ECJ bans stem cell patents
Could force research to the US, where no such ban exists
The European Court of Justice has banned the issuing of patents for embryonic stem cell research, in a case that could have major implications for medical research.
Lawyers say the Court of Justice decision could impede European research into the use of stem cell therapies, or drive research abroad.
The ruling follows a challenge by Greenpeace over a patent for nerve cells derived from human embryonic stem cells.
The patent, filed in 1997 by Oliver Brüstle of Bonn University, said there were many potential applications for such cells, especially for patients suffering from neurological diseases such as Parkinson’s.
The Court of Justice concluded that ‘scientific research entailing the use of human embryos cannot access the protection of patent law’.
The Court also said an invention could not be patented ‘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’.
However, the Court said it would permit patents where the technique was useful to the human embryo itself ‘to correct a malformation and improve the chances of life’.
The case will now return to the German courts, which will rule on whether Brüstle’s invention counts as the commercial or industrial exploitation of a human embryo. In the likely case that it is found to count as such, the patent will be invalidated.
Dr Richard Gibbs, associate at patent and trade mark attorney Marks & Clerk, said this ruling from the ECJ will have far-reaching consequences.
‘While the Court has been careful to emphasise that its decision affects only the patentability of certain biotechnological inventions and does not seek to impose any direct regulation on the use of human embryos in research, the effect is likely to be much the same.
‘The potential for successful commercialisation is the major pre-requisite for attracting much-needed funding and investment in the arena of stem cell technology – just as in other fields – and this decision will have a significant impact on that potential.’
Gibbs warned that those with existing patents will be uncertain of their enforceability; those intending to apply may need to reconsider their options.
‘There will be widespread dismay in the scientific and medical communities. Research and expertise could migrate en masse to other territories such as the US, where no such ban exists,’ he said.
‘Indeed, only this year the US Supreme Court upheld Obama’s overturning of the Bush administration’s ban on federal funding for stem cell research, making the US market far more attractive than it has been previously. Stem cell technology is widely touted as a future source of treatments for a wide range of conditions such as Parkinson’s and Alzheimer’s, but progress will almost certainly be slowed by this ruling.’
Dr David Martin, an expert in life sciences patents at legal firm Mathys & Squire, commented: ‘EU institutions are out of touch with the reality of innovation and in this case the ECJ has applied an overly restrictive approach in an area rife with differing emotional, ethical and moral concerns.
‘Without doubt clarity is needed in such a delicate area, but the answer is not to deem all inventions from stem cell research using human embryos immoral and therefore not patentable.’
He said that inadequate patent protection would drastically reduce the incentive scientists and researchers have to invest in embryonic stem cell research.
‘Today’s advice has gone against the more fluid position recommended by patent experts across Europe. It is unfortunate as this ruling could act to drive research and development into embryonic stem cell therapies away from Europe.’