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Ban on embryonic stem cell patents by European Court of Justice

24 October 2011
Appeared in BioNews 630
The European Court of Justice (ECJ) has ruled that stem cell processes which require the prior destruction of human embryos or are based upon the use of human embryos are not patentable. The decision may have wide implications for scientists engaged in embryonic stem cell research.

A press release from the ECJ said: 'The Court holds that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process, as in the present case, does not refer to the use of human embryos'.

The case originated from an appeal brought by Dr Oliver Brüstle of the University of Bonn against the decision of the German Federal Patent Court that his patent, which concerns isolated and purified neural precursor cells produced from human embryonic stem cells used to treat neurological diseases, was invalid.

The ECJ was asked by the German Federal Court of Justice - the Bundesgerichtshof - for its interpretation of the concept of a 'human embryo' under European law for it determine whether Dr Brüstle's patent was excluded from patentability.

The ECJ, which explained it restricted itself to a legal interpretation of the relevant provisions of European law and did not address any medical or ethical issues, explained that European law intended to exclude any possibility of patentability where 'respect for human could thereby be affected'. It ruled that the concept of a 'human embryo' must be defined it its broadest sense.

It went on to say: 'Accordingly, any human ovum must, as soon as fertilised, be regarded as a ''human embryo''... if that fertilisation is such as to commence the process of development of a human being'. It also said it was not possible to distinguish the use of human embryos for research purposes from industrial and commercial use in the application of patent law.

As to the question over whether stem cells obtained from a human embryo at a blastocyst stage - the subject matter of Dr Brüstle's patent - were included within the concept of 'human embryo', the ECJ said this was a decision for the referring court. The Bundesgerichtshof must now rule on the validity of Brüstle's patent specifically.

Reuters quoted Dr Brüstle speaking after the ruling, saying: 'It means that fundamental research can take place in Europe, but that developments that follow from that cannot be implemented in Europe'. 'It means European researchers can prepare these things but others will pick the fruits in the US or Asia. That is very regrettable'.

Alex Denoon of the life sciences lawyers Lawford Davies Denoon told BioNews: 'The practical ramifications of this decision are likely to be limited as it will be possible to obtain these kinds of patents in other countries such as the US, and further it will be virtually impossible for a competitor to obtain approval for a ''generic'' version of an approved embryonic stem cell therapy'.

A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented (.pdf 47.9KB)
European Court of Justice |  18 October 2011
Judgment in Case C-34/10: Oliver Brüstle v Greenpeace
European Court of Justice |  18 October 2011
21 July 2014 - by Antony Starza-Allen 
An advisor to the Court of Justice of the European Union (CJEU) has said that certain stem cells derived from unfertilised human eggs that have undergone parthenogenesis should not be excluded from patentability....
2 June 2014 - by Patricia Cassidy 
The European Commission has rejected a petition requesting a stop to the funding of research involving the 'presupposed destruction' of human embryos....
17 December 2012 - by Julian Hitchcock 
In November the case of Brüstle v Greenpeace was remitted to the German Federal High Court. How would a national court interpret the controversial ruling of the Court of Justice of the European Union which held that patent rights could not be granted in the EU for the use of any entity 'capable of commencing the process of development of a human being'?...
3 December 2012 - by Antony Starza-Allen 
The German Federal Court of Justice has ruled that a disputed patent held by Dr Oliver Brüstle, and the subject of a ruling by the European Court of Justice (ECJ) against the patentability of human embryonic stem cells, is valid in its revised form....
8 October 2012 - by Tom Barrow 
The future funding of human embryonic stem cell research under the European Union may be in jeopardy after its inclusion in the next research funding programme is challenged by MEPs....
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