Stem cell research companies and organisations will welcome a recent decision from the European Court of Justice (CJEU) which has extended the scope of patentability in the field of stem cell research. The decision opens the door for inventions relating to unfertilised human eggs whose division and further development have been stimulated by parthenogenesis to be patented in Europe.
In practice, it remains to be seen how the European Patent Office and national patent offices in Europe will interpret the decision.
The England and Wales High Court (the Patents Court) referred a question to the CJEU in April 2013 stemming from an appeal to a decision by the UK Intellectual Property Office to refuse two UK patent applications in the name of International Stem Cell Corporation (ISCC).
The two patent applications included claims to (1) methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and stem cells produced by such methods; and (2) methods of producing synthetic cornea or corneal tissue, which involve the isolation of pluripotent stem cells from parthogenetically-activated oocytes and synthetic cornea or corneal tissue produced by these methods.
Parthogenesis refers to a process of activation of an oocyte, in the absence of sperm, by chemical and/or electrical techniques. The resultant oocyte ("parthenote") is capable of division and further development. Human parthenotes are currently considered unable to develop to term due to the lack of paternal DNA which is required for the development of extra-embryonic tissue.
The European Biotech Directive (Directive 98/44/EC) provides that inventions that relate to the use of human embryos for industrial or commercial use are ineligible for patent protection. Thus, the question referred by the Patents Court sought clarification on whether the parthenotes formed as part of the invention were "human embryos" and therefore incapable of patent protection in Europe.
The question referred by the Patents Court was similar to an earlier question referred by the same court. In response to this question, an earlier decision from the CJEU (Brüstle) http://curia.europa.eu/juris/liste.jsf?language=en&num=C-34/10 had explicitly ruled that parthenotes were to be considered non-patentable human embryos per se. The patenting of inventions relating to parthenotes was thus expressly excluded by the decision. The Patents Court noted that, in coming to its decision in Brüstle, the CJEU may have relied on inaccurate scientific presentation which stated that human parthenotes were in fact capable of development into a human embryo.
The CJEU in the ISCC decision ruled that parthenotes are not excluded from patentability since they are not capable of developing to full term and therefore are not considered "human embryos". Particularly, in order to be classified as a human embryo, a non-fertilised human ovum must have the inherent capacity of developing into a human being.
The CJEU therefore concluded that parthenotes generated using current processes are not excluded from patentability. However, the Court stated that it was up to national offices to determine on a case by case basis whether an unfertilised human ovum has the inherent capacity to develop to full term, based on current scientific knowledge.
The decision has provided welcome clarification on the patentability of certain stem cell types.
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