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Court rules embryonic stem cell technologies unpatentable

The European Court of Justice has ruled that any process involving the destruction of an embryo, such as harvesting stem cells, cannot be patented.

The ruling reflects the fact that, under European laws on biotechnology, human embryos cannot be used for industrial or commercial purposes.

A top-level judgement was requested on the matter by the German federal court in the case of Greenpeace versus Oliver Brüstle, a cell biologist at the University of Bonn. Brüstle was granted a patent in 1999 for neural precursor cells, which have the potential to treat Parkinson’s disease.

Speaking after the ruling, Brüstle, said the decision meant while European research could continue, commercialisation would have to happen elsewhere.

“With this unfortunate decision, the fruits of years of translational research by European scientists will be wiped away and left to the non-European countries,” he said in a statement. “European researchers may conduct basic research, which is then implemented elsewhere in medical procedures, which will eventually be re-imported to Europe. How do I explain this to my students?” he added.

Meanwhile other researchers stressed that the discovery process itself was often hinged on industrial funding.

Robin Lovell-Badge of the National Institute for Medical Research, says that any decision needs to take into account the overall potential benefit for patients. “If this requires individuals and companies having some degree of patent protection on materials and methods developed from human embryonic stem cells otherwise they will not invest in finding treatments, then so be it—this is what is needed,” he said in a statement.

The court ruled that even if, as in Brüstle’s application, the patent application does not refer to the use of human embryos, the invention could not be patented where their implementation “requires either the prior destruction of human embryos or their prior use as base material”.

This suggests that it may be impossible to patent technologies derived from pre-existing stem cell lines as well as those that actively require the destruction of human embryos.

In making the ruling, the European judges defined a human embryo “in a wide sense” as anything with the potential to become a complete human being, and applying from the first instance of egg fertilisation.

However, the ruling does leave it up to the referring court to decide, “in light of scientific developments”, whether an entity is capable of commencing the process of development of a human being, and thus is a human embryo.

This may leave some leeway for argument over whether technologies could be patentable when stem cells were harvested from naturally unviable embryos.

The ruling also allows for the use of human embryos for creating cures applicable to the embryo itself.

The ruling brings European courts into line with the European Patent Office’s interpretation of the 1998 EU Biotechnology Directive and is binding for national courts in all 27 EU member states.