European Court bans stem cell patents

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.

"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."

Oliver Bruestle

Professor 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.

"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."

Pete Coffey

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. We're interested in your views - why not post a comment below?

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: "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".

Update 20 Oct: Alzheimer's Research UK expresses concern
Alzheimer's Research UK has posted their response to the European Court of Justice's verdict on their website, including this statement from Dr Simon Ridley, Head of Research at Alzheimer’s Research UK:

“We are currently funding a number of projects which use embryonic stem cells as a tool for research. Our scientists rely on the interest of commercial companies to take their discoveries forward and develop new treatments and diagnostic methods. Although we will have to wait before we can see the real impact of this ban on Alzheimer’s research, there is a concern that this commercial interest may be lost. As dementia research is so underfunded, any potential loss of research interest or investment could slow down the progress that is so desperately needed.”

 

Related links

Press coverage
Just a few examples of press coverage on this issue:


Given the diversity of

Given the diversity of ethical, legal and public policy approaches to research involving or presupposing the destruction of human embryos it seems illiberal for people to be forced to subsidise these activities through centralised European funds. In the USA it is well understood that there are activities on which moral judgments differ very sharply and this is grounds both for allowing people the freedom to pursue them and for allowing people not to have to fund them.

A Comment on Morality

As one who has spoken out pretty clearly about the lack of impact of this case (at least from a commercial perspective informed by I hope competent legal skills), I would like to make one thing perfectly clear. The work conducted by Oliver Brüstle, Austin Smith, Peter Coffey and other researchers using human embryonic stem cells is of extraordinary moral value. The effect of this case should on no account be seen as a criticism of them personally or of the ethical standing of their work. I hope very much that those who oppose the work will nonetheless acknowledge that it was undertaken according to the most stringent requirements and the the highest ethical standards sanctioned by the will of the people acting through Parliament (in the UK, those required as licence conditions under the Human Fertilisation & Embryology Act 1990 (as amended). In a case that has sought to extend the dignity of human personhood to the level of an entity that lacks a body, the dignity of real people,- patients-, has been most unjustly impugned in an effort to harmonise European moral values. Such harmonisation cannot succeed because ethical values are made by people like ourselves, who may not (and look above,- do not!) agree. My ethical values are not about to be altered by a bunch of judges and a duff Advocate General and nor should yours,- wherever you stand on the debate so eloquently debated in this commentary. You can't do ethics by force. That said,- and with great respect and admiration for the scientists concerned-, the real and immediate effect of the judgment is far better judged by legal and commercial people than by scientists: especially scientists who have lost rights in Europe. I am terribly sorry for all those whose work has been trimmed in Europe,- not only Oliver and other Europeans, but their colleagues from Asia/Pacific and the US. And I share their outrage at this decision. But its impact will be negligible,- certainly in the UK. The MRC's position is unchanged, so is Wellcome's and the UK government remains committed to a TIC and to the value of regenerative medicine, as witnessed by David Willett's letter to the BioIndustry Association.

European Court bans stem cell patents

What about the children who cannot walk because after a car accident , know is paraplegic ? What about a father who have never seen his children because he is blind?They are waiting for scientists to as quick as possible to find an answer throughout stem cells research and clinical application .They will have to wait more because people who have no idea what is being so sick , so ill , are playing politics and they don't care about the patients ... that's so sad! Brilliant minds are trying to help but people with , for example , religious issues who are still in medieval times are blind .. Let's move on ! STEM CELLS ARE THE FUTURE OF MEDICINE AND BRING NEW HOPE TO THE HUMAN SPECIES , WE NEED HOPE IN THIS WORLD, URGENTLY !!!!!!

Do not be naïve....

Because stem cell research holds great promise to cure different diseases, this type of research should not be kept into the hands of commercial monopolies (as patents confer it). A patent is an industrial property that confers on its owner, a right to prohibit the use by one third of the patented invention, for a limited duration (10-20 years in general depending of the country). The European Court did not banned research on stem cells, or the use of embryonic stem cells to develop new treatments, but did banned commercial monopolies on stem cell research. In the world of big pharmaceutical companies, patents allow shareholders (few privileged persons) to do exorbitant benefits (millions of Euros). Around the world, millions of patients (and this is specially true for patients with chronic diseases who need a huge amount of medications, and patients from the third world countries) do not have access to these medicines because of their unaffordable prices. Prices that far exceed the costs for their development and production. Do you really want to reproduce that for stem cell research? With patents, only very few rich patients would have access to stem cell treatments. Capitalism is capitalism and the main premise of capitalism is that very few individuals make profits at the expense of the vast majority and that’s what allows patent. Do not be naïve, the willingness of the few stem cell researchers who want to put patents on their research does not reflect their empathy toward patients, but their thirst for benefits. All of them (those mentioned by another commentator below) have their own private companies, and all of them (and they are always the same) receive millions of Euros from European consortiums (European public founds) to finance their own private companies....and the benefits of private companies always go into the pockets of the shareholders, they do not return back into the public sphere (or very little). Companies and shareholders receive very large tax benefits.... Beyond the ethical aspect there are social consequences of patenting stem cell research, and according to me the decision of the European Court is socially a good thing. There is no doubt for me, stem cell research can be financed through a non-profitable way and can be beneficial for every one.

