**New: European Court Decision, 18 October 2011** Stem cell scientists have raised serious concerns about the impact of a possible ban on patents for techniques using human embryonic stem cells.
On 10th March the advocate-general of the European Court of Justice, Yves Bot, gave his opinion on a long-running legal debate about a patent filed several years ago in Germany. If the Court follows Bot’s recommendations, patenting of applications using embryonic stem cells will be prohibited on moral grounds.
This week leaders of major stem cell projects in Europe responded to the advocate-general’s statement with the open letter below, published in the journal Nature on 28th April (Nature 472, 418; 2011). The authors, representing both embryonic and adult stem cell research, point to a potential wide-ranging impact on the entire stem cell field if the European Court chooses to uphold Bot’s opinion in a final and legally binding ruling.
Patenting is a key step in the development of academic research findings into new medical treatments. Without the possibility of patent protection, companies are unlikely to invest in the cell manufacturing technologies needed to develop and provide innovative stem cell treatments. In their letter, the scientists state that the advocate-general’s opinion undermines years of funding from the European Commission and individual EU member states for research aimed at developing human embryonic stem cell based therapies. They suggest that citizens may find that new therapies are developed elsewhere and will not be available in Europe, or will be prohibitively expensive.
This case has implications for public perception and funding of research. If the application of embryonic stem cells to develop medical therapies is branded immoral, continued government support will be challenged. Leading stem cell scientists see that as disastrous: the first clinical trials using human embryonic stem cells are now commencing, and there is currently no suitable alternative to these cells.
The consequences are likely to extend beyond those working directly with human embryonic stem cells. Embryonic stem cell studies inform research with other types of stem cells. Researchers fear that prohibition of embryonic stem cell patents could break up existing pan-European research collaborations and cripple the European stem cell research community.
The International Society for Stem Cell Research (ISSCR) have also issued a statement on this case.
Open letter from scientists: 'No' to ban on stem-cell patents
Nature 472, 418; 2011
The advocate-general of the European Court of Justice has recommended the prohibition on ethical grounds of patents involving human embryonic stem cells (Nature 471, 280; 2011). We write to express profound concern over this recommendation, as co-ordinators of multinational European stem-cell projects, working with both adult and embryonic stem cells.
Embryonic stem cells are cell lines, not embryos. They are derived using surplus in vitro fertilized eggs donated after fertility treatment and can be maintained indefinitely. As more than 100 established lines are now supplied through national and international cell banks, concern about commercialization of the human embryo is misplaced.
"European discoveries could be translated into applications elsewhere, at a potential cost to the European citizen"
It is premature to suggest that human embryonic stem cells can be replaced in development of therapies. Although induced pluripotent stem cells offer additional possibilities, particularly for disease modelling, the reprogramming process is still imperfect. Scientists working in stem-cell medicine will not be able to deliver clinical benefits without the involvement of biological industry . But innovative companies must have patent protection as an incentive to become active in Europe. The advocate-general’s opinion therefore represents a blow to years of effort to derive biomedical applications from embryonic stem cells in areas such as drug development and cell-replacement therapy. If implemented, European discoveries could be translated into applications elsewhere, at a potential cost to the European citizen. The advocate-general’s opinion will now be considered by members of the court. We trust that they will deliberate on the full implications before making a legally binding ruling.
Peter Andrews (ESTOOLS), Clare Blackburn (EuroStemCell), Anders Bjorklund (NeuroStemcell), Elena Cattaneo (NeuroStemcell), Giulio Cossu (OptiStem), Juergen Hescheler (ESNATS), Olle Lindvall (NeuroStemcell), Marc Peschanski (Stem-HD), Daniel Pipeleers (BetaCellTherapy), David Sassoon (EndoStem), Austin Smith (EuroSyStem), Anna Veiga (hESCreg), Catherine Verfaille (HemiBio)