Patenting Human Embryonic Stem Cells in the United States: The Legal and Ethical Debate

Abstract:     
This article explores the legal and moral implications surrounding human embryonic stem cells (HESCs). Derived from human embryos that have been artificially fertilized but not yet implanted in a woman's uterus, HESCs are capable of giving rise to cells found in all tissues of the body. Public awareness of stem cell technology's enormous potential ignited in November 1998, when University of Wisconsin biologist Dr. James Thomson and his team announced that they had successfully isolated and cultured HESCs. The Wisconsin Alumni Research Foundation (WARF), the licensing arm of Dr. Thomson's employer, owns a broad portfolio of U.S. patents directed to the fruits of Thomson's work in primate/human embryonic stem cells. WARF contends that its patents "apply to all human embryonic stem cells in the United States." Despite WARF's policy of granting free licenses for academic research use of the patented cells, the patents' existence and their licensing and commercialization have proved controversial. As detailed in this article, the United States Patent and Trademark Office is currently reexamining three of WARF's fundamental patents on HESCs, signaling that substantial new questions exist concerning the patents' validity.

Keywords: Patent law, human embryonic stem cells, HESCs, stem cell research, United States Patent and Trademark Office, USPTO, Wisconsin Alumni Research Foundation, WARF, Dr. James Thomson, morality

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