ECJ Bans the Patenting of hESCs: A New Frontier in Regulating R&D Activities in Europe
November 2011
Jacquelyn F. MacLennan, Mihalis Kritikos
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On 18 October 2011, the European Court of Justice (ECJ) rendered its decision regarding the patent-eligibility of human embryonic stem cells (hESCs), following the recommendation of the court's Advocate General that hESCs are not patent-eligible subject matter. The Court was asked to give its opinion on the legality of the patentability of the use of stem cell techniques exclusively for research. It ruled against the patentability of this particular type of research on the basis that such use of embryos 'is not patentable' and that 'the patenting of any processes, techniques and products in the European Union that involve stem cell research that involves destroying a human embryo on the basis of the fact that EU law protects human embryos from any use that could undermine their dignity'.
The judgment states that any fertilised human egg is an embryo, that scientific research does fall within the scope of industrial or commercial purposes, and that the ban applies to any procedure that draws on stem cells created by destroying embryos. The decision from the European Court of Justice is a legal clarification for a court case brought by Greenpeace against a German scientist who patented a way to turn stem cells into healthy brain cells. However, despite the widespread protection of human embryos offered by this particular decision, the court does not enter into the wider debate regarding the limits of scientific research, but simply provides a legal interpretation of the Directive on the legal protection of biotechnological inventions. It should be noted though that the Directive does not mention embryonic stem cells, as the technology did not exist when the directive was discussed and adopted in 1998.
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