Who owns what?: Private ownership and the public interest in recombinant DNA technology in the 1970s

ISIS

Volumn 102, Issue 3, 2011, Pages 446-474

  Yi, Doogab ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT DNA;

ARTICLE; GOVERNMENT; HISTORY; HUMAN; LEGAL ASPECT; MEDICAL RESEARCH; ORGANIZATION AND MANAGEMENT; PATENT; POLITICS; PUBLIC RELATIONS; UNITED STATES; UNIVERSITY;

BIOMEDICAL RESEARCH; DNA, RECOMBINANT; FEDERAL GOVERNMENT; HISTORY, 20TH CENTURY; HUMANS; INTERPROFESSIONAL RELATIONS; OWNERSHIP; PATENTS AS TOPIC; POLITICS; PRIVATE SECTOR; PUBLIC SECTOR; UNITED STATES; UNIVERSITIES;

EID: 80053531302     PISSN: 00211753     EISSN: 15456994     Source Type: Journal    
DOI: 10.1086/661619     Document Type: Article

References (179)

1. The Stanford and UC patent application cited three papers as crucial evidence for Boyer and Cohen's invention of recombinant DNA technology.
2. Stanley N. Cohen, Annie Chang, Herbert W. Boyer, and Robert B. Helling, "Construction of Biologically Functional Bacterial Plasmids In Vitro," Proceedings of the National Academy of Sciences, USA, 1973, 70:3240-3244;
3. Chang and Cohen, "Genome Construction between Bacterial Species In Vitro: Replication and Expression of Staphylococcus Plasmid Genes in Escherichia coli," ibid., 1974, 71:1030-1034;
4. John F. Morrow, Cohen, Chang, Boyer, Howard M. Goodman, and Helling, "Replication and Transcription of Eukaryotic DNA in Escherichia coli," ibid., pp. 1743-1747.
5. For a historical analysis of the rise of recombinant DNA technology out of the vibrant circulation of materials and technologies within the dense research network formed around Stanford biochemists see Doogab Yi, "Cancer, Viruses, and Mass Migration: Paul Berg's Venture into Eukaryotic Biology and the Advent of Recombinant DNA Research and Technology, 1967-1974," Journal of the History of Biology, 2008, 41:589- 636. For Cohen's contribution to the transformation of plasmid from an object of research into a technology for genetic engineering see Angela N. H. Creager, "Adaptation or Selection? Old Issues and New Stakes in the Postwar Debates over Bacterial Drug Resistance," Studies in History and Philosophy of Biological and Biomedical Sciences, 2007, 38:159-190;.
6. Mathias Grote, "Hybridizing Bacteria, Crossing Methods, Cross Checking Arguments: The Transition from Episomes to Plasmids (1961-1969)," History and Philosophy of the Life Sciences, 2008, 30:407-430.
7. For the evolution of regulatory regimes for recombinant DNA research and technology see Susan Wright, Molecular Politics: Developing American and British Regulatory Policy for Genetic Engineering, 1972-1982 (Chicago: Univ. Chicago Press, 1994);.
8. Sheldon Krimsky, Genetic Alchemy: The Social History of the Recombinant DNA Controversy (Cambridge, Mass.: MIT Press, 1985).
9. Robert M. Rosenzweig to Donald S. Fredrickson, 18 June 1976, Folder: "Recombinant DNA Patent," Archives, Office of Technology Licensing, Stanford University, Stanford, California (hereafter cited as OTL Archives).
10. "Institutional Patent Agreement Governing Grants and Awards from the Department of Health, Education, and Welfare," Aug. 1968 (reinstitution of the IPA); and Barry Leshowitz, "The Demise of Technology Transfer in DHEW," 1978 (regarding the NIH decision to suspend the transfer of ownership of inventions): Norman J. Latker Personal Papers.
11. Stanley N. Cohen and Herbert W. Boyer, "Process for Producing Biologically Functional Molecular Chimeras," U.S. Patent 4,237,224, granted 2 Dec. 1980 (filed 4 Nov. 1974). Historians have instead attributed the prolonged prosecution of recombinant DNA technology patent applications to heated public health discus sions about the safety of the technology and the lack of legal means for patenting organisms in the 1970s.
12. Sally S. Hughes, "Making Dollars Out of DNA: The First Major Patent in Biotechnology and the Commercial ization of Molecular Biology, 1974-1980," Isis, 2001, 92:541-575.
13. Daniel J. Kevles, "Ananda Chakrabarty Wins a Patent: Biotechnology, Law, and Society, 1972-1980," Historical Studies in the Physical and Biological Sciences, 1994, 25:111-135;
14. Kevles, "Of Mice and Money: The Story of the World's First Animal Patent," Daedalus, 2002, 131:78-88.
15. For a broader overview of the commercialization of science, with an emphasis on shifts in funding and in the organization of science in the latter half of the twentieth century, see Philip Mirowski and Esther-Mirjam Sent, "The Commercialization of Science and the Response of STS," in Handbook of Science, Technology, and Society Studies, ed. Edward J. Hackett, Olga Amsterdamska, Michael Lynch, and Judy Wajcman (Cambridge, Mass.: MIT Press, 2007), pp. 635-689.
16. My analysis builds on the work of social scientists who have examined the broader political and economic context of American research universities' involvement in patent management.
