See generally Guttmacher, A. E. and Collins, F. S., “Welcome to the Genomic Era,” N. Eng. J. Med. 349 (2004): 996–98, available at <www.nejm.org>. See also Noah, L., “The Coming Pharmacogenomics Revolution: Tailoring Drugs to Fit Patients' Genetic Profiles,” Jurimetrics: The Journal of Law, Science, and Technology 43 (2002): 4–11, at 1; Malinowski, M. J., “Law, Policy, and Market Implications of Genetic Profiling in Drug Development,” Houston Journal of Health Law & Policy 2 (2003): 31–63, at 31–43.Google Scholar

See generally Noah, , supra note 1; Malinowski, , “Genetic Profiling,” supra note 1.Google Scholar

See generally Buchanan, A., “An Ethical Framework for Biological Samples Policy,” in National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Volume II, Commissioned Papers (Rockville, Maryland: January 2000), available at <http://www.georgetown.edu/research/nrcbl/nbac/hbmII.pdf> (last visited February 18, 2005).Google Scholar

See generally Proceedings, The Genomics Revolution: Law, Science and Policy (February 4–6, 2003) (transcripts and audio tapes on file with the author).Google Scholar

The United States has distinguished itself globally through federal policy that releases IP funded with taxpayer dollars to academic institutions for commercial application. See generally Malinowski, M. J., “Biotechnology in the USA: Responsive Regulation in the Life Science Industry,” International Journal of Biotechnology 2 (2000): 16–26. This policy is a complement to receptiveness to the patentability of biotechnology, aggressive federal funding of basic research, significant investment in federal-state technology programs, and regulatory responsiveness to biotechnology commercial applications through modernization of the FDA. See generally Malinowski, M. J., Biotechnology: Law, Business and Regulation (Gaithersburg: Aspen 1999).Google Scholar

See generally Juma, C. et al. , “Global Governance of Technology: Meeting the Needs of Developing Countries,” International Journal of Technology Management 22 (2001): 629–648, at 646; Sachs, J. D., “Balms for the Poor,” The Economist, August 14, 1999, at 63.10.1504/IJTM.2001.002982CrossRefGoogle Scholar

See generally General Accounting Office, “Report to Congressional Committees: Technology Transfer, Administration of the Bayh-Dole Act by Research Universities, GAO/RCED-98-126” (May 1998) [hereinafter “GAO Report”], available at <www.access.gpo.gov> (last visited February 18, 2005); Piercey, L., “Technology Transfer Goes Professional,” Bioventure View, December 1998, at 9–11; Press, E. and Washburn, J., “The Kept University,” Atlantic Monthly, (March 2000): At 39–42, 45–48, 50–54. See also Blumenthal, D. et al. , “Participation of Life-Science Faculty in Research Relationships with Industry,” N. Eng. J. Med. 335 (1996): 1734–39. Cf. Department of Health and Human Services, National Institutes of Health, NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers' Interests are Protected (July 2001) [hereinafter “NIH Report”], available at <http://www.nih.gov/news/070101wyden.htm> (last visited February 18, 2005).Google Scholar

See generally GAO Report, supra note 7.Google Scholar

This observation is based upon the author's personal experience as an attorney engaged in biotechnology R&D in the MA area during the 1990s, and as an employee of the Massachusetts Biotechnology Council (MBC) responsible for government affairs and communications in 1997–1998. For example, significant controversy arose in 1997–1998 over the terms of technology transfer deals entered into by the University of Massachusetts in the early 1990s.Google Scholar

See Lawler, A., “Last of the Big-Time Spenders?” Science 299 (2003): 330–333, available at <www.sciencemag.org> (last visited February 18, 2005) (reporting with hindsight on the positive university impact of major industry-funded deals entered in the 1990s, including a highly-debated deal between Novartis and the University of California at Berkeley).10.1126/science.299.5605.330CrossRefGoogle Scholar

See generally GAO Report, supra note 7.Google Scholar

See supra note 7.Google Scholar

See generally Washburn, , supra note 7; Blumenthal, , supra note 7.Google Scholar

See generally “Symposium, Conflicts of Interest in Clinical Research,” Widener Law Journal 8 (2001): ii-152; Cho, M. K., “Policies on Faculty Conflicts of Interest at US Universities,” JAMA 284 (2000): 2203–08; See Korn, D., “Conflicts of Interest in Biomedical Research,” JAMA 284 (2000): 2234–37.Google Scholar

See generally Eisenberg, R. S., “Patents, Product Exclusivity, and Information Dissemination: How Law Directs Biopharmaceutical Research and Development,” Fordham Law Review 72 (2003): 477–91; Andrews, L. B., “The Gene Patent Dilemma: Balancing Commercial Incentives with Health Needs,” Houston Journal Health Law and Policy 2 (2002): 65–101. Affymetrix, arguably the world's leading bioinformatics company and an aggressive for-profit commercial entity, shares many of these sentiments. See Wells, R., Presentation, “Intellectual Property/Ownership Issues,” The Genomics Revolution? Science, Law and Policy, February 5, 2004 (transcript on file with author). With the state of the art in biotechnology advancing in an explosive manner and the life of patents extending twenty years from the date of filing, applications of the patent criteria and determinations of patentability made even in the late 1990s often appear questionable today. The U.S. Patent and Trademark Office acknowledged as much when it issued new guidelines on utility and novelty in gene patenting in 2001, largely in response to patent applications filed for expressed sequence tags (ESTs). See Utility Examination Guidelines, 66 Fed. Reg. 1092–99, 1097–99 (January 5, 2001); “Written Description” Requirement, 66 Fed. Reg. 1099 (2001). Although the USPTO has discretion to initiate reexamination proceedings to revisit issued patents, it typically relies on others to do so. Malinowski, , Biotechnology, supra note 5, at 2–30. Presumably, if the market impediments suggested by Professors R. Eisenberg, L. Andrews and others are realized, the USPTO will have to exercise more self-initiative. Similarly, the U.S. may have to start exercising federal technology transfer “march-in” rights to reclaim interests in patented intellectual property not actually being applied commercially. U.S. Patent Act, 35 U.S.C. § 202(c)(4)(2000). See also 35 U.S.C. § 210(c) (2000).Google Scholar

