Biobusiness on campus: Commercialization of university-developed biomedical technologies

Food and Drug Law Journal

Volumn 52, Issue 4, 1997, Pages 453-509

  Dueker, Kenneth Sutherlin ^a  

^a HARVARD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMMERCIAL PHENOMENA; FINANCE; GOVERNMENT; HEALTH CARE COST; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; REVIEW; UNITED STATES; UNIVERSITY;

HISTORY, 20TH CENTURY; HUMANS; INDUSTRY; INTELLECTUAL PROPERTY; LEGISLATION, MEDICAL; NATIONAL INSTITUTES OF HEALTH (U.S.); PATENTS; RESEARCH; RESEARCH SUPPORT; TECHNOLOGY TRANSFER; UNITED STATES; UNIVERSITIES;

EID: 0031449249     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (397)

1. ASSOCIATION OF UNIVERSITY TECHNOLOGY MANAGERS, AUTM LICENSING SURVEY: FY 1994 SURVEY SUMMARY AND SELECTED DATA FY 1991 - FY 1994, at 1 (1995).
2. For the sake of convenience and efficiency, this article uses the term "biomedical" to encompass all chemicals, devices, and other inventions with medical or health-industry applications.
3. Paul Selvin, The Future University: Leaner and Meaner? (Graduate Schools Respond to Declining Federal Funding), SCI., Oct. 6, 1995, at 135.
4. Universities Across U.S. Invent a Way to Bring in More Money, Cashing in on Research, OMAHA WORLD-HERALD, May 30, 1995, at 2.
5. Other technology transfer mechanisms such as sponsored research, although extremely important and interesting, are outside the scope of this article and will only be treated as they relate to licensing.
6. For the purposes of this article: "Harvard University" shall mean Harvard University's academic departments and faculties, but not Harvard-affiliated hospitals (unless otherwise specified). These hospitals have their own TTOs and generally operate functionally separate from Harvard University. The Harvard Faculty of Medicine (a subset of "Harvard University") is comprised of the Harvard Medical School and the Harvard School of Dental Medicine; "Harvard Medical School" shall be used to refer to these schools collectively. "MIT" shall mean MIT's academic departments and faculties, including the Whitehead Institute, but not the Lincoln Laboratory (a federal laboratory managed by MIT). Although the MIT Technology Licensing Office manages technology transfer for the Lincoln Laboratory, it is not part of the Institute. Furthermore, the Association of University Technology Managers does not include Lincoln Laboratory in its definition of "MIT" for statistical reporting. ASSOCIATION OF UNIVERSITY TECHNOLOGY MANAGERS, AUTM LICENSING SURVEY, FY 1991-FY 1995: A FIVE-YEAR SURVEY SUMMARY OF TECHNOLOGY LICENSING (AND RELATED) PERFORMANCE FOR U.S. AND CANADIAN ACADEMIC AND NONPROFIT INSTITUTIONS, AND PATENT MANAGEMENT FIRMS 28 (1997) [hereinafter AUTM LICENSING SURVEY (1997)]. "Stanford University" shall mean Stanford University's academic departments, faculties, and other groups utilizing the Stanford Office of Technology Licensing.
7. Howard W. Bremer, Testimony on the Effectiveness of the Bayh-Dole Act, 5 J. ASS'N U. TECH. MANAGERS (1993) (reprinting testimony made at the Public Meeting on Regulations (35 C.F.R. § 401) Relating to Rights to Inventions Made with Federal Funding by Nonprofit Organizations and Small Business Firms in Washington, D.C. (Oct. 25, 1993)), available in 〈http://www.crpc.rice.edu/autm/journal/93/testimony93.html〉.
8. Lori Pressman et al., Pre-Production Investment and Jobs Induced by MIT Exclusive Patent Licenses: A Preliminary Model to Measure the Economic Impact of University Licensing, 7 J. ASS'N U. TECH. MANAGERS 49, 73 (1995).
9. Lita Nelsen, The Lifeblood of Biotechnology; University-Industry Technology Transfer, in THE BUSINESS OF BIOTECHNOLOGY: FROM THE BENCH TO THE STREET 39 (R. Dana Ono ed. 1991).
10. Process for Producing Biologically Functional Molecular Chimeras, U.S. Patent No. 4,237,224 (Dec. 2, 1980); Biologically Functional Molecular Chimeras, U.S. Patent No. 4,468,464 (Aug. 28, 1984); see infra text accompanying notes 251-75.
11. UC is the largest academic research organization in the world. "Each of the University of California's nine campuses, five medical schools and three UC-managed government research laboratories has extensive research programs and facilities that support the discovery and dissemination of significant scientific advances. UC has a long history of cooperating with industry to facilitate the development and transfer of such advances to the marketplace." University of California, UC Bridges to Industry (visited Sept. 30, 1997) 〈http://www.ucop.edu/ ott/industry.html〉.
12. L. Rosenthal & C. Fung, Technology Survey of 20 Universities, in THE LAW AND BUSINESS OF LICENSING: LICENSING IN THE 1990s, at 969, 975 (Paul Bell, Jay Simon, & Woody Friedlander eds. 1995).
13. COUNCIL ON GOVERNMENTAL RELATIONS, UNIVERSITY TECHNOLOGY TRANSFER 2 (1993). The fundamentals of magnetic resonance imaging (MRI) were developed in the 1940s by Professor Felix Bloch of Stanford and Professor Edward Purcell of Harvard. These physicists shared a Nobel Prize in 1952 for this work. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING, CONNECTIONS 10 (1993).
14. COUNCIL ON GOVERNMENTAL RELATIONS, UNIVERSITY TECHNOLOGY TRANSFER 2 (1993). The fundamentals of magnetic resonance imaging (MRI) were developed in the 1940s by Professor Felix Bloch of Stanford and Professor Edward Purcell of Harvard. These physicists shared a Nobel Prize in 1952 for this work. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING, CONNECTIONS 10 (1993).
15. See, e.g., infra text accompanying notes 21, 174, 246, 298.
16. Bremer, supra note 7.
17. In addition to general endowments, many benefactors provided for an increase in the natural sciences and other "practical" additions to the curricula of universities. In the medical sciences, this was evidenced by the creation of the Lawrence Scientific School at Harvard in 1847 and the Sheffield School at Yale in 1861. HENRY BEECHER & MARK ALTSCHULE, MEDICINE AT HARVARD: THE FIRST THREE HUNDRED YEARS (1977). The development of university science education in Prussia (Germany) was very influential in American higher education. See, e.g., HERBERT MESCHKOWSKI, VON HUMBOLDT BIS EINSTEIN: BERLIN ALS WELTZENTRUM DER EXAKTEN WISSENSCHAFTEN (1989).
18. In addition to general endowments, many benefactors provided for an increase in the natural sciences and other "practical" additions to the curricula of universities. In the medical sciences, this was evidenced by the creation of the Lawrence Scientific School at Harvard in 1847 and the Sheffield School at Yale in 1861. HENRY BEECHER & MARK ALTSCHULE, MEDICINE AT HARVARD: THE FIRST THREE HUNDRED YEARS (1977). The development of university science education in Prussia (Germany) was very influential in American higher education. See, e.g., HERBERT MESCHKOWSKI, VON HUMBOLDT BIS EINSTEIN: BERLIN ALS WELTZENTRUM DER EXAKTEN WISSENSCHAFTEN (1989).