17. David C. Mowery, Richard R. Nelson, Bhaven N. Sampat, and Arvids A. Ziedonis, Ivory Tower and Industrial Innovation (Stanford, Calif.: Stanford Univ. Press, 2004).
18. Elizabeth P. Berman, "Why Did Universities Start Patenting? Institution-Building and the Road to the Bayh-Dole Act," Social Studies of Science, 2008, 38:835-871.
19. For a historical overview of the emergence of biotechnology see Martin Kenney, Biotechnology: The University-Industrial Complex (New Haven, Conn.: Yale Univ. Press, 1986);
20. Sheldon Krimsky, Biotechnics and Society: The Rise of Industrial Genetics (New York: Praeger, 1991).
21. For a pioneering attempt to historicize the emergence of biotechnology see the essays in Arnold Thackray, ed., Private Science: Biotechnology and the Rise of Molecular Sciences (Philadelphia: Univ. Pennsylvania Press, 1998).
22. N. Cohen, "The Manipulation of Genes," Scientific American, 1975, 233:24-33.
23. For an analysis of the transformation of recombinant DNA technology from a research technique in molecular biology to a commercial technology see Susan Wright, "Recombinant DNA Technology and Its Social Transformation, 1972-1982," Osiris, 1986, N.S., 2:303-360.
24. For a historical account of the rise of biotech companies in the 1970s and 1980s see Stephen S. Hall, Invisible Frontiers: The Race to Synthesize a Human Gene (New York: Atlantic Monthly, 1987);.
25. Cynthia Robbins-Roth, From Alchemy to IPO: The Business of Biotechnology (Cambridge, Mass.: Perseus, 2000).
26. Kevles, "Ananda Chakrabarty Wins a Patent" (cit. n. 6);
27. Hughes, "Making Dollars Out of DNA" (cit. n. 6);
28. Mowery et al., Ivory Tower and Industrial Innovation (cit. n. 7);
29. Roger L. Geiger, Knowledge and Money: Research Universities and the Paradox of the Marketplace (Stanford, Calif.: Stanford Univ. Press, 2004).
30. A wave of economic analyses pointed out the slower growth of productivity in the 1970s, especially a substantial drop in the growth of labor productivity between 1973 and 1976.
31. Edward F. Denison, Accounting for Slower Economic Growth: The United States in the 1970s (Washington, D.C.: Brookings Institution, 1979);
32. William J. Baumol, Sue Anne Batey Blackman, and Edward N. Wolff, Productivity and American Leadership: The Long View (Cambridge, Mass.: MIT Press, 1989).
33. Rebecca S. Eisenberg, "Public Research and Private Development: Patents and Technology Transfer in Government-Sponsored Research," Virginia Law Review, 1996, 82:1663-1727.
34. Robert E. Kohler, "The Management of Science: The Experience of Warren Weaver and the Rockefeller Foundation Programme in Molecular Biology," Minerva, 1976, 14:279-306.
35. Critics of the commercialization of academic research have characterized this framework as emblematic of the "corruption" of academic scientists. See Jennifer Washburn, University, Inc.: The Corporate Corruption of American Higher Education (New York: Basic, 2005).
36. For an overview of the law and economics perspective on intellectual property rights see Edmund W. Kitch, "The Nature and Function of the Patent System," Journal of Law and Economics, 1977, 20:265-290. For a historical analysis of the rise of the law and economics movement see Steven M. Teles, The Rise of the Conservative Legal Movement: The Battle for Control of the Law (Princeton, N.J.: Princeton Univ. Press, 2008).
37. For an insightful analysis of the scientific life in the age of commercial biotechnology see Steven Shapin, The Scientific Life: A Moral History of a Late Modern Vocation (Chicago: Univ. Chicago Press, 2008).
38. Berman, "Why Did Universities Start Patenting?" (cit. n. 7). On the central role of law in reshaping the relationship between technoscience and public policy see Sheila Jasanoff, Science at the Bar: Law, Science, and Technology in America (Cambridge, Mass.: Harvard Univ. Press, 1995). For a historical analysis of the role of patents in the creation and regulation of new markets see the essays in the special issue of History and Technology, 2008, 24(2), esp. Jean-Paul Gaudilliere, "How Pharmaceuticals Became Patentable: The Production and Appropriation of Drugs in the Twentieth Century," pp. 99-106.
39. Roger L. Geiger, Research and Relevant Knowledge: American Research Universities since World War II (New York: Oxford Univ. Press, 1993);
40. Nathan Reingold, "Science and Government in the United States since 1945," History of Science, 1994, 32:361-386.
41. David A. Hollinger, "Science as a Weapon in Kulturkampfe in the United States During and After World War II," Isis, 1995, 86:440-454.
42. Stuart W. Leslie, The Cold War and American Science: The Military-Industrial-Academic Complex at MIT and Stanford (New York: Columbia Univ. Press, 1993);
43. Peter Galison and Bruce Hevly, eds., Big Science: The Growth of Large-Scale Research (Stanford, Calif.: Stanford Univ. Press, 1992);
44. Rebecca S. Lowen, Creating the Cold War University: The Transformation of Stanford (Berkeley: Univ. California Press, 1997).
