In a final judgement the European Court of Justice (ECJ) has said that any invention based on human embryonic stem cells which involves the prior destruction of human embryos or their prior use as base material is unethical and therefore cannot be patented.
The finding is a devastating blow to the prospects of commercialising cell therapies based on embryonic stem cell research carried out in Europe. It rules out, for example, any therapy that relies on established embryonic stem cell lines held in publicly-funded stem cell banks.
A case in point is the work being carried out by Pete Coffey at the Institute of Ophthalmology at University College London (UCL) in collaboration with the pharma company Pfizer, to develop retinal cells for use in treating macular degeneration, a major cause of blindness.
Coffey has been working on retinal cells that were derived from an embryonic stem cell line originally generated at Sheffield University. He has proof from using patients’ own specially-prepared cells that administering retinal cells can correct defective vision. The collaboration with Pfizer is intended to scale-up to a product that can be made available off-the-shelf and is suitable for treating any patient.
On hearing of the ECJ’s decision Coffey said, “This is a devastating decision, which will stop [the use] of stem cell therapies in medicine. The potential to treat disabling and life-threatening disease […] using stem cells will not be realised in Europe.”
He added, “I can give a therapy, I can show how it works in a small group of patients, but we need companies to commercialise this work.”
Coffey is rightly affronted that such important research in an area of huge and growing unmet medical need is judged to be unethical. He says, “I now find that Europe, the continent in which I am doing this research is basically calling me immoral.”
Coffey’s views were echoed by Oliver Brüstle, Director of the Institute of Reconstructive Neurobiology at Bonn University, whose research in turning embryonic stem cells into neural cells for treating Parkinson’s disease, was the object of the ECJ’s ruling. Brüstle said European researchers will conduct legally-sanctioned research but because the findings cannot be patented, the outputs will be commercialised elsewhere. “With this unfortunate decision, the fruits of years of translational research by European scientists will be wiped away and left to non-European countries.”
In 1997, Brüstle was granted a German patent on his neural stem cells. This patent was successfully contested by the environmental group Greenpeace. Following an appeal by Brüstle to the Bundesgerichtshof (German Federal Court), the ECJ was asked for a ruling on how ‘human embryo’ should be defined under the European Biotechnology Directive of 1998, which covers such inventions. The ECJ has given the broadest possible definition, including human eggs that have just been fertilised. It also includes human eggs that have had their nucleus replaced by an adult human cell and unfertilised eggs that have been prompted to divide, both of which, it is hoped, could be sources of embryonic stem cells for use in cell therapies.
It will now be up to the German Federal Court to apply the ECJ’s ruling in making its final ruling on Brüstle’s patent. The ECJ’s ruling will also be applied in any other national courts hearing similar cases.
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