See generally infra note 123. For example, Myriad Genetics' test for BRCA1 and BRCA2, genetic alleles associated with breast and ovarian cancers, is priced at $3,850, which has resulted in a dispute between Myriad and the Canadian provinces of Alberta and Ontario. See “Gene-Patent Policy Review Urgently Needed,” The Edmonton Journal (2003) (no author identified and page numbers unavailable), available at <http://www.canada.com/health/story/html?id=%7BEDD607C3-E3F4-423E-BADF-9336B11BDDC7%7D> (last visited February 18, 2005). (last visited February 18, 2005).' href=https://scholar.google.com/scholar?q=See+generally+infra+note+123.+For+example,+Myriad+Genetics'+test+for+BRCA1+and+BRCA2,+genetic+alleles+associated+with+breast+and+ovarian+cancers,+is+priced+at+$3,850,+which+has+resulted+in+a+dispute+between+Myriad+and+the+Canadian+provinces+of+Alberta+and+Ontario.+See+“Gene-Patent+Policy+Review+Urgently+Needed,”+The+Edmonton+Journal+(2003)+(no+author+identified+and+page+numbers+unavailable),+available+at++(last+visited+February+18,+2005).>Google Scholar

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According to the University of California, Berkeley's internal review of its 1998, five-year, $25 million deal with Novartis, the collaboration was “a smashing success....the university's academic soul was never for sale and...the only real drawback was the negative publicity generated by critics of the high-profile collaboration.” Lawler, A., “Berkeley Review Dismisses Critics' Fears,” Science 299 (2003): At 332, available through <www.sciencemag.org> (last visited February 18, 2005).10.1126/science.299.5605.332CrossRefGoogle Scholar

See generally GAO Report, supra note 7 (citing supportive studies by the Massachusetts Institute of Technology and others); Boston Consulting Group, The Pharmaceutical Industry Into Its Second Century: From Serendipity to Strategy (1999).Google Scholar

See generally GAO Report, supra note 7; NIH Report, supra note 7.Google Scholar

The National Science Foundation, which tracks science trends, has recognized that: (1) the extent to which the U.S. “out-patents” other countries is lessening, (2) publication of American science papers has slipped from sixty-one percent in 1983 to twenty-nine percent in 2003 (publication by Americans peaked in 1992), and (3) the number of Americans winning Nobel Prizes has fallen from a position of clear domination to fifty-one percent in the 2000s. See Broad, W. J., “U.S. Is Losing Its Dominance in the Sciences,” New York Times, May 3, 2004, at A1, A19. The U.S. also faces a serious shortage of scientists attributable to international competition and too few Americans entering technical fields. See Broad, W. J., “National Science Panel Warns of Far Too Few New Scientists,” New York Times, May 5, 2004, at A18 (reporting that the U.S. ranks seventeenth among nations surveyed, behind Taiwan and South Korea, in the share of eighteen-to twenty-four-year-olds who earn degrees in natural science and engineering). Moreover, the U.S.'s restrictive policy on stem cell research (as of May 2004, federal funding was limited to research on nineteen available cell lines and excluded new lines created in South Korea and other countries) has seriously impeded the progress and global participation of federally funded researchers in arguably the most important field of research for human health. See Stolberg, S. G., “Limits on Stem-Cell Research Re-Emerge as a Political Issue,” New York Times, May 6, 2004, at A1, A23.Google Scholar

Admittedly, commercial application is not necessarily synonymous with health care improvements. For example, in spite of exciting clinical data, Iressa, a small cell lung cancer treatment developed by AstraZeneca, was deemed effective in just ten percent of a small clinical trial. See Pollack, A., “An F.D.A. Advisory Panel Rejects 2 Cancer Drugs,” New York Times, May 4, 2004, at C2. But see Pollack, A., “Genetic Link Seen in Cancer Drugs' Power,” New York Times, April 30, 2004. In May 2004, the FDA Advisory Panel rejected two biotech cancer drugs — Genasesne, developed by Genta Inc. and RSR13 developed by Allos Therapuetics. See Pollack, , “F.D.A. Advisory Panel,” supra, at C2.Google Scholar

Visit <www.bio.org> (last visited February 18, 2005), the Internet site of the Biotechnology Industry Organization (“BIO”), the world's largest biotechnology trade organization. BIO's site contains numerous links (regional, national, and international) that help to network commercial biotechnology globally, as well as industry reports and data.Google Scholar

See generally GAO Report, supra note 7; NIH Report, supra note 7.Google Scholar

Unfortunately, academic universities have failed miserably in developing policies and enforcement mechanisms to address resulting conflicts of interest. See generally Cho, , “Policies,” supra note 15.Google Scholar

See Association of University Technology Managers, at <http://www.autm.net/index_ie.html> (last visited January 6, 2005).+(last+visited+January+6,+2005).>Google Scholar

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See supra note 1 and accompanying text. HGP was driven to completion years ahead of schedule through competition between industry and government-led teams that ultimately joined forces to declare a joint victory. See generally Science 291 (February 16, 2001): 1145–1265 (issue entitled “The Human Genome”); Nature 409 (2001): at 745 (issue dedicated to the release of a draft map of the human genome).Google Scholar

The SNPs Consortium is discussed infra at notes 41–42 and in the accompanying text.Google Scholar

Pollack, A., “Three Universities Join Researcher to Develop Drugs,” New York Times, July 31, 2003, at C1, C2. The consortium, PharmaStart (also known as the “West Coast Clinical Trial Initiative”), was inspired by the reluctance of venture capitalists and pharmaceuticals to invest in the clinical development of academic research – especially for rare diseases. Id. at C2. Similarly, in the area of screening of potential drug targets with a focus on rare diseases (e.g., Huntington's and amyotrophic lateral sclerosis), Harvard (Cambridge, MA) has established the Laboratory for Drug Discovery in Neurodegeneration, and the City of Hope National Medical Center (Duarte, CA) has established a factory to make experimental drugs for use in clinical trials. “Beyond academic centers, patient advocacy groups are also taking a much more active role in sponsoring or doing research aimed at finding cures for specific diseases. And nonprofit drug organizations, backed by contributions from philanthropists, have arisen to try to develop drugs for diseases in developing countries, like malaria and tuberculosis, which tend to be neglected by pharmaceutical companies.” Id. at C2.Google Scholar