Stem Cell Naivety

You comment doesn't reflect the content of the article. The scientists quoted weren't talking about monopolies. They were talking about losing their research and non-European sources having to move that forward.

Who is naive here!

Who is naive here! Research needs money! Lots of money. In the absence of commercial interests of companies, researchers are not able to found their work. By the way, with this decision nothing is changed in the matter of ethical aspects & social consequences for benefit of patients in Europe. By developing of the stem cell therapies outside Europe, and more founds which facilitate research outside Europe, only those rich patients would have more benefit as usual!

The problem is that companies

The problem is that companies invest no more than 10-20% (rarely 20%) of their budgets into research and development (and they will never invest more than that). Their strategy is to bind to universities (funded by public money ..), let them finance the research and development and when the discoveries appear to be attractive to the market, put patents on the discoveries or buy the existing patents and....get the profits (which do not return to the universities). The big money for research does not come from companies but from the public sphere. And will never come from companies... Moreover, without patent the field of stem cell research will not be monopolized by only few researchers who do business. All researchers in the field will have a chance to be financed by their respective governments according to the excellence of their work and not according to some rules of commercial laws (which do not guarantee the scientific quality). Overall, the research in the field will become better and of higher quality.

Sorry Austin, Pete, Oliver, Elena, Ian, Robin and Biotech Co!

The veredict of the European Court of Justice (ECJ) is absolutely right. The ECJ is not banning research with human embryos, is banning business based on human cell trafficking. Basic research needs to be supported by public interest not commercial interest. Thanks a lot Greenpeace!!!!!

Thanks God!

Human embryo is HUMAN and cannot be used as mere biological material. Obviously, human embryonic stem cells line aren't anymore human beings because forced to take a specific pluripotent way, but where pluripotent embryonic stem cells are from? They are from totipotent human embryos (human beings). So ... the decision of the Court is correct.

If I understand you

If I understand you correctly, you think it is better to sacrifice the lives of countless numbers of human beings, who could deeply benefit from developing stem cell technologies to fulfill our "moral obligations" to treat embryonic cells as fully developed human beings. Don't you think this may be an over-generalization? Embryonic cells certainly have the potential to be human, but they are far from representative of the sentience, consciousness, and complexity that forms a human being. The road we are treading now will lead us to a stagnant future, and it will prevent us from granting our children with necessary improvements to the human condition. I certainly respect the views expressed by the religious and spiritual community, but honestly, I think such views have less relevance here.

consequences?

Will this mean that more money will be put towards research on iPS-cells, or will scientists simply flee to Switzerland, Norway and across the pond?

DEVASTATING NEWS

Who are these people who make these ridiculous decisions. I cannot think of any good reason why the European Court should ban stem cell patents. Where is the humanity here, we are talking about children and adults with life threatening diseases like Muscular Dystrophy who need cures for their conditions, they don't have time for all this bureaucratic nonsense. We cannot afford for scientists to move away from Europe, this is sadly not progress. Tania

SAD DAY

As a parent who has a child suffering from a neuro degenerative disease I wonder if this decision would have been different if they were in similar situation.

Dark Ages

Sliding to Dark Ages, but instead of catholic it is now under political correctness and false humanity banners. People will travel outside the EU to treat their unwell loved ones.

Ban on Stem Cell Research in Europe

A devastating decision. I too support the Muscular Dystrophy Campaign, having one of the many forms of the disease as does my oldest son, and am hoping my two younger children do not inherit it also. The hopes of thousands of people suffering with one of the hundreds of disabling conditions who may have possibly been helped to some degree have now been dashed. One more excellent reason for withdrawing from the EU. European Court of Justice. Justice for whom? More of our most able scientists will possibly move out of Europe, another blow for Britain. Christine S.

