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Europe’s highest court has been asked to declare stem cell patents immoral and therefore illegal. Researchers warn that this will ruin the prospects for stem cell treatments in Europe and drive potential investors into patent-friendly China, Japan and the US. New Scientist investigates what it’s about.
Who Says Stem Cell Patents Are Immoral? And what turned that upside down?
Greenpeace, the international environmental lobby group, started in 1999 when it questioned a patent held by Oliver Brüstle at the University of Bonn. The patent related to neuronal progenitor cells obtained from publicly available sources of human embryonic stem cells (hESCs) – the cells in embryos that can grow into all 200 tissues in the human body. They argued that his patent violated the 1973 European Patent Convention, which prohibits patents on inventions “against public order and morality”.
Within the next few weeks the European Court of Justice will have to decide whether patents relating to stem cells derived from embryos should be banned in the European Union because they are immoral. As soon as the 12 judges of the court have made their decision, it is immediately binding across the EU.
Why the fear that the court will declare such patents immoral?
On March 10, the court’s Advocate General, Yves Bot, issued a prior statement in which he could conclude exactly – and the court supports the Advocate General’s previous recommendations in 80 percent of the disputes it is asked to resolve.
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Which patents would be affected and why did the Advocate General declare them immoral?
They would be intended for treatments derived from hESCs. Although extracted hESCs can be purified and multiplied indefinitely for researchers to study, they all originally came from embryos that had to be destroyed in order to obtain them. The Advocate General therefore concluded that any patentable uses of hESCs resulting from the previous destruction of an embryo must violate a European patent directive from 1998 which prohibits the “use of human embryos for industrial and commercial purposes”.
What difference would it make if such patents were banned?
According to a group of 13 leading European researchers who wrote a letter of protest to nature this week and held a press conference in London to ask for support, doing so would destroy the prospects for breakthrough stem cell treatments in Europe. They also oppose allegations that their work is immoral, claiming that the aim of their research is to develop treatments that will alleviate the suffering, including potential cures for some types of blindness, diabetes, and a host of other degenerative diseases.
Could your work not continue without patents?
The researchers do not say. Even if an important discovery is made that could lead to new treatments, it can only happen if drug companies or investors pay to turn it into a high quality commercial product. They say investors won’t risk their money if the investment can’t be protected by patents. Otherwise, unscrupulous copycats could create competing copycat products without incurring the costs and risks of investing in the original discovery.
So what kind of treatments could be lost?
The most advanced treatment is age-related macular degeneration, a form of blindness that usually affects people over 65. Pete Coffey and colleagues from University College London are developing tiny spots about one millimeter in diameter that consist of a layer of supporting cells that nourish and maintain the light-sensitive cells of the retina. Coffey derived the supporting cells from embryonic stem cells, so that these would be affected by a patent ban.
The pharmaceutical company Pfizer is funding the production of the patches and the preparation for a trial with the patches on patients, which is due to begin next year. Work could be jeopardized if related patents were invalidated as Pfizer would not be able to prevent competing companies from “stealing” the idea and profiting from it without funding the original research.
And what about the morale of treating patients?
Exactly the point that the researchers took up. “There is an ethical need to treat diseases that seem to have been lost in this debate,” Coffey said at the press conference. Co-signer Robin Lovell-Badge of the National Institute for Medical Research in London agreed. “We believe that finding cures for disease and making a decision about the morality of the embryo without thinking about that problem is a big problem for us,” he said.
Coffey also pointed out that even if Europe bans patents on hESCs, countries like the US, China and Japan can still use them. “So do we expect European patients to board airplanes to receive therapy that I might have developed here?” he asked.
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