The European Court of Justice (ECJ) has held that human parthenotes, which are incapable of developing into a human being, are not excluded from patentability under the Biotechnology Directive (98/44/EC) (the Directive).
EU member states must protect biotechnological inventions under national patent law (Article 1(1), the Directive). Article 5(1) of the Directive excludes from patentability the human body, at the various stages of its formation and development, and the simple discovery of one of its elements.
Inventions are unpatentable where their commercial exploitation would be contrary to “ordre public” or morality (Article 6, the Directive) (Article 6). Under Article 6(2)(c), the use of human embryos for industrial or commercial purposes is unpatentable.
In Oliver Brüstle v Greenpeace eV, the ECJ held that a non-fertilised human ovum was classified as a human embryo within the meaning of Article 6(2)(c) in so far as it was capable of commencing the process of development of a human being (C-34/10).
I’s two UK patent applications relating to human stem cells were rejected by the examiner. On appeal, the intellectual property office hearing officer held, following Brüstle, 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), and he also rejected the patent applications. I appealed.
The High Court asked the ECJ whether 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, are included in the term “human embryos” in Article 6(2)(c).
The ECJ held that, in order to be classified as a human embryo, a non-fertilised human ovum had to have the inherent capacity of developing into a human being. Where a non-fertilised human ovum did not fulfil that condition, the mere fact that organism commenced a process of development was not sufficient for it to be regarded as a human embryo for the purposes of the application of the Directive. By contrast, where such an ovum had the inherent capacity of developing into a human being, it should for the purposes of Article 6(2)(c) be treated in the same way as a fertilised human ovum, at all stages of its development.
The High Court had stated that, according to current scientific knowledge, a human parthenote, due to the effect of the technique used to obtain it, was not capable of commencing the process of development that led to a human being. That assessment was shared by all of the interested parties that submitted written observations to the court. In addition, I had amended its applications to exclude the prospect of the use of additional genetic manipulation.
It followed that this case related solely to the classification of a human parthenote in itself, and not of a parthenote that was the subject of additional manipulation falling within the scope of genetic engineering. It was for the High Court to determine whether or not, in the light of current international medical knowledge, human parthenotes had the inherent capacity of developing into a human being.
Parthenotes are cells that are not fertilised but stimulated by parthenogenesis to divide and grow like human fertilised eggs, but are incapable of completing the process of development into a human being. They are used, for example, in stem cell research. Provided that they have not been genetically modified to acquire the capacity to develop into a human being, parthenotes are not human embryos and are therefore patentable. If, however, a parthenote is genetically altered so that it becomes capable of becoming a human being, it would cease to be patentable.
The biotechnology industry in the EU will be relieved that the ECJ has confirmed the patentability of human parthenotes that are incapable of developing into a human being. I’s patent applications concerning the development of a method of obtaining human pluripotent cells can now proceed to the normal examination process. However, the ECJ has observed that inventions involving further genetic engineering of the parthenote risk being unpatentable as they will raise again the question of whether there is the inherent capacity to develop into a human being.
Case: International Stem Cell Corporation v Comptroller General of Patents C-364/13.
First published in the December 2014 issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.