European Agency Rules Against Human Embryonic Stem Cell Patents

Reuters, November 27, 2008

In a decision that pleases embryonic stem cell critics and displeases embryonic stem cell advocates, European regulators have ruled not to allow patents on anything related to human embryonic stem cells. The decision is seen simultaneously as ethically sound but commercially discouraging to business ventures that seek economic profit from embryonic stem cells - which is all the more reason why the decision is applauded by opponents of embryonic stem cells.

Not only did the European Patent Office rule against allowing patents for embryonic stem cells, but an appeal panel at the European Patent Office also upheld a June decision to reject a patent application that was filed for the use of embryonic stem cells by the Wisconsin Alumni Research Foundation in 1995. At that time, Dr. James Thomson of the University of Wisconsin at Madison became the first person to isolate embryonic stem cells, first from a monkey in 1995 and then from a human in 1998. Although both processes were patented in the U.S., the patent that was issued for the human embryonic stem cells has since been challenged.

Embryonic stem cells are highly controversial since the destruction of an embryo is required to harvest the embryonic stem cells, and many opponents of embryonic stem cell research believe that it is unethical to destroy an embryo. There are many opponents of embryonic stem cell research, however, who oppose the research for reasons which have nothing to do with ethics, and everything to do with science. Politics and ethics aside, embryonic stem cells are notoriously problematic in the laboratory and have not been developed into clinical therapies primarily for scientific, not ethical or political, reasons. Among their numerous inherent risks, embryonic stem cells cause the formation of teratomas, which are a very specific, and hideous, type of tumor. Indeed, the ability of a cell to form a teratoma is, by definition, the global laboratory test by which embryonic stem cells are identified and distinguished from other types of cells: if a cell is capable of forming a teratoma, then it is recognized as an embryonic stem cell or as some other type of pluripotent cell, whereas if a cell is not capable of forming a teratoma, then it is neither an embryonic stem cell nor any other type of pluripotent cell. The ability of a pluripotent cell to form the type of tumor known as a teratoma is part of the formal, scientific definition of pluripotency, and as such this definition is universally understood among stem cell scientists to apply to all embryonic stem cells. Indeed, teratoma formation is one of the key, defining traits of embryonic stem cells. Adult stem cells, by contrast, which are not pluripotent but instead are multipotent, and therefore do not form teratomas, are ethically noncontroversial and scientifically non-problematic and have already been used in a multitude of clinical therapies for years.

For biotech companies seeking monetary gain from the booming stem cell industry, European investors will now be reluctant to invest money in embryonic stem cell research without the existence of any laws for patent protection. According to a statement issued by the European Patent Office, "European patent law prohibits the patenting of human stem cell cultures whose preparation necessarily involves the destruction of human embryos. That is the decision reached by the Enlarged Board of Appeal of the European Patent Office."

If ethical and scientific considerations, such as the risk of teratoma formation, are not enough, per se, to dissuade investment in embryonic stem cell research, perhaps economic considerations will be. The recent ruling by the European Patent Office, for example, just might offer more investors the incentive that they need to put their money into other, more viable, sectors, such as adult stem cell research - which is already paying hefty dividends to its supporters and patients, financially as well as medically.