Cutting edge stem cell research not affected

With respect this decision is not a "ban" on research nor does it concern "stem cell research" generally. It does not prevent reserach on human embryos, it does not prevent governments or medical charities (the largest funders in this area) from funding research, it does not prevent companies from making profits out of research on human embryos (if anything comes of this research). It restricts one way to protect these profits, the mechanism of patent law, which in any case may have limited application to stem cells (as Julain Hitchcock argues convincingly). Alex Denoon and Julian Hitchcock and I'm sure other lawyers in this area are alreday seeking for ways to avoid or mitigate the effect of this decision. The decision is not therefore an earth-shattering one but I hope it will act as a "nudge" that which will encourage stem cell scientists to make more use of non-embryonic sources of stem cells, (such as amniotic fluid, cord blood, bone marrow, olfactory cells, adipose tissue (from liposuction!) and perhaps most importantly by modifying adult cells, so called induced pluripotent stem cells (iPS cells)). An ethical preference for research that does not involve or presupoose the destruction of human embryos does not mean less research or less interesting research. If you look at the journals or the proportion of funding (both processes judged by peer review), the evidence is that most work in this area, and some of the most interesting new work, is being done on non-embryonic stem cells. The media reporting of this story, especially in the UK has been very misleading (Fergus Walsh at the BBC being an exception): The most cutting edge stem cell research will not be inhibited by this decision, if anything it will be encouraged.

Please take care

Dear All, I would encourage colleagues please to take the greatest care in their public response to this case. I am hugely sympathetic and share the anger expressed so clearly in these pages. It is indeed a terrible, stupid decision based on legal and scientific nonsense. However, the absence of commercial voices declaring the end of the world is very telling. To the best of my knowledge, the only lawyers to speak on this today have been Alex Denoon and myself. We have both been at pains to make it clear to investors that the game is very far from up and that, indeed, this is in large part a neat shot through the foot for Greenpeace. I understand how bitter colleagues will feel at having protection stripped from what is, in other jurisdictions, valuable intellectual property. However, please be VERY careful that you do not in your anger bring about the very fears that are expressed here. We NEED investment and there is every reason why investors SHOULD do so. There is an immediate danger that governments may actually believe that all the value HAS been pulled from the sector and, in these straightened time, withdraw or limit funds, for example at a TSB level. Please bear this in mind when speaking in public and please read my comments below and on www.cellfate.com Regards, Julian

Listening to the other side

Before this judgment was made I suggested that it would be unwise of people only to listen to lawyers who told then what they wished to hear. This decision was widely predicted and broadly in line with previous decisions (such as the WARF case) though perhaps at the more restrictive end of the possible outcomes. It was not a calamity that came out of the blue. Nor was it "based on legal and scientific nonsense". The best legal definition of the human embryo of which I am aware is that provided by the Human Fertilisation and Embryology Act 2008. There are aspects of that act I disagree with but I admire its careful definitions. The European Court of Justice has a very similar approach in its definition of the human embryo, indeed it may be influenced by UK law. Nor is it legal nonsense, given certain premises. The judgment is based on the premise that it should not be permissible to profit financially from the destruction of human embryos. This premise is not applied consistently in European law, but, if one accepts the premise, then the legal judgment seems reasonable (I am not a lawyer but this seems to have been the line of ethical reasoning that influenced the court). Thus I disagree with Mr Hitchcock about the judgment, but I agree with him that the hysteria with which the story has been reported is unwaranted and that warnings of doom could be self fulfilling. My own hope, which I expressed to Fergus Walsh (http://www.bbc.co.uk/news/health-15355991) is that this decision will act as a "nudge" to encourage scientists and investers to pursue stem cell therapies through non-embryonic routes. I had also hoped it might encourage people to listen more carefully to the other side of the argument (in case it won) but this was a vain hope on my part, regards, David Albert Jones

