post Thursday October 27, 2011
Last week, the Court of Justice of the European Union convened to rule on the case of Oliver Brüstle v Greenpeace eV, referred to the CJEU by the German Supreme Court. In this case, scientist Oliver Brüstle sought to patent a human stem cell, but the Court of Justice ruled that inventions which make use of human embryos are not patentable on grounds of morality.
Normally to be considered patentable material under a utility patent, an invention must be a new, nonobvious, and useful a) process, b) composition of matter, c) machine, or d) improvement of any of these. What cannot be patented, however, is any invention that is offensive to public morality, which is the issue this case dealt with.
The case materials outline that the patent specifications filed by Brüstle argue that the transplantation of brain cells into the nervous system is a promising method of treatment of numerous neurological diseases, including Parkinson’s disease. The argument goes on to claim that the process of remedying such neural defects includes the transplantation of immature precursor cells that are still capable of developing. The moral dilemma is that these types of cells only exist during the brain’s development phase. The issue then is the question of whether it is ethically correct to use cerebral tissue from human embryos.
The morality of Brüstle’s patent was challenged in the German courts by Greenpeace under an EU Biotech Directive stating that inventions which involve the “use of human embryos for industrial or commercial purposes” are immoral. The German courts, unable to arrive at a verdict, sent the case to the European Court so that they could provide guidance on how the EU Biotech Directive should be applied in this case. The verdict of this case (the first of its kind in Europe) could have far-reaching consequences for subsequent human stem cell-based inventions, so the European Courts had to consider that their decision could potentially have harmful effects on future stem cell innovations.
After reviewing the facts, the European Court first decided on the proper definition of the term “embryo”. The Court ruled that embryo includes any human egg cell after fertilization and any non-fertilized human egg cell into which either a cell nucleus has been implanted or has undergone parthenogenesis. The Court then went on to decide that since the process to obtain human embryonic stem cells results in the death of the embryo, inventions based on human stem cells were immoral and therefore not patentable.
The ruling may in fact have a profound effect on stem cell research in Europe and could possibly result in European stem cell companies fleeing to the US as there is no such ruling under US patent law.
More information on this court case can be found at http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=EN&Submit=Submit&numaff=C-34/10.
