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A ruling from the Court of Justice of the European Union stated that research processes involving stem cells produced from human embryos cannot be patented.
See: http://curia.europa.eu/jcms/jcms/P_81409/
Dr Celia Caulcott, Director of Innovation and Skills, BBSRC, said:
“Whilst the full consequence of this ruling is yet to be understood, it is important to BBSRC to ensure that a clear path to commercialisation is maintained for researchers working across our remit. For fundamental research to reach its full potential for social and economic impact in the future, we need supportive regulatory and business environment.
“BBSRC funds researchers who are investigating the basic biology of stem cells. For these researchers, perhaps more so than those working closer to commercialisation, we must ensure access to the widest variety of avenues through which to explore the potential of their science; it would be a shame if this were jeopardised by this ruling.”
Ben Sykes, Executive Director, UK National Stem Cell Network, said:
“The detail of this judgement, published today on the ECJ website, warrants further consideration by the legal profession. The initial impression is that the decision is disappointing and will have implications for European companies investing in hESC research as well as the exploitation of world class European research in the field on other continents such as Asia and North America. There might also be unintended consequences arising from a restricted environment for commercialisation of this research within Europe, though we must await further scrutiny to see precisely how limiting this judgement is.”
Alexander Denoon, Lawyer at Lawford Davies Denoon (law firm specialising in life sciences), said:
“While this is an unwelcome decision, this is not catastrophic for the sector for a variety of reasons:
(1) Despite the plea not to undertake skilful drafting to circumvent the decision, I suspect that inventors and patent attorneys will find ways around some of this. In fact, inventors and patent attorneys have known about this concern for some time and have been drafting to try to take account of this issue.
(2) It is possible to obtain patents for these types of inventions in most other countries in the world, including the US.
(3) It should be possible to obtain patents on allied technologies, such as biomarkers and diagnostics related to the particular therapy.
(4) Under the current regulatory framework, it will be virtually impossible to convince a regulator to approve a generic (technically a biosimilar as the threshold for biologicals is higher than normal generics), thus the regulatory protection for approved medicines will be very high.
(5) This affects the sector generally and not European scientists or patients disproportionately.
(6) Finally, we still await the decision of the Federal Patent Court in Germany (Bundespatentgericht) and subsequent guidance from patent offices.”
Dr Tony Peatfield, director of corporate affairs at the Medical Research Council, said:
“While the full impact of the European Court of Justice Ruling will need to be considered, this seems to be a very disappointing conclusion.
“The MRC expects to invest over £130m in research to promote the application of stem cell and related technologies for regenerative medicine over the next four years, and strives to ensure that the UK remains a world leader in this area of research. Patents have an important role to play in encouraging and protecting industry investment in human embryonic stem cell research, and in effecting the delivery of stem-cell based therapies in the longer term. It’s likely this decision will hamper inward industry investment.
“The MRC is committed to working hard with its partners to provide as supportive an environment as possible within this new patent era.”
Prof Sir Ian Wilmut, MRC Centre for Regenerative Medicine, University of Edinburgh, said:
“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.”
Prof Austin Smith, Wellcome Trust Centre for Stem Cell Research, University of Cambridge, said:
“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.”
Prof Pete Coffey, Institute of Ophthalmology, University College London, said:
“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.”
Prof Oliver Bruestle, Director of the Institute for Reconstructive Neurobiology at Bonn University, said:
“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 this to my students?”
Prof Robin Lovell-Badge, the MRC National Institute for Medical Research, said:
“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.”