Patents: CJEU defines the term “human embryos”

On 18 August 2014 we reported on this webpage about the Advocate General’s opinion regarding a request for a preliminary ruling submitted by the UK High Court of Justice before the CJEU (C-643/13). Exactly four months later the Court found a decision. Pursuant to Art. 6 (2) (c) of the Biotechnology Directive (98/44/EC) the use of “human embryo” for industrial or commercial purposes is non-patentable. The UK High Court of Justice asked the CJEU whether non-fertilised human ova whose division and further development have been stimulated by parthenogenesis are included in the term „human embryos“ of the Directive. Parthenogenesis is a kind of asexual reproduction in which the offspring develops from unfertilized eggs through electro-chemical activation. 

The biotechnology company International Stem Cell Cooperation (ISC) applied to the UK Intellectual Property Office for two patents for a technology that stimulates the development of non-fertilised ova by parthenogenesis. The UK IPO rejected both applications by referring to the CJEU “Brüstle“-judgement (C-34/10). Following “Brüstle“ even non-fertilized egg cells, including parthogenic eggs, can fall under the term “human embryo”,. ISC appealed the decision of the UK IPO to the UK High Court of Justice, and the Court referred the case to the CJEU. ISC argued that the rules as laid out in „Brüstle“ do not apply to ISC’s technology, because the ova in question are not capable of commencing the process of developing into a human being.      

The CJEU now agreed with the plaintiff and partly deviated from its ruling in the “Brüstle”-case. It held that an organism can only be classified as a human embryo if it has the inherent capacity of developing into a human being. Only then a non-fertilised human ovum should be treated in the same way as a fertilised human ovum for the purposes of Art. 6 (2) (c). Following the current scientific knowledge parthogenic eggs cannot develop into a human being. The case is now back with the UK High Court of Justice to decide about the questions of fact.  

With this decision it is clear that in the future it should not be the CJEU that decides about the question if a stem cell is a “human embryo”, but rather the national courts in the light of the current scientific knowledge. However, taking in regard the fast developments in that field of technology, it increases the risk that it will be scientific developments that decide about a fundamental concept, the dignity of man.