Reply to David A. Jones

Hi David. It's good to hear from you. Wise words about lawyers: we're terrible people to have around. Except, perhaps, on this occasion. Yes, I do believe that the decision is legal and scientific nonsense. It's academic to discuss why, but the basic fault arises from the improper interpretation of Article 5, which the Advocate General correctly identified as providing the only basis for a definition. Article 5 refers to "the human body" at the various stages of its formation and development. When the human body begins to form is a scientific question which our fellow correspondents are far more competent to discuss than you or I. However, you will note that it refers to a single human body, not a hydra, and that the formation of such a body cannot take place upon conception: we are taken back to Anne McLaren's wise arguments of so many years ago. We need not invoke the operation of the Hox genes; we can simply look at the formation of the primitive streak. But the point is this: NO expert evidence was taken. None at all! M. Bot confuted "human body" with "human life",- which is not in the Directive-, and then talked about "human dignity", as opposed to the "dignity of the person" that is the subject matter of the Charter. In fact, the Biotechnology Directive states that (recital 16) “patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person”. The Universal Declaration of Human Rights also refers to the "human person". And, whatever it's theoretical capacity to become one, a fertilised egg is not a home owner, driver or the owner of any other legal rights. It is emphatically NOT a person. Many of our co-correspondents will be revolted that the Advocate General equated these cells with identifiable Yugoslavian prisoners of war being murdered for the sake of their bodily organs. They may also be dismayed to hear that this argument was treated as the trump card,- the matter that decided the matter once and for all. Finally, the decision flies in the face of the democratic position reached in the European Parliament and forming hard-won recitals to European statutes, which reserve such controversial matters to the member states. So it is not only an immoral decision in the view of most correspondents to this page, but a deeply undemocratic one. I do listen to the other side in these matters and value engagement, but you will surely concede that Greenpeace members who funded the action will be somewhat surprised to discover that it leads to an increase in the opportunities to conduct valuable research using material derived from what would otherwise be IVF waste material, and not a decrease. Yes indeed; for this is the effect of removing patents. Finally, I encourage my scientific colleagues to take heart: ignore the negative pronouncements about investment (they are entirely unfounded); set aside the mumbo-jumbo reasoning of this ridiculous case; and,- please-, push ahead with your valuable research. If you're outside Europe,- come on over, - the water's lovely...

Changing your tune

It is charming to hear the harmonius sound of back-peddling as those who co-ordinated a misleading scare-mongering campaign over the summer, alleging that this decision would be a "devastating blow to stem cell research" and hence to desparate patients, now compete to list the many silver linings of this particular cloud. This article in Nature is a lovely example: http://www.nature.com/news/2011/111024/full/478441a.html?WT.ec_id=NATURE... Unfortunately not everyone has caught up with where they are supposed to be on the hymn-sheet as when Ian "Dolly the Sheep" Wilmut who was interviewed with me on the Today programme and was asked directly by Evan Davis whether there might be a silver lining to this decision, he replied "I think not". If this controversy has scared off potential investors in hESC technologies the damage will have been done not by the ECJ or its defenders (such as myself) but by an over enthusiatsic hESC lobby keen to portray any opposition as an imminent threat to patients. If the "its not really so bad" story has some plausibility (and I argued as early as June this year that patents had a downside as well as an upside financially) it would have been better if someone had had the courage to make it before the ECJ decision came out. I cannot think that this dramatic volte-face will impress potential investors. The reality is that patent protection is of marginal relevance to embryonic stem cell innovations, and some patents have adverse effects, but nevertheless on the whole they are probably beneficial (before the judgment I heard not one hESC scientist or spokesman saying that a blanket ban on hESC patents would be a good thing - I would be glad to be corrected on this). Hence the decison will be a mild and minimal economic "nudge" which will favour non-embryonic sources of stem cells. This will be welcomed by people who are in favour of stem cell reserach but wish to see it pursued in ways that do not presuppose the prior destruction of human embryos. Thank you Greenpeace. David Albert Jones

stem cell patents

I am a life long supporter of the Muscular Dystrophy Compaign. this decision means that progress will be severely restricted. . The progress made in recent times is now curtailed Once again the seriously insular outlook of the European Court prevails. Brian

This is most stupid decision

This is most stupid decision I have heard from EU Court so far. It was the biggest step backwards for medicine since the start of the whole EU. Greenpeace (ecoterrorists) proved again that their actions are against human kind. How many people just lost their chance now to be healthy and lead normal life? How many children will die now and in the near future because of this mindless ecoterrorists. Shame on you, greenpeace, Shame on you EU