45. Angela N. H. Creager, The Life of a Virus: Tobacco Mosaic Virus as an Experimental Model, 1930-1965 (Chicago: Univ. Chicago Press, 2002), esp. Ch. 5, "The War against Polio," pp. 141-184.
46. Charles E. Rosenberg, No Other Gods: On Science and American Social Thought (Baltimore: Johns Hopkins Univ. Press, 1976).
47. Clark Kerr, The Uses of the University (Cambridge, Mass.: Harvard Univ. Press, 1963);
48. Daniel J. Kevles, "The National Science Foundation and the Debate over Postwar Research Policy, 1942-1945: A Political Interpretation of Science-The Endless Frontier," Isis, 1977, 68:5-26.
49. Kerr relied on Fritz Machlup's The Production and Distribution of Knowledge in the United States (Princeton, N.J.: Princeton Univ. Press, 1962) in his discussion of the emergence of the knowledge economy. According to Machlup, "the production, distribution, and consumption of knowledge' in all its forms is said to account for 29 percent of gross national product... and knowledge production' is growing at about twice the rate of the rest of the economy": quoted in Kerr, Uses of the University, p. 66.
50. Paddy Riley, "Clark Kerr: From the Industrial to the Knowledge Economy," in American Capitalism: Social Thought and Political Economy in the Twentieth Century, ed. Nelson Lichtenstein (Philadelphia: Univ. Pennsylvania Press, 2006), pp. 71-87.
51. Daniel J. Kevles, The Physicists: The History of a Scientific Community in Modern America (New York: Knopf, 1977), pp. 413-416;
52. Eric J. Vettel, Biotech: The Countercultural Origins of an Industry (Philadelphia: Univ. Pennsylvania Press, 2006), esp. Ch. 6, "A Season of Policy Reform," pp. 129-156.
53. A wave of economic studies in the 1970s questioned the efficiency of government investment in scientific and technological enterprises.
54. Bruce Williams, "The Economic Impact of Science and Technology in Historical Perspective," Minerva, 1982, 20:301-312.
55. Donald Stokes, Pasteur's Quadrant: Basic Science and Technological Innovation (Washington, D.C.: Brookings Institution, 1997);
56. David Edgerton, "The 'Linear Model' Did Not Exist: Reflections on the History and Historiography of Science and Research in Industry in the Twentieth Century," in The Science-Industry Nexus: History, Policy, Implications, ed. Karl Grandin, Nina Wormbs, and Sven Widmalm (Sagamore Beach, Mass.: Science History Publications, 2004), pp. 31-57.
57. Chalmers W. Sherwin and Raymond S. Isenson, "Project Hindsight: A Defense Department Study of the Utility of Research," Science, 1967, 156:1571-1577, on p. 1571.
58. Sherwin and Isenson, "First Interim Report on Project Hindsight," Summary, 30 June 1966, No. AD 642-400 (Springfield, Va: Clearinghouse for Federal Scientific and Technical Information, 1966);
59. Office of the Director of Defense Research and Engineering, Project Hindsight: Final Report (Washington, D.C.: U.S. Department of Defense, 1969). For a historical analysis of Project Hindsight see Glen R. Asner, "The Linear Model, the U.S. Department of Defense, and the Golden Age of Industrial Research," in Science-Industry Nexus, ed. Grandin et al., pp. 3-30.
60. Kenneth J. Arrow, "Economic Welfare and the Allocation of Resources for Invention," P-1856-RC, RAND Corporation, 15 Dec. 1959, pp. 1-23
61. Philip Mirowski and Esther-Mirjam Sent, eds., Science Bought and Sold: Essays in the Economics of Science (Chicago: Univ. Chicago Press, 2002), pp. 165-180.
62. David A. Hounshell, "The Medium Is the Message; or, How Context Matters: The RAND Corporation Builds an Economics of Innovation, 1946-1962," in Systems, Experts, and Computers: The Systems Approach in Management and Engineering, World War II and After, ed. Thomas P. Hughes and Agatha C. Hughes (Cambridge, Mass.: MIT Press, 2000), pp. 255-310.
63. Kevles, "National Science Foundation and the Debate over Postwar Research Policy, 1942-1945" (cit. n. 20). On the growth of the federal research economy through institutional pluralism see Geiger, Research and Relevant Knowledge (cit. n. 18).
64. Kenneth S. Pitzer to Robert H. Finch (Secretary of the DHEW), 9 June 1969, Richard W. Lyman Papers, Box 8, Folder: "Federal Government," Stanford University Archives, Stanford, California.
65. The White House, Biomedical Science and Its Administration: A Study of the National Institutes of Health (Washington, D.C.: U.S. Government Printing Office, 1965), p. xv ("money's worth");.
66. Stephen P. Strickland, Politics, Science, and Dread Disease: A Short History of United States Medical Research Policy (Cambridge, Mass.: Harvard Univ. Press, 1972), p. 207 (quoting Johnson);
67. Vettel, Biotech (cit. n. 22), p. 136 ("bomb shell"). For calls for a national program for a cure for cancer see Jean-Paul Gaudilliere, "The Molecularization of Cancer Etiology in the Postwar United States: Instruments, Politics, and Management," in Molecularizing Biology and Medicine: New Practices and Alliances, 1910-1970s, ed. Soraya de Chadarevian and Harmke Kamminga (Amsterdam: Harwood Academic, 1998), pp. 139-170;.
