Harnessing the Benefits of Biobanks

Biotechnology Industry Organization, Biotechnology Industry Facts, at <http://www.bio.org/speeches/pubs/er/statistics.asp> (last visited December 23, 2004).

Biotechnology Industry Organization, Biotechnology Industry Facts, at <http://www.bio.org/speeches/pubs/er/statistics.asp> (last visited December 23, 2004).

Watson J. A. , “Embryonic Stem Cell Lines Derived From Human Blastocysts,” Science 282 (1998): 1145–1147.

“Incarnate” exhibition in Gagosian Gallery, New York City: Catalog (New York: Gagosian, February, 1998).

“Fetus Earrings Made to Promote Debate Says Artist,” Daily Telegraph (London), February 8, 1989, at 3.

“Korperwelten,” Catalog of the exhibit at the State Museum of Technology and Labor (Mannheim, October 30, 1997, to February 1, 1998); see also, Andrews E. L. , “Anatomy on Display and It's All Too Human,” New York Times, January 7, 1998, at A1.

National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (Rockville, MD: National Bioethics Advisory Commission, 1999).

Wadman M. , “Privacy Bill Under Fire From Researchers,” Nature 392 (1998): 6.

American Tissue Culture Catalogue, at <http://www.atcc.org> (last visited December 23, 2004).

See, e.g., World Data Center for Microorganisms, at <http://wdcm.nig.ac.jp/DOC/menu3.xml> (last visited December 23, 2004).

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.

Marshall E. , “Whose DNA is it anyway?” Science 278 (1997): 564–567.

Andrews L. and Nelkin D. , Body Bazaar (New York: Crown Publishers, 2001): at 9–11; see also Witelson S. F. Kigar D. L. , and Harvey T. , “The Exceptional Brain of Albert Einstein,” Lancet 353 (1999): 2149–2153, at 2150.

The Nuremberg Code states that “the voluntary consent of the human subject is absolutely essential.”

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

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.

MacKay C. and Schatz G. S. , “The Unfinished Research Agenda,” presentation to the National Institutes of Health Inter-Institute Bioethics Internet Group, June 7, 2004. This has led the Secretary of Health and Human Services to release a new guidance, “Financial Relationships and Interest in Research Involving Human Subjects: Guidance for Human Subjects Participation.”

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.

Jewish tradition maintains that as man was created in the image of God, in death the body should retain the unity of that image. Lamm M. , The Jewish Way in Death and Mourning (New York: Jonathan David Publishers, 1969): at 10. If parts are removed, they must be returned and buried with the body. Kohn v. United States, 591 F.Supp. 568 (E.D.N.Y. 1984), citing Rosner Fred , “Autopsy in Jewish Law and the Israeli Autopsy Controversy,” in Rosner F. and Bleich J. D. (eds.), Jewish Bioethics (New York: Hebrew Publications, 1979): At 332. Court cases have recognized that a patient's religious beliefs should be taken into consideration in determining what is proper handling of their bodies. See, e.g., Lott v. State of New York, 32 Misc. 2d 296, 225 N.Y.S.2d 434 (Ct. Cl. 1962).

In fact, when Menorah Gardens and Funeral Chapels lost an amputated leg of an Orthodox Jewish woman, it made a $1.25 million lawsuit settlement with her daughter. “Orthodox Jews believe that at the end of time, not only will a person's soul be resurrected, but the body as well…. It's important that the whole body, including blood, be buried.” Fitzgerald H. Jr. , “Woman Awarded $1.25 million in Suit; Funeral Home Must Compensate for Losing Mother's Amputated Legs,” Sun-Sentinel (Fort Lauderdale), May 16, 1997, at 1B.

See LaFee S. , “Einstein's Mind: His Brain Sits on a Shelf, Largely Unsought by the World,” The San Diego Union-Tribune, May 17, 1995, at E1.

Riding J. In, “Without Ethics and Morality: A Historical Overview of Imperial Archaeology and American Indians,” Arizona State Law Journal 24 (1992): 11–34, at 11, 13.

Prior to the 1980s, if a university or federal researcher discovered or invented something using federal funds, that advance belonged to the public. The researchers could not personally profit. But with the passage of the Bayh-Dole Act, and the Stevenson-Wydler Act in 1980, and the Federal Technology Transfer Act, in 1986, the rules changed completely.

