Court of Justice, Judgment of 18 October 2011, C-34/10
The Court of Justice of the European Union (CJEU) handed down its long-awaited judgment in the Brüstle case on the patentability of stem cell inventions. Unsurprisingly, the CJEU followed the Advocate General's opinion and held that an invention which uses human embryonic stem cells is not patentable if the destruction of a human embryo is required. The CJEU gave a broad interpretation of the term "human embryo", essentially anything capable of commencing the process of development of a human being is included. The CJEU's decision may have a significant impact on the future of stem cell research in Europe. Patents will not be granted in Europe for any inventions that use embryonic stem cells if obtaining them resulted in the destruction of an embryo. Destruction of one embryo in the history of the research (however far back) would be enough to prevent patentability.
The Law and the Questions Referred
Under European law an invention is not patentable if it concerns uses of human embryos for industrial or commercial purposes. But what exactly is a human embryo? Does it cover all developmental stages from fertilisation? Where do you draw the line?
Brüstle is the owner of a patent concerning isolated and purified neural progenitor cells and the use of such cells in the therapy of neural defects such as Parkinson's disease. In a case brought by Greenpeace, the German Federal Patent Court revoked the patent to the extent it concerned cells that were obtained from human embryonic stem cells. The patent stated that the claimed teaching could be carried out with human cells and that stem cells from human embryonic tissue could be considered as a starting material.
As the case raised issues of interpretation of the Biotech Directive, several questions were referred by the German Federal Court of Justice to the CJEU.
The CJEU broadly followed the Advocate General's line of reasoning. Having pointed out that it is not required to broach questions of a medical or ethical nature, it restricted itself to a legal interpretation of the relevant provisions of the Directive.
Accordingly, the CJEU held that:
- any human ovum, as soon as it is fertilised, must be regarded as a "human embryo" 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 must also be classified as a "human embryo".
Although the latter have not, strictly speaking, been the object of fertilisation, due to the techniques used to obtain them, they are equally capable of commencing the process of development of a human being.
As regards stem cells obtained from a human embryo at the blastocyst stage – those cells used in the invention covered by the Brüstle patent – the CJEU held that it was for the referring court to ascertain, in the light of scientific developments, whether they would be capable of commencing the process of development of a human being and, therefore, are "human embryos".
When considering whether "uses of human embryos for industrial or commercial purposes" covered scientific research, the CJEU concluded that research which is the subject of a patent application must be intended for industrial or commercial purposes. Consequently, such scientific research cannot be patentable in Europe. The only exception would be where the use of human embryos was for therapeutic or diagnostic purposes for the embryo itself – for example to correct a deformity and improve the chances of life.
Finally, as regards the question of the patentability of an invention involving the production of neural precursor cells, the CJEU pointed out that this presupposed that stem cells were obtained from a human embryo at the blastocyst stage and that the removal of a stem cell necessarily entailed the destruction of that embryo. If such inventions were not excluded from patentability, applicants could avoid the exclusion by skilful drafting of the patent claims.
In conclusion, the CJEU held that an invention will be excluded from patentability where the implementation of the claimed process requires either the prior destruction of human embryos or their use as a base material, even if in the patent application itself the description of the process does not refer to the use of human embryos.
The case will now be referred back to the German Federal Patent Court which will apply the CJEU's decision to the facts of the case. The German court will have to evaluate – in the light of scientific developments – whether the stem cells obtained from a human embryo at the blastocyst stage according to Brüstle's patent are "human embryos". In all probability, the revocation decision will be upheld.
We now appear to have a consistent approach to stem cell patenting in Europe. Similar issues were considered by the Enlarged Board of Appeal of the European Patent Office in the 2008 WARF decision. In that case the EBA held that Rule 28(c) of the European Patent Convention (equivalent to Article 6(2) of the Biotech Directive) forbids the patenting of products which - as described in the application - at the filing date could only be prepared by a method which necessarily involved the destruction of the human embryos from which the said products were derived - even if the method was not part of the claims. Although in the WARF case, the patent claimed embryonic stem cells (rather than the precursor cells used in Brüstle), at the application date, obtaining such precursor cells also required the destruction of human embryos. So, it was anticipated by many commentators that the CJEU in Brüstle would come to the same conclusion as the Advocate General and the EBA in WARF. Otherwise there would be discrepancies in interpretation of the law by the national courts (which would be bound by the CJEU decision) and the EPO (which is not bound by the CJEU).
However, consistency may come at a price. Lack of patent protection may deter companies from pursuing stem cell research in Europe. R&D is expensive and the monopoly provided by a patent is often the main means of recovering these costs. Now the European biotech industry's hopes must lie in finding suitable alternatives to embryonic stem cells to use in their R&D programmes.