One of the questions that the European court is tasked with answering is whether the term “human embryos” includes all stages of development. [© Joseppi - Fotolia.com]
For some time now in Europe there has been a limited availability for patents to human embryonic stem cells (hESCs). A pending court case, however, may now lead to a total ban on such patents. The morality of allowing such patents has been thrust into the spotlight, with eminent scientists and activist groups wading into the debate.
In Europe patents are prohibited for inventions that are contrary to morality. While this is a general prohibition applicable across all technical fields, such objections primarily arise in relation to certain aspects of biotechnology. There are several technical areas that are specifically excluded from patentability on the basis that these technical aspects are inherently contrary to morality. One such exclusion is patents for inventions comprising “uses of human embryos for industrial and commercial purposes.” It is this provision that has created difficulties in obtaining patents for hESCs.
The issue first arose at the European Patent Office (EPO) in the WARF decision, which prohibited patents that claimed products that “could be prepared exclusively by a method that necessarily involved the destruction of the human embryo from which said products are derived, even if the method is not part of the claims.” Whether or not the hESC could be prepared exclusively by a method involving the destruction of an embryo was assessed based on the filing date of the patent.
So if at the time of filing the hESC claimed in the patent could only be obtained by destroying an embryo, no patent would be granted. However, if at the date the patent was filed the hESC could be made from a pre-existing cell line then a patent could be allowed. This was the case even if the pre-existing cell line had ultimately been produced by a method involving the destruction of an embryo.
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.
AG Tending Toward Ban
The AG thus concluded that an invention must be excluded from patentability 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 AG’s conclusions as to the meaning of the term embryo and the exclusion of patentability are not in themselves incompatible with the current legal position under the WARF ruling. However, an interpretation of the AG’s reasoning underpinning his conclusion is that hESCs are unpatentable, even when derived from pre-existing cell lines rather than directly from embryos because the creation of the cell lines would have necessitated the destruction of an embryo.
We now await the decision of the CJEU itself. Only the CJEU’s judgment will have legal effect, and it is not obliged to follow the AG’s opinion, although it does so about 80% of the time. There is significant concern within Europe about the consequences if the CJEU does follow the AG’s opinion. It would be seen as a disincentive for European research into human cell therapies, and not just hESCs, since potentially any human cell as well as the uses of that cell would be unpatentable if the cell line was derived from an hESC.
This concern was expressed by 13 leading scientists in a letter to Nature, calling on the CJEU to reject the AG’s opinion. Austin Smith, director of the Wellcome Trust Centre for Stem Cell Research in Cambridge and one of the authors of that letter has stated, “This will put Europe at a huge disadvantage. It will wipe out the European bioindustry in this area. It will also cause the governments and the European Commission to say, ‘why should we be funding research in this area anymore? There’s nothing that can be protected.’”
In contrast, Christoph Then, speaking on behalf of Greenpeace, said, “We want clarification that the industrial and commercial use of human embryos is not encouraged. There needs to be some kind of specific protection for human embryos in European patent law.”
There is no date set for the CJEU’s judgment, although it is likely to be later this year, possibly in the next few months. Whatever the CJEU decides, its judgment will attract criticism, but it remains to be seen from which side of the argument.