19. In 1862, the federal government also spurred the creation of educational institutions with ties to industry through the Land Grant College Act (Morrill Act). Act donating Public Lands to the Several States and Territories which may provide Colleges for the benefit of Agriculture and Mechanical Arts, ch. CXXX, 12 Stat. 503 (1862). MIT became a Land Grant institution in 1863. GARY MATKIN, TECHNOLOGY TRANSFER AND THE UNIVERSITY 23 (1990).
20. JEFF CRUIKSHANK, A DELICATE EXPERIMENT: THE HARVARD BUSINESS SCHOOL, 1908-1945 (1987).
21. The first university patent policies were adopted by Lehigh University and Columbia University, in 1924. Lynne Jordan Bowers & Vickie Leon, Patent Policies of 65 Educational Institutions: A Comparison, SRA J., Mar. 22, 1994, available in 1994 WL 13595732.
22. Wisconsin Alumni Research Foundation, WARF Overview, Background and Mission (visited Sept. 30, 1997) 〈http://www.wiscinfo.wisc.edu/warf/warfmiss.html〉.
23. See id. See also David Blumenthal et al., Commercializing University Research: Lessons from the Experience of the Wisconsin Alumni Research Foundation, 314 NEW ENG. J. MED. 1621 (1986).
24. Wisconsin Alumni Research Foundation, WARF Overview, Contributions to the UW-Madison (visited Sept. 30, 1997) 〈http://www.wiscinfo.wisc.edu/warf/warfcont.html〉.
25. See AUTM LICENSING SURVEY (1997), supra note 6, at 53.
26. See id.
27. Peter Finn, Government Financing of Biotechnology Companies, in BIOTECH '94. NEW ENGLAND BIOTECHNOLOGY LAW CONFERENCE '94, at 2 (Massachusetts Continuing Legal Education, 1994). "Extramural awards" are defined as grants, contracts, and training awards at academic and other nonprofit, excluding the NIH's own laboratories. "The government has not limited the use of its funds to research grants, and has included allocations for training programs; construction; medical library grants and grants for the repair, renovation and modernization of existing facilities." Id. See also National Institutes of Health, NIH Homepage (visited Sept. 30, 1997) 〈http://www.nih.gov〉.
28. Peter Finn, Government Financing of Biotechnology Companies, in BIOTECH '94. NEW ENGLAND BIOTECHNOLOGY LAW CONFERENCE '94, at 2 (Massachusetts Continuing Legal Education, 1994). "Extramural awards" are defined as grants, contracts, and training awards at academic and other nonprofit, excluding the NIH's own laboratories. "The government has not limited the use of its funds to research grants, and has included allocations for training programs; construction; medical library grants and grants for the repair, renovation and modernization of existing facilities." Id. See also National Institutes of Health, NIH Homepage (visited Sept. 30, 1997) 〈http://www.nih.gov〉.
29. NATIONAL INSTITUTES OF HEALTH, NIH EXTRAMURAL DATA AND TRENDS, FISCAL YEARS 1986-1995 (Nov. 26, 1996), available in 〈http://www.nih.gov/grants/award/trends95/PREFACE.HTM〉 [hereinafter NIH EXTRAMURAL DATA FY 1986-1995].
30. This paradigm continues. The FY 1997 NIH budget was $12.7 billion, of which $6.9 billion was spent on external awards. The proposed FY 1998 NIH budget increases spending to $13.1 billion, with $7.1 billion going to external awards. Andrew Lawler, Smoother Road for R&D Spending, SCI., Feb. 14, 1997, at 918. See also National Science Foundation, NSF Fiscal Year 1998 Budget Request (visited Sept. 30, 1997) 〈http:// www.nsf.gov/bfa/bud/fy1998〉.
31. This paradigm continues. The FY 1997 NIH budget was $12.7 billion, of which $6.9 billion was spent on external awards. The proposed FY 1998 NIH budget increases spending to $13.1 billion, with $7.1 billion going to external awards. Andrew Lawler, Smoother Road for R&D Spending, SCI., Feb. 14, 1997, at 918. See also National Science Foundation, NSF Fiscal Year 1998 Budget Request (visited Sept. 30, 1997) 〈http:// www.nsf.gov/bfa/bud/fy1998〉.
32. NIH EXTRAMURAL DATA FY 1986-1995, supra note 26.
33. Susannah Hunnewell, The Medical-Industrial Complex, HARV. MAG., Jan.-Feb. 1994, at 35.
34. NIH EXTRAMURAL DATA FY 1986-1995, supra note 26.
35. Id. In this table, figures for "Federal" include program management and direct operations costs attributable to biomedical R&D; figures for "Industry" and "Private Nonprofit" include federally-funded R&D centers.
36. Id.
37. The national laboratories had their origins in the Atomic Energy Act of 1946, Pub. L. No. 79-585, 60 Stat. 755 (codified as amended at 42 U.S.C. §§ 2011-2297g (1994)). The author's grandfather, Kenneth E. Dueker, was involved in a special radar development program at Harvard and MIT during World War II. Concurrently, the author's great-great uncle, Professor Edmund P. Learned of the Harvard Business School, served as a military consultant and advisor in logistics.
38. A former MIT researcher who had served as a presidential adviser during the war released a book in which he asserted that federal funding for university research should be a national priority. This book was highly influential in the development of federal science policy. VANNEVAR BUSH, SCIENCE: THE ENDLESS FRONTIER (1945).
39. AUTM LICENSING SURVEY (1997), supra note 6, at 2.
40. Bremer, supra note 7.
41. Edward C. Walterscheid, The Need for A Uniform Government Patent Policy: The DOE Example, 3 HARV. J.L. & TECH. 103 (1990).
42. University and Small Business Patent Procedure Act, Pub. L. No. 96-517, § 6(a), 94 Stat. 3014, 3015, 3018-29 (1980) (codified as amended at 35 U.S.C. §§ 200-212 (1994)).
43. Bremer, supra note 7.
44. Eliot Marshall, Japan and the Economics of Invention, SCI., Apr. 12, 1985, at 157.
45. Id.
46. S. REP. NO. 480, 96th Cong., 1st Sess., at 19 (1979).
47. S. 414, 96th Cong., 1st Sess. (1979) (enacted).
48. Senator Birch Bayh, Keynote Address: Sixteen Years of Bayh-Dole, MIT Conference on Intellectual Property Rights: Corporate Survival and Strategic Advantage (Dec. 9-10, 1996).
49. Pub. L. No. 96-517, § 6(a), 94 Stat. 3014, 3015, 3018-29. The Bayh-Dole Act was implemented initially by the Office of Management and Budget on Feb. 10, 1982, in OMB Circular A-124. This circular later was superseded by 37 C.F.R. § 401.
50. 35 U.S.C. § 200.
51. Bayh, supra note 44.
52. Hearings Before the Subcomm. on Patents, Copyrights and Trademarks of the Sen. Judiciary Comm., 103d Cong., 2d Sess. (1994), available in 1994 WL 14185684 (testimony of Sen. Birch Bayh).
