The CJEU has confirmed that, in the context of the exclusions from patentability in the Biotech Directive, an organism must have the "inherent capacity of developing into a human being" in order to be considered a "human embryo".
In Europe, uses of human embryos for industrial or commercial purposes are excluded from patentability under the Biotech Directive. The CJEU has decided that unfertilised human ova which have been stimulated into division and further development by a process known as parthenogenesis should not be considered as being human embryos if they do not have the inherent capacity to develop into a human being. The process of parthenogenesis leads to the production of pluripotent stem cells, which are of interest in scientific and medical research.
The CJEU decision in Oliver Brüstle v Greenpeace e.V. of 2011 regarding the patentability of inventions in the field of stem cell research was criticised by many after it was handed down, with suggestions that it could have an adverse effect on investment in stem cell research in Europe.
Yesterday's decision of the CJEU may allay some of those concerns, giving potential patentees more options for protecting inventions in the field of stem cell research and, therefore, for commercialising their work.
International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks, Case C-364/13, 18 December 2014. A copy of the press release announcing the CJEU's decision can be found here.
In 2012, the UKIPO Hearing Officer rejected applications for two UK patents by International Stem Cell Corporation on the grounds that in Europe uses of human embryos for industrial or commercial purposes are excluded from patentability under the Biotech Directive.
Stem Cell Corporation's applications related to the process of "parthenogenetic activation" which involves the use of chemical or electrical techniques to activate unfertilised human eggs ("ova"). The activated ova (known as "parthenotes") start to divide and develop in a way which is similar, at least initially, to the process by which an embryo forms from a fertilized egg. This process of division and development includes the formation of pluripotent stem cells, which are of interest for medical research.
The Hearing Officer referred to the case of Oliver Brüstle v Greenpeace e.V. in 2011, in which the CJEU held that the term "human embryo" should be defined broadly including, inter alia, "any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis".
The Hearing Officer's decision was appealed to the English High Court where Henry Carr QC (sitting as a Deputy Judge of the High Court) considered the law and the evidence before him. He decided that the test for whether or not something should be considered a human embryo set out by the CJEU in Brüstle was not sufficiently clear for him to decide the case. In addition, the evidence before the English court was that parthenotes, being unfertilized, lack paternal DNA and this limits their ability to develop fully (the evidence before the High Court suggested that human parthenotes have so far only been shown to develop for about five days). In light of this, the High Court referred the following question to the CJEU:
"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 [the Biotech Directive]?"
In yesterday's judgment in response to this question the CJEU has clarified the meaning of "human embryos" for the purposes of the Biotech Directive, following the approach proposed by Advocate General Cruz Villalón in his opinion of 17 July 2014.
The CJEU first reviewed the decision in Brüstle and concluded that a human embryo is an organism that is "capable of commencing the process of development of a human being". The court went on to note that in Brüstle the written observations before the court indicated that parthenotes did have the capacity to develop into a human being and this explained why, in that case, they were found to fall within the definition of human embryos and so were excluded from patentability.
In contrast, the CJEU noted that in the International Stem Cell Corporation case it was common ground between the parties that parthenotes are not capable of commencing the process of development which leads to a human being, as described above.
In light of that finding, the CJEU held that parthenotes would not, in and of themselves, constitute human embryos, provided that they are not inherently capable of developing into human beings. The CJEU said that the question of whether a parthenote is inherently capable of developing into a human being was one which the referring court should determine, "in light of current scientific knowledge".
The case will now return to the English High Court where we anticipate that, in light of the comments in his initial judgment and the evidence before him, Mr Carr QC will find that parthenotes are not excluded from patentability.