68. Daniel J. Kevles, "Pursuing the Unpopular: A History of Courage, Viruses, and Cancer," in Hidden Histories of Science, ed. Robert B. Silvers (New York: New York Review of Books, 1995), pp. 69-114.
69. Philip M. Boffey, "Federal Research Funds: Science Gets Caught in a Budget Squeeze," Science, 1967, 158:1286-1288;
70. Earl Frank Cheit, The New Depression in Higher Education: A Study of Financial Conditions at Forty-one Colleges and Universities (New York: McGraw-Hill, 1971).
71. Daniel S. Greenberg, Science, Money, and Politics: Political Triumph and Ethical Erosion (Chicago: Univ. Chicago Press, 2001), Appendix.
72. National Cancer Institute, "A New Attack upon Disease Research Problems," 15 July 1964, p. 3, Carl Baker Papers, Box 2, Folder: "1964" (effort comparable to space and atomic energy programs);
73. Kenneth Endicott to James Shannon (NIH director), "Applied Developmental Research and Research Services: Need for Legis lation" (memo), 28 Feb. 1963, p. 2, Carl Baker Papers, Box 2, Folder: "1963": Office of NIH History Collections, National Institutes of Health, Bethesda, Maryland.
74. Shannon to the Surgeon General, PHS (Public Health Service), "Need for Changes in Department Patent Policy to Permit Effective Collaboration with Industry," 14 Aug. 1964, Norman J. Latker Personal Papers. For Shannon's role in the antimalaria drug project see Leo B. Slater, War and Disease: Biomedical Research on Malaria in the Twentieth Century (New Brunswick, N.J.: Rutgers Univ. Press, 2009).
75. U.S. General Accounting Office, Problem Areas Affecting Usefulness of Results of Government-Sponsored Research in Medical Chemistry: A Report to the Congress (Washington, D.C.: U.S. Government Printing Office, 1968); and Harbridge House, Inc., Government Patent Policy Study: Final Report, prepared for the Federal Council for Science and Technology Committee on Government Patent Policy (Washington, D.C.: U.S. Gov ernment Printing Office, 1968). Regarding these reports' focus on the disparities among government agencies see Eisenberg, "Public Research and Private Development" (cit. n. 13).
76. As one referee pointed out, some scholars view the DHEW's commitment to the public availability of the results of biomedical research as a consequence of the failed attempt of the Truman administration to implement universal health care. See Strickland, Politics, Science, and Dread Disease (cit. n. 28). The Atomic Energy Commission instituted a title policy as a way for the U.S. government to monopolize inventions with national security implications. See Alex Wellerstein, "Patenting the Bomb: Nuclear Weapons, Intellectual Property, and Technological Control," Isis, 2008, 99:57-87.
77. Norman Latker testimony, Hearings before the Committee on Science and Technology, in Government Patent Policy: The Ownership of Inventions Resulting from Federally Funded Research and Development (Washington, D.C.: U.S. Government Printing Office, 1976), p. 723. On Latker's central role in the enactment of the Bayh-Dole Act see Washburn, University, Inc. (cit. n. 14); and Berman, "Why Did Universities Start Patenting?" (cit. n. 7).
78. Berman, "Why Did Universities Start Patenting?";
79. Jon Sandelin, "A History of the Association of University Technology Managers," unpublished manuscript, Oct. 2005 (document courtesy of Sandelin).
80. David Mowery and Bhaven N. Sampat, "University Patents and Patent Policy Debates in the USA, 1925-1980," Industrial and Corporate Change, 2001, 10:781-814.
81. On a few occasions, universities and academic researchers used patenting as a means to control beneficial medical inventions and therapeutics for the public benefit.
82. Angela N. H. Creager, "Biotechnology and Blood: Edwin Cohn's Plasma Fractionation Project, 1940-1953," in Private Science, ed. Thackray (cit. n. 8), pp. 39-62;
83. Maurice Cassier and Christiane Sinding, "'Patenting in the Public Interest': Administration of Insulin Patents by the University of Toronto," Hist. & Technol., 2008, 24:153-171.
84. The RC was established in 1912 by the Berkeley chemist Frederick G. Cottrell as a nonprofit organization for managing academic patents.
85. David Mowery and Bhaven N. Sampat, "Patenting and Licensing University Inventions: Lessons from the History of the Research Corporation," Indust. Corp. Change, 2001, 10:317-355.
86. The WARF was founded as a separate corporation in the 1920s to handle the University of Wisconsin's patents, most notably those related to vitamin D.
87. Rima D. Apple, "Patenting University Research: Harry Steenbock and the Wisconsin Alumni Research Foundation," Isis, 1989, 80:375-394.
88. Eisenberg, "Public Research and Private Development" (cit. n. 13).
89. Ibid., p. 1700 (universities' advantages in recognizing viable inventions);
90. Mowery and Sampat, "Patenting and Licensing University Inventions" (cit. n. 38), esp. pp. 338-341.
91. Niels Reimers, "Tiger by the Tail," Chemtech, 1987, 17:464-471.
92. For a history of Stanford's Office of Technology see Hughes, "Making Dollars Out of DNA" (cit. n. 6).
93. David L. Webster, private note, 15 Dec. 1939, David L. Webster Papers, Addendum, Box 1, Stanford University Archives, quoted in Lowen, Creating the Cold War University (cit. n. 19), p. 42.