These legal measures were enacted to encourage the commercial development of government-funded research. The Bayh-Dole Act allows universities and non-profit institutions to apply for patents on federally-funded inventions and discoveries and provides significant tax incentives to companies investing in academic research. 35 U.S.C. § 200–211 (2004). The Technology Transfer Act allows researchers in government facilities, including scientists at the National Institute of Health, to patent their inventions, and keep up to $150,000 of the yearly royalties on top of their government salaries. 15 U.S.C. § 3710c (a) (3) (2004). The law allows government researchers to enter into commercial arrangements (known as CRADAs – cooperation research and development agreements) with for profit companies. 15 U.S.C. § 3701–3714 (2004).

Overnight, behavior that would have sent federally-funded university researchers to the penitentiary in the 1960s and 1970s – personally profiting from research done on taxpayers' expense – was not only legal, but encouraged. See Hayflick L. , “Novel Techniques for Transforming the Theft of Mortal Human Cells Into Praiseworthy Federal Policy,” Experimental Gerontology 33 (1998): 191–207, at 204. Largely as a result of these legal changes, NIH patent applications increased nearly 300 percent. See Krimsky S. , “The Profit of Scientific Discovery and its Normative Implications,” Chicago-Kent Law Review 75 (1999): 15–39, at 22. But not all political leaders were convinced it was a wise move. Then-Congressman Al Gore argued that the arrangement was akin to “selling the tree of knowledge to Wall Street.” Shulman S. , Owning the Future (New York: Houghton Mifflin Company, 1999): At 114.

Reilly P. R. Boshar M. F. , and Holtzman S. H. , “Ethical Issues in Genetic Research: Disclosure and Informed Consent,” Nature Genetics 15 (1997): 16–20.

Washington H. A. , “Henrietta Lacks – An Unsung Hero,” Emerge, October 1994, at 29.

Moore v. Regents of University of California, 51 Cal. 3d 120, 132–133, 793 P.2d 479, 486, 271 Cal. Rptr. 146, 153 (1990) (physician/researcher had a duty of informed consent to disclose that he was undertaking research and that he was commercializing it).

Id. at 130.

Fla. Stat. Ann. § 760.40 (1995).

American Society of Human Genetics, “Statement on Informed Consent for Genetic Research,” American Journal of Human Genetics 59 (1996): 471–474.

American Medical Association, Code of Ethics, E-2.08, at <http://www.ama-assn.org/ama/pub/category/2512.html> (last visited December 23, 2004).

See Chisholm R. , “Protocol Title: Gene-Disease Association and Treatment Outcomes,” September 18, 2002 (on file with author).

In 2002, Ardais earned over $4 million in subscription and licensing revenue for the library, with revenue projections set at $18 million for 2004. Connolly A. , “Ardais Ambitious With Plans For Clinical Genomics,” Boston Business Journal, November 22, 2002, available at <http://boston.bizjournals.com/boston/stories/2002/11/25/story2.html> (last visited December 23, 2004).

Thomas S. M. , “Ownership of the Human Genome,” Nature 380 (1996): 387–388.

Kunzig R. , “Blood of the Vikings,” Discover 19 (1998): 90–99.

College of American Pathologists Advocacy, Gene Patents Detrimental to Care, Training, Research, at <www.cap.org/apps/docs/advocacy/advocacy_issues/issue_genepat.html> (last visited December 23, 2004).

Phone conversation with Myriad representative (June 2, 2004).

Kotulak R. , “Taking License with Your Genes: Biotech Firms Say They Need Protection,” Chicago Tribune, September 12, 1999, at 1, citing a survey of 120 labs by University of Pennsylvania bioethicist Jon Merz.

Blanton K. , “Corporate Takeover Exploiting the US Patent System,” Boston Globe, February 24, 2002, at 10.

Anand G. , “Big Drug Makers Try to Postpone Custom Regimens,” Wall Street Journal, June 18, 2001, at B1.

15 USCS § 1127 (2004).

Macfarlane N. , “The Tension Between National Intellectual Property Rights and Certain Provision of EC Law,” European Intellectual Property Review 16 (1994): 525–530, at 526. To “work” the patent means to sufficiently commercialize the invention and make it available in order to meet the needs of the particular country.

HUGO Ethics Committee, Statement on Benefit-Sharing, April 9, 2000, at <http://www.gene.ucl.ac.uk/hugo/benefit.html> (last visited December 23, 2004).

