In a decision handed down today, the Court of Justice of the European Union (CJEU) has decided that unfertilised human egg cells stimulated to divide in a manner analogous to that of a human embryo are not excluded from patentability within the European Union under the Directive on the Legal Protection of Biotechnological Inventions (Directive 98/44/EC, known as the “Biotech Directive”). This new decision has consequences for European Patents and applications at the EPO, and for national patents and applications in EU member states.
The Biotech Directive provides that patents cannot be granted for inventions that relate to uses of human embryos for industrial or commercial purposes. In 2011 the CJEU clarified (in decision C-34/10 Brüstle v. Greenpeace) that the correct interpretation of this provision excluded all methods that involved the destruction of a human embryo, whether this was a feature of the claimed invention, or an inherent step. This had far-reaching consequences for the patentability of stem cell related inventions; even inventions that used established stem cell lines were now excluded from patentability, if the only way of generating those cell lines at the time the patent application was filed necessarily required the destruction of a human embryo. This applied even if no further embryos needed to be destroyed to practice the invention. Inventions relating to human embryonic stem cells in patent applications filed before 10 January 2008 (the earliest recorded date of publication of how to obtain embryonic stem cells without destroying an embryo) were now excluded from patentability.
In the present case, the High Court of Justice (England and Wales) had asked the CJEU to clarify the definition of “human embryo”.
The questions the High Court referred to the CJEU relate to two patent applications relating to parthenotes (ISCO v. Comptroller  EWHC 807 (Ch)), which are unfertilised human egg cells that have been stimulated to divide by parthenogenesis. Parthenotes are incapable of developing to term, but their initial development resembles that of a human embryo commencing the process of development of a human being. Because of the wording in the earlier CJEU judgement it was not clear to the High Court whether or not parthenotes fell within the CJEUs definition of a “human embryo”, and therefore whether methods involving destruction of a parthenote could be patented.
The CJEU followed the earlier opinion of the Advocate General in finding that a “human embryo” within the meaning of the Directive must have the inherent capacity of developing into a human being, this being a matter for the national courts of the member states to decide. Consequently, it held that based on current scientific knowledge parthenotes do not constitute a “human embryo” for the purposes of the Directive.
The decision clarifies that patent protection can be obtained for inventions relating to certain types of stem cells in the European Union.