94. C. Stewart Gillmor, Fred Terman at Stanford: Building a Discipline, a University, and Silicon Valley (Stanford, Calif.: Stanford Univ. Press, 2004), pp. 152-154.
95. Richard W. Lyman (Stanford Provost) to Department Chairmen and Principal Investigators, "Patent Licensing," 16 May 1969, Paul Berg Papers, Box 17, Folder: "Faculty Meeting, 1968-69," Stanford University Archives. Lyman served as president of Stanford from 1970 to 1980.
96. William F. Miller (Vice President for Research), "University Patent Policy and Patent Licensing Program," Guide Memo: 75, Patents, 10 June 1970, Joshua Lederberg Papers, Box 22(B), Folder: "Patents," Stanford University Archives.
97. Niels Reimers, "A Personal History of the Stanford University Office of Technology Licensing," unpub lished manuscript (as of 2003) (document courtesy of Stanford OTL). The RC, whose royalty income had largely been dependent upon a few "home run" patents pertaining to chemical, pharmaceutical, and agricultural inventions, such as vitamin B, cortisone, reserpine, and hybrid seed corn, was also affected by this industry- specific disparity in academic patenting.
98. Stanford OTL's first patent was granted to Johnson: William S. Johnson, "Intermediates in Synthesis of 16-Dehydroprogesterone," U.S. Patent 3,598,845, granted 10 Aug. 1971 (filed 30 Dec. 1968).
99. Latker testimony, Hearings before the Committee on Science and Technology, in Government Patent Policy (cit. n. 34), p. 723.
100. Niels Reimers to NIH, 24 May 1976, OTL Archives.
101. Niels Reimers, "Stanford's Office of Technology Licensing and the Cohen/Boyer Cloning Patents," an oral history conducted by Sally Smith Hughes in 1997, Regional Oral History Office, Bancroft Library, University of California, Berkeley, 1998; and Stanford University News Service, 20 May 1974, as quoted in Hughes, "Making Dollars Out of DNA" (cit. n. 6), p. 545.
102. Hughes, "Making Dollars Out of DNA," pp. 548-549.
103. Cohen already held a patent on a laboratory instrument: Stanley Cohen and Myron Tannenbaum, "Filtration Apparatus," U.S. Patent 3,730,352, granted 1 May 1973 (filed 6 Dec. 1971).
104. Reporting on work in Berg's laboratory see David A. Jackson, Robert H. Symons, and Paul Berg, "Biochemical Method for Inserting New Genetic Information into DNA of Simian Virus 40: Circular SV40 DNA Molecules Containing Lambda Phage Genes and Galactose Operon of Escherichia coli," Proc. Nat. Acad. Sci. USA, 1972, 69:2904-2909;.
105. Peter E. Lobban, "An Enzymatic Method for End-to-End Joining of DNA Molecules" (Ph.D. diss., Stanford Univ., 1972);
106. Janet E. Mertz and Ronald W. Davis, "Cleavage of DNA by RI Restriction Endonuclease Generates Cohesive Ends," Proc. Nat. Acad. Sci. USA, 1972, 69:3370-3374.
107. Stanley N. Cohen, "Science, Biotechnology, and Recombinant DNA: A Personal History," an oral history conducted by Sally Smith Hughes in 1995, Regional Oral History Office, Bancroft Library, University of California, Berkeley, 2009, p. 150.
108. William Carpenter to Reimers, "S74-43 Gene Transplantation" (memo), 18 Oct. 1974, OTL Archives.
109. The first recombinant DNA paper was Cohen et al., "Construction of Biologically Functional Bacterial Plasmids In Vitro" (cit. n. 1). For Cohen's recollection of the initial decision to collaborate with Boyer see Stanley N. Cohen, "The Stanford DNA Cloning Patent," in From Genetic Engineering to Biotechnology: The Critical Transition, ed. W. J. Whelan and Sandra Black (New York: Wiley, 1982), pp. 213-216;.
110. John Lear, Recombinant DNA: The Untold Story (New York: Crown, 1978), pp. 59-60.
111. The Stanford biochemists' contribution to the development of recombinant DNA-related technologies became a subject of intense discussion between Stanford scientists and PTO examiners.
112. Yi, "Cancer, Viruses, and Mass Migration" (cit. n. 2).
113. John Morrow to Stanley Cohen and Herbert Boyer, 23 Jan. 1975, OTL Archives;
114. John Poitras, "Meeting on DNA Patent: May 17, 1976," OTL Archives. The attendees at the 17 May meeting were Clayton Rich, Joshua Lederberg, William Massy, William Baxter, Robert Rosenzweig, Peter Carpenter, Paul Berg, John Poitras, and Stanley Cohen.
115. Cohen to Bertram Rowland, 22 Jan. 1975, OTL Archives.
116. "In Confidence, Re: Process and Composition for Biologically Functional DNA Chimeras," 1 July 1975, OTL Archives (concern regarding the "public service ideals of the University"); and "Meeting with Bill Massy, Stanley Cohen, Charles Yanofsky, Paul Berg, Ronald Davis, David Hogness, and Niels Reimers at the Stanford Medical School," 9 Apr. 1975, File: "Gene Transplant," OTL Archives. Cohen reneged on his promise not to benefit personally from the recombinant DNA patent sometime in 1983, after Stanford first began to distribute royalty income from the recombinant DNA patent to the inventors in the fall of 1982 (the university began to receive licensing fees in December 1981, and by August 1982 the royalty income from the recombinant DNA patent was 1.4 million).