See Pollack, A., supra note 31, at A13 (“Saying the development of crops that could feed millions of people is being choked off by biotechnology patents held by large corporations, several leading universities are joining to share information on their patented technologies and make them more widely available”) Participants in this free exchange of seeds and technology that could improve crop breeding include Cornell, the University of California, the University of Florida, Michigan State, Rutgers, and the University of Wisconsin, with support from the Rockefeller Foundation and the McKnight Foundation. The methodology includes reservation of some rights for humanitarian uses-applications and pooling patents into packages to reduce transaction costs for crop developers. “Corporations seeking to generate support for biotechnology have become more willing to provide royalty-free licenses to their patents for humanitarian purposes. The major companies agreed to cooperate with the African Agricultural Technology Foundation, formed this year by the Rockefeller Foundation to speed the transfer of biotechnology to Africa.” Id. at A13.Google Scholar

This coalition, led by Dr. H. Varmus, former director of NIH, seeks to create the Public Library of Science (PLoS) to overcome impediments to distribution of knowledge attributable to the cost of research publications. See Editorial, “Open Access to Scientific Research,” New York Times, August 7, 2003, at A24. The PLoS methodology is to establish a new series of peer-reviewed journals that will be available on the Internet free of charge and that increase dissemination of data about research. See Goldberg, C., “Scientists Seek Open Access to Medical Research,” Boston Globe, August 14, 2003, at A1, A17.Google Scholar

The case studies include the disease group PXE and Howard University's biobanking initiative, which are discussed infra at notes 63–66 and in the accompanying text.Google Scholar

The time to develop innovative pharmaceuticals has been estimated to reach fifteen years, and much of the HGP-related commercial biotechnology was undertaken during the 1990s. Tufts Center for the Study of Drug Development, Backgrounder: How New Drugs Move through the Development and Approval Process (November 1, 2001), available at <http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=4> (last visited February 18, 2005). Moreover, heavy pharmaceutical investment in biotechnology took place in the mid and late-1990s. See Boston Consulting Group, supra note 20, at 38–39. Commercial life science therefore is in an awkward R&D transition period that includes clinical disappointments, adverse events, and considerable second-guessing. Notable examples include the FDA's recent call for more studies on the anemia drugs Procrit by Johnson & Johnson and Aransesp by Amgen in response to concerns that these drugs, prescribed often in conjunction with cancer treatment and among the best selling drugs in the world, actually make cancer worse. See Pollack, A., “F.D.A. Wants More Study on 2 Drugs for Anemia,” New York Times, May 5, 2004, at C8. The impact of genetic precision in drug development on access, cost, and overall medicinal practicality also is a basis for question. See generally Malinowski, , supra note 1. This issue has been raised recently by the FDA's approval of AstraZeneca's Iressa, a treatment for non-small-cell lung cancer but one that shrank tumors in only 10 percent of patients in a small trial. See supra note 23.+(last+visited+February+18,+2005).+Moreover,+heavy+pharmaceutical+investment+in+biotechnology+took+place+in+the+mid+and+late-1990s.+See+Boston+Consulting+Group,+supra+note+20,+at+38–39.+Commercial+life+science+therefore+is+in+an+awkward+R&D+transition+period+that+includes+clinical+disappointments,+adverse+events,+and+considerable+second-guessing.+Notable+examples+include+the+FDA's+recent+call+for+more+studies+on+the+anemia+drugs+Procrit+by+Johnson+&+Johnson+and+Aransesp+by+Amgen+in+response+to+concerns+that+these+drugs,+prescribed+often+in+conjunction+with+cancer+treatment+and+among+the+best+selling+drugs+in+the+world,+actually+make+cancer+worse.+See+Pollack,+A.,+“F.D.A.+Wants+More+Study+on+2+Drugs+for+Anemia,”+New+York+Times,+May+5,+2004,+at+C8.+The+impact+of+genetic+precision+in+drug+development+on+access,+cost,+and+overall+medicinal+practicality+also+is+a+basis+for+question.+See+generally+Malinowski,+,+supra+note+1.+This+issue+has+been+raised+recently+by+the+FDA's+approval+of+AstraZeneca's+Iressa,+a+treatment+for+non-small-cell+lung+cancer+but+one+that+shrank+tumors+in+only+10+percent+of+patients+in+a+small+trial.+See+supra+note+23.>Google Scholar

See generally Noah, , supra note 1; Malinowski, , supra note 1; Yoon, P. W., Presentation, “Risk Prediction for Common Diseases,” The Genomics Revolution? Science, Law and Policy (February 5, 2004) (transcript on file with author); Woodcock, J., Presentation, “Law/Regulatory Issues Affecting the Pace of Advancement of this Field,” The Genomics Revolution? Science, Law and Policy (February 5, 2004) (transcript on file with author). See generally Watson, J. D., DNA: The Secret of Life (2003). Cf. World Health Organization, Genomics and World Health: Report of the Advisory Committee on Health Research (World Health Organization 2002, released April 30, 2002) (fully recognizing the impact of genomics on the practice of medicine in developed economies). Genetic testing is entering the medical setting as an accompaniment to drug delivery. Malinowski, , supra note 1; Noah, , supra note 1. Examples include the market entry of Herceptin accompanied by a test to screen for over-expression of Her2-neu and genotyping kits for HIV that assist doctors in making best use of available medicines. For discussion of these and additional examples, see Noah, , supra note 1, at nn.26–39 and accompanying text.Google Scholar

