Is an Invention in Human Embryonic Stem Cell Research Patentable?

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Introduction
The ethics in the use of stem cells in research remains one of the most controversial aspects in the development and application of biological science. The recent decision of International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks (Case C-364/13) by the Court of Justice of the European Union (“CJEU”) in December 2014 marks an important development in European law on the issue of whether such invention is patentable. This article examines the CJEU’s decision in this case and explains its significance.

Facts
In 2012, International Stem Cell Corporation, a biotechnology company specializing in human stem cell research, filed two patent applications to the Intellectual Property Office of the United Kingdom for two new inventions in human embryonic cell research.

The first application, entitled “Parthenogenetic activation of oocytes for the production of human embryonic stem cells”, concerned methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and stem cell lines produced according to the methods. The second application, named “Synthetic cornea from retinal stem cells”, claimed methods of producing synthetic cornea or corneal tissue which involved the isolation of pluripotent stem cells from parthenogenetically-activated oocytes, and product-by-process claims to synthetic cornea or corneal tissue produced by these methods.

The two new embryonic cell inventions are produced from human ova through a process called parthenogenesis, which is a form of asexual reproduction. It is known in current scientific knowledge that unlike other animals, a human or other mammals’ embryo cannot develop into an offspring without paternal DNA. Therefore, under parthenogenesis, a human ovum would develop, but could never develop into a fetus without fertilization. Thus, the use of such human ova may not be said to be in contravention of Article 6(2)(c) of the European Union Biotechnology Directive 98/44 (as analysed below) which prevents the “uses of human embryos for industrial or commercial purposes” from patenting.

However, the Intellectual Property Office in London refused the two patent applications. Contrary to current scientific knowledge, the UK Intellectual Property Office decided that inventions related to unfertilized human ova whose division and further development have been stimulated by parthenogenesis are not patentable, since such ova were “capable of commencing the process of development of a human being just as an embryo created by fertilization of an ovum can do”. International Stem Cell Corporation appealed to the High Court of England and Wales, which in turn referred the case to the CJEU.

Legal Analysis
The issue before the CJEU in the present case is whether an unfertilized human ovum, whose division and development to a certain stage have been stimulated by parthenogenesis, constitutes a “human embryo” within the meaning of the provisions in Article 6(2)(c) of Directive 98/44.

Article 6(2)(c) of Directive 98/44 states that “uses of human embryos for industrial or commercial purposes” are not patentable, and this prohibition is incorporated into United Kingdom law in paragraph 3(d) of Schedule A2 to the Patents Act 1977. Article 6(1) of Directive 98/44 and Recital 37 in the preamble to Directive 98/44 state that the rationale for such prohibition is that “inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality”.

The CJEU in the present case reviewed its previous decision in 2011 of Oliver Brüstle v Greenpeace eV (Case C-34/10). In Brüstle, the CJEU held that any organism that is “capable of commencing the process of development of a human being” should be considered a human embryo, and this includes both fertilized and non-fertilized human ova. The United Kingdom Intellectual Property Office interpreted that the CJEU in Brüstle had issued a blanket prohibition on the use of both fertilized and non-fertilized human ova in scientific research.

In the present case, the CJEU clarified its position in Brüstle, and held that in order to be classified as a “human embryo”, a non-fertilized human ovum must necessarily have the inherent capacity of developing into a human being. Consequently, if a non-fertilized human ovum does not fulfill the above condition, the mere fact that such human ovum has commenced any process of development is not sufficient for it to be classified as a “human embryo”. The CJEU therefore held that an unfertilized human ovum, whose division and further development have been stimulated by parthenogenesis, does not constitute a human embryo if, in the light of current scientific knowledge, that ovum does not in itself have the inherent capacity of developing into a human being. The CJEU thus remitted the issue of whether human parthenotes constitute “human embryos” to be decided by the High Court of England and Wales based on the latest knowledge “which is sufficiently tried and tested by international medical science”.

Significance
The CJEU in the present case clarified its previous decision in Brüstle, and limited the scope of prohibition of the use of “human embryos” in Directive 98/44. For biotechnology and life science companies which aspire to developing cellular therapies for actual clinical use, they are more likely to successfully secure patent protection for such therapies in countries within the European Union. This removes uncertainty for investors in investing in such industries.

In Hong Kong, sections 93(5) and 93(6) of the Patents Ordinance state that “an invention the publication or working of which would be contrary to public order (“ordre public”) or morality shall not be a patentable invention…”, and “a plant or animal variety or an essentially biological process for the production of plants or animals, other than a microbiological process or the products of such a process, shall not be patentable”. However, no provisions comparable to Directive 98/44 which explicitly state that inventions involving the use of human embryos are unpatentable are in force. It remains to be seen how Hong Kong courts would interpret the sections in relation to such inventions in the future.

 
IMPORTANT:
The law and procedure on this subject are very specialized and complicated. This article is just a very general outline for reference and cannot be relied upon as legal advice in any individual case. If any advice or assistance is needed, please contact our solicitors.
 
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Published by ONC Lawyers © 2015