The environmental group Greenpeace has won its battle in Europe to prevent the patenting of human embryonic stem (hES) cells. Processes and products that involve such cells are not patentable in the European Union, according to a ruling today from the Court of Justice of the E.U. Such patents are forbidden by a 1998 E.U. Directive that bans the "use of human embryos for industrial or commercial purposes," the court concluded. Many stem cell scientists who believe the ruling will discourage investment in the therapeutic applications of ES cell research reacted with dismay to the ruling, but the ultimate implications are far from clear. Some patent law experts have said the impact may be limited. It is also possible that the ruling could instead increase hES cell work in Europe, since the region will be free of intellectual property hurdles.
The ruling involved a case brought by Greenpeace in 2004 against a German patent granted to neuroscientist Oliver Brüstle in 1999. That patent covers methods for turning mammalian ES cells into neural precursor cells. Greenpeace challenged the patent, arguing that it amounted to commercialization of human embryos, and the German Federal Patent Court agreed, saying the patent was invalid for applications using human cells since the starting material would be hES cells. Brüstle, who works at the University of Bonn, appealed the decision to the German Federal Court of Justice. That court referred the case to the European Court of Justice, asking it to decide several questions, including what the E.U. law means when it refers to "human embryos," and whether the ban also covers patents that don't involve embryos directly but where the use of embryos "is a necessary precondition" for the covered process or product.
The 14-judge panel ruled that the term "human embryo" in the European Patent Directive covers "any human ovum after fertilization" as well as the product of a nuclear transfer experiment or a parthenote—an unfertilized egg that is prompted to start dividing. It referred the question of whether human ES cells are embryos back to the German court. The court also ruled that if "the subject matter of the patent application requires the prior destruction of human embryos or their use as base material," the application is not patentable.
Greenpeace's patent advisor Christoph Then welcomed the decision. "The court has clearly strengthened protection of human life over economic interests," he said in a statement. Initial reaction from Brüstle and many other stem cell scientists, on the other hand, was disappointment. "It's a disaster," Brüstle says. "It leaves European scientists with just basic research. They have to watch as their research gets made into treatments around the world. It's a very discouraging message for young researchers."
But other observers say the impact may be relatively minor. Europe-based companies can still file for patents in the United States and other countries where such protection is allowed. And any therapies using ES cells will have to go through significant regulatory hurdles before they are approved for use in Europe, notes Alexander Denoon, of the London law firm Lawford Davies Denoon, which specializes in biotechnology patents. "Under the current regulatory framework, it will be virtually impossible to convince a regulator to approve a generic," he said in a statement. "Thus the regulatory protection for approved medicines will be very high."
The court's ruling is likely the final word on the matter, says Clara Sattler de Sousa e Brito, one of Brüstle's lawyers. For another case to reach the European court, a country would have to argue that something about today's ruling was not clear, which will be difficult, she says. "The only possibility for getting around this judgment is to change the law."