See generally Proceedings, The Genomics Revolution? Science, Law and Policy (February 4–6, 2004) (transcripts on file with author). Bioinformatics is the integration of biology and information technology to identify gene and protein structure and function, usually with the ultimate objective of discovering drug targets. See Winickoff, D. E., “Governing Population Genomics: Law, Bioethics, and Biopolitics in Three Case Studies,” Jurimetrics: The Journal of Law, Science, and Technology 43 (2003): 187–209, 189. See also Noah, supra note 1; Malinowski, , supra note 1; Pharmaceutical Research and Manufacturers of America, 2004 Industry Profile (2004), available at <http://www.phrma.org/publications/> (last visited February 18, 2005);Pharmaceutical Research and Manufacturers of America, 2003–04 Annual Report (2003), available at <http://www.phrma.org/publications/publications//2003-11-20.870.pdf> (last visited February 18, 2005); Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2001: A Century of Progress 14 (2001), available at <www.phrma.org> (last visited February 18, 2005); Pharmaceutical Research and Manufacturers of America, The Pharmaceutical Industry Profile (2000). See generally Ernst, & Young, , Convergence: The Biotechnology Industry Report (2000).Google Scholar

Affymetrix and several other companies now offer commercial chips that contain the entire human genome. Wells, R., Presentation, supra note 16. In fact, bioinformatics is necessitating the creation of new numbers. Beyond terabytes (a trillion bits of genetic data), these measurements include “petabytes (equivalent to half the contents of all academic libraries in America), exabytes, yottabytes and zettabytes. All the words ever uttered by everyone who ever lived would amount to five exabytes.” Gibbs, N., “The Secret of Life,” Time (February 17, 2003): At 42–45.Google Scholar

Buchanan, , supra note 3; Noah, , supra note 1. The pharmaceutical sector has embraced research and development methodology centered on gene and protein function and put into a motion “[a] shift from decades of dependence on approximately 3,000 relatively crude pharmaceuticals derived from 483 drug targets for the treatment of all human diseases to identification of 10,000 or more drug targets for use in developing potentially tens of thousands of drugs.” Malinowski, , supra note 1.Google Scholar

All human variation is attributable to environmental factors and 0.1 percent of DNA, meaning 3,000,000 base pairs. See SNP Consortium, at <http://snp.cshl.org> (last visited February 18, 2005). See also Brooks, L. and Guyer, M., National Human Genome Research Institute (HGRI), Resource for Studying Human Genetic Variation (March 1998), available at <www.georgetown.edu/research/nrcbl/nbac/transcripts/mar98/hbmr_spkrs.htm> (last visited February 18, 2005). However, in July 2004, researchers studying genes linked to cancer risk, how much people eat, and reactions to drugs, discovered significant genetic differences among healthy people – i.e., researchers found that some of these people are missing large portions of DNA, while others have extra copies of entire stretches of DNA. Sebat, J. et al. , “Large-Scale Copy Number Polymorphism in the Human Genome,” Science 305 (2004): 525–28.Google Scholar

See SNPs Consortium, supra note 41; Brooks, Guyer, , Resource, supra note 41. Just as disparate and competing interests came together to create a biocommons in the form of the map of the human genome, a well-financed and diligent consortium orchestrated largely by the SNPs Consortium Ltd is constructing a much more expansive SNPs biocommons see The SNP Consortium Ltd., at <http://snp.cshl.org> (last visited February 18, 2005). See also Malinowski, M. J., “Separating Predictive Genetic Testing from Snake Oil: Regulation, Liabilities, and Lost Opportunities,” Jurimetrics: The Journal of Law, Science, and Technology 41 (2000): 32–43, at 32–33. The SNPs consortium draws together pharmaceutical, biotech, and academic participants – many market competitors in other contexts – with the unified mission of identifying connections between variations of single letters in the genetic code and human health characteristics, such as adverse drug reactions. See SNP Consortium, supra note 41. The entity at the center of the SNP Consortium is Orchid Bio-sciences, Inc., and information about the effort is available at <http://www.orchid.com>. The databases presently are being utilized for drug development, but they ultimately also will be used to personalize health care delivery. “Subscriber services to inform individuals about the latest SNP identifications that could impact their responses to commercially available drugs and drug interactions in an ongoing manner are already under development.” See Malinowski, , supra note 1.Google Scholar

See Brooks, Guyer, , supra note 41. The International HapMap Project involves identifying genetic variations that travel with populations. See Recer, P., “International Project to Map Genome Called a Step Toward Finding Genes that Trigger Diseases,” Toronto Star, November 3, 2002, available at 2002 WL 101966302. The effort is premised on the observations that SNPs are organized into DNA neighborhoods called haplotype blocks comprising about 10,000 or more base pairs, and that many people share the same haplotype blocks and common variations. For more information about the HapMap project, visit the HapMap Data Coordinating Center at <http://hapmap.cshl.org/> (last visited February 18, 2005). Proponents contend that hapmapping will introduce collective medical benefits based upon genetic subtleties. For example, “Some studies show that 40 percent of African-Americans compared to 60 percent of Caucasians responded well to beta blockers, a class of drugs for lowering blood pressure.” Pollack, A., “Big DNA Files to Help Blacks Fight Diseases,” N.Y. Times, May 27, 2003, at A1, A20. However, this methodology is not beyond reproach: “It is not known to what extent such differences in health arise from genetic, environmental or social factors. Some scientists say that race is not a useful concept in medicine, and that genes can vary as much within races as between them. Other experts say that genetic variations tend to cluster in ethnic groups and that it is foolhardy to ignore such differences.” Id. Detractors of the methodology point out that there is ten times more difference between a Caucasian husband and wife than between white and African American populations of the same gender. Id. See generally Kidd, K., “Commentary: Haplotype Mapping – Tensions in Process and Discovery” The Genomics Revolution? Science, Law and Policy (Conference, February 6, 2004).Google Scholar

See Johnston, J., “Resisting a Genetic Identity: The Black Seminoles and Genetics Tests of Ancestry,” Journal of Law, Medicine & Ethics 31 (2003): 262–71 (Seminole Indians case study: Use of genetic testing to ostracize Freedmen from the tribe after centuries of integration in response to land reparation payments).CrossRefGoogle Scholar

