January 19, 2015

International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks (Case C-364/13)

Summary

In International Stem Cell Corporation, the Court of Justice of the European Union (“CJEU”) held that a parthenote does not constitute a ‘human embryo’ if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being.  As a result stem cells derived from parthenotes are not necessarily excluded from patentability in Europe, as seemed to be implied by the CJEU’s earlier decision in Brüstle.

The Biotech Directive

In Europe, Article 6(1) of the Biotech Directive provides that inventions are not patentable where their commercial exploitation would be “contrary to ordre public or morality’. Article 6(2) then goes on to provide some examples of inventions which are unpatentable because their commercial exploitation would be contrary to ordre public or morality.  One of the examples (given in Article 6(2)(c)) is “uses of human embryos for industrial or commercial purposes”. However, the Directive does not define ‘human embryo’ and this has created uncertainty and prompted numerous referrals to be made to the CJEU for guidance on the meaning of the term.

Brüstle

The CJEU first clarified the meaning of ‘human embryo’ in Brüstle.  It held that the term “must be understood in a wide sense” and included a fertilised human ovum “since that fertilisation is such as to commence the process of development of a human being”.

The CJEU went on to say that parthenotes also constituted human embryos on the basis that:  “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.” (own emphasis)

International Stem Cell Corporation

Following the Brüstle decision, the UK Intellectual Property Office (“UKIPO”) examined two UK patent applications submitted by the International Stem Cell Corporation (“ISC”). The applications related to the generation of, and derivation of stem cells from, parthenotes and associated therapeutic applications. The patent applications were refused by the UKIPO on the basis of the CJEU’s ruling in Brüstle.  ISC appealed to the Patents Court.

The key issue in the appeal was the meaning of the phrase “capable of commencing the process of development of a human being” used by the CJEU in Brüstle.  ISC contended that it meant ‘capable of commencing the process of development which leads to a human being’ and not ‘capable of commencing a process of development even if that process is incapable of leading to a human being’.

ISC also argued that in Brüstle the CJEU had wrongly understood that parthenotes were capable of developing into human beings, and its ruling to the effect that parthenotes were ‘human embryos’ within the meaning of the Biotech Directive applies only to parthenotes which are actually capable of such development.

The CJEU’s decision

The CJEU noted that in Brüstle, written observations put before the court indicated that parthenotes had the capacity to develop into human beings.  By contrast, in the present case, all parties and the referring court agreed that parthenotes do not have such a capacity. The CJEU decided that the phrase “capable of commencing the process of development of a human being” meant that a non-fertilised human ovum must have “the inherent capacity of developing into a human being”. In other words, the relevant test is whether a parthenote can itself become a fully formed human being.  The fact that a parthenote might be capable of starting that process, or at least a closely analogous process, is not enough to bring it within the meaning of a ‘human embryo’.

The CJEU also took into account the possibility that future scientific advances might allow parthenotes to develop into human beings for example by means of additional genetic manipulation. It therefore ruled that Article 6(2)(c) of the Biotech Directive “must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine” (own emphasis).

Comment

This case provides some welcome clarity for innovators in the field of stem cell research.  It implies that a distinction is to be draw between stem cells which derive from ancestry which had totipotent character and stem cells derived from cell bodies that only ever had pluripotent character.

However, it must be borne in mind that it does not go so far as to say patents claiming parthenotes (or other cells with pure pluripotent lineage) and stem cells derived from them are allowable.  First of all, Article 6(2) merely provides a non-exhaustive list of examples of inventions the commercial exploitation of which is contrary to ordre public or morality.  So merely because parthenotes fall outside of the specific exception of Article 6(2)(c) does not mean that they necessarily escape the general prohibition in Article 6(1).  The English court’s view (expressed in the decision making the reference to the CJEU) seems to be that patents for inventions relating to parthenotes and stem cells derived therefrom should be patentable, but the same approach may not be taken in all European jurisdictions.  Secondly, the English court’s view seems to have been influenced by ISC’s proposal to limit the relevant claims to pluripotent stem cells derived from cell structures that lack paternal imprinting, thereby excluding inventions that overcome the effects of genomic imprinting and allow parthenotes to develop into human beings.

Furthermore, if as the science advances it proves to be possible to stimulate human parthenotes to develop into human beings, the CJEU’s guidance is likely to lead to further uncertainty.  For example, at what date is the ‘current scientific knowledge’ to be assessed, the date of filing or some later date?  Further questions may be asked of the meaning of ‘inherent’.  Thus it seems at least possible that patents granted in Europe for parthenotes and stem cells derived therefrom following this decision may subsequently become vulnerable to an invalidity attack if the state of scientific knowledge advances in a particular way.  This possibility suggests that limitations of the type sought by ICS to avoid such risks may be important.

Published with minor alternations in the January 2015 edition of Biotech Buzz the newsletter of the Biotechnology Committee of the AIPLA. A copy of the version as published can be viewed here.