117. Reimers, "Stanford's Office of Technology Licensing and the Cohen/Boyer Cloning Patents" (cit. n. 50), pp. 13-14.
118. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Opinion Regarding Validity, Enforceability, and Infringement Issues Presented by the Cohen and Boyer Patents, Prepared for Leland Stanford Junior University (Confidential Opinion of Counsel, 9 Aug. 1985), "VI: Prosecution History of the Cohen and Boyer Patents," pp. 35-55. Regarding the Chakrabarty case see Kevles, "Ananda Chakrabarty Wins a Patent" (cit. n. 6). For a history of Genentech see Hughes, "Making Dollars Out of DNA" (cit. n. 6); and Hall, Invisible Frontiers (cit. n. 10).
119. Niels Reimers, "Licensing Plan (Original Draft, May 14, 1976)," 13 July 1976, OTL Archives. For the enthusiasm about the industrial uses of life see Robert Bud, The Uses of Life: A History of Biotechnology (Cambridge: Cambridge Univ. Press, 1993).
120. Poitras, "Meeting on DNA Patent: May 17, 1976," OTL Archives. Tanenholtz ultimately acquiesced to some of Rowland's counterarguments, granting the first Cohen- Boyer patent in 1980 (the other two Cohen-Boyer patents were granted in 1984 and 1986, respectively).
121. Yi, "Cancer, Viruses, and Mass Migration" (cit. n. 2), esp. pp. 622-627;
122. Albert P. Halluin, "Patenting the Results of Genetic Engineering Research: An Overview," in Patenting of Life Forms, ed. David W. Plant, Niels J. Reimers, and Norton D. Zinder (Cold Spring Harbor, N.Y.: Cold Spring Harbor Laboratory Press, 1982), pp. 67-126.
123. Paul Berg (chairman), David Baltimore, Herbert Boyer, Stanley Cohen, Ronald Davis, David Hogness, Daniel Nathans, Richard Roblin, James Watson, Sherman Weissman, and Norton Zinder, "Potential Biohazards of Recombinant DNA Molecules," Science, 1974, 185:303 (moratorium letter);.
124. Berg, personal correspondence with Doogab Yi, Sept. 2009 (discussion with Fredrickson).
125. Poitras, "Meeting on DNA Patent: May 17, 1976," OTL Archives. As the controversy continued, one commentator criticized Stanford's patenting attempt, writing bitterly that "a research institution is taking steps to patent strains and procedures derived from work done during the moratorium by people calling for it": Letter to Paul Berg, 1977, Paul Berg Papers, Box 5, Personal Correspondence, Stanford University Archives. For useful background information see Charles Weiner, "Patenting and Academic Research: Historical Case Studies," in Owning Scientific and Technical Information: Value and Ethical Issues, ed. Vivian Weil and John W. Snapper (New Brunswick, N.J.: Rutgers Univ. Press, 1989), pp. 87-109.
126. Niels Reimers, "Memo: Meeting on Gene Transplant at the Medical School," 7 Apr. 1975, OTL Archives; and Poitras, "Meeting on DNA Patent: May 17, 1976," OTL Archives (Rosenzweig's view).
127. Cohen, "Science, Biotechnology, and Recombinant DNA" (cit. n. 53), p. 152;
128. News: Genetic Manipulation to Be Patented? Nature, 1976, 261:624.
129. Niels Reimers, "Meeting with Norman Latker and David Eden," 24 May 1976, OTL Archives.
130. Here my interpretation differs from Hughes's view of Rosenzweig's letter in "Making Dollars Out of DNA" (cit. n. 6). Though his letter does exhibit Stanford's prudence, it is also relevant that the political situation of recombinant DNA technology at the NIH, especially Latker's temporary resignation in 1978, underlined the contentiousness of the NIH's patent waiver in this particular case.
131. William J. Broad, "Patent Bill Returns Bright Idea to Inventor," Science, 1979, 205:473-476;
132. Mowery et al., Ivory Tower and Industrial Innovation (cit. n. 7), esp. Ch. 5, "A Political History of the Bayh-Dole Act of 1980," pp. 85-98.
133. Under the terms of the IPA, the DHEW reserved its right to revoke the entire title right if the grantee failed to comply with the IPA obligations.
134. See Appendix II, "Institutional Patent Agreement Governing Grants and Awards from the Department of Health, Education, and Welfare," in Office of Director, NIH, Recombinant DNA Research, Vol. 2: Documents Relating to "NIH Guidelines for Research Involving Recombinant DNA Mole cules," June 1976-November 1977, prepared by the Office of the Director, NIH, Department of Health, Education, and Welfare Publication No. 78-1139 (Washington, D.C.: U.S. Government Printing Office, 1978). It should be noted that the DHEW had never exercised this stipulation. See Washburn, University, Inc. (cit. n. 14).
