Following WARF and Brüstle, here comes International Stem Cell Corporation v Comptroller General of Patents  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.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.
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.
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 , 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 :
“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 EPOR 2 at ),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