What’s the News: As a European court looks poised to ban the patenting of technologies using human embryonic stem cells (hESCs), a group of prominent scientists has issued a warning: regenerative medicine is never going to leave the lab if no one can make money on it.
What’s the Context:
- Embryonic stem cells are derived from human embryos, usually donated after fertility treatments. They can develop into many different types of cells, which has raised hopes that they can be used to grow tissues for transplant, including retinas and spinal cord tissue.
- Generally, before a technique can be developed for use in the clinic, it must be patented—the promise of profit is what drives pharmaceutical and other biomedical companies to invest in the idea.
- Research with hESCs has been limited in the US because until recently the government would not fund the vast majority of proposed hESC projects. Europe has fewer such restrictions, which means that it has seen a blossoming in hESC research.
- Now, scientists are waiting with bated breath for the ruling of the highest EU court on a case that could declare patents of hESC techniques illegal. In March, an advocate-general of the court gave his opinion that they should indeed be banned, and the court usually follows advocate-generals’ advice. (For a detailed description of the case, which was brought by Greenpeace in 2004 and charges that such patents violate an EU directive prohibiting the commercial use of human embryos, see ScienceNOW’s coverage.)
- In a public appeal published in Nature, thirteen scientists from the Wellcome Trust today argued that because hESCs are cell lines—derived from human embryos, yes, but not dependent on embryos for a supply of cells—such patents do not violate the law. They urged the court to think carefully before ruling:
Scientists working in stem-cell medicine will not be able to deliver clinical benefits without the involvement of biological industry. [And] innovative companies must have patent protection as an incentive to become active in Europe.
- Some EU countries agree with the distinction made by the Wellcome Trust scientists: Science reports that according to the lawyer for the defense,
four EU member countries and the European Commission [have] submitted legal opinions that found that inventions involving already-derived hES cells should be patentable. The full court “would have a hard time completely ignoring them,” she says.
The Future Holds: The court is expected to give its ruling in the next few months. If it does deem hESC patents illegal, it could be a major blow to the commercialization of stem cell medicine. What comes next isn’t clear, but scientists would likely have to seek companies outside the EU to keep the possibility of stem cell medicine viable.
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