The European Union's highest court ruled Tuesday that scientists cannot patent stem cell techniques that use human embryos for research, a decision some scientists said could threaten major medical advances if it prevents biotech companies from turning a profit.
This could set Europe apart from other countries of the world. Most other countries do not have such restrictions, and this latest development arose from a lawsuit filed not by a religious group but by the environmental group Greenpeace.
The decision from the European Court of Justice in Luxembourg centered on the case of a University of Bonn researcher who in 1997 filed a patent on a technique to turn embryonic stem cells into nerve cells. Greenpeace challenged Oliver Bruestle's patent, arguing that it allowed human embryos to be exploited.
The court said patents would be allowed if they involved therapeutic or diagnostic techniques that are useful to the embryo itself, like correcting defects. But the justices concluded that the law protects human embryos from any use that could undermine their dignity. The court also objected to any stem cell techniques used exclusively for research, saying such use of embryos “is not patentable.”
Embryonic stem cells can develop into any type of cell in the body. The hope is that one day they might be used to replace or repair damaged tissue from ailments such as heart disease, Parkinson's and stroke. But using stem cells from embryos has always been controversial—opposed by some groups for religious and moral reasons.
Greenpeace spokesman Christoph Then explained that the lawsuit was an effort to get a clear, legal definition of what constitutes a living embryo. The group is concerned that patents on plants and animals could lead to monopolies in food production. Greenpeace approaches the issue from “a completely different angle” than anti-abortion activists, specifically a fear that living creatures will be abused for the sake of profits, Then said. “We took an ethical approach,” he said, noting that European patent law had failed to define what constitutes a human embryo. “We are mostly concerned about commercialization of the human body.”
Scientists worried that the decision could further restrict stem cell research. “This casts real doubt on the possibility of new medicines from stem cell research,” said Pete Coffey, a researcher at University College London running several projects on eye disease and stem cells. “Getting a stem cell technique to cure blindness is fantastic, but it may never get out as a medicine because no manufacturer will get any financial reward from it,” he said.
Robert Lanza, chief scientific officer at Massachusetts-based Advanced Cell Technology, called the ruling “a devastating decision for the field.” Lanza, whose company has several stem cell projects, described the European court's decision as “the kiss of death” for research that requires the embryos. But, he said, other techniques, such as those used by his company, would not be banned.
Sir Ian Wilmut, who led the team that cloned Dolly the sheep, said the decision was “very much to be regretted”. “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,” he said. Wilmut, who is director of the MRC Centre for Regenerative Medicine at Edinburgh University, added, “Sadly this judgment 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.”
Austin Smith, head of the Wellcome Trust Centre for Stem Cell Research at Cambridge University, said the decision left European 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,” he said.
Some European religious groups welcomed the ruling. “We are in favor of research and development in biotechnology, but human beings must not be destroyed, not even in the early stages of their development,” said Peter Liese of the EPP Christian Democrat group at the European Parliament. The German Bishops' Conference, part of the Catholic Church, called the decision a “victory for human dignity” and said it strengthened the view that life begins at conception.
“This is an unwelcome judgment, but for reasons that are specific to the sector, I think the practical ramifications will be limited,” said Alex Denoon at Lawford Davies Denoon, a London-based law firm that specialises in stem cell regulation. “I suspect that inventors and patent attorneys will find ways around some of this.” Even without patent protection, said Denoon, companies that develop stem cell therapies are unlikely to face competition from rivals that copy their work, because of the difficulty in getting regulatory approval. The decision would not affect Europeans disproportionately, because stem cell research was a global sector, he added.
Chris Mason of the UK National Stem Cell Network agreed, adding that while the judgment was unwelcome, stem cell researchers faced more serious funding and manufacturing problems. “This decision is important and it creates uncertainty, which is a problem in itself, but it is not as big as the other barriers we are grappling with. Funding is a major issue and that has to come from central government. Then there is manufacturing, in that we need to make these therapies at a scale and price that works,” Mason said. “This is not a bolt from the blue, and I think people will be able to work around it. Does it impact upon potential therapies? The answer has to be no.”