A number of currently incurable human diseases (e.g. Alzheimer’s or Parkinson‘s) are open for the application of promising new technologies based on the application of human embryonic stem cells (hESCs), which however are not patentable in Europe if „human embryos“ are used as an original source [Art. 6 (2) (c) of the EU Directive 98/44/EC, implemented in the European Patent Convention (EPC) by Article 53 (a) and Rule 28].
The European Court of Justice (CJEU) defined in its decision C-34/10 (Oliver Brüstle v. Greenpeace e.V.) the term “human embryo” as follows:
- any human ovum after fertilization,
- any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted; and
- any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis,
and the EPO closely followed said interpretation of the term „human embryo“ when applying Rule 28 EPC.
However, from a biological and ethical perspective point at least item c) appears to be somewhat questionable. With regard to biology, a parthenote has not the capacity to develop into a “real” human embryo as, according to the current scientific knowledge, it stops at a multi-cell stage. With regard to the ethical question of misuse of original material which might be suitable to develop into a human being, it has to be noted that once the parthenotes cannot further develop to “real” embryos and further to a human beings, this question has resolved itself and must not be considered further.
Importantly, in its later judgement C-364/13 of December 18, 2014 (International Stem Cell Corporation v. Comptroller General of Patents) the CJEU narrowed the definition of the term „human embryo“ with regard to item c), to exclude an unfertilized human ovum whose division and further development have been stimulated by parthogenesis, if, according to the current scientific knowledge, such a human parthenote does not, in itself, have the inherent capacity to develop into a human being. In other words, parthenotes are not to be considered as human embryos, since according to the current scientific knowledge, they do not have the inherent capacity to develop into a human being. Following this rationale, inventions based on human parthenotes, including hESCs derived therefrom, are patentable.
Unfortunately, current EPO guidelines do not reflect said applicant friendly newer view of the CIEU yet. On the contrary, in item G-II, 5.3 (iii) of said guidelines it has been pointed out that judgements of the CJEU on the interpretation of the EU Directive 98/44 /EC are not binding for the EPO.
Applicants having pending applications at the EPO and struggling with this issue may take the advantage to refer to co-pending applications (e.g. EP 13186524, EPO communication of October 30, 2015) or appeals (see. e.g. decision T 2365/13 of May 31, 2016) according to which at least some of the Examining Divisions and Boards of Appeal adjusted their view analogous to the CIEJ and now accept claims with regard to parthenote based subject-matter which has been originally objected under Article 53 (a) in combination with Rule 28 EPC.