Menu

The patentability of embryonic stem cells made from unfertilised eggs

Print publication

03/02/2015

Article 5(1) of the Biotechnology Directive [1] states that “The human body, at the various stages of its formation and development, and the simple discovery of one of its elements … cannot constitute patentable inventions”. Article 6(2)(c) adds that “uses of human embryos for industrial or commercial purposes” shall be considered unpatentable.

In International Stem Cell Corporation v Comptroller General of Patents [2] ISCC made two UK patent applications relating to human stem cells. The cells in question are created through a process called “parthenogenesis”, a type of asexual reproduction in which the offspring develops from unfertilised eggs. The applications were rejected. On appeal, the hearing officer held that the inventions disclosed in the patent applications were excluded from patentability under paragraph 3(d) of Schedule A2 to the Patents Act 1977, which implements Article 6(2)(c) into English law. ISCC appealed again and the High Court referred the following question for a preliminary ruling:

“Are unfertilised human ova whose division and further 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, included in the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions?”

The Court of Justice answered this question by ruling that an unfertilised human ovum whose division and further development have been stimulated by “parthenogenesis” does not constitute a “human embryo” within the meaning of Article 6(2)(c) if, in the light of the current state of scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being.

The Court emphasised that its job in this case was not to regulate the use of human embryos in the context of scientific research. Its job was limited to an assessment of the patentability of biotechnological inventions.

The key factor in the Court’s decision was that a human parthenote (an organism produced from an unfertilised ovum, which is incapable of developing beyond the early embryonic stage), due to the effect of the technique used to obtain it, was not capable of commencing the process of development which led to a human being. It will be for the referring court to determine whether or not, in the light of knowledge which was sufficiently tried and tested by international medical science, human parthenotes had the inherent capacity of developing into a human being.

This ruling is good news for the European biotechnology industry, which should encourage the development of cell-based therapies. The applications can now proceed to examination in the usual way.

______________________

[1] Directive 98/44/EC
[2] Case C-364/13

Contacts