135. Hearings before the Committee on Science and Technology, in Government Patent Policy (cit. n. 34), p. 1260 ("greater rights than a non-exclusive license"); and Niels Reimers, "Mechanisms for Technology Transfer: Marketing University Technology," in Technology Transfer: University Opportunities and Responsibilities: A Report on the Proceedings of a National Conference on the Management of University Technology Resources (Cleveland, Ohio: Case Western Reserve Univ., 1974), pp. 100-108, on pp. 100-101 (quoting from the lawsuit).
136. Technology Transfer, p. 8 ("intense interest and encouragement"); and Reimers, "Mechanisms for Tech nology Transfer," pp. 100-101. On the establishment of the Society of University Patent Administrators see Sandelin, "History of the Association of University Technology Managers" (cit. n. 35) (the organization's name changed in the late 1980s). On the ascendancy of market rationales in public policy debates see Mark A. Smith, The Right Talk: How Conservatives Transformed the Great Society into the Economic Society (Princeton, N.J.: Princeton Univ. Press, 2007).
137. Donald S. Fredrickson, The Recombinant DNA Controversy: A Memoir: Science, Politics, and the Public Interest, 1974-1981 (Washington, D.C.: ASM Press, 2001), pp. 94-95 (Nelson's plans), 95 (characterizing Latker's aim).
138. For Fredrickson's letter, dated 8 Sept. 1976, see Recombinant DNA Research, Vol. 2 (cit. n. 69), pp. 21-24.
139. David Baltimore to Fredrickson, 20 Sept. 1976, in Recombinant DNA Research, Vol. 2, p. 80; Garret M. Ihler (Department of Biochemistry, University of Pittsburgh) to Fredrickson, 30 June 1976, ibid., pp. 62-63; and Berg to Fredrickson, 27 Sept. 1976, ibid., pp. 90-92.
140. Ronald Cape to Fredrickson, 28 Sept. 1976, in Recombinant DNA Research, Vol. 2, pp. 94-97. It is important to note that Cetus had commercial interests in recombinant DNA technology, and if the patent was upheld Cetus would have to license it from Stanford and UC.
141. Jerome Birnbaum to Fredrickson, 30 Sept. 1976, in Recombinant DNA Research, Vol. 2, pp. 129-130;
142. C. Joseph Stetler to Fredrickson, 29 Sept. 1976, ibid., pp. 106-108.
143. Latker testimony, Hearings before the Committee on Science and Technology, in Government Patent Policy (cit. n. 34), pp. 705, 724.
144. Niels Reimers, "Meeting with Genentech," 2 June 1976, OTL Archives;
145. Reimers "Various Telephone Conversations and Meetings," 2 Aug. 1976, File S74-43: "Recombinant DNA," OTL Archives.
146. Reimers, "Various Telephone Conversations and Meetings," 2 Aug. 1976.
147. Fredrickson, Recombinant DNA Controversy (cit. n. 72), p. 98;
148. Marshall Dann (Commissioner of Patent and Trademark Office), "Patent and Trademark Office: Recombinant DNA Accelerated Processing of Patent Applications for Inventions," Federal Register, 1977, 42:2712-2713. This new policy was approved by Betsy Ancker-Johnson on 7 Jan. 1977.
149. The term "tragedy of the commons" was popularized by the biologist Garrett Hardin, who was concerned about market failures in areas of common goods such as the environment and natural resources.
150. Garrett Hardin, "The Tragedy of the Commons," Science, 1968, 162:1243-1248.
151. In the 1970s the phrase gained a life of its own among scholars of law and economics, who argued that market failures in public goods could be addressed by "privatizing" the commons.
152. James Boyle, The Public Domain: Enclosing the Commons of the Mind (New Haven, Conn.: Yale Univ. Press, 2008).
153. Harold Demsetz, "Toward a Theory of Property Rights," American Economic Review, 1967, 57:347-359;
154. Richard A. Posner, Economic Analysis of the Law (Boston: Little, Brown, 1973).
155. Johan Van Overtveldt, The Chicago School: How the University of Chicago Assembled the Thinkers Who Revolutionized Economics and Business (Chicago: B2 Books, 2007).
156. Kitch, "Nature and Function of the Patent System" (cit. n. 15), p. 287.
157. Machlup's warning had become a legal basis for the public ownership of common resources and goods in the 1950s and 1960s.
158. Fritz Machlup, An Economic Review of the Patent System, Study No. 15 of the Subcommittee on Patents, Trademarks, and Copyrights of the Committee on the Judiciary, U.S. Senate, 85th Cong. (Washington, D.C.: U.S. Government Printing Office, 1958).
159. Betsy Ancker-Johnson and David B. Change, U.S. Technology Policy: A Draft Study (Office of the Assistant Secretary for Science and Technology, U.S. Department of Commerce, National Technical Information Service, PB-263 806, Mar. 1977), pp. 72, 26.
160. Joseph A. Califano, Jr., to Juanita M. Kreps, Secretary of Commerce, 8 Feb. 1977, in Recombinant DNA Research, Vol. 2 (cit. n. 69), p. 11; Joseph A. Hill, Department of Justice, "Patenting of Recombinant DNA Research Inventions" (memo), 5 May 1977, MS.C 526, Donald S. Fredrickson Papers, Box 15, Folder 8: "Patents, 1977-1981," National Library of Medicine, Bethesda, Maryland; and Leshowitz, "Demise of Technology Transfer in DHEW" (cit. n. 5).
