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John Moore's cells are for sale as CRL-8066; a plasmid containing Moore's DNA sequence that codes for colony stimulating factor is sold as ATCC 39754.Google Scholar

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See 45 C.F.R. § 46.101 et seq. (1997).CrossRefGoogle Scholar

The Code of Federal regulations provisions governing federal research 45 CFR § 46.101 et seq. were adopted in 1974 as 45 C.F.R. 46. The provision that is the current 46.101(b)(4) was adopted in 1981.Google Scholar

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Einstein's brain tissue was tested for a genetic propensity to aneurysm. McCartney, S., “Believing Einstein's Brain Matters, Doctors Keep the Remains,” Asian Wall Street Journal, May 6, 1994. If such a propensity was found, it could have implications for his blood relatives – since their insurers might refuse to insure them based on this genetic flaw. “Einstein's Brain,” The Economist, April 2, 1994, at 82.Google Scholar

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The idea of benefit sharing has been addressed on numerous occasions in the international context. 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This prohibition, however, does not include agreements with individuals, families, groups, communities or populations that foresee technology transfer, local training, joint ventures, provision of health care or of information infrastructures, reimbursement of costs, or the possible use of a percentage of any royalties for humanitarian purposes.”); UNESCO, International Declaration on Human Genetic Data, October 16, 2003, at <http://portal.unesco.org/shs/en/ev.php-URL_ID=1882&URL_DO=DO_TOPIC&URL_SECTION=201.html> (last visited December 23, 2004)(Article 19: Sharing of Benefits: “...benefits resulting from the use of human genetic data, human proteomic data or biological samples collected for medical and scientific research should be shared with the society as a whole and the international community.” These benefits include “access to medical care,” “provision of new diagnostics, facilities for new treatments or drugs stemming from the research,” and “support for health services.”); UNESCO, Universal Declaration on the Human Genome and Human Rights, July 17, 2002 at <http://wwwl.umn.edu/humanrts/instree/Udhrhg.htm> (last visited December 23, 2004)(Article 12(a): “Benefits from advances in biology, genetics and medicine, concerning the human genome, shall be made available to all, with due regard to the dignity and human rights of each individual.”); 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This is especially true since international genetics research tends to target certain isolated populations that have greater genetic homogeniety and thus disease genes can be more readily identified since they stand out. The Pima Indians in Arizona, for example, have had a very high rate of diabetes. The Bedouins in Israel include many people with a congenital form of deafness, and the Amish have a high rate of apparently inherited depression. Rowe, P. M., “Lessons About NIDDM from the Pima Indians,” Lancet 347 (1996): 1320; Salopek, P., “Genes Offer Sampling of Hope and Fear; Cures Possible, but Groups Worry about Exploitation,” Chicago Tribune, April 28, 1997, at 1. Other targeted populations have been chosen as research subjects because their genes seem to protect them against specific diseases. People from the village of Limone Sur Gardi in Italy were relatively isolated until the 1950s because the road system was not nearby. They are of scientific interest because of the striking absence of heart disease in the population. Blood samples from the people, taken in 1994, revealed that thirty citizens had a unique gene that protected them from arterio-sclerosis and, therefore, from heart disease. Salopek, P., “Basically, We Are All the Same; Controversial Genetic Quest is Unlocking Secrets of the Human Rainbow,” Chicago Tribune, April 27, 1997, at 1; Goetnick, S., “Artherosclerosis Prevention a la Milanese,” Harvard Health Letter (May 1996). The Cherokee of Oklahoma seem resistant to Alzheimers. Risser, R. C. et al. , “Genetic Factors for the Development of Alzheimer's Disease in the Cherokee Indians,” Archives of Neurology 997–1000 (1996); and the Hagahai from Papua, New Guinea are resistant to a leukemia-causing virus, HTLV. Taubes, G., “Scientists Attacked for Patenting Pacific Tribe,” Science 270 (1995): 1112. Elderly Chinese people are genetically interesting as research subjects because of their unusual longevity. Dang, Z. and Lei, X., “Chinese Center Sues over Study Coverage,” Science 283 (1999): 1990–1992. The genes of all these groups are potentially valuable resources.Google Scholar

When Sharon Terry learned that her two young children had inherited PXE (pseudoxanthorma elasticum), a connective tissue disorder that leads to blindness and potential heart attacks, several groups of researchers called to ask for tissue samples from her children to try to find the gene. Fleischer, M., “Seeking Rights to Crucial Gene,” The National Law Journal, June 25, 2001, at C1. She inquired as to why they did not get samples from other researchers and was told that scientists would not share the samples. Terry started a bank with tissue samples from her children and began a collaborative project with researchers. When University of Hawaii pathobiologist Charles Boyd isolated the gene, he listed Sharon Terry as a co-inventor on the patent. The PXE patients' group she formed will make the decisions about how to license the rights to the gene. Additionally, the PXE group will give 50% of the resulting royalties to the University. This way the PXE patients' group can keep the price of diagnostic tests down by licensing providers who charge a lower fee.Google Scholar

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See University of Colo. Found, v. American Cyanamid, 153 F. Supp. 2d 1231, 2001 U.S. Dist LEXIS 10679 (D. Colo., 2001) for disgorgement of patent royalties in an unjust enrichment context.Google Scholar

Greenberg v. Miami Childrens Hospital, 264 F. Supp. 2d 1064, 1070 (S.D. Fla. 2003).Google Scholar

For example, there is a question about whether a person can have a property interest in his or her tissue.Google Scholar

As a report of a committee of the National Academy of Sciences on genetic research notes, “It is not ethically or legally acceptable to ask research participants to ‘consent’ to future yet unknown uses of their identifiable DNA samples.” Evaluating Human Genetic Diversity (Washington, D.C.: National Academy Press, 1997): At 65.Google Scholar

U.S. Members of Congress Lynn Rivers and David Weldon introduced such a bill covering health care providers and non-commercial researchers in 2002, the proposed Genome Research and Diagnostic Accessiblity Act. Andrews, L. B., “Genes and Patent Policy: Rethinking Intellectual Property Rights,” Nature Reviews Genetics 3 (2002): 803–808, at 806.CrossRefGoogle Scholar