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See Appendix. See also Press Release, Department of Health and Human Services, Secretary Shalala Bolsters Protections for Human Research Subjects (May 23, 2000), available at <http://www.hhs.gov/news/press/2000pres/20000523> (last visited February 18, 2005); Shalala, D., “Protecting Human Subjects – What Must Be Done,” N. Engl. J. Med. 343 (2000): 808, at 809.CrossRefGoogle Scholar

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Examples of these commercial suppliers include The First Genetic Trust, see First Genetic Trust, at <www.firstgenetic.net> (last visited February 18, 2005), and Genomics Collaborative, Inc., see Genomics Collaborative, at <www.dnarepository.com> (last visited January 6, 2005). See Krasner, J., “Gene Pooling: Company Builds World's Largest Library of Genetic Material,” Boston Globe, August 22, 2001, at F1, F4. As addressed in Part II, many of the hundreds of millions of samples held in preexisting repositories were collected during the course of routine diagnostic and other medical procedures under a theory of medical waste and donor abandonment, and without meaningful consent. See National Bioethics Advisory Commission, Recommendations: Ethical and Policy Issues in Research Involving Human Participants (May 18, 2001).Google Scholar

See generally Greely, H. T., “Iceland's Plan for Genomics Research: Facts and Implications,” Jurimetrics: The Journal of Law, Science, and Technology 40 (2000): 153–91. Iceland is making the DNA and medical records of its citizenry commercially available through deCODE Genetics, Inc., a private company founded in 1996. For information about this company and its endeavor, visit <www.deCode.com> (last visited February 18, 2005).Google Scholar

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The U.K. project's backers have pledged $65.6 million (45 million British Pounds) to build a biobank with samples from 500,000 Britons, thereby establishing the world's largest genetic database. See “Genetic Database Receives Funding,” Wall Street Journal, April 30, 2002, at 2002 WL-WSJ 3393326 (no author identified) (samples to be gathered from volunteers age 45 to 69 and held in public ownership); “UK Genetic Database to Rival Iceland's Set Up,” Marketletter, May 6, 2002 (available through Westlaw at 2002 WL 7179539) (no author identified).Google Scholar

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See Furrow, B. R. et al. , Health Care Law (West 2001, Supp. 2003) (“Bioethics”): 22–23.Google Scholar

Academics and academic institutions are showing renewed interest in biobanking after a false start in the early 1990s with the Human Genome Diversity Project (HGDP). See Reardon, J., “The Human Genome Diversity Project: A Case Study in Coproduction,” Journal of Social Studies and Science 31 (2001): 357–358; Lock, M., “Genetic Diversity and the Politics of Difference,” Chicago-Kent Law Review 75 (1999): 83–111, at 92; Cavalli-Sforza, L. L. et al. , “Call for a Worldwide Survey of Human Genetic Diversity: A Vanishing Opportunity for the Human Genome Project,” Genomics 11 (1991): 490–492, at 491.Google Scholar

Hospitals are uniquely situated to engage in biobanking because of their access to and trust from patients. See Winickoff, , supra note 38, at 214; Krasner, J., “Partners Healthcare Planning Tissue Bank: Hospital Group Cites Research Potential,” Boston Globe, September 4, 2001, at D1; Pollack, , “Big DNA Files,” supra note 43, at A1, A20 (“Hospitals are a natural place to gather such samples and medical information; several are starting such DNA or tissue banks”) In fact, research trends and market forces are driving them to do so: “In the United States, where health institutions have come upon difficult financial times, hospitals are beginning to explore ways to generate revenue by tapping into the financial promise of the biotechnology industry. In particular, hospitals have begun to realize that they are uniquely poised to be the suppliers of tissue and medical information for the new industry.” Winickoff, , supra note 38, at 207; Pollack, , “Big DNA Files,” supra note 43, at A1, A20 (reporting on biobanking initiative launched by the Long Island Jewish Hospital).Google Scholar

The political success of AIDs, breast cancer and other disease group activists during the late 1980s and 1990s, increased investment in biomedical R&D, and global communication have inspired extensive disease group organization. See Winickoff, , supra note 38, at 222–23. Some of these groups now are creating tissue banks to advance research and control research design, implementation, and allocation of benefits. See id. Such initiatives may prove essential for very small disease groups where commercial incentives are marginalized.Google Scholar

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See id. See also Cancer Web, On-line Medical Dictionary, “PXE” at <http://cancerweb.ncl.ac.uk/cgi-bin/omd?PXE> (last visited January 6, 2004). For discussion of PXE International and its approach to technology transfer, see Winickoff, , supra note 38, at 207. See also Gitter, D. M., “Ownership of Human Tissue: A Proposal for Federal Recognition of Human Research Participants' Property Rights in Their Biological Material,” Washington & Lee Law Review 61 (2004): 257–345, 315–24.Google Scholar

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BI serves more than 500,000 patients annually and is the third largest recipient of National Institutes of Health biomedical research funding. Winickoff, , supra note 38, at 207. For information about BI, visit <http://www.bidmc.harvard.edu/general_info.asp> (last visited February 18, 2005).+(last+visited+February+18,+2005).>Google Scholar

