Scientists have reacted with shock and dismay at a recent decision from the Court of Justice of the European Union (CJEU) on the patentability of human stem cells. The decision, which issued on 18 October, has said that inventions which are based on human embryonic stem cells cannot be patented in the EU on ethical grounds.
The issues stem from the requirement under European patent law for the commercial exploitation of a invention not to be “contrary to morality”. In particular, the European Commission passed a directive in 1998 on the patenting of biotechnological inventions (known as the Biotech Directive, 98/44/EC) which included for the first time a list of inventions which were said to be immoral, and hence not patentable. This list included “uses of human embryos for industrial or commercial purposes”.
The recent CJEU decision related to a German patent which had claims to neuronal cells which, at the filing date of the patent, had to be obtained from human embryos. Such cells, and human embryonic stem cells in general, are obtained from 3-5 day old embryos by a process which results in the death of the embryo. The patent was challenged by Greenpeace, who alleged that the invention fell within the “uses of human embryos” morality exclusion. Subsequently, the German courts referred a number of questions to the CJEU including a request for them to provide a definition of a “human embryo” and guidance on how the “uses of human embryos" exclusion should be interpreted.
In their decision, the CJEU ruled that the full history of the invention needed to be taken into account when considering its morality. It was not sufficient merely to consider what was being claimed in the patent or whether the invention could be put into practice in a moral manner at the filing date of the patent (which is the line currently taken by the European Patent Office, EPO). In particular, the CJEU stated that: "The fact that destruction [of embryos] may occur at a stage long before the implementation of the invention ... is ... irrelevant". Hence all inventions which require or have required in their past the destruction of a human embryo have now been deemed to be immoral, and hence unpatentable, by the CJEU.
The decision will be binding on the courts of the EU member states, and hence granted patents which cover such inventions are likely to be unenforceable. It remains to be seen, however, whether the decision will affect any other technologies which have arguably dubious foundations. Although the decision will not have direct effect on the EPO (because the EPO is not an EU institution), it seems likely that the EPO will now have to change its practice to bring it into line with the CJEU decision.
Whilst the decision has been welcomed by Greenpeace and some church groups, many scientists have expressed deep concern that, in the absence of patents to protect their innovations, investors will no longer support stem cell-based companies in Europe. Their worry is that European stem cell companies will move to the US or Asia. The decision does not affect the patentability of other areas of stem cell research, such as adult stem cells or induced pluripotent stem cells (iPS cells). However, it would be unfortunate if humanity were to be deprived of the (potentially large) benefits of human embryonic stem cell research, merely because of the unavailability of patents.
It is rather ironic that the original intention of the Biotech Directive was to protect biotech inventions and to promote investment in this area in Europe, whereas the application of the Biotech Directive by the CJEU in this case could well lead to the destruction of a significant part of the European stem cell industry.
Philip Webber, Partner
First published in The Lawyer, November 2011
