UNMODIFIED stem cells shouldn’t be patentable, says the bioethics think tank that advises the European Commission.
Stem cells, the undifferentiated cells that can give rise to all sorts of specialised tissues, are thought to have tremendous potential for treating a wide range of diseases. But there are fears that patents could hamper basic research and bump up the cost of any future treatments.
Now the European Group on Ethics in Science and New Technologies has said it favours creation of a Europe-wide bank of unmodified stem cells that would be freely available to all. If the European Patent Office (EPO) accepts its recommendations, only the processes used to obtain or create stem cells, or stem cell lines that have been modified in some way, could be patented. Countries would also be able to force a patent holder to grant licences if they thought it was abusing its rights,by charging exorbitant fees for instance.
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The recommendations are at odds with US law, which allows unmodified stem cells to be patented. Of the 2000 or so applications for stem cell patents lodged so far, most have been to the US Patent and Trademark Office, and around a third have already been granted.
The group’s report also suggests that any process for creating stem cells through cloning techniques—so-called therapeutic cloning—should not be patented, as this would contravene a 1998 European Union directive on biotechnology. “It would stillbe allowable but not patentable,” says chairwoman Noëlle Lenoir.
Its conclusions are certain to influence which types of stem cell patent applications will be granted by the EPO in Munich, which has many applications awaiting attention. “The EPO is awaiting our report very eagerly, because till now they haven’t known what to do,” says Lenoir.
She says the group decided against the patenting of unmodified stem cells because it could be regarded as the commercialisation of body parts. “Stem cells on their own are too close to being body parts.”
In the US, there’s already been a lot of controversy about the US stem cell patents awarded to the Wisconsin Alumni Research Foundation, which were based on the work of James Thompson of the University of Wisconsin and licensed to the private company Geron.
The patents are so broad they threatened to give Geron a virtual monopoly on embryonic stem cell technologies in the US. They were also hindering the limited federally funded research permitted since last year. The National Institutes of Health had to intervene to negotiate an agreement that limits Geron’s licence and allows researchers to obtain and use cell lines covered by the patent.
“Giving one organisation that sort of monopoly in an area that’s so new and medically important is not a good idea,” says Donald Bruce, a spokesman for the European Churches Working Group on Bioethics. “The argument that patents encourage research is contingent on single patentsnot being able to block everyone else.”
Bruce thinks the European recommendations don’t go far enough.The patenting of differentiated cells should be banned as well, he says, since they’re as close to being “body parts” as stem cells themselves. “That’s the one thing you mustn’t patent, because that’s what you want to use in patients.”