The claims of the application pertain to the first isolation of human embryonic stem cells (hESCs) by Dr. James Thomson at the University of Wisconsin.
The decision upholds the rejection of WARF’s claims as being impermissible under a rule of the European Patent Convention that prohibits the patenting of inventions which concern “the uses of human embryos for industrial or commercial purposes.”
In reaching its decision, the Enlarged Board of Appeals emphasised the fact that at the time that the priority patent application was filed (in 1995), the only method of obtaining hESCs, as described in the application, required the use of a human embryo. In contrast, following Thomson’s discovery, many hESC lines became widely available through stem cell banks, obviating the need for researchers to culture the cells from embryonic material. Therefore, this decision should not affect patent applications for later-developed hESC technologies, including technologies developed by Geron to enable scalable manufacture of hESCs for therapeutic and drug discovery applications, and their differentiation into a range of functional cell types, such a pancreatic islet cells and cardiomyocytes.
Indeed the EPO’s own commentary on the decision states that the “decision does not concern the general question of human stem cell patentability.” Furthermore the decision does not affect the patentability of hESCs in other jurisdictions, such as the U.S., that do not have similar restrictions on patentable subject matter. Moreover, some European countries, such as the U.K., explicitly permit the patenting of hESCs.
“While this result is not unexpected given the language of the EPC rule, given the narrow basis for the decision, it should have very limited impact on Geron’s ability to protect our hESC technologies in Europe,” said David J. Earp, J.D., Ph.D., Geron’s chief patent counsel and senior vice-president of business development.
“The facts underlying the decision are specific to the WARF patent application and, importantly, the EPO did not rule that hESC technologies in general are not patentable in Europe. We are optimistic that the EPO will now move to allow the backlog of Geron’s European patent applications that have been on hold pending this decision. These patent applications will underpin Geron’s proprietary position in Europe for both therapeutic and drug discovery applications based on hESCs.”
Geron has an extensive portfolio of patents covering hESC technologies, including Geron-owned patents covering technologies developed by Geron scientists, as well as in-licensed patents. Geron’s hESC patent portfolio includes
34 issued U.S. patents, 15 issued U.K patents and approximately 60 issued in other countries, as well as over 220 applications pending worldwide.