By Devanand Crease --
The Court of Justice of the European Union has issued its final verdict in the case of Bruestle v Greenpeace (C‑34/10) and has finally put an end to the long running saga of whether or not human embryonic stem (ES) cells can be subject to patent protection in Europe. The case concerned Dr Bruestle's German patent which claimed neural precursor cells and the processes for their production from human ES cells and their use for therapeutic purposes. Greenpeace had sought annulment of the German Patent on the grounds of lack of morality and in particular that the claimed subject matter contravened an EU Directive that forbids uses of human embryos for industrial or commercial purposes.
The Court considered three questions of interpretation of EU law. On the main issue of patentability, it was held that the law excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that destruction takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos. The Court was clear that the interpretation of the law should be such that it does not allow skilful claim drafting to overcome the exclusion, such as by simple omission of the prohibited step in a method claim.
Other issues decided included that the term "human embryo" should be interpreted more widely than just fertilised human eggs and included human ova subjected to nuclear transfer as well as unfertilised eggs stimulated to develop by parthenogenesis. In addition,"scientific research" is considered to fall within the scope of commercial and industrial use by virtue of the desire for a patent on that research.
In practical terms the decision has reduced the scope of patent protection for inventions in the ES cell field within the member states of the EU. It should be noted that the European Patent Office (EPO) grants patents in Europe that cover the EU and other non-EU countries (e.g., Switzerland and Turkey). There is no obligation for the EPO to follow the ruling of the Court and there are informal indications that they may not do so, having already considered this matter in detail themselves (EPO Enlarged Board of Appeal Decsion G2/06). If this is so, it may result in a peculiar situation whereby the EPO grants patents containing claims for cells derived from human ES cell lines, which are then held invalid within the EU nation states. In particular, the present Court decision has direct effect in key European scientific research hubs including the UK, France, Germany, and Sweden, all of which are states designated within EPO patents and patent applications.
On a positive note, the Court's decision clears the way for increased research and patenting activity in the areas of enabling stem cell technologies, adult stem cells and induced pluripotent stem (iPS) cell technologies. However, the effects of this decision on already granted ES stem cell patents may be profound, resulting in some claims now being rendered entirely unenforceable within the EU.
Dr. Crease is a Partner at Keltie LLP in London, UK.
Comments