BI announced its biobanking effort with Ardais in September 2000, and the collaboration was expanded subsequently to include Duke University Medical Center, Maine Medical Center, and the University of Chicago. See Donors & Institutions, at the internet site of Ardais Corporation, at <http://www.ardais.com/donor_overview.asp> (last visited January 14, 2005). Ardais is a private company based in Lexington, MA. See id. Ardais' growing collection exceeds 160,000 samples and is attracting significant users, such as Xantos Biomedicine AG of Munich, which is using Ardais' bank to validate drug targets in inflammatory and degenerative diseases. “German Firm to Use Ardais's Tissue Bank,” Boston Globe, May 14, 2003, at C4. Ardais is representative of an emerging biobanking commercial sector. This sector includes The First Genetic Trust (“First Genetic”), located in Chicago, Illinois, and Genomics Collaborative, Inc. in the Boston area. Like Ardais, First Genetic collects and organizes genetic information while concealing patients' identities, and one of First Genetic's ongoing projects is to create GRAD Biobank to research African diaspora. See First Genetic Trust, at <www.firstgenetic.net> (last visited January 6, 2005); Pollack, , “Big DNA Files,” supra note 43, at 20. Similarly, Genomics Collaborative, Inc. is building a global repository of tissue and white blood cell samples. See Krasner, J., “Gene Pooling: Company Builds World's Largest Library of Genetic Material,” Boston Globe, August 22, 2001, at F1, F4. The company creates serum by removing all cells from blood samples, which it freezes at minus 80 degrees Celsius, and stores tissue and white blood cell samples at minus 160 Celsius in liquid nitrogen. See id. (last visited January 6, 2005); Pollack, , “Big DNA Files,” supra note 43, at 20. Similarly, Genomics Collaborative, Inc. is building a global repository of tissue and white blood cell samples. See Krasner, J., “Gene Pooling: Company Builds World's Largest Library of Genetic Material,” Boston Globe, August 22, 2001, at F1, F4. The company creates serum by removing all cells from blood samples, which it freezes at minus 80 degrees Celsius, and stores tissue and white blood cell samples at minus 160 Celsius in liquid nitrogen. See id.' href=https://scholar.google.com/scholar?q=BI+announced+its+biobanking+effort+with+Ardais+in+September+2000,+and+the+collaboration+was+expanded+subsequently+to+include+Duke+University+Medical+Center,+Maine+Medical+Center,+and+the+University+of+Chicago.+See+Donors+&+Institutions,+at+the+internet+site+of+Ardais+Corporation,+at++(last+visited+January+14,+2005).+Ardais+is+a+private+company+based+in+Lexington,+MA.+See+id.+Ardais'+growing+collection+exceeds+160,000+samples+and+is+attracting+significant+users,+such+as+Xantos+Biomedicine+AG+of+Munich,+which+is+using+Ardais'+bank+to+validate+drug+targets+in+inflammatory+and+degenerative+diseases.+“German+Firm+to+Use+Ardais's+Tissue+Bank,”+Boston+Globe,+May+14,+2003,+at+C4.+Ardais+is+representative+of+an+emerging+biobanking+commercial+sector.+This+sector+includes+The+First+Genetic+Trust+(“First+Genetic”),+located+in+Chicago,+Illinois,+and+Genomics+Collaborative,+Inc.+in+the+Boston+area.+Like+Ardais,+First+Genetic+collects+and+organizes+genetic+information+while+concealing+patients'+identities,+and+one+of+First+Genetic's+ongoing+projects+is+to+create+GRAD+Biobank+to+research+African+diaspora.+See+First+Genetic+Trust,+at++(last+visited+January+6,+2005);+Pollack,+,+“Big+DNA+Files,”+supra+note+43,+at+20.+Similarly,+Genomics+Collaborative,+Inc.+is+building+a+global+repository+of+tissue+and+white+blood+cell+samples.+See+Krasner,+J.,+“Gene+Pooling:+Company+Builds+World's+Largest+Library+of+Genetic+Material,”+Boston+Globe,+August+22,+2001,+at+F1,+F4.+The+company+creates+serum+by+removing+all+cells+from+blood+samples,+which+it+freezes+at+minus+80+degrees+Celsius,+and+stores+tissue+and+white+blood+cell+samples+at+minus+160+Celsius+in+liquid+nitrogen.+See+id.>Google Scholar

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See First Genetic Trust, supra note 68. First Genetic Trust has developed the enTRUST Genetic Banking System, which consists of “two powerful web-based applications for investigators and institutions involved in genomic research: enTRUST® Study Management and enTRUST Genetic Bank.” First Genetic Trust also has developed algorithms for biobanking and bioinformatics with the objective of offering users research support “while addressing human subject protection, data privacy, and ethical issues associated with this research.” Id.Google Scholar

See Ardais, at <http://www.ardais.com> (last visited February 18, 2005). Ardais portrays itself as “a leading clinical genomics company that is dedicated to enhancing and accelerating biomedical research by applying actual human disease as the discovery model in pharmaceutical research.” Id.+(last+visited+February+18,+2005).+Ardais+portrays+itself+as+“a+leading+clinical+genomics+company+that+is+dedicated+to+enhancing+and+accelerating+biomedical+research+by+applying+actual+human+disease+as+the+discovery+model+in+pharmaceutical+research.”+Id.>Google Scholar

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The company's major engagements include: a collaboration with Affymetrix to develop DNA-based tests to predict responsiveness to treatments for common diseases; a strategic alliance with Emory University School of Medicine in clinical as well as laboratory research; an alliance with Merck to develop treatments for obesity; an alliance with Pharmacia to identify genetic influences on advanced heart disease; an alliance with Roche to develop treatments for common diseases; an alliance with Roche Diagnostics to develop integrated diagnostic tools, services and software; a collaboration with Vertex to gather and analyze pharmacogenomic data in conjunction with clinical trials carried out by Encode – a deCode subsidiary; and a collaboration with Wyeth centered on a candidate drug for the treatment of respiratory disease. See DeCode Genetics, supra note 70.Google Scholar

See “deCODE and IBM to Form Strategic Alliance,” January 23, 2003 (available through Westlaw at 2003 WL 4565891). According to deCode, CGM Discovery TM is a “unique data management and bioinformatics tool, which allows researchers to integrate their own genotypic, phenotypic and pedigree data and to mine this information for knowledge on human disease.” See DeCode Genetics, supra note 70.Google Scholar

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The ethical, social, and legal implications of the collection and use of human biological materials was addressed somewhat thoroughly by the NBAC, which resulted in a comprehensive written compilation of commissioned papers and its own Report and Recommendations, which in turn generated extensive debate and publication. See NBAC, Recommendations, supra note 3.Google Scholar

These issues are summarized in the Appendix to this article. A more direct and detailed treatment of these issues is contained in other articles in this symposium. See also Greely, H. L., Presentation, “Population Participation and Other Factors that Impact the Compilation and the Utility of Resulting Databases,” The Genomics Revolution? Science, Law and Policy (Conference, February 5, 2004) (transcript on file with author).Google Scholar

