The European Court of Justice has today announced a landmark decision banning patenting of inventions based on embryonic stem cells. Scientists are concerned that the verdict, which is legally binding for all EU states, will drive development of stem cell therapies outside Europe.
A ban on embryonic stem cell patents
Today’s announcement is the culmination of a long-running legal battle that hit the headlines in April this year. The dispute turns on the question of whether the origin of embryonic cell lines – fertilized human eggs – means that patents cannot be granted for any techniques based on use of these cells. The German Federal Patent Court referred the case to the European Court of Justice for clarification on how to interpret European biotechnology regulations.
In its verdict today, the European Court of Justice ruled that no patents can be granted for inventions based on embryonic stem cells, even if the cell lines were established in the laboratory many years ago and the invention itself does not involve obtaining new embryonic stem cells. This decision is based on the argument that even established embryonic stem cell lines were originally derived from fertilized eggs.
Many European countries allow embryonic stem cells to be obtained from the large numbers of surplus embryos produced during fertility treatment. Several hundred such cell lines are now available to researchers worldwide. The cells, once obtained, can be grown and multiplied in the lab to give ‘cell lines’ that are able to produce an almost infinite number of embryonic stem cells and can be converted into all the different cell types of the body. This gives embryonic stem cells enormous potential for medical research and cell therapies.
Oliver Bruestle, Director of the Institute for Reconstructive Neurology at the University of Bonn is disappointed and worried by the Court’s verdict. “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. 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 that to the young scientists in my lab?” said Bruestle.
Professor Austin Smith of the Wellcome Trust Centre for Stem Cell Research at the University of Cambridge, agrees: “This unfortunate decision by the Court leaves scientists in a ridiculous position. We are funded to do research for the public good, yet prevented from taking our discoveries to the market place where they could be developed into new medicines. One consequence is that the benefits of our research will be reaped in America and Asia”
The history of the case
Today’s decision is the outcome of legal dispute that began when Greenpeace challenged a patent granted in 1999 to Professor Bruestle for a method of producing neural progenitor cells (precursors of nerve cells) from embryonic stem cell lines. At the heart of Greenpeace’s argument: since human embryonic stem cell lines originate from fertilized eggs, the patent represented a forbidden use of human embryos and contravened ordre public. Bruestle argued that the patented method did not itself include the use of embryos or the acquisition of embryonic stem cells, but used already established embryonic stem cell lines, which can be obtained around the world and can be legally used for research in Germany.
In a controversial and much-discussed verdict, the German Federal Patent Court ruled in favour of Greenpeace and declared the patent invalid. Bruestle took the case to the German Federal Court of Justice, which questioned the decision of the Patents Court. “If something is legally allowed, then it should not really be forbidden to patent it,” said Judge Peter Meier-Beck.
Reactions to the verdict
Bruestle criticised the final decision of the European Court of Justice (ECJ) today: „The ECJ has taken a more restrictive position than the European Commission and all the member states who submitted opinions on this case.“ Even states generally expected to take conservative positions, such as Portugal and Ireland, had argued that stem cell technologies should not be excluded from patenting if they use existing embryonic stem cell lines.
Brueslte’s lawyers, Dr Martin Grund and Clara Sattler de Sousa e Brito, see the ECJ’s verdict as inconsistent with its mandate to promote harmonised legislation across Europe. „It would not occur to anybody in Britain or Sweden to question the patenting of this kind of technique. Since today’s verdict is binding for all EU states, over 100 embyronic stem cell patents in Britain and Sweden will become as open to attack as Bruestle’s patent and therefore practically ineffectual“ said Sattler de Sousa e Brito.
Bruestle finds the ECJ’s decision impossible to understand in the light of current developments in this field of research: „Just a few weeks ago the first clinical trials based on transplantation of embryonic-stem-cell derived retina cells began in Britain, and now the ECJ has stigmatized patenting of such technologies as immoral.“
Professor Pete Coffey of UCL, London, takes a similar view: “This is a devastating decision which will stop stem cell therapies’ use in medicine. The potential to treat disabling and life threatening disease commonly using stem cells will not be realised in Europe.”
Despite his strong disappointment about the Court’s verdict, Bruestle remains optimistic and believes that stem cell technology will continue to progress on an international level. Nevertheless, he detects in the judgement a sad message for many young European scientists who are enthusiastically working on the development of biomedical applications for human embyronic stem cells, saying „One couldn’t blame them if they turned their back on Europe.“
Further comments from scientists
Here are comments from some leading scientists in response to today’s Court decision.
Professor Sir Ian Wilmut, MRC Centre for Regenerative Medicine, University of Edinburgh: “It is very much to be regretted that the Court has taken this view. It will unfortunately make it less likely that companies in Europe will invest in the research to develop treatments to use embryonic stem cells for treatment of human diseases. Once a fundamental discovery has been made in the laboratory further research is required to produce a clinically safe and effective product. This is a particularly expensive part of the entire process. Companies in Europe will now be less likely to invest in this stage of the research with embryo stem cells because they would be unable to protect their procedures. Sadly this judgement may mean that initial research carried out in Europe in some cases with European funds will be more likely to be developed and used in other parts of the world.”
Robin Lovell-badge, MRC National Institute for Medical Research in London, UK: “The issue of patents in biomedicine, especially where they involve human material, is often contentious and is one where there perhaps needs to be a bigger debate about how to ensure the involvement of biotech and other companies and rewards to them and inventors can be managed in way that is equitable and, critically, of maximum benefit to patients. But given the limitations of the current system, any decision taken now needs to take the moral imperative of maximising the likelihood of benefits to 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. In this respect I am very disappointed in the European Court of Justice’s decision not to permit patenting in this area. To prevent a lack of investment in this research, we urgently need to come up with alternative methods that will allow this type of science and its application to progress. ”
Elena Cattaneo, University of Milan and Neurostemcell coordinator: “For scientists like myself working in Italy, Europe has always been our hope. I am afraid now the European Court has settled our continent to suicide. European patients should thank this Court, Greenpeace and their supporters if the search for cures is left without such an important arm as the translational aspect of our basic research because it will find no sponsors in Europe. The time spent in the lab, the several research lines we pursue, the pressure on discoveries and on translating our discoveries into cures … it is all gone. I wonder who is taking the rights of the patients into Court. It is also clear that we have provided the USA and Asia with an unexpected gift. They will be able to patent, companies will invest there and we, in Europe, will pay for the new drugs their discoveries may produce”.
More resources on EuroStemCell website