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Challenges to Stem Cell Patents in Europe and the U.S.

By A. Antony Pfeffer and John Murray
November 29, 2007

Recently, scientists have announced the discovery of how to convert human skin cells into stem cells. Gina Kolata, Man Who Helped Start Stem Cell War May End It, N.Y. TIMES, Nov. 22, 2007, at A1. Stem cells are cells with the nascent ability to grow into fully formed organisms. Certain types of human stem cells have the potential to grow into individual human beings, which has resulted in a great deal of controversy surrounding stem cell research. Many individuals, as well as certain organizations, particularly religious organizations, see human stem cell research as a fundamental challenge to human dignity and the sanctity of life. This debate has affected patent law in Europe, to the extent that inventions based on certain kinds of research may be excluded from patentability. However, new methods of stem cell research, such as the recent conversion of skin cells into stem cells, may escape the ethical barriers that currently exist in European patent law. In addition to their potential ability to sidestep the ethical barriers to patenting stem cells, these new research approaches can open new scope for researchers to perform stem cell research in the United States.

European Ethical Regulations

At this time, in Europe, researchers are restricted in their ability to obtain patents on their research because of ethical regulations that bar the patenting of the 'human embryo.' Under Rule 23d(c) of the European Patent Convention, the patenting of biotechnological inventions is prohibited for uses of human embryos for industrial or commercial purposes. This regulation derives from Article 53(a) of the European Patent Convention, which prohibits patenting inventions contrary to morality or 'ordre public.' The European Patent Office ('EPO') has taken a broad interpretation of this prohibition, and thus has excluded from patentability both patents that cover processes of extracting human stem cells from human blastocysts and patents covering human embryonic stem cell lines.

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