On 18 December 2014, the EU Court of Justice ("ECJ") answered a preliminary question in International Stem Cell Corporation ("ISCC") v. Comptroller General of Patents, Designs and Trade Marks (Case C-364/13). The ECJ offered guidance on the concept of a "human embryo" and essentially held that an organism which is not capable of developing into a human being does not constitute a human embryo within the meaning of the Biotech Directive and is, as a consequence, not excluded from patent protection.
The aim of Article 6(2) (c) of Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (the "Biotech Directive") is to strike a balance between encouraging biotechnical research by way of patent law and protecting the dignity and integrity of the person. As such, it provides on ethical grounds that all inventions involving "the use of human embryos for industrial or commercial purposes" are excluded from patent protection. However, it does not define the concept of a "human embryo".
On 18 October 2011, the ECJ defined the concept of a "human embryo" in Brüstle (Case C-34/10). The German Bundesgerichtshof had asked whether "unfertilised human ova whose division and further development have been stimulated by parthenogenesis" fall under the scope of the term "human embryos" in the sense of the Biotech Directive. The ECJ answered this question in the affirmative. It held that an ovum becomes a human embryo as soon as it is "capable of commencing the process of a human being". (See VBB on Belgian Business Law, Volume 2011, No. 10, p. 9-10, available at www.vbb.com)
In the facts underlying the case at hand, ISCC sought to register two UK patents relating to unfertilized human ova which have been stimulated to divide in the absence of sperm (so-called "parthenotes"). Essentially, the procedure involves the activation of human ova using a series of chemical and electrical techniques. Such an ovum could potentially develop into the blastocyst phase (structure formed in the early development of mammals) but would be unable to develop any further, as it lacks any paternal DNA necessary to form the placenta. An objection to the patentability of this process was raised by the UK Intellectual Property Office. It argued that, in line with Brüstle, the inventions disclosed constitute uses of human embryos that are not patentable.
The High Court of Justice (England and Wales) asked the ECJ whether unfertilised human ova whose division and 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, are included in the term "human embryo" in the Biotech Directive.
The ECJ clarified that, in order to be classified as a "human embryo", the decisive criterion is whether a human ovum has the "inherent capacity of developing into a human being". The ECJ changed its emphasis and stressed that the crux hinges on whether the parthenote is able to develop into a human being, rather than whether it can merely commence this process, as it stated in Brüstle. The organisms subject to the patent application are, according to the current scientific knowledge, only capable of commencing a process of development, but cannot eventually develop into a human being. Therefore, they cannot be regarded as a "human embryo". As a consequence, the use of parthenotes is not excluded from patentability.
The ECJ left if for the referring Court to determine whether, in light of the current scientific knowledge, the human parthenotes, such as those which are subject to the patent applications, have the inherent capacity to develop into a human being. The ECJ also noted that even if this is not the case, the national court could still refuse the patentability on grounds of morality or public order.
This judgment represents a nuance to the ECJ's previous ruling in Brüstle, in the sense that patenting parthenotes is not automatically prohibited due to their classification as "human embryos". This has important consequences for stem cell research and could be seen as beneficial for the biotech and regenerative medicine industries, as it opens the door for the patenting of stem cell related inventions in the EU. The ECJ did not indicate whether and when the parthenote by itself has the "inherent capacity to develop into a human being". This is left to be determined on a case-by-case basis by the national courts.
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