161. On the coalition of those who shared the benevolent view of private ownership see Washburn, University, Inc. (cit. n. 14); and Berman, "Why Did Universities Start Patenting?" (cit. n. 7). For Latker's criticism see his testimony, Hearings before the Subcommittee on Monopoly and Anticompetitive Activities of the Select Committee on Small Business, in Government Patent Policies: Institutional Patent Agreements, U.S. Senate, 95th Cong., 1st sess., Dec. 1977, Vol. 1, and 2nd sess., May and June 1978, Vol. 2 (Washington, D.C.: U.S. Government Printing Office, 1978). Regarding Dole's support see Nancy K. Eskridge, "Dole Blasts HEW for Stonewalling' Patent Applications," BioScience, 1978, 28:605-606, on p. 605; and Washburn, University, Inc., pp. 66-67.
162. Fredrickson to Rosenzweig, Mar. 1978, OTL Archives.
163. Hearings before the Committee on the Judiciary, U.S. Senate, 96th Cong., 1st sess., on S. 414, in The University and Small Business Patent Procedures Act, 16 May and June 1979, Serial No. 96-11 (Washington, D.C.: U.S. Government Printing Office, 1979). The bill became Public Law 96-517 when President Jimmy Carter signed it into law on 12 Dec. 1980. The PTO issued the first recombinant DNA patent on 2 Dec. 1980: "Process for Producing Biologically Functional Molecular Chimeras," U.S. Patent 4,237,224 (cit. n. 6).
164. On the increasing calls for accountability see Vettel, Biotech (cit. n. 22). For the role of lay activists in the formation of the nation's biomedical research policy in the post-World War II era see Angela N. H. Creager, "Mobilizing Biomedicine: Virus Research between Lay Health Organizations and the U.S. Federal Government, 1935-1955," in Biomedicine in the Twentieth Century: Practices, Policies, and Politics, ed. Caroline Hannaway (Amsterdam: IOS Press, 2008), pp. 171-201.
165. For federal budget data for academic research and on the broader implications of federal budget trends in the 1970s for the commercialization of science see Greenberg, Science, Money, and Politics (cit. n. 29); and Mirowski and Sent, "Commercialization of Science and the Response of STS" (cit. n. 6).
166. On the rise of American conservatism and the ascendency of market ideology see George H. Nash, The Conservative Intellectual Movement in America since 1945 (New York: Basic, 1976). For the reconfiguration of public policy in terms of economic rationales in the 1970s see Smith, Right Talk (cit. n. 71).
167. Doogab Yi, "The Scientific Commons in the Marketplace: The Industrialization of Biomedical Materials at the New England Enzyme Center, 1963-1980," Hist. & Technol., 2009, 25:69-87.
168. Edward Yoxen, "Life as a Productive Force: Capitalizing the Science and Technology of Molecular Biology," in Science, Technology, and the Labor Process: Marxist Studies, ed. Les Levidow and Robert M. Young (London: Blackrose, 1981), pp. 66-122.
169. Michael Mackenzie, Alberto Cambrosio, and Peter Keating, "The Commercial Application of a Scientific Discovery: The Case of the Hybridoma Technique," Research Policy, 1988, 17:155-170;
170. Soraya de Chadarevian, Designs for Life: Molecular Biology after World War II (Cambridge: Cambridge Univ. Press, 2002), pp. 336-362.
171. The rise of a discourse of the tragedy of the commons in intellectual property exhibited the shifting nexus between intellectual property, open science, and economic innovation forged in the early twentieth century. For the co-production of open science and intellectual property in the 1930s see Adrian Johns, "Intellectual Property and the Nature of Science," Cultural Studies, Mar.-May 2006, 20:145-164;.
172. Johns, Piracy: The Intellectual Property Wars from Gutenberg to Gates (Chicago: Univ. Chicago Press, 2009).
173. "Cumulative Cohen-Boyer Royalties," Folder: "Recombinant DNA Patent Files," OTL Archives.
174. Sheldon Krimsky, Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? (Lanham, Md.: Rowman & Littlefield, 2003);
175. Philip Mirowski, Science-Mart: Privatizing American Science (Cambridge Mass Harvard Univ. Press, 2011).
176. Bruno J. Strasser, "The Experimenter's Museum: GenBank, Natural History, and the Moral Economies of Biomedicine," Isis, 2011, 102:60-96.
177. Jeremy Greene's recent work provides a nuanced analysis of the role of the pharmaceutical industry in bringing about the current prescription drug regime. See Jeremy A. Greene, Prescribing by Numbers: Drugs and the Definition of Disease (Baltimore: Johns Hopkins Univ. Press, 2007).
178. Gerald J. Kutcher, Contested Medicine: Cancer Research and the Military (Chicago: Univ. Chicago Press, 2009).
179. For a discussion of the legal and ethical issues in gene patenting see Myles W. Jackson, "Intellectual Property and Molecular Biology: Biomedicine, Commerce, and the CCR5 Gene," Francis Bacon Lecture, Caltech, 5 May 2011. For a critical analysis of the theory of the tragedy of the commons in intellectual property rights see James Boyle, Shamans, Software, and Spleens: Law and the Construction of the Information Society (Cambridge, Mass.: Harvard Univ. Press, 1996); and Michael A. Heller, "The Tragedy of the Anticommons: Property in the Transition from Marx to Markets," Harvard Law Review, 1998, 111:621-688.