53. 34 U.S.C. § 210(a).
54. The university must elect title by notifying the federal agency within two years of the initial disclosure. Should the university not elect to retain title, the funding agency may grant title to the inventor (that is, the university employee). 34 C.F.R. § 401.9 (1997); 35 U.S.C. § 202(d).
55. A "subject invention" is defined by the Act as "an invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement." 35 U.S.C. § 310.
56. A "funding agreement" is defined by the Act as "any contract, grant, or cooperative agreement entered into between any Federal Agency, other then the Tennessee Valley Authority, and any contractor for the performance of experimental, developmental, or research work funded in whole or in part by the Federal Government." Id. § 201. A special exception, however, is made such that "[n]o scholarship, fellowship, training grant, or other funding agreement made by a Federal agency primarily to an awardee for educational purposes will contain any provision giving the Federal agency any rights to inventions made by the awardee." Id. § 212.
57. Id. § 202.
58. Trademark Clarification Act, Pub. L. No. 98-620, 98 Stat. 3347 (1984) (amending 35 U.S.C. ch. 18).
59. 52 Fed. Reg. 8552 (Mar. 18, 1987) (codified at 37 C.F.R. pt. 401.1-401.16 (1997)).
60. 37 C.F.R. § 401.14.
61. 37 C.F.R. § 401.14(k)(2). It is interesting to note that no formula is stipulated for the amount to be shared with the inventor under the Bayh-Dole Act. The Federal Technology Transfer Act, by comparison, requires a minimum level of 15% of royalties be shared with the inventor. Pub. L. No. 99-502, 100 Stat. 1785 (1986) (codified at 15 U.S.C. § 3710c). "An effective intellectual property program allows the faculty member to share in the economic potential of his or her discoveries without having to leave the university. (Most university programs share between 15 and 50% of the net earnings from patents with the inventors, with the most common fraction being one-third of net.)" Lita Nelsen, Identifying, Evaluating, and Reporting Innovative Research Developments at the University, in UNDERSTANDING BIOTECHNOLOGY LAW 25 (Gale Peterson ed. 1993).
62. 35 U.S.C. § 201(i) (defining nonprofit organization); id. § 201(b).
63. 37 C.F.R. § 401.14(h). See also 35 U.S.C. § 202.
64. 37 C.F.R. § 401.15(k)(4).
65. Id. § 401.14(i). Title 35 of the United States Code, section 204, requires that nonprofit organizations retaining title to inventions resulting from federal grants not grant any exclusive license to such inventions in the United States unless the licensee is obligated to manufacture the invention primarily in the United States, except when such terms or domestic manufacture "is notcommercially feasible." See also id. § 401.14(a).
66. Id. § 401.14(j). See also 35 U.S.C. § 203; 37 C.F.R. § 401.6.
67. 34 U.S.C. § 202(c)(4). See also 37 C.F.R. § 401.14(a). Because the Bayh-Dole Act grants the federal government a nonexclusive license to inventions developed with federal funding, it is common practice to include a "confirmatory license" clause in a university license of such subject inventions, such as: "The Licensee herewith acknowledges that the United States government has certain rights in this invention under 37 C.F.R. [§] 401, including a non-exclusive, non-transferable, paid-up license heretofore granted by the Licensor." 1 ASSOCIATION OF UNIVERSITY TECHNOLOGY MANAGERS, TECHNOLOGY TRANSFER PRACTICE MANUAL I-1-2 (1993) [hereinafter AUTM TTPM].
68. 37 C.F.R. § 401.1.
69. See generally EDMUND P. LEARNED, PROBLEMS IN MARKETING (1936).
70. See, e.g., 3 AUTM TTPM, supra note 63, at I-1-3 to I-1-9.
71. HARVARD UNIVERSITY, RESEARCH, DISCOVERY AND THE REWARD OF INVENTION. YOUR ROLE IN HARVARD's TECHNOLOGY PROGRAM (1995).
72. Id. at 5. The booklet responds to this last concern by asserting that, "[i]n situations where publishing and patenting conflict, Harvard works to meet its patent requirements without interfering with the inventor's freedom to discuss and publish research results. Since public disclosure of anew discovery via written or oral presentation jeopardizes foreign patent rights, our Offices are prepared to move quickly to review the planned disclosure while laying the groundwork for the associated patent application." Id. at 6.
73. "The only practical way to bring inventions from academic research to light is through education of the researchers. If they understand the potential value of their inventions, believe that the technology transfer office can effectively commercialize such inventions with minimum hassle to the inventors, and understand their obligations to research sponsors, most will remain alert to identifying valuable intellectual property and will bring it to the attention of the technology transfer office." Nelsen, supra note 57, at 34.
74. Lori Pressman, Marketing University Technology, in AUTM ADVANCED LICENSING COURSE, PHOENIX, AZ (1994) (finding that licensing officers, although the second-greatest source of leads, were responsible for only 20%).
75. 37 C.F.R. § 401.14(k)(2).
76. See generally RICHARD HOLZMANN, INFRINGEMENT OF THE UNITED STATES PATENT RIGHT: A GUIDE FOR EXECUTIVES AND ATTORNEYS (1995).
77. See, e.g., Li-Hsien Rin-Laures & Diane Janofsky, Note, Recent Development Concerning the Orphan Drug Act, 4 HARV. J.L. & TECH. 269, 271 (1991).
78. Bremer, supra note 7.
79. GENERAL ACCOUNTING OFFICE, PATENT POLICY: UNIVERSITIES' RESEARCH EFFORTS UNDER PUBLIC LAW 96-517, at 2 (1986).
80. GENERAL ACCOUNTING OFFICE, UNIVERSITY RESEARCH: CONTROLLING INAPPRORIATE ACCESS TO FEDERALLY FUNDED RESEARCH RESULTS 13 (1992).
81. GENERAL ACCOUNTING OFFICE, supra note 75, at 3.
82. GENERAL ACCOUNTING OFFICE, supra note 76, at 13.
83. Dennis Normile, Japan Hopes to Cash in on Industry-University Ties, SCI., Nov. 29, 1996, at 1457.
84. For examples of apocalyptic predictions, see DOROTHY NELKIN, SCIENCE AS INTELLECTUAL PROPERTY: WHO CONTROLS RESEARCH? (1984); MARTIN KENNEY, BIOTECHNOLOGY: THE UNIVERSITY-INDUSTRIAL COMPLEX (1986).
85. For examples of apocalyptic predictions, see DOROTHY NELKIN, SCIENCE AS INTELLECTUAL PROPERTY: WHO CONTROLS RESEARCH? (1984); MARTIN KENNEY, BIOTECHNOLOGY: THE UNIVERSITY-INDUSTRIAL COMPLEX (1986).
