CJEU Ponders hESC Patentability
This application of the law has been challenged by Greenpeace in Brüstle v. Greenpeace, which has sought to invalidate a patent granted to Oliver Brüstle, Ph.D., a professor at the University of Bonn Medical Centre. The patent in question relates to neural precursor cells and methods for their production from hESCs. Proceedings were brought before the German courts, but as the case concerned an interpretation of European law, the case was referred to the Court of Justice of the European Union (CJEU), the highest court in Europe. Specifically, the CJEU was asked to provide guidance on a series of questions:
• What is meant by the term “human embryos” in the relevant prohibition; does it include all stages of the development of human life, beginning with the fertilization of the ovum, or must further requirements such as the attainment of a certain stage of development be satisfied?
• What is meant by the expression “uses of human embryos for industrial or commercial purposes?”
• Is technical teaching to be considered unpatentable even if the use of human embryos does not form part of the technical teaching claimed with the patent but is a necessary precondition for the application of that teaching, because the patent concerns a product whose production necessitates the prior destruction of human embryos, or because the patent concerns a process for which such a product is needed as base material?
The procedures of the CJEU require that, before the court reaches a decision but after the case is heard, the Advocate General (AG) must publish his or her view of the case. On March 10, AG M. Yves Bot published his opinion.
The AG did not attempt to decide between different philosophies or religion but instead based his conclusions on an analysis of the law. In doing so, he concluded that the concept of a human embryo applies from fertilization to the initial totipotent cells and to the entire ensuing process of the development of the human body, including the blastocyst. This therefore covered all totipotent cells, as well as unfertilized ova into which a mature cell nucleus has been transplanted or which has been stimulated by parthenogenesis. However, an isolated pluripotent cell was not an embryo, and so an hESC was not in itself an embryo.
The AG also reaffirmed that patents to hESCs are only allowable if they are not obtained to the detriment of an embryo. In the AG’s view, though, it is not acceptable to ignore the origin of a pluripotent cell, the way it has been isolated, and the consequences of such isolation. In AG Bot’s opinion, even though the claims of the patent did not mention the use of human embryos, in fact the use of human embryos was a necessary precursor to the exploitation of the invention claimed by the patent.