|European court bans stem-cell patents |
By Andrew Jack in London
October 18, 2011 5:56 pm
Europe’s top court has ruled that stem cells from human embryos cannot be patented, dealing a blow to the commercial development of such treatments within the European Union and potentially driving research elsewhere.
On Tuesday the European Court of Justice upheld the opinion of the EU’s advocate general in a long-running case originally brought by Greenpeace, the environmental watchdog, against Oliver Brüstle, a scientist investigating the use of stem cells to treat neurological disorders including Parkinson’s disease.
Human embryonic stem cells are extracted from surplus in vitro fertilised eggs donated for research after fertility treatment. These cells are then modified and injected into patients for treatment.
The legal decision, which could trigger calls for fresh legislation, means that while there are no ethical restrictions on academic embryonic stem cell research in Europe, it will be more difficult to patent and commercialise any discoveries that are made. In contrast, companies in the US can patent embryonic stem cells. President Barack Obama overturned a long-running ban, which had been in place because of ethical concerns, of federal funding for stem-cell research in 2009.
Prof Brüstle, director of the Institute for Reconstructive Neurobiology at Bonn University, whose 1997 patent was the object of the original legal challenge, told the Financial Times: “We are creating a no-man’s-land for intellectual property in Europe between Asia and the US. There are no incentives for European companies to operate because they don’t get protection.”
Christoph Then, of Greenpeace in Germany, which brought the case on the grounds that human life should not be patented, said: “We think it was a necessary clarification because there was no harmonisation in Europe about what should be considered a human embryo.”
The ECJ supported advocate general Yves Bot’s interpretation that – in the absence of clear EU legislation – the potential for life existed much earlier and thus that stem cells from human embryos could not be patented. The Warnock Committee’s report, a UK analysis of stem cell research, said life began 14 days after fertilisation.
Several leading researchers warned the judgment would destabilise stem-cell research across Europe. But others said it affected a relatively narrow field as most trials instead used adult stem cells.
Only two pharmaceutical companies, Geron and ACT, are at present testing embryonic stem-cell therapies in patients. Others investigating their potential include Cellectis and Pfizer. This contrasted with the more than 2,700 trials using adult stem cells unaffected by the ruling, said Professor Chris Mason, chair of regenerative medicine bioprocessing at University College, London. “Patent lawyers have been anticipating this for a number of years. We’ll engineer around it,” he said.
Tony Peatfield, director of corporate affairs at the Medical Research Council, the UK government funding agency, which has earmarked £130m for the field over the next four years, said: “This seems to be a very disappointing conclusion. It’s likely this decision will hamper inward industry investment.”
Richard Willoughby, a partner at the law firm Rouse, said: “The upshot of the [ruling] is that it makes it quite difficult to obtain patents for therapeutics based on embryonic stem cells in the EU, something which has implications for industry and patients.”
Julian Hitchcock, a patent specialist with the law firm Field Fisher Waterhouse, said: “The ruling may actually present an opportunity for researchers who in the past have complained that their work is held back by the fear of inadvertently infringing a patent.”