Brüstle v Greenpeace

My views are essentially as stated in The Times and The Independent, but as they were brief I should like to elaborate. Legally, the Judgment is extremely poor and even goes slightly beyond the cavalier Opinion of Advocate General Yves Bot. My response to the Opinion were set out on the CellFate site and in the legal press. They hardly matter here, save to say that they underscore the injustice done to those who have worked so hard to derive cell lines by this very broad decision, which reaches not only cells directly acquired, but it seems progeny many times removed from the original source. I do not, however, by any means share the view of Austin or Pete that this is disastrous for research, although I share their anger at this foolish and idealogically-inspired decision. My first reason is that the excision of patent protection, especially where the sought after industrial application is as a research tool, actually improves the research environment by ridding it of the need to pay royalties or tiptoe about in fear of infringement, as has been suggested by, inter alia, the Hinxton Group. Overseas parties may thus see Europe as a research haven and even more worthy of collaboration than in the past. My second reason concerns the fact that cells are difficult to patent anyway because, by and large, they are not new. The chances of getting a return on a hESC patent from clinical deployment are limited because many basic hESC patents will have expired anyway, because of the long regulatory route. The balance of value of such lines is therefore as a research tool. While this is a means of keeping a company going while the technology moves ahead, as stated above it effectively taxes research. Third, investors can be satisfied that the patentless cell lines which they have sponsored will nevertheless be protected from competition and provide them with what is in effect a patent position. For 8 years after the grant of marketing authorisation in Europe through the EMA, the owner has data exclusivity: a competitor with an identical cell line could not use the data filed by the owner for that period. For a further 2 years, he cannot market a competing product and, if the owner identifies a new indication within the first 8 year period, he is granted an additional year of exclusivity. Given that patent protection of a pharmaceutical product is reduced by the regulatory approval process and inadequately compensated for by the supplementary protection certificate period, this is an appreciable monopoly. There are mad investors, but not so mad as to fail to see the opportunity here. My fourth reason is that we are failing to see the wood for the trees. The value,- and there is an immense amount of it-, lies not in the cells (mere phenotype!) but in the processes, equipment and methodologies employed to ensure that a very highly specified cell results. It is about controlling cell fate, not about the cells themselves. The value is set, not by patents per se, but by the market in which they operate. That market is the market of clinical, and indeed state, need. It is plainly immense. If value is lost to one portion, we need have no fear that another aspect of our enterprise will absorb it. Readers will reflect that, for all the howls in relation to the failure to patent monoclonal antibodies, the market did not exactly collapse! Finally, should anyone have any trouble securing funding from the European Commission, please draw their attention to certain provisions of the law of the European Union. There are a few references, each supportive of research and, indeed the patenting of stem cells,- in the Advanced Therapy Medicinal Products Regulation (recital 7), the Tissue and Cell Directive (which provides detailed rules for the use of hESC derived products) and, most aptly, the very statute in dispute in the Brüstle case, the Biotechnology Directive, Recital 17 of which states that: “Whereas significant progress in the treatment of diseases has already been made thanks to the existence of medicinal products derived from elements isolated from the human body and/or otherwise produced, such medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, research aimed at obtaining and isolating such elements valuable to medicinal production should be encouraged by means of the patent system.” If funding is withdrawn, may I suggest that EuroStemCell publishes details. CellFate will support any effort made to resist any erosion of grant funding attributable to this lamentable decision. If members have particular enquiries, please contact me at julian.hitchcock@ffw.com

Forced to fund unethical research

Human embryonic stem cell research involves the manipulation and destruction of human embryos for prospective benefits that ostensibly cannot be obtained in any other way. As this technology has become politicised the likelihood of benefit and the possibility of alternative avenues of stem cell research have been distorted, so that people wrongly believe that diverting money from embryonic to adult and induced stem cell research will necessarily inhibit future therapies. This is of course not testable and judgments in this area are based on a complex amalgum of experience, hope, and financial and professional interest. In other commercial contexts such predictions of benefit would, I think, be subject to greater scrutiny. Given the diversity of ethical, legal and public policy approaches to research involving or presupposing the destruction of human embryos it seems illiberal for people to be forced to subsidise these activities through centralised European funds. In the USA it is well understood that there are activities on which moral judgments differ very sharply and this is grounds both for allowing people the freedom to pursue them and for allowing people not to have to fund them. It is to be hoped that the ECJ decision takes Europe a step towards the same separation of permissibility and funding. Individuals and countries should not be forced to fund experiements they regard as fundamentally unethical, regards David Albert Jones.

Damaging

Implications of this decision for European Stem Cell Sector are damaging. Perception now is Europe will not have a progressive legislature to allow translation of embryonic stem cell research to the clinic. This undoes a lot of good work done at national level to regulate around this area. Will also be damaging to fundamental research too as Europe will not invest in what Europe cannot translate competitively. Many jobs, projects, clinical trials and investment now likely to move to US and Asia. Stephen Sullivan - Chief Scientific Officer, Irish Stem Cell Foundation

STEM CELLS PATENT

THE COURT'S DECISION IS NOT VERY DIFFERENT FROM THAT OF GEORGE BUSH..IT CONDEMNS THE PATIENTS WITHOUT A TREATMENT FOR THEIR AILMENTS...I FIND TO TAKE AWAY HOPE FROM ANYONE IS CALLOUS..I SUPPPOSE IF ANY OF THEN HAD A LOVED ONE WITH A NON-TREATABLE CONDITION..THE VOTE WILL BE DIFFERENT..HOW DARE THEY

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