The European Court of Justice recently decided that no product or process requiring a stem cell derived from a human embryo can receive patent protection in the EU member states. This decision directly and indirectly weakens worldwide patent protection for stem cell therapies. As commercial investment in stem cell therapies requires strong intellectual property protection, the European Court of Justice decision reduces the motivation to develop and field such therapies.
In essence, the European Court of Justice has decided that embryonic stem cell lines and their uses are against public policy and morality. Totipotent stem cells are considered as human embryos. Pluripotent stem cells are unpatentable as they derive from the destruction of an embryo. However, the European Court of Justice got the science wrong on this point. There exist medical procedures such as pre-implantation genetic diagnosis that remove pluripotent stem cells from early embryos with no residual damage. This part of the decision will likely evolve through additional court tests.
We are faced with a curious contridiction. For example, Germany allows pluripotent stem cells to be used therapeutically. However, the European Court of Justice ruling prohibits patent protection for such therapies. As a result, medical doctors in Germany will be able to practice pluripotent stem cell therapy completely unrestricted by patents and license fees. This could make stem cell therapy dramatically less expensive in Europe, while also reducing commercial motivation to develop such therapies.
In effect, then, this decision by the European Court of Justice reduces patent protection on embryonic stem cell therapies throughout the world. It seems likely that corporate R&D on stem cells will shift away from applications with weakened protection. Alternatives to the use of embryonic stem cells will doubtless be developed. In the interim, however, many people will suffer and die in the absence of effective treatments. This seems to me, a non-optimal solution to the moral challenges facing society.
- EU court bars stem cell patents when embryos destroyed, Christians hail ruling (Reuters, October 2011)
- European science stemmed (The Economist, October 2011)