Thirteen European stem cell scientists have issued a public appeal to the European Court of Justice (ECJ) not to prohibit patents on discoveries made with human embryonic stem (hES) cells. The appeal, published online today in Nature, says that such a restriction would pose a major obstacle to bringing hES cell research to the clinic. "European discoveries could be translated into applications elsewhere, at a potential cost to the European citizen," the researchers write.
Last month, the court's Advocate General M. Yves Bot issued a preliminary opinion that because hES cells are derived from human embryos, patents involving them are not allowed under a 1998 European Union directive that forbids patents on "uses of human embryos for industrial or commercial purposes."
The case that prompted Bot's opinion involves a German patent granted to neuroscientist Oliver Brüstle in 1999 for a method for turning mammalian ES cells into neurons. In 2004, Greenpeace challenged the patent, claiming that granting it amounted to commercialization of human embryos. The German high court asked ECJ for advice on the case.
The ECJ judges, who are expected to issue a final ruling in the coming months, are not bound by the Advocate General's opinion. They do follow such opinions in a majority of cases, however. Their ruling will not only impact the German case. If the court follows Bot's opinion, it would invalidate dozens of patents granted in countries such as Sweden and the United Kingdom, which have fairly liberal patent policies regarding hES cell inventions.
The authors of today's letter urge the court's judges to "deliberate on the full implications before making a legally binding ruling." Without industry following up on their discoveries, they say, "scientists working in stem-cell medicine will not be able to deliver clinical benefits. … But innovative companies must have patent protection as an incentive to become active in Europe."
Bot's opinion seems contrary to the European Union's own policies regarding stem cell research, says Austin Smith, director of the Wellcome Trust Centre for Stem Cell Research in Cambridge, U.K., and the letter's lead author. "We are doing publicly funded research, and we're expected to file patents," he says. "A lot of effort went in to reach a compromise about this difficult area [of science policy]. To throw that out and say that scientists are behaving immorally … is very damaging, not just to this particular area, but to science in general."
EuroStemCell, an E.U.-funded consortium of European stem cell researchers, has posted the letter on its Web site, inviting scientists and the general public to comment or sign on in support.