The Court of Justice of the EU (CJEU) has recently issued a decision clarifying the situation on patentability, in Europe, of inventions relating to human embryonic stem cells. In the decision it is declared that the concept of a “human embryo”, the exploitation of which is excluded from patentability according to the EU Biotechnology Directive 98/44/EC, should be understood in a wide sense. This implies that patents relating to human embryonic stem cells will likely be more difficult to obtain, or at least enforce, also in more embryonic stem cell friendly states of the EU.
The case (C-34/10) pertains to a method and cells invented and patented by Oliver Brüstle, Professor of Reconstructive Neurobiology at the University of Bonn. Professor Brüstle invented a method for converting human embryonic stem cells into neural precursor cells, which can be used for the treatment of a range of neurological disorders, such as Parkinson’s disease. The embryonic stem cells used in the method of Professor Brüstle were cells isolated at the blastocyst stage. Thus, they were pluripotent but not totipotent, i.e. they had the ability to develop into all cell types of a human, but were not able to develop into a human being since they could not form extra-embryonic tissue, such as the placenta.
The patent was opposed by Greenpeace in Germany, and the case was subsequently referred by the German Federal Court to the CJEU. In its decision, the CJEU provides an interpretation of Article 6 of the European Biotechnology Directive (98/44/EC), which states that inventions related to ”use of human embryos for industrial and commercial purposes” shall be considered unpatentable.
Three main points are made:
1. The term “human embryo” should be understood in a broad sense.
According to the Court, the purpose of Article 6 of the European Biotechnology Directive was to ensure exclusion from patentability where respect for human dignity could be affected. Thus, any cell or organism that is capable of commencing the process of developing into a human being must be considered a “human embryo” within the context of the Directive.
The Court explicitly mentions that a fertilised ovum, a non-fertilised ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division is stimulated by parthenogenesis all must be considered “human embryos”.
Regarding the pluripotent cells of Professor Brüstle’s invention, the Court notably held that it is for the referring court to decide whether a stem cell obtained from a blastocyst is capable of commencing the process of developing into a human being and therefore would fall within the definition of a “human embryo”. It is thus left to the national courts to decide on the patentability of blastocyst-derived, pluripotent stem cells, as long as the capability of the cells to develop into a human being is considered. The evaluation of patentability should also be made “in light of scientific development” and may therefore vary over time. This might have the rather interesting effect that the more technology in this field progresses, the less of the same technology constitutes patentable subject-matter.
2. The use of human embryos in scientific research is excluded from patentability.
The Court states that the use of human embryos for purposes of scientific research cannot in this context be distinguished from industrial and commercial use. Consequently, the Court concludes that scientific research entailing the use of human embryos cannot access the protection of patent law.
3. Inventions that require the destruction of human embryos are excluded from patentability.
In the case of Professor Brüstle, the patent specification does not mention the use or destruction of human embryos or blastocysts to obtain pluripotent stem cells. The Court, however, holds that an invention is excluded from patentability where its implementation requires either destruction or prior use of human embryos, even if the patent application does not explicitly refer to this use. Also, the Court states that the fact that destruction may occur at a stage long before the implementation of the invention, e.g. as is the case with embryonic stem cell lines, is irrelevant.
In conclusion, the CJEU interprets the term “human embryo” broadly, such that all cells that are capable of developing into a human being are excluded from patentability. Whether pluripotent human stem cells fall within this definition or not is left for the national courts to decide and may vary from case to case. In addition, only embryonic stem cells that are obtainable by methods that do not involve use or destruction of human embryos can be patentable. As is pointed out in the decision, inventions that are for therapeutic or diagnostic purposes which are applied to the embryo and are useful to it remain patentable.
Although the decision is not binding on the European Patent Office (EPO), it is binding on the EU member states, and will consequently most likely be followed by the EPO examiners in the grant procedure of European patent applications. Of note, the Enlarged Board of Appeal of the EPO has also, in decision G 2/06, reached the same conclusions as above with regard to points 2 and 3.
So what are the implications of this decision? On the one hand it might be sound that the economic incentives for developing therapies involving the destruction of embryos are reduced, and that the funding of such research will be more dependent on sources under public control. On the other hand, such research, which has the potential to be of immense benefit for patients with various serious diseases, might be more efficient when carried out with private funding. How this decision will affect the development of therapeutic methods based on embryonic stem cells thus remains to be seen.
Maria Malmqvist, Associate, Awapatent