See generally Watson, , supra note 37; Yoon, , Presentation, supra note 37; Woodcock, , Presentation, supra note 37; Noah, , “Pharmacogenomics,” supra note 1; Malinowski, , “Genetic Profiling,” supra note 1. See also WHO, Genomics and World Health, supra note 37.Google Scholar

See generally Watson, , supra note 37; Robbins-Roth, C., From Alchemy to IPO: The Business of Biotechnology (Cambridge, MA: Perseus Publishing, 2000): 73–78, 225 tbl. B.1; Yoon, , Presentation, supra note 37; Woodcock, , Presentation, supra note 37; Noah, , supra note 1; Malinowski, , supra note 1.Google Scholar

This assessment is based upon an inventory of samples and calculated rate of ongoing sample collection by authors commissioned by the National Bioethics Advisory Commission who relied heavily on 1996 data. See Buchanan, A., “Ethical Framework,” supra note 3; Korn, D., supra note 49; Eiseman, E., “Stored Tissue Samples: An Inventory of Sources in the United States,” in National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Vol. II Commissioned Papers (Rockville, Maryland January 2000), available at <http://www.georgetown.edu/research/nrcbl/nbac/hbmII.pdf> (last visited February 18, 2005). Based on 1996 data: “A conservative estimate is that there is a total of more than 282 million specimens form more than 176.5 million cases of stored tissue in the United States, with cases accumulating at a rate of more than 20 million per year.” Eiseman, , supra, at D-38 and D-39 & Tables 8 (“Sources of Stored Tissue Samples in the United States) & 9 (“Summary of Stored Tissue Samples in the United States”).Google Scholar

See supra notes 63–66 and accompanying text.Google Scholar

But see generally Gitter, , “Ownership,” supra note 65 (discussing instances where research participants have not negotiated and established written contractual property rights in advance of participating and later claimed interests).Google Scholar

Cf. Juma, et al. , “Global Governance of Technology,” supra note 6; Sachs, , “Balms,” supra note 6.Google Scholar

See supra note 54 and accompanying text.Google Scholar

NOVA, Cracking the Code of Life (2001, WGBH video). This is a commonsensical expectation given that the Icelandic population is relatively homogenous and their shared genetic identity and medical history are the research subject matter, but only time will tell.Google Scholar

A meaningful quid pro quo for participation has been realized by PXE and has been proposed in virtually all proposed guidances. See supra notes 65–66 and accompanying text (PXE case study).Google Scholar

See supra note 60 and accompanying text.Google Scholar

For example, hospitals could make access to database and DNA chip technologies for their researchers a quid pro quo for access to their biobanks, along the lines of PXE's successful negotiations. See supra notes 65–66.Google Scholar

See Appendix.Google Scholar

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See supra note 65–66 (PXE case study).Google Scholar

See supra note 63 (Howard University case study).Google Scholar

See supra note 67 (BI case study).Google Scholar

NIH Report, supra note 7 and accompanying text and infra at Appendix; GAO Report, supra note 7; WHO, Genomics and World Health, supra note 37; Boston Consulting Group, “Pharmaceuticals,” supra note 20.Google Scholar

Arguably, the United States has been applying its patent criteria too loosely in the midst of an explosion in the state of the art in genetics and, therefore, has been over patenting – i.e., what appeared to constitute innovation in genetics five years ago often is readily recognized by many in the science communities as insignificant, which is a serious problem given the duration of patent life is twenty years from the date of issuance. Agreement on Trade Related Aspects of Intellectual Property Rights, April 15, 1994; Agreement on Trade Related Aspects of Intellectual Property Rights, April 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round, vol. 31, 33 I.L.M. 81, 84 (1994) (expressing a desire to reduce obstacles to international trade through protection of intellectual property rights). This author has previously recognized that, in light of this problem, reexamination perhaps should be expanded and implemented more broadly in the context of genetics-based patents. See Malinowski, , supra note 1, at n.167. The USPTO has essentially admitted as much with the 2001 release of heightened standards for utility and written disclosure in the context of genetic innovations. In January 2001, the agency announced new “Utility Examination Guidelines” and “Written Description Guidelines” intended to make it more difficult to patent genes. See Utility Examination Guidelines, 66 Fed. Reg. 1092–1099, 1097–99 (January 5, 2001) (setting forth specific standards); Guidelines for Examination of Patent Applications Under the 35 U.S.C. § 112, P1, “Written Description” Requirement, 66 Fed. Reg. 1099 (2001). These guidelines clarify that a claimed invention must have a specific and substantial utility that is credible or a readily apparent, well-established utility. See 66 Fed. Reg. at 1092–99.Google Scholar

See generally, Symposium, “Conflicts of Interest,” supra note 15.Google Scholar

See id. See also Malinowski, , “Genetic Profiling,” supra note 1, at 47–49.Google Scholar

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See generally, Symposium, “Conflicts of Interest,” supra note 15. See also Malinowski, , Choosing Genes, supra note 96, at 168–169; Malinowski, , supra note 1, at 47–49.Google Scholar

See supra notes 63–66 and accompanying text. Contractual property rights established through technology transfer are, of course, only as sound and valuable as the agreements entered into. Case studies such as PXE on foundations of meaningful technology transfer negotiation and agreements are juxtaposed against case studies to the contrary where people were subjected to research and later claimed rights. See, e.g., Moore v. Regents of the University of California, 793 P.2d 479, 497 (Cal. 1990); Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003; Gitter, , “Ownership,” supra note 65, at 325–338 (discussing the Greenberg case).Google Scholar

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See generally Clayton, , supra note 115; Ossorio, , supra note 115.Google Scholar

As stated by Dr.Clayton, , unless DNA is deemed not personal, protected information under HIPAA, “genetics research is going to come to a screeching halt....” Clayton, Presentation, supra note 115.Google Scholar

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This position is supported by Dr. G. Koski, former Director of the Office for Human Research Protections (OHPR) in HHS, who called for the introduction of universal standards for IRBs. See DHHS, Office for Human Research Protections, at <http://ohrp.osophs.dhhs.gov/> (last visited January 6, 2004). IRBs will be expected to shoulder many novel questions associated with biobanking. See Rothstein, M. A., “The Role of IRBs in Research Involving Commercial Biobanks,” Journal of Medicine & Ethics 30 (2002): 105–112.Google Scholar

