21 January 2015

Update of the Patentability of Stem Cells

In an eagerly anticipated decision, the Court of Justice of the European Union (CJEU) has now confirmed the preliminary view of its Advocate General (AG), Cruz Villalon, that an unfertilised human ovum whose division and further development has been stimulated by parthenogenesis (i.e. a parthenote), and which, in contrast to fertilised ova, contain only pluripotent cells and, as such, are incapable of developing into human beings, are not encompassed by the phrase “human embryo”.Consequently, stem cells derived from parthenotes, and inventions concerning such cells, are now potentially patentable in Europe.

Background to the Decision

An attempt to harmonise certain different national patent laws that existed in Europe was made through the adoption by the European Parliament in 1998 of a Directive on the Legal Protection for Biotechnological Inventions (Directive 98/44/EC, colloquially known as the “Biotech Directive”).  Each of the member states of the European Union (EU) were obliged to implement all of the provision of the directive.
Despite the fact that the European Patent Office (EPO) was not bound by the Biotech Directive (the EPO is not a member state of the EU or an EU organisation), the rules of the European Patent Convention (EPC) have been amended to incorporate a number of the provision of the Biotech Directive.

Whilst the Biotech Directive does not contain any specific references to the patenting of human embryonic stem cells, there are some provisions of the directive which have been interpreted as having an indirect effect on whether or not these cells can be patented.  In particular, Article 6(2)(c) of the Biotech Directive prohibits the patenting of “uses of human embryos for industrial or commercial purposes” on grounds of morality.  This is incorporated in Rule 28(c) of the EPC and Section 76A and Schedule A2 of the UK Patents Act 1977 (UKPA).

The Patents at the Centre of the Decision

Parthenogenesis is an artificial method by which unfertilised human eggs (ova) can be stimulated to develop further without fertilisation.  It forms the basis of asexual reproduction in some invertebrate animals (including nematodes, water fleas, some scorpions, aphids, some bees and some parasitic wasps) and a few vertebrates (some fish, amphibians and reptiles, and very rarely birds), but it does not occur naturally in any mammals.
International Stem Cell Corporation (ISCO) filed two patent applications at the UK Intellectual Property Office (UKIPO) relating to stem cells obtained from parthenogenetically activated oocytes.  These applications were entitled “Parthenogenetic activation of oocytes for the production of human embryonic stem cells” and “Synthetic cornea from retinal stem cells”.

However, both of the above applications were refused by the UKIPO after a hearing in 2012 for the reason that the applications were held to comprise statutory non-patentable subject matter relating to the use of human embryos, even though they were unfertilised.  The UKIPO followed the ruling from the CJEU in an earlier case, Oliver Brustle v. Greenpeace (C-34/10).  The ruling in Brustle touched upon the question of the patentability of the same type of stem cells involved in the two ISCOf applications, but explicitly stated in paragraphs 36 and 38 that human parthenotes were considered to be non-patentable “human embryos”.  This ruling, though, would later be found to have been arrived at using erroneous scientific information.

ISCO then appealed to the UK High Court.  The UK High Court decided on appeal in 2013 that the point of law at issue regarding parthenotes was unclear and that a referral to the CJEU was required in order to resolve matters.  The wording of the question to the CJEU was as follow:

“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?”

The Decision and its Impact

In Decision C-364/13 issued on 18 December 2014, the CJEU answered the above question as follows:

“Article 6(2)(c) of Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions 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 light of current scientific knowledge, it does not, in itself, have inherent capability of developing into a human being, this being a matter for the national court to determine”.

The immediate impact of this decision is that cells derived from parthenotes, such as the stem cells produced and used by ISCO, and inventions that necessitate the use or manipulation of such cell, are eligible for patent protection in Europe, subject to the usual requirements of patentability (they must be novel, inventive and capable of use in industry).

Further Implications of the Decision

Decision C-364/13 may also have an important effect on patent applications relating to stem cells in general, and not just stem cell specifically derived from parthenotes.

The EPO’s current view is that it has only been possible to obtain stem cells without requiring the destruction of human embryos, and thereby contravening the Biotech Directive, since 10 January 2008 (the date of publication of Chung’s paper detailing how this could be done).  As such, patent applications relating to stem cells but filed before this date would be automatically refused by the EPO.  Conversely, applications concerning such subject matter and filed after this date would, though, be seen by the EPO as being potentially patentable.

The date upon which stem cells are considered to be derivable from parthenotes has yet to be decided, but it is thought to be earlier than the above date, which would mean that some patent applications for stem cell inventions filed before 10 January 2008 may now be allowable.
Furthermore, the fact that human parthenotes are now not construed as “human embryos”, due to the fact that they are incapable of developing into human beings, means that other sources of human stem cell, which are also not able to develop in this way, will also not be considered to be “human embryos”.

On behalf of our clients, we are very pleased with this decision as it increases the possibility of obtaining patent protection in this highly controversial area.