86. Bremer, supra note 7.
87. Rosenthal & Fung, supra note 12, at 975.
88. Nelsen, supra note 9, at 41.
89. Id. at 44. See also Memorandum from Joyce Brinton, Harvard Univ. Off. for Patents, Copyrights, & Licensing, to Robert Scott, The First Ten Years - Report on PCL Activity FY 1977-1987 (Nov. 12, 1987) [hereinafter Harvard Licensing Report FY 1977-1987] (stating that "[a]ll university programs have found that more than half of their income is the result of one or two important inventions."). For example, the Harvard University Office for Technology and Trademark Licensing has asserted that "Harvard's research-dependent technology transfer situation is typical of other academic institutions: We have many active licenses, but the bulk of our royalty income derives from a very small number." HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, ANNUAL REPORT TO THE COMMITTEE ON PATENTS AND COPYRIGHTS FISCAL YEAR 1995, at 1 (1995) [hereinafter HARVARD OTTL/OTL ANNUAL REPORT FY 1995].
90. Id. at 44. See also Memorandum from Joyce Brinton, Harvard Univ. Off. for Patents, Copyrights, & Licensing, to Robert Scott, The First Ten Years - Report on PCL Activity FY 1977-1987 (Nov. 12, 1987) [hereinafter Harvard Licensing Report FY 1977-1987] (stating that "[a]ll university programs have found that more than half of their income is the result of one or two important inventions."). For example, the Harvard University Office for Technology and Trademark Licensing has asserted that "Harvard's research-dependent technology transfer situation is typical of other academic institutions: We have many active licenses, but the bulk of our royalty income derives from a very small number." HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, ANNUAL REPORT TO THE COMMITTEE ON PATENTS AND COPYRIGHTS FISCAL YEAR 1995, at 1 (1995) [hereinafter HARVARD OTTL/OTL ANNUAL REPORT FY 1995].
91. 1 AUTM TTPM, supra note 63, at VI-3-1.
92. TUFTS UNIVERSITY CENTER FOR THE STUDY OF DRUG DEVELOPMENT, MOVING PRESCRIPTION DRUGS TO THE OVER-THE-COUNTER MARKET: THE IMPACT OF COST CONTAINMENT AND HEALTH CARE REFORM (Sheila R. Shulman & Louis Lasagna eds. 1994).
93. In addition to the famous Cohen-Boyer licenses, a preponderance of the highest-grossing university licensed invention to date have heen biomedical. For example, the UC patent for the development of the hepatitis-B vaccine, licensed to Merck & Co., generated $23,100,000 for the university during FY 1994 through FY 1995, with cumulative revenues of over $66,200,000 since it won approval from the FDA in 1986. Bruce V. Bigelow, UC Leads in Royalty Race: Its Inventions Produce Hefty Annual Payoffs, SAN DIEGO UNION & TRIB., Feb. 9, 1996, at C1.
94. Id.
95. Letter from Allegra Helfenstein, Legal Counsel, Molecular Probes, Inc., to Kenneth Sutherlin Dueker (Feb. 26, 1997) (on file with author) (emphasis in original).
96. 1 AUTM TTPM, supra note 63, at VI-3-11. See generally PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW CASES AND MATERIALS (2d ed. 1991).
97. 1 AUTM TTPM, supra note 63, at VI-3-11. See generally PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW CASES AND MATERIALS (2d ed. 1991).
98. Nelsen, supra note 9, at 41.
99. Id. at 42.
100. Id. at 43.
101. Id.
102. Id. at 44.
103. The technology transfer managers for all three universities studied in this article specifically cited this factor.
104. COUNCIL ON GOVERNMENTAL RELATIONS, supra note 13, at 4.
105. According to NIH, a "sponsored research agreement" is "a written document which describes the relationship between Recipients and commercial entities in which Recipients receive funding or other consideration to support their research in return for preferential access and/or rights to intellectual property deriving from Recipient research results." Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts, 59 Fed. Reg. 55,674 (Nov. 8, 1994). Income from such agreements currently dwarfs the revenue that universities receive from technology licensing. Sponsored research itself, however, plays a secondary role to federal government funding. Furthermore, while sponsored research has grown in importance to universities, it remains only a minor part of most companies' budgets: Formal sponsored research at universities only accounts for two percent of R&D expenditures by U.S. industry. Id. at 55,677.
106. Michael B. Goldstein, Technology Transfer and Risk Management, in AMERICAN BAR ASSOCIATION, SECTION OF BUSINESS LAW, TECHNOLOGY TRANSFER: LEGAL ISSUES IN THE COMMERCIAL EXPLOITATION OF GOVERNMENT, ACADEMIC AND FOUNDATION RESEARCH DEVELOPMENT (PROCEEDINGS OF THE 1995 SPRING MEETING, SAN ANTONIO, TEXAS) (1995).
107. Nelsen, supra note 9, at 41.
108. "Considering the voracious appetite of world industry for innovation, a university technology marketing program has a statistically favorable chance of succeeding in the long run." ROBERT GOLDSCHEIDER, TECHNOLOGY MANAGEMENT 436 (1995).
109. Some of the better articles on the topic include Katherine L. Chapman, Intellectital Property Policies, Research Agreements, Consulting Agreements, and Conflicts of Interest, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 295; Peter Barton Hutt, University/Corporate Research Agreements, 5 TECH. SOC'Y 107 (1983); Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547. One of the earliest attempts to address the issue of conflicts in university research was a 1964 report of the American Association of University Professors and the American Council on Education. American Ass'n of Univ. Professors & American Council on Educ., Preventing Conflict of Interest in Government-Sponsored Research in Universities (1964), reprinted in ASSOCIATION OF AMERICAN UNIVERSITIES, UNIVERSITY POLICIES ON CONFLICT OF INTEREST AND DELAY OF PUBLICATION 10 (1985). See also Pajaro Dunes Conference: Draft Statement, 9 J.C. & U.L. 533 (1982). See generally Victoria Slind-Flor, University Patent Licensing Operations Draw Legal Battles and Free Speech Critics, NAT'L L.J., Oct. 3, 1994, at A1 (discussing various legal difficulties technology transfer operations have created for universities).
110. Some of the better articles on the topic include Katherine L. Chapman, Intellectital Property Policies, Research Agreements, Consulting Agreements, and Conflicts of Interest, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 295; Peter Barton Hutt, University/Corporate Research Agreements, 5 TECH. SOC'Y 107 (1983); Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547. One of the earliest attempts to address the issue of conflicts in university research was a 1964 report of the American Association of University Professors and the American Council on Education. American Ass'n of Univ. Professors & American Council on Educ., Preventing Conflict of Interest in Government-Sponsored Research in Universities (1964), reprinted in ASSOCIATION OF AMERICAN UNIVERSITIES, UNIVERSITY POLICIES ON CONFLICT OF INTEREST AND DELAY OF PUBLICATION 10 (1985). See also Pajaro Dunes Conference: Draft Statement, 9 J.C. & U.L. 533 (1982). See generally Victoria Slind-Flor, University Patent Licensing Operations Draw Legal Battles and Free Speech Critics, NAT'L L.J., Oct. 3, 1994, at A1 (discussing various legal difficulties technology transfer operations have created for universities).
