid=155123&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=330197


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