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By Joe Kirwin
July 18 --European Union member states should be allowed to deny for “ethical and moral” considerations patents to companies that produce stem cells even though the technology falls outside the EU Biotechnology Directive restrictions on inventions using the human body in any stage of development, said the legal adviser to the EU's highest court.
European Court of Justice Advocate General Pedro Cruz Villalon, whose opinions are not binding on the court but adhered to 80 percent of the time, said the Biotechnology Directive (EEC/98/44) only “expresses a minimum, EU-wide prohibition.”
“This does not prevent a member state from excluding parthenotes from patenability on the grounds of ethical and moral considerations,” he said. “By excluding human embryos from patentability, the directive only expresses a minimum, EU-wide prohibition, whilst allowing the member states to extend the prohibition of patentability to other organisms on the basis of ethical and moral considerations.”
The case at issue (C-364/13) involved a patent request by the U.K.-based International Stem Cell Corp. to the U.K. Intellectual Property Office for two patents for a technology that produces pluripotent stem cells, which can develop into all cells that make up the human body but not the embryonic tissue that can develop into the human body. The technology produces the pluripotent stem cells from “parthenogentically-activated oocytes.”
The U.K. IP office rejected the patent request on the grounds that the inventions “entail uses and even the destruction of human embryos and are therefore not patentable based on a previous ECJ ruling (C-34/10) that any non-fertilized human ovum whose development has been stimulated by parthenogenesis and which is capable of commencing the process of development of a human being constitutes a human embryo.”
The U.K. company appealed the decision, saying that as the “activated oocyte,” in the absence of paternal DNA, is not capable of becoming a human being, the restrictions of the ECJ ruling do not apply to its technology.
The U.K. court referred the case to the ECJ asking whether unfertilized human ova whose development has been stimulated by parthenogenesis and which are not capable of becoming human beings should be considered as human embryos.
The ECJ legal adviser emphasized the “inherent capacity” of an ova becoming a human being. That, he said, is “the decisive criterion.”
A ruling from the court is expected in the coming months.
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For the full opinion of the ECJ advocate general, go to the court's website at http://curia.europa.eu, click on the search form and submit case number C-364/13.
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