111. Some of the better articles on the topic include Katherine L. Chapman, Intellectital Property Policies, Research Agreements, Consulting Agreements, and Conflicts of Interest, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 295; Peter Barton Hutt, University/Corporate Research Agreements, 5 TECH. SOC'Y 107 (1983); Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547. One of the earliest attempts to address the issue of conflicts in university research was a 1964 report of the American Association of University Professors and the American Council on Education. American Ass'n of Univ. Professors & American Council on Educ., Preventing Conflict of Interest in Government-Sponsored Research in Universities (1964), reprinted in ASSOCIATION OF AMERICAN UNIVERSITIES, UNIVERSITY POLICIES ON CONFLICT OF INTEREST AND DELAY OF PUBLICATION 10 (1985). See also Pajaro Dunes Conference: Draft Statement, 9 J.C. & U.L. 533 (1982). See generally Victoria Slind-Flor, University Patent Licensing Operations Draw Legal Battles and Free Speech Critics, NAT'L L.J., Oct. 3, 1994, at A1 (discussing various legal difficulties technology transfer operations have created for universities).
112. Some of the better articles on the topic include Katherine L. Chapman, Intellectital Property Policies, Research Agreements, Consulting Agreements, and Conflicts of Interest, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 295; Peter Barton Hutt, University/Corporate Research Agreements, 5 TECH. SOC'Y 107 (1983); Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547. One of the earliest attempts to address the issue of conflicts in university research was a 1964 report of the American Association of University Professors and the American Council on Education. American Ass'n of Univ. Professors & American Council on Educ., Preventing Conflict of Interest in Government-Sponsored Research in Universities (1964), reprinted in ASSOCIATION OF AMERICAN UNIVERSITIES, UNIVERSITY POLICIES ON CONFLICT OF INTEREST AND DELAY OF PUBLICATION 10 (1985). See also Pajaro Dunes Conference: Draft Statement, 9 J.C. & U.L. 533 (1982). See generally Victoria Slind-Flor, University Patent Licensing Operations Draw Legal Battles and Free Speech Critics, NAT'L L.J., Oct. 3, 1994, at A1 (discussing various legal difficulties technology transfer operations have created for universities).
113. Some of the better articles on the topic include Katherine L. Chapman, Intellectital Property Policies, Research Agreements, Consulting Agreements, and Conflicts of Interest, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 295; Peter Barton Hutt, University/Corporate Research Agreements, 5 TECH. SOC'Y 107 (1983); Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547. One of the earliest attempts to address the issue of conflicts in university research was a 1964 report of the American Association of University Professors and the American Council on Education. American Ass'n of Univ. Professors & American Council on Educ., Preventing Conflict of Interest in Government-Sponsored Research in Universities (1964), reprinted in ASSOCIATION OF AMERICAN UNIVERSITIES, UNIVERSITY POLICIES ON CONFLICT OF INTEREST AND DELAY OF PUBLICATION 10 (1985). See also Pajaro Dunes Conference: Draft Statement, 9 J.C. & U.L. 533 (1982). See generally Victoria Slind-Flor, University Patent Licensing Operations Draw Legal Battles and Free Speech Critics, NAT'L L.J., Oct. 3, 1994, at A1 (discussing various legal difficulties technology transfer operations have created for universities).
114. Some of the better articles on the topic include Katherine L. Chapman, Intellectital Property Policies, Research Agreements, Consulting Agreements, and Conflicts of Interest, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 295; Peter Barton Hutt, University/Corporate Research Agreements, 5 TECH. SOC'Y 107 (1983); Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547. One of the earliest attempts to address the issue of conflicts in university research was a 1964 report of the American Association of University Professors and the American Council on Education. American Ass'n of Univ. Professors & American Council on Educ., Preventing Conflict of Interest in Government-Sponsored Research in Universities (1964), reprinted in ASSOCIATION OF AMERICAN UNIVERSITIES, UNIVERSITY POLICIES ON CONFLICT OF INTEREST AND DELAY OF PUBLICATION 10 (1985). See also Pajaro Dunes Conference: Draft Statement, 9 J.C. & U.L. 533 (1982). See generally Victoria Slind-Flor, University Patent Licensing Operations Draw Legal Battles and Free Speech Critics, NAT'L L.J., Oct. 3, 1994, at A1 (discussing various legal difficulties technology transfer operations have created for universities).
115. Some of the better articles on the topic include Katherine L. Chapman, Intellectital Property Policies, Research Agreements, Consulting Agreements, and Conflicts of Interest, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 295; Peter Barton Hutt, University/Corporate Research Agreements, 5 TECH. SOC'Y 107 (1983); Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547. One of the earliest attempts to address the issue of conflicts in university research was a 1964 report of the American Association of University Professors and the American Council on Education. American Ass'n of Univ. Professors & American Council on Educ., Preventing Conflict of Interest in Government-Sponsored Research in Universities (1964), reprinted in ASSOCIATION OF AMERICAN UNIVERSITIES, UNIVERSITY POLICIES ON CONFLICT OF INTEREST AND DELAY OF PUBLICATION 10 (1985). See also Pajaro Dunes Conference: Draft Statement, 9 J.C. & U.L. 533 (1982). See generally Victoria Slind-Flor, University Patent Licensing Operations Draw Legal Battles and Free Speech Critics, NAT'L L.J., Oct. 3, 1994, at A1 (discussing various legal difficulties technology transfer operations have created for universities).
116. Gregory Hauth, Theories Opposing the Imposition of Product Liability on (University) Patent Licensors, 3 J. ASS'N U. TECH. MANAGERS (1992), available in 〈http://www.crpc.rice.edu/autm/journal/92/ liability92.html〉.
117. Goldstein, supra note 99, at 30.
118. Ronald Rosenberg, Tropix Wins Legal Battle, BOSTON GLOBE, Apr. 16, 1995, at 74.
119. The putative purity of academia ex ante, however, is questionable. See, e.g., J. WATSON, THE DOUBLE HELIX: A PERSONAL ACCOUNT OF THE DISCOVERY OF THE STRUCTURE OF DNA (1968).
120. David Blumenthal et al., University-Industry Research Relationships in Biotechnology: Implications for the University, 232 SCI. 1361 (1986); David Blumenthal, Academic-Industry Relationships in the Life Sciences: Extent, Consequences, and Management, JAMA, Dec. 16, 1992, at 3344 [hereinafter Blumenthal, Academic-Industry Relationships].
121. David Blumenthal et al., University-Industry Research Relationships in Biotechnology: Implications for the University, 232 SCI. 1361 (1986); David Blumenthal, Academic-Industry Relationships in the Life Sciences: Extent, Consequences, and Management, JAMA, Dec. 16, 1992, at 3344 [hereinafter Blumenthal, Academic-Industry Relationships].
122. Blumenthal, Academic-Industry Relationships, supra note 108, at 3344.
123. ARTHUR KORNBERG, THE GOLDEN HELIX 27 (1995); see also Julia Porter Liebeskind et al., Social Networks, Learning, and Flexibility: Sourcing Scientific Knowledge in New Biotechnology Firms, 1 ORG. SCI. 428 (1996).
124. ARTHUR KORNBERG, THE GOLDEN HELIX 27 (1995); see also Julia Porter Liebeskind et al., Social Networks, Learning, and Flexibility: Sourcing Scientific Knowledge in New Biotechnology Firms, 1 ORG. SCI. 428 (1996).
