Viewing the issue as a matter of morality, the advocate general of the European Court of Justice (ECJ) recently delivered a non-binding ruling that would render unpatentable the cells removed from the human embryo at the blastocyst stage, because the removal involves the embryo’s destruction. Case C-34/10, Brüstle v. Greenpeace eV, Op. of Adv. Gen’l (Mar. 10, 2011).
The issue arose in a case involving Greenpeace’s action to annul a German patent concerning “isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects.” A German patent court declared the patent invalid, and the patent holder filed an appeal, which was stayed pending the resolution of questions referred to the ECJ.
The advocate general, whose rulings do not bind the ECJ but are considered influential, concluded that “an invention must be excluded from patentability, in accordance with that provision, where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.” The ruling also included in the “concept of a human embryo” an “unfertilised ova into which a cell nucleus from a mature human cell has been transplanted or whose division and further development have been stimulated by parthenogenesis . . . insofar as the use of such techniques would result in totipotent cells being obtained.” The advocate general did not include “pluripotent embryonic stem cells” in the human embryo concept, because “they do not in themselves have the capacity to develop into a human being.”
The ruling triggered a call by research scientists in an open letter published in Nature to urge the court to consider the “full implications before making a legally binding ruling.” They contend that (i) stem-cell researchers need patent protection “to become active in Europe”; (ii) “[e]mbryonic stem cells are cell lines, not embryos. 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”; (iii) no suitable alternatives exist to using the stem cells currently undergoing their first clinical trials; and (iv) “[t]he advocate-general’s opinion . . . represents a blow to years of effort to derive biomedical applications from embryonic stem cells in areas such as drug development and cell-replacement therapy.” See Reuters, April 27, 2011; EuroStemCell.org Press Release, April 28, 2011.