Posted on behalf of Meera Swami
LONDON — A group of leading stem cell biologists is raising alarm bells about how a landmark intellectual property decision that would make it illegal for European researchers to patent procedures involving human embryonic stem (ES) cell lines could do irreparable damage to European stem cell research.
The proposed prohibition “represents a blow to years of effort to derive biomedical applications from embryonic stem cells in areas such as drug development and cell-replacement therapy,” the 13 scientists write in today’s issue of Nature.
On 10 March, the court’s advocate-general concluded that “inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo.” The opinion is not legally binding. But the European Court follows the Advocate General’s advice in approximately 80% of cases, which has led the stem cell community to worry about the continent’s future competitive edge in regenerative biomedicine. Some scientists also fear that the opinion could prompt EU nations to tighten legislation on research involving embryos, or ban such work altogether.
Speaking yesterday at the Science Media Centre in London, Austin Smith, director of the Wellcome Trust Centre for Stem Cell Research at the University of Cambridge, UK, who spearheaded today’s letter, echoed many of the concerns raised in the correspondence. He challenged the advocate-general’s argument that patenting ES cell lines represents immoral commercialization of the human embryo. He noted that ES cell lines derived from surplus in vitro fertilized eggs can be maintained and proliferated indefinitely without the deliberate creation or destruction of embryos. What’s more, he argued that when scientists seek patents surrounding ES cells, they generally wish to protect the technology and methods used to manipulate the cells — not the cells themselves or any form of human life.
Smith and his colleagues also highlighted the need to preserve patent protection as an incentive for the drug industry to invest in stem-cell medicine. If all intellectual property relating to ES cells is fair game in Europe, they warned, multinational pharmaceutical companies might simply move their operations to another continent where they can patent their discoveries, all to the detriment of European biomedical innovation and the economy. “The real price will be paid in the future,” Smith said.
If the ban goes ahead, there could also be far-reaching consequences for patient care in Europe. Without patents, companies might be reluctant to carry out clinical trials using ES cells in Europe, and, further down the line, there may be difficulties licensing ES cell-based therapies in the continent, the scientists cautioned. This is especially pertinent as the first ES cell therapies are now entering clinical trials. For example, a team led by Pete Coffey at University College London is currently testing ES cell derivatives to treat age-related macular degeneration. According to Coffey, who also signed the letter, something that has been lost in advocate-general’s advisory is “the ethical need to treat disease.”