125. See generally EDMUND P. LEARNED, PROBLEMS OF GENERAL MANAGEMENT: BUSINESS POLICY (1961).
126. For an in-depth treatment of this topic, see Pat K. Chew, Faculty-Generated Inventions: Who Owns the Golden Egg?, 1992 WIS. L. REV. 259 (1992); Sandip H. Patel, Graduate Students' Ownership and Attribution Rights in Intellectual Property, 71 IND. L.J. 481 (1996); B. Jean Weidemier, Ownership of University Inventions, 3 J. ASS'N U. TECH. MANAGERS (1992), available in 〈http://www.crpc.rice.edu/autm/journal/92/ownership92.html〉.
127. For an in-depth treatment of this topic, see Pat K. Chew, Faculty-Generated Inventions: Who Owns the Golden Egg?, 1992 WIS. L. REV. 259 (1992); Sandip H. Patel, Graduate Students' Ownership and Attribution Rights in Intellectual Property, 71 IND. L.J. 481 (1996); B. Jean Weidemier, Ownership of University Inventions, 3 J. ASS'N U. TECH. MANAGERS (1992), available in 〈http://www.crpc.rice.edu/autm/journal/92/ownership92.html〉.
128. For an in-depth treatment of this topic, see Pat K. Chew, Faculty-Generated Inventions: Who Owns the Golden Egg?, 1992 WIS. L. REV. 259 (1992); Sandip H. Patel, Graduate Students' Ownership and Attribution Rights in Intellectual Property, 71 IND. L.J. 481 (1996); B. Jean Weidemier, Ownership of University Inventions, 3 J. ASS'N U. TECH. MANAGERS (1992), available in 〈http://www.crpc.rice.edu/autm/journal/92/ownership92.html〉.
129. 37 C.F.R. § 100.6.
130. For a discussion questioning this norm, see Sunil R. Kulkarni, All Professors Create Equally: Why Faculty Should Have Complete Control Over the Intellectual Property Rights in Their Creations, 47 HASTINGS L.J. 221 (1995).
131. Luckett v. Delpark, Inc., 270 U.S. 496, 511 (1926). Copyright assignment, however, is a federal law issue. See, e.g., 35 U.S.C. § 261. Furthermore, patent law considerations make initial "ownership" relevant to the validity of a patent in the context of inventorship, because one key requirement of patent law is that a patent application be filed by the true inventor (even if the inventor prepared the work as part of his or her employment). The patent laws permit an employer or other third party to file an application on behalf of an inventor who has assigned the invention to that person/entity, but even then the patent is issued to the inventor initially, requiring that the assignment be registered ex post. Id. § 111.
132. Even without such assignments a university may have rights (of some sort) to the invention. In instances where inventions are brought forth using substantial university resources, the university may assert ownership under the concept of "shop rights" (or "bench rights"), an equitable doctrine that grants an employer a nonexclusive, nonassignable right to use an invention developed on the employer's time or resources, even if the employer is not entitled to a formal assignment of the invention. See, e.g., United States v. Dubilier Condenser, 289 U.S. 178; Francklyn v. Guilford Packing Co., 695 F.2d 1158 (9th Cir. 1983).
133. 35 U.S.C. § 102(b).
134. 1 AUTM TTPM, supra note 63, at IV-2.1-14. MIT was the situs of one of the more famous cases on the definition of "printed." In 1937, the Patent Office Board of Appeals denied a patent application for a synchronous motor, because the thesis of an MIT student completed two years prior had fully described the applicant's invention. Gulliksen v. Halberg, 75 U.S.P.Q. (BNA) 252 (1937). See also Lita Nelsen, Protecting Your Ability to Get a Patent: What Counts as a Bar to Patenting? (visited Sept. 30, 1997) 〈http://web.mit.edu/tlo/www/ patentbars.html〉.
135. 1 AUTM TTPM, supra note 63, at IV-2.1-14. MIT was the situs of one of the more famous cases on the definition of "printed." In 1937, the Patent Office Board of Appeals denied a patent application for a synchronous motor, because the thesis of an MIT student completed two years prior had fully described the applicant's invention. Gulliksen v. Halberg, 75 U.S.P.Q. (BNA) 252 (1937). See also Lita Nelsen, Protecting Your Ability to Get a Patent: What Counts as a Bar to Patenting? (visited Sept. 30, 1997) 〈http://web.mit.edu/tlo/www/ patentbars.html〉.
136. Massachusetts Institute of Technology v. A.B. Fortia, 774 F.2d 1104 (Fed. Cir. 1985).
137. For example, Japan will deny a patent for a specification that is put on public display. 1 AUTM TTPM, supra note 63, at IV-2.2-11. In the United States, however, mere display will not violate section 102 of the Patent Act if such display does not disclose the invention to the extent necessary to enable a person skilled in the art to make oruse the invention (such a description is called "enabling"). 35 U.S.C. § 102(a). See Regents of the Univ. of Cal. v. Howmedica, Inc., 530 F. Supp. 846, 849 (D.N.J. 1981) (holding that projection of slides at medical association meeting did not bring the invention into the public domain, because they did not disclose the invention to the extent to be enabling).
138. MATKIN, supra note 17, at 95.
139. For further treatment of these issues, see David E. Korn, Patent and Trade Secret Protection in University-Industry Research Relationships in Biotechnology, 24 HARV. J. ON LEGIS. 191 (1987); C. Steven Mcdaniel, Protecting Biotechnology Trade Secrets in University and Industrial Research, 16 HOUS. J. INT'L L. 565 (1994).
140. For further treatment of these issues, see David E. Korn, Patent and Trade Secret Protection in University-Industry Research Relationships in Biotechnology, 24 HARV. J. ON LEGIS. 191 (1987); C. Steven Mcdaniel, Protecting Biotechnology Trade Secrets in University and Industrial Research, 16 HOUS. J. INT'L L. 565 (1994).
141. THOMAS MCCARTHY, MCCARTHY'S DESK ENCYCLOPEDIA OF INTELLECTUAL PROPERTY 17-4 (1989).
142. Nelsen, supra note 57, at 33.
143. "A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it . . . ." RESTATEMENT (1ST) OF TORTS § 757 (1939).
144. 1 AUTM TTPM, supra note 63, at IV-2.5-3.
145. Sometimes, the problem can be compounded by the standard practices of academic publishing itself. In 1984, Nature received a manuscript from an author whose research had been funded by Astron Biotechnology, Inc. The journal's editors sent the paper to a researcher at a rival firm, Immunex Corp., with its standard cover letter boilerplate that the manuscript was "a confidential matter." The manuscript contained a description of the cloning and sequencing of the human interleukin-1 (IL-1) gene and the IL-1β protein. Immunex subsequently patented the sequence. See Kenneth Crimaldi, Trade Secret Law and Confidentiality of Peer Review Process for Scientific Papers (BLR 2334), 15 BIOTECH. L. REP. 159, 229 (1996). For further discussion of potential ethical and other conundra related to peer review, see Marcia Barinaga, Confusion on the Cutting Edge, SCI., July 31, 1992, at 616.
146. Sometimes, the problem can be compounded by the standard practices of academic publishing itself. In 1984, Nature received a manuscript from an author whose research had been funded by Astron Biotechnology, Inc. The journal's editors sent the paper to a researcher at a rival firm, Immunex Corp., with its standard cover letter boilerplate that the manuscript was "a confidential matter." The manuscript contained a description of the cloning and sequencing of the human interleukin-1 (IL-1) gene and the IL-1β protein. Immunex subsequently patented the sequence. See Kenneth Crimaldi, Trade Secret Law and Confidentiality of Peer Review Process for Scientific Papers (BLR 2334), 15 BIOTECH. L. REP. 159, 229 (1996). For further discussion of potential ethical and other conundra related to peer review, see Marcia Barinaga, Confusion on the Cutting Edge, SCI., July 31, 1992, at 616.