See generally “Government Cooperative Technology Programs and Tax Incentives,” in Malinowski, , Biotechnology, supra note 5, at 7–1 to 7–171.Google Scholar

See generally WHO, “Report,” supra note 137.Google Scholar

Buchanan, , supra note 3, at B-9 to B-10. These concerns have been raised frequently by R. Eisenberg, L. Andrews, D. Nelkin, and others. See supra notes 16, 46, and accompanying text.Google Scholar

See, e.g., deCode, discussed supra note 73–75 and in accompanying text.Google Scholar

Winickoff, , supra note 38, at 196 (concerns influential in the HGDP debate).Google Scholar

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The Health Insurance Portability and Accountability Act of 1996 (HIPAA), H.R. 3103, Pub. L. No. 104-191.Google Scholar

See supra note 29 (PhRMA estimates that during the 1990s the time required to develop a new drug stretched to 15 or more years). See supra note 36.Google Scholar

Malinowski, , supra note at 46.Google Scholar

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Informed consent is the means to protect individuals from nonconsensual invasions of their bodies and thereby avoid dignatory harms: “Because the right of informed consent, which includes the right to refuse treatment, allows the individual to decide whether the risk of these harms is worth taking, it can also protect individuals from other tangible harms that may result from the bodily invasion, if the individual refuses to give consent.” Buchanan, , supra note 3, at B-10. According to Prof. Buchanan, when an individual gives a blanket consent to future uses of her tissue, her choice is not likely to reflect a reasonable estimate of what is good for her on balance because the information she has about possible future risks is too indeterminate. Prof. Buchanan has concluded, therefore, that “blanket consent requirements will not provide protection against most of the more tangible and serious harms that might occur from the uses of stored biological.” Id. at B-18.Google Scholar

Tuskegee, a study spanning decades in which a group of African-American males was deprived treatment for syphilis, is perhaps the most cited and infamous example of discrimination against African Americans in the context of biomedical research. Price-waterhousecoopers LLP, Institutional Review Board (IRB) Reference Book, Russell-Einhorn, M. K. and Publisihed, T. eds., (2001): 11–12.Google Scholar

Countries with developing economies already have contributed much to contemporary medical care: “Hundreds of important and efficacious drugs have already been developed from plants found in developing countries. In fact, four-fifths of all drugs have their basis in nature plant resources.” Heald, P. J., “Traditional Knowledge, Intellectual Property, and Indigenous Culture,” Cardozo Journal of International and Comparative Law 11 (2003): 519–546, at 531, citing Brush, and Stabinsky, , Valuing Local Knowledge (1996). Others have estimated that “two-thirds of the drugs sold in pharmacies are of natural origin. They account for some $30 billion in sales every year.” Gulerin, C., “Out of the Forest and Into the Bottle,” Unesco Courier, May 1, 2000, at 30. Unfortunately, many of these contributions have not been made voluntarily and with full informed consent, thereby giving rise to the concept of “biopiracy.” Winickoff, , supra note 38, at 200–01. Well-reported case studies include a patent application submitted by the U.S. Department of Commerce in the early 1990s whereby the DOC sought to establish intellectual property rights in the cell line of a women who was a citizen of Guaymi, an indigenous group in Panama. Lock, , “Genetic Diversity,” supra note 60, at 99–100. “The woman who was illiterate and unschooled, was said to have given ‘informed oral consent’ to the research, even though neither the tribe nor the woman knew anything about the development of the cell line or the patent application. RAFI and the Guaymi demanded the withdrawal of the application, and the Department of Commerce acquiesced.” Winickoff, , supra note 38, at 200 (internal citations omitted). Another well-reported case study involves an attempt by NIH biomedical researchers to patent the T-lymphotrophic virus, which is found in the blood of the Hagahai people in Papua New Guinea. Ching, K. H., Note, “Indigenous Self-Determination in an Age of Genetic Patenting: Recognizing an Emerging Human Rights Norm,” Fordham Law Review 66 (1997): 687–730, 702. The researchers believed that they could develop related research into a diagnostic tool or vaccine for defined types of leukemia. Id. They allegedly negotiated a profit-sharing agreement with the Hagahaia – a tribe that had no contact with outsiders until 1984, when tribal members sought help for illness that afflicted the group. Id. RAFI deemed the arrangement human bioprospecting, and NIH relinquished rights to the patent.Google Scholar

See, e.g., Editorial, “Bayer's Bad Medicine,” Boston Globe, June 2, 2003, Al2 (reporting that Cutter Biological, a division of Bayer, after switching to heated version for customers in North America, continued to sell unheated med. in Asia and Latin America knowing it might be spreading the virus).Google Scholar

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See generally Malinowski, , supra note 1; Annas, and Grodin, , eds., supra note 96; Buchanan, , supra note 3, at B-7. For example, African Americans typically suffer certain harms because they are identified as African Americans: others often perceive African American individuals through the distorted lens of negative racial stereotypes. The harm of negative racial stereotyping is a harm to individuals, but it befalls individuals because of their ascriptive group identity. The term ascriptive here indicates that the identity in question is assigned by others, independently of the choice of the individual thus identified. Individuals who are vulnerable to ascriptive identify harms have a special interest in avoiding situations in which information obtainable from their biological samples may contribute to the reinforcement of harmful group stereotypes, not only because they themselves may be harmed but also because they may wish to avoid harm to other members of their ascriptive group. As pointed out by Tom Caskey, genetic information gleaned from biological samples might be used in research on the role of genotype in criminal behavior or in intelligence. In the past, such research has sometimes both embodied and been taken to validate negative racial stereotypes. See generally Caskey, Thomas C., Presentation, “Haplotype Mapping: Where will Haplotype Mapping Take Us?” The Genomics Revolution? Science, Law and Policy (Conference, February 6, 2004) (transcript of file with author).Google Scholar

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