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By Joe Kirwin
BRUSSELS—A process developed for medical research that involves the removal of a stem cell from a human embryo but also leads to the destruction of the embryo cannot be patented, the European Court of Justice ruled Oct. 18.
In a decision (C-34/10) hailed by religious and environment groups but heavily criticized by scientists doing cutting-edge medical research in the stem cell field, the European Court of Justice ruled that an EU law concerning biotechnological inventions (EEC/98/44) was intended to exclude any possibility of “patent ability where respect for human dignity” could thereby be affected.
“The concept of ‘human embryo’ must be understood in a wide sense,” the ECJ said. “Consequently the ECJ concludes that scientific research entailing the use of human embryos can not access the protection of patent law.”
It added that this was particularly true for “a process that involves removal of a stem cell from a human embryo at the blastocyst stage and entails the destruction of that embryo.” The blastocyst stage occurs five days after fertilization.
The ECJ also ruled that an invention is excluded from being patented where the implementation of the process requires either the prior destruction of human embryos or their prior use as a base material, even if, in the patent application “the description of that process … does not refer to the use of human embryos.”
However, the ECJ also stated that EU law does not prohibit stem cell patenting for industrial or commercial purposes when it “concerns the use for therapeutic or diagnostic purposes that are applied to the human embryo and that are useful to it—for example to correct a malformation and improve the chances of life.”
The ruling stems from a legal challenge brought by the environmental group Greenpeace against Oliver Bruestle, who is the head of reconstructive neurology research at the University of Bonn. The German doctor obtained a patent on an invention involving the production of neural precursor cells produced from human embryonic stem cells used to treat neurological diseases.
The German patent court ruled that the Bruestle patent was invalid, and a German appeals court referred the case to the ECJ. The ECJ said that it was up to the German court to determine whether or not stem cells obtained by Bruestle from an human embryo at the blastocyst stage for his patented process are “capable of commencing the process of development of a human being and, therefore, are included within the concept of human embryo.”
Reacting to the ECJ ruling, Bruestle said, “With this unfortunate decision the fruits of years of transnational research by European scientists will be wiped away and left to the non-European countries. European researchers may conduct basic research which will then be implemented elsewhere in medical procedures that will eventually be re-imported to Europe.”
Earlier, a group of scientists sent a letter to the EU high court warning them not to follow the advice of the EU advocate general, who opined in April that patenting of the stem cells from destroyed embryonic stem cells was illegal.
“Embryonic stem cells are cell lines not embryos,” according to the scientists, more than 100 of whom signed the letter. “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.”
“Scientists working in stem-cell medicine will not be able to deliver clinical benefits without the involvement of the biological industry,” the scientists added. “But innovative companies must have patent protection as in incentive to become active in Europe.”
In direct contrast to the scientists' reaction, Peter Liese—a member of Germany's Christian Democratic party as well as a member of the European Parliament, who has a doctorate in human genetics—said that the ruling set clear ethical boundaries for the EU biotechnological invention legislation.
“We are in favor of research and development in biotechnology, but human beings must not be destroyed not even in the early stages of their development,” Liese said. “Since from now it will not be possible to get a patent on the research with embryos and embryonic stem cells, research will focus on fields that do not raise ethical concerns, i.e., on adult stem cells
“As opposed to embryonic research there are already more than 70 diseases that have been cured with adult stem cells,” Liese added. “That is why today is also a good day for patients.”
Various religious affiliated organizations such as the European Center for Law and Justice as well environmental groups led by Greenpeace also hailed the decision. The environmental groups welcomed the decision because they did not believe companies should be able to patent human life.
“Greenpeace is not anti-stem cell research” the environmental organization said in a statement. “Europe has outlawed patents on uses of human embryos for industrial or commercial purpose and this case aims to clarify the law as patents on such cells would encourage commercialization of human embryos. This decision clearly set clear limits to the commercialization of human life and we welcome it.”
The ECJ decision can be found on the ECJ web site at http://curia.europa.eu. Click on Case law and Search form, and then submit case No. C-34/10.
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