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

The idea of benefit sharing has been addressed on numerous occasions in the international context. See, e.g., HUGO Ethics Committee, Statement on Human Genomic Databases, December 2002, at <http://www.gene.ucl.ac.uk/hugo/HEC_Dec02.html> (last visited December 23, 2004) (recommendation 6: “Researchers, institutions, and commercial entities have a right to a fair return for intellectual and financial contributions to databases.” They recommend that there should be “reciprocity and exchange of information with fair return” with fair return mechanisms being “non-exclusive licenses, copyright, monetary, non-monetary (e.g. publication or credits), database pools, and central repositories.” They also provide that “any fees should not restrict the free flow of scientific information and equitable access.”); HUGO Ethics Committee, Statement on Benefit-Sharing, April 9, 2000, at <http://www.gene.ucl.ac.uk/hugo/benefit.html> (last visited December 23, 2004) (Recommendation 3: “…there should be prior discussion with groups or communities on the issue of benefit-sharing.”); HUGO Ethical, Legal, and Social Issues Committee Report to HUGO Council, Statement on the Principled Conduct of Genetics Research, March 21, 1996, at <http://www.gene.ucl.ac.uk/hugo/conduct.htm> (last visited December 23, 2004) (Recommendation bullet 9: “That undue inducement through compensation for individual participants, families, and populations should be prohibited. 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.”); Council for International Organizations of Medical Services (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002 at <http://www.cioms.ch/frame_guideunes_nov_2002.htm> (last visited June 4, 2004)(Geneva)(Guideline 10: Research in populations and communities with limited resources: “Before undertaking research in a population or community with limited resources, the sponsor and the investigator must make every effort to ensure that: the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community”)

HUGO Ethical, Legal, and Social Issues Committee Report to HUGO Council, Statement on the Principled Conduct of Genetics Research, Recommendation 9, March 21, 1996, at <http://www.gene.ucl.ac.uk/hugo/conduct.htm> (last visited December 23, 2004).

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. , “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.

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.

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

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.

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

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

For example, some commentators suggest that genes should not be patented in the first place. Patents are not allowed on formulas or products of nature. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). Yet genes seem to be both. Patents are central to drug development and thus appropriate in the pharmaceutical context, but discovery of genes does not require the same incentives as drug development. Molecular biologists were attempting to identify genes long before the U.S. Patent and Trademark Office made clear that genes could be patented. As opposed to the development of drugs, which is undertaken primarily with private funds (for which investors expect a commercial return), the discovery of genes has been undertaken with vast quantities of public funds. Over $1.8 billion of taxpayer money was spent by the U.S. government and non-profit institutions on genomics in the year 2000 alone. Myriad, the genetics company that first isolated and described BRCA1, utilized over $5 million from a government agency, the National Institutes of Health. Jones B. W. , “History of a Gene Patent: Tracing the Development and Application of Commercial BRCA Testing,” Health Law Journal 10 (2002): 123–146, at 123, 131. Even the private company that made its own efforts to sequence the human genome, Celera, used sequence data from the publicly-funded project in its sequencing.

Moreover, no expensive clinical trials are necessary for the transition from a gene discovery and knowledge to the actual use of the gene sequence in clinical diagnostics. In some cases, a disease gene has been identified one day and testing begun almost immediately. Because the Food and Drug Administration (“FDA”) does not regulate the clinical services of genetic tests (as opposed to the sale of genetic diagnostic kits or gene therapies), there is no costly FDA approval process. Thus, the need to financially compensate a gene-discoverer is not as great as the need to compensate the developer of a drug that must take it through costly clinical trials, with only a small number of drugs actually becoming commercially-viable products.

Gene patents do not seem necessary to encourage technology transfer in the move from gene discovery to the availability of a genetic diagnostic test. As soon as information about the discovery of the hemachromatosis gene was published, laboratories began testing for mutations in the gene. After a patent on the gene was granted seventeen months later, 30% of the 119 U.S. laboratories surveyed reported discontinuing or not developing a genetic test for the disease. The patent holder was asking for an up-front fee of $25,000 from academic laboratories and as much as $250,000 from commercial laboratories, plus a fee of $20 per test. Merz J. F. Kriss A. G. Leonard D. G. B. , and Cho M. K. , “Diagnostic Testing Fails the Test,” Nature 415 (2002): 577–579, at 578. The patent interfered with clinical adoption of the test and potentially compromised the quality of testing by limiting the development of higher quality or lower cost alternative testing methods.

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.

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.