Biotechnological inventions: patentability of ova

by leapuigmal

By contrast, in the present case, the Court hold that in order to be classified as a ‘human embryo’, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being. Consequently, the simple fact that a parthenogenetically-activated human ovum commences a process of development is not enough for it to be regarded as a ‘human embryo’. Accordingly, uses of this organism for industrial or commercial purposes may be patented.

In fact, this case opposed the UK Intellectual Property Office (IPO) to a biotechnology company called International Stem Cell Corporation (ISC). The latter applied to the IPO for two national patents regarding the processes that produces pluripotent stem cells from parthenogenetically-activated human ova. Nevertheless, the Hearing Officer of the UK IPO refused the two applications on the basis of the case Brüstle. Consequently, he concluded that these applications were excluded from patentability according to the Article 6(2)(c) of the Biotech Directive. ISC appealed the decision to the UK High Court of Justice. Considering that the question of the patentability of human embryionic stem cell was unclear, the referring court stayed the proceedings and asked to referred the CJUE whether unfertilised human ova whose division and further development which have been stimulated by parthenogenesis, and are incapable of developing into human beings, are included in the term “human embryos” under the Biotech Directive.

In the same sense that the conclusions of the Advocate General, the CJUE holds that, in order to be classified as a ‘human embryo’, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being. The reasoning of the Court and the Advocate General follows the submissions of the applicant that a parthenote is not capable of commencing the process of the development of a human being, in the light of knowledge which is sufficiently tried and tested by international medical science. However, one caveat concerns the eventuality that a parthenote is manipulated genetically in such a way that it can develop to term and thus into a human being. For instance, certain manipulations have already been tried successfully on mouses in the UK. Hence, it cannot be excluded categorically.

In connection with this problematic, several concerns should be taken into account not only economic but also ethic. Indeed, the capacity of human embryonic stem cells to form various tissues has created hopes for finding therapies for numerous heretofore incurable diseases. As a result, it is important to find a balance between economic interests, ethical concerns and legal issues.

To conclude, this decision will remove a threat to biotech research in Europe, the unfertilised human ova whose division and further development have been stimulated by parthenogenesis do not fall under the restrictions on patentability laid down by the court in the case Brüstle. Now, it is time to the UK Court to determine whether or not the International Stem Cell Corporation’s work is patentable.

 

Lea Puigmal
QMJIP Assistant Editor

1. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions
2. Brüstle v. Greenpeace, 18 October 2011 (case C-34/10)
3. “Parthenogenesis consists in the activation of an oocyte, in the absence of sperm, by a variety of chemical and electrical techniques and the organism thus created is called a parthenote.” (Curia, Press release No. 181/14)