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, issued on 18 October, states that inventions that 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 an 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), which included for the first time a list of inventions that were said to be immoral, and hence not patentable. This list includes “uses of human embryos for industrial or commercial purposes”.
The recent CJEU decision relates to a German patent that has claims to neuronal cells which, at the filing date of the patent, had to be obtained from human embryos.
uch cells, and human embryonic stem cells in general, are obtained from three- to five-day old embryos by a process that results in the death of the embryo. The patent was challenged by Greenpeace, which 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 its decision, the CJEU rules that the full history of the invention needs to be taken into account when considering its morality. It is not sufficient merely to consider what is 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 ruling states: “The fact that destruction [of embryos] may occur at a stage long before the implementation of the invention […] is irrelevant.”
Hence all inventions that require or have required in their past the destruction of a human embryo are now deemed immoral, and hence unpatentable, by the CJEU.
The decision will be binding on the courts of the EU member states, and so granted patents that cover such inventions are likely to be unenforceable. It remains to be seen, however, whether the decision will affect any other technologies that 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 in line with the CJEU decision.
While 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 and such 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. 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.