147. See Pat Shockley, The Availability of "Trade Secret "Protection for University Research, 20 J.C. & U.L. 309 (1994).
148. HARVARD MEDICAL SCHOOL, GUIDE TO PROTECTING AND MANAGING INTELLECTUAL PROPERTY 29 (1993).
149. Massachusetts Institute of Technology, TLO: Questions Frequently Asked (visited Sept. 30, 1997) 〈http://web.mit.edu/tlo/www/qfa.html〉. Universities' policies differ about whether know-how can be licensed exclusively and whether there should be such a thing as a nontangible trade secret in an open university. The debate centers around the issue of free dissemination of information form the university. By definition, an exclusive license to a trade secret implies the obligation notto reveal the information to any other parties. If university policy states that "all results must be publishable," then such exclusivity cannot exist. Nelsen, supra note 9, at 56.
150. The guidelines, technically, came from NIH's parent, the Department of Health and Human Services, National Institutes of Health, Requestfor Comment on Proposed Guidelines for Policies on Conflicts of Interest, in NIH GUIDE TO GRANTS AND CONTRACTS 3-4 (1989). See also Kenneth H. Bacon, U.S. Issues Rules Aimed at Policing Fraud in Research, WALL ST. J., August 9, 1989, available in WESTLAW, 1989 WL-WSJ 472172.
151. The guidelines, technically, came from NIH's parent, the Department of Health and Human Services, National Institutes of Health, Requestfor Comment on Proposed Guidelines for Policies on Conflicts of Interest, in NIH GUIDE TO GRANTS AND CONTRACTS 3-4 (1989). See also Kenneth H. Bacon, U.S. Issues Rules Aimed at Policing Fraud in Research, WALL ST. J., August 9, 1989, available in WESTLAW, 1989 WL-WSJ 472172.
152. See, eg., H.R. REP. NO. 688, 101st Cong., 2d Sess. 61-68; Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547.
153. See, e.g., H.R. REP. NO. 688, 101st Cong., 2d Sess. 61-68; Michael D. Witt & Lawrence O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, Feb. 16, 1994, at 547.
154. NIH, Developing Sponsored Research Agreements, Considerations for Recipients of NIH Research Grants and Contracts, reprinted in 59 Fed. Reg. 55,674, 55,674-79 (Nov. 18, 1994), available in 〈http:era.info.nih.gov/edison/sponsored.html〉 (visited Nov. 3, 1997).
155. Id.
156. Id.
157. Id.
158. Id. Many universities allow longer publication delay periods. Stanford University, for example, allows delays of 90 days and has revised recently its policy to allow for delays in excess of this period. Cooperating on Multi-Site Data, in COLLABORATIONS 4 (1996).
159. NIH, supra note 134. This type of ethical pronouncement also is indicative of the development of technology transfer as a profession with its own ethical canons. See, e.g., MODEL CODE OF PROFESSIONAL RESPONSIBILITY Canon 9 (1980) ("A lawyer should avoid even the appearance of professional impropriety"). For further discussion of the development of university technology transfer as a profession, see infra Part III.B.
160. But see Gina A. Kuhlman, Comment, Alliances for the Future: Cultivating a Cooperative Environment for Biotech Success, 11 BERKELEY TECH. L.J. 311 (1996) (criticizing the NIH guidelines as redundant and overly-restrictive).
161. NJH, supra note 134.
162. In its early years, AUTM was known as the Society of University Patent Administrators. AUTM LICENSING SURVEY (1997), supra note 6, at 2.
163. Id. at 4.
164. 1 AUTM TTPM, supra note 63, ("About the Association").
165. AUTM LICENSING SURVEY (1997), supra note 6, at 52.
166. Id.
167. Letter from Penny Dalziel, Admin., AUTM, to Kenneth Sutherlin Dueker (July 23, 1996) (on file with author).
168. Association of University Technology Managers Finds Its Political Voice, TECH. ACCESS REP., Apr. 1, 1994, at 1.
169. Licensing Executive Society International, History, Formation, and Structure of LES International (visited Sept. 30, 1997) 〈http://www.lesi.org/about.html〉.
170. Id.
171. The Internet also has been a stimulant to the technology transfer profession. See generally Philip Jones, Using the Internet to Promote Technology Transfer (BLR 2229), 15 BIOTECH. L. REP. 622 (1996).
172. Nelsen, supra note 9, at 41.
173. See generally R.H. Coase, The Problem of Social Cost, 3 J.L. & ECON. 1 (1960). Justice Douglas articulated the principles of freedom of contract with regard to royalties in the U.S. Supreme Court decision, Brulotte v. Thys Co. According to Douglas' opinion, a "patent empowers the owner to exact royalties as high as he can negotiate with the leverage of [the patent] monopoly." 379 U.S. 29 (1964); see also JAY DRATLER, LICENSING OF INTELLECTUAL PROPERTY 328 (1995) (noting that although Justice Douglas' comment was originally dictum, the "statement has been adopted by the courts and now fairly reflects the absence of general restrictions on the amount or royalties a licensor may charge"). There are, however, other constraints (such as antitrust) that impact licensing practices. Susan Progoff, Avoiding the Potential Pitfalls in Licensing, in DRAFTING LICENSING AGREEMENTS 69 (Anne Jordan et al. eds. 1996). For further discussion of invention/license valuation techniques and norms, see Steve L. Bertha, Intellectual Property Activities in U.S. Research Universities, 36 IDEA: J.L. & TECH. 513 (1996); Timothy Cesarek, Special Article: Unleashing the Value of Technology: What's It Worth? (BLR 1358), 11 BIOTECH. L. REP. 529 (1992); Yoshio Matsunaga, Determining Reasonable Royalty Rates, LES NOUVELLES, Dec. 1983, at 216-19.
174. See generally R.H. Coase, The Problem of Social Cost, 3 J.L. & ECON. 1 (1960). Justice Douglas articulated the principles of freedom of contract with regard to royalties in the U.S. Supreme Court decision, Brulotte v. Thys Co. According to Douglas' opinion, a "patent empowers the owner to exact royalties as high as he can negotiate with the leverage of [the patent] monopoly." 379 U.S. 29 (1964); see also JAY DRATLER, LICENSING OF INTELLECTUAL PROPERTY 328 (1995) (noting that although Justice Douglas' comment was originally dictum, the "statement has been adopted by the courts and now fairly reflects the absence of general restrictions on the amount or royalties a licensor may charge"). There are, however, other constraints (such as antitrust) that impact licensing practices. Susan Progoff, Avoiding the Potential Pitfalls in Licensing, in DRAFTING LICENSING AGREEMENTS 69 (Anne Jordan et al. eds. 1996). For further discussion of invention/license valuation techniques and norms, see Steve L. Bertha, Intellectual Property Activities in U.S. Research Universities, 36 IDEA: J.L. & TECH. 513 (1996); Timothy Cesarek, Special Article: Unleashing the Value of Technology: What's It Worth? (BLR 1358), 11 BIOTECH. L. REP. 529 (1992); Yoshio Matsunaga, Determining Reasonable Royalty Rates, LES NOUVELLES, Dec. 1983, at 216-19.
175. See generally R.H. Coase, The Problem of Social Cost, 3 J.L. & ECON. 1 (1960). Justice Douglas articulated the principles of freedom of contract with regard to royalties in the U.S. Supreme Court decision, Brulotte v. Thys Co. According to Douglas' opinion, a "patent empowers the owner to exact royalties as high as he can negotiate with the leverage of [the patent] monopoly." 379 U.S. 29 (1964); see also JAY DRATLER, LICENSING OF INTELLECTUAL PROPERTY 328 (1995) (noting that although Justice Douglas' comment was originally dictum, the "statement has been adopted by the courts and now fairly reflects the absence of general restrictions on the amount or royalties a licensor may charge"). There are, however, other constraints (such as antitrust) that impact licensing practices. Susan Progoff, Avoiding the Potential Pitfalls in Licensing, in DRAFTING LICENSING AGREEMENTS 69 (Anne
176. See generally R.H. Coase, The Problem of Social Cost, 3 J.L. & ECON. 1 (1960). Justice Douglas articulated the principles of freedom of contract with regard to royalties in the U.S. Supreme Court decision, Brulotte v. Thys Co. According to Douglas' opinion, a "patent empowers the owner to exact royalties as high as he can negotiate with the leverage of [the patent] monopoly." 379 U.S. 29 (1964); see also JAY DRATLER, LICENSING OF INTELLECTUAL PROPERTY 328 (1995) (noting that although Justice Douglas' comment was originally dictum, the "statement has been adopted by the courts and now fairly reflects the absence of general restrictions on the amount or royalties a licensor may charge"). There are, however, other constraints (such as antitrust) that impact licensing practices. Susan Progoff, Avoiding the Potential Pitfalls in Licensing, in DRAFTING LICENSING AGREEMENTS 69 (Anne Jordan et al. eds. 1996). For further discussion of invention/license valuation techniques and norms, see Steve L. Bertha, Intellectual Property Activities in U.S. Research Universities, 36 IDEA: J.L. & TECH. 513 (1996); Timothy Cesarek, Special Article: Unleashing the Value of Technology: What's It Worth? (BLR 1358), 11 BIOTECH. L. REP. 529 (1992); Yoshio Matsunaga, Determining Reasonable Royalty Rates, LES NOUVELLES, Dec. 1983, at 216-19.
177. See generally R.H. Coase, The Problem of Social Cost, 3 J.L. & ECON. 1 (1960). Justice Douglas articulated the principles of freedom of contract with regard to royalties in the U.S. Supreme Court decision, Brulotte v. Thys Co. According to Douglas' opinion, a "patent empowers the owner to exact royalties as high as he can negotiate with the leverage of [the patent] monopoly." 379 U.S. 29 (1964); see also JAY DRATLER, LICENSING OF INTELLECTUAL PROPERTY 328 (1995) (noting that although Justice Douglas' comment was originally dictum, the "statement has been adopted by the courts and now fairly reflects the absence of general restrictions on the amount or royalties a licensor may charge"). There are, however, other constraints (such as antitrust) that impact licensing practices. Susan Progoff, Avoiding the Potential Pitfalls in Licensing, in DRAFTING LICENSING AGREEMENTS 69 (Anne Jordan et al. eds. 1996). For further discussion of invention/license valuation techniques and norms, see Steve L. Bertha, Intellectual Property Activities in U.S. Research Universities, 36 IDEA: J.L. & TECH. 513 (1996); Timothy Cesarek, Special Article: Unleashing the Value of Technology: What's It Worth? (BLR 1358), 11 BIOTECH. L. REP. 529 (1992); Yoshio Matsunaga, Determining Reasonable Royalty Rates, LES NOUVELLES, Dec. 1983, at 216-19.
178. See generally R.H. Coase, The Problem of Social Cost, 3 J.L. & ECON. 1 (1960). Justice Douglas articulated the principles of freedom of contract with regard to royalties in the U.S. Supreme Court decision, Brulotte v. Thys Co. According to Douglas' opinion, a "patent empowers the owner to exact royalties as high as he can negotiate with the leverage of [the patent] monopoly." 379 U.S. 29 (1964); see also JAY DRATLER, LICENSING OF INTELLECTUAL PROPERTY 328 (1995) (noting that although Justice Douglas' comment was originally dictum, the "statement has been adopted by the courts and now fairly reflects the absence of general restrictions on the amount or royalties a licensor may charge"). There are, however, other constraints (such as antitrust) that impact licensing practices. Susan Progoff, Avoiding the Potential Pitfalls in Licensing, in DRAFTING LICENSING AGREEMENTS 69 (Anne Jordan et al. eds. 1996). For further discussion of invention/license valuation techniques and norms, see Steve L. Bertha, Intellectual Property Activities in U.S. Research Universities, 36 IDEA: J.L. & TECH. 513 (1996); Timothy Cesarek, Special Article: Unleashing the Value of Technology: What's It Worth? (BLR 1358), 11 BIOTECH. L. REP. 529 (1992); Yoshio Matsunaga, Determining Reasonable Royalty Rates, LES NOUVELLES, Dec. 1983, at 216-19.
179. Interview with Dr. Leighton Read, Pres., Aviron, Inc. (Feb. 22, 1996).
180. Goldstein, Technology Transfer and Risk Management, supra note 99, at 43.
181. AUTM LICENSING SURVEY (1997), supra note 6. The AUTM survey is based upon responses from U.S. universities. One hundred and sixty-eight universities responded in the first survey, while 196 responded in the latest (FY 1995) survey; 78 universities responded every year. Id. at 10.
182. Id. at 43.
183. Id.
184. AUTM defines "gross royalties" as "license issue fees, payments under options, annual minimums, running royalties, termination payments, the amount of [cash for] equity received when cashed-in, and software end user license fees equal to $1,000 or more, but not research funding, patent reimbursement fees, a valuation of equity not cashed-in, software end user license fees less than $1,000, or trademark licensing royalties from university insignia." Id. at 29-30 (emphasis in original).
185. Id. at 43. "In spite of its drawbacks, especially in making comparisons between universities, royalty income is likely to remain the most commonly used measure of patent administration effectiveness . . . ." MATKIN, supra note 17, at 129, See also Albert E. Muir, Technology Transfer Office Performance Index, 4 J. ASS'N U. TECH. MANAGERS (1993), available in 〈http://www.crpc.rice.edu/autm/journal/93/performance93.html〉 (proposing an index-based system for evaluation TTO efficacy). Licensing revenues also are incomplete indicators, because they fail to reflect the many biomedical inventions that for various reasons were not patented (or commercialized) by the university. See, e.g., Lisa Eckelbecker, Technology Transfer: Guarded Patents Help Colleges Exploit Market, TELEGRAM & GAZETTE (Worcester), Mar. 3, 1996, at El (discussing the invention of the birth control pill by the Worcester Foundation for Experimental Biology