The Court of Justice of the European Union (the CJEU) has handed down its judgment in Case C 34/10, regarding the patentability of inventions involving human stem cells.
Their decision followed the opinion of the Advocate General, ruling that an invention which uses human embryonic stem cells is not patentable if the destruction of a human embryo is required at any point, whether or not that process forms part of the claimed invention.
This case originated with a patent owned by a Mr Brüstle, which relates to isolated and purified neural progenitor cells and to their use in the therapy of neural diseases. As the result of a suit brought by Greenpeace, the German Federal Patent Court revoked the patent to the extent that it concerned cells obtained from human embryonic stem cells. On appeal, a number of questions were referred to the CJEU.
Directive 98/44/EC outlines the legal protection obtainable for biotechnological inventions. In particular, it states that:
...uses of human embryos for industrial or commercial purposes must also be excluded from patentability; whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it; ...
The CJEU focused on the legal interpretation of the Directive and did not consider the surrounding medical and ethical issues. In particular, they focused on the definition of "human embryo", which they considered included the following:
- Any human ovum, as soon as it is fertilised, if fertilisation is such as to commence the process of development of a human being;
- A non-fertilised human ovum into which the nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis.
The term "human embryo" must therefore be taken to apply from fertilization through the entire ensuing process of the development and formation of the human body.
The patent in suit related to stem cells obtained from a human embryo at the blastocyst stage. Such cells, in isolation, are not capable of developing into a complete individual. However, the CJEU considered that the origin of the cells must also be taken into account. Obtaining the isolated stem cells necessitates the destruction of a human embryo. An invention including the use of such cells therefore falls under the exclusion laid down in the Directive.
A further question raised was whether scientific research can be considered to be used for "industrial or commercial purposes". In response to this the CJEU stated that, if it is the subject of a patent application, then the intention must be for the process to be used for industrial or commercial purposes.
This decision could have a big impact on the future of stem cell research in Europe. Without the ability to obtain protection for discoveries involving stem cells, there may be a new push to find alternatives to stem cells. It is also possible that companies will instead rely on trade secrets to protect their inventions. As the European Medicines Agency keeps data submitted for regulatory approval private for eight years and blocks others from using this information for a further two years, this could prove an effective strategy, if not providing the length of protection provided by a patent.
This is a difficult issue, and one in which it is not possible to entirely ignore the medical and ethical issues at stake. Directive 98/44/EC is aimed at protecting the dignity of human life, and states that "patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person". Though this decision may have economic ramifications for companies which currently use stem cell research, it nevertheless upholds the dignity of human life, by not granting legal protection to processes which necessitate the destruction of life.
This case will now be referred back to the German Federal Patent Court, which will apply the CJEU's ruling to the Brüstle case. It seems likely that the revocation of the patent will be upheld.
7 November 2011