The process to harvest human embryonic stem cells (hESC) may be old news in the scientific community; however, the issues raised by this area of science continue to be debated in law and politics.
The moral and social arguments for and against embryonic stem cell research are well documented. Proponents argue that stem cells, derived from embryos, hold the most promise for developing therapeutic treatments and diagnostics due to their ability to differentiate into any type of human tissue. Opponents counter that harvesting stem cells from an embryo necessitates the destruction of the embryo and therefore the destruction of human life. As such, the challenge for governments and authorities has been to balance the rights of a human embryo to life against the medical potential of stem cell research for the rest of humanity.
Besides laws that explicitly prohibit certain types of hESC research, governments have also indirectly influenced research in this area. In the United States, the Bush administration passed a bill in 2001 prohibiting taxpayer funding for research on hESC cell lines that were not already in existence. It was rationalized that federal funding should still be provided for the 60 stem cell lines that had already been developed because "the life and death decision has already been made".
Similarly in 2006, the European Union confirmed that "projects which include research activities which destroy human embryos, including for the procurement of stem cells," would not be eligible for EU funding. However, mirroring the US, the EU also said it "[will] not prevent the Community funding of subsequent steps involving human embryonic stem cells."
Another indirect method of influencing and controlling research is through the granting of patents. The US Patent and Trademarks Office (USPTO) has already granted a number of patents to Wisconsin Alumni Research Foundation (WARF) that have withstood repeated attacks, the most recent in March 2008.
In contrast, the European Patent Office (EPO) has rejected, on multiple occasions, WARF's patent for a primate stem cell line. A recent decision by the EPO's Enlarged Board of Appeal held that WARF's patent application for an hESC line was invalid because "the use of a human embryo as starting material for the generation of a product of industrial application [is] prohibited".
The Board's decision relied on Rule 28(c) in conjunction with Article 53(a) EPC 1973. Rule 28(c) states:
Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern ...(c) uses of human embryos for industrial or commercial purposes"
Article 53(a) further specifies that:
European patents shall not be granted in respect of:
(a) inventions the publication or exploitation of which would be contrary to "ordre public" or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
In their decision, the EPO said that because of their wording, Rule 28(c) and Article 53(a) not only apply to patent claims, but the invention as a whole. Though WARF's claims were for a stem cell line, the technical teachings of the patent application to acquire these stem cells necessitated the use and destruction of an embryo and were therefore part of the invention. As such, WARF's application is caught by Rule 28(c) and Article 53(a).
The Board went on to say that because the invention requires the destruction of an embryo, something contrary to "ordre public" or morality, it is considered exploitation under Article 53(a). The Board concluded that because a monopoly would be granted for the cell line and excludes others from making or using the product, this would be considered commercial exploitation.
It should be questioned, however, if granting a patent truly results in the commercialization of embryos. The majority of hESC lines (including all of those endorsed by the US National Institute of Health) were developed from excess embryos which were donated by patrons of In-vitro Fertilization (IVF) clinics and would have been otherwise destroyed. It could be argued, however, that stem cell lines are a derivative product of embryos and that by selling hESCs it is indirectly commercializing embryos. By that logic, would the EPO not grant a patent for a drug as it too may be considered a derivative if it was tested on tissues differentiated from hESCs?
Another important fact is that stem cell lines could theoretically divide and remain undifferentiated in perpetuity given the correct environmental conditions. This means that once the stem cells are harvested from an embryo, most likely no additional embryos will need to be destroyed. Can the commercial exploitation of embryos really be said to occur when only one is destroyed as opposed to requiring an embryo for every stem cell?
In the short term, the EPO's decision may actually frustrate the purpose of laws that are meant to prevent the destruction of human embryos. By not granting a patent to WARF, other researchers who require this stem cell line are now free to create their own. This would necessitate the acquisition and destruction of additional embryos and the demand may even cause a market for embryos to develop. On the other hand, if a patent was granted, then researchers would be forced to acquire their stem cells from WARF and this would reduce the number of embryos that would need to be destroyed.
The fact that certain jurisdictions, such as the US, have granted multiple patents and made the teachings available to the public, while other jurisdictions such as Europe have not, has also arguably resulted in an exodus of U.S. scientific talent and funding to offshore locales.
The only saving grace of the EPO's decision may be the long-term effect on scientific research in this area. By not granting a patent in this case, the EPO is discouraging innovation (and experimentation) in developing stem cell lines from embryos, and encouraging research in stem cell harvesting from alternative sources that are not plagued by the same moral issues. That said, how many important hESC lines will be developed that, because of the lack of patent protection, will be kept secret and used internally by their inventors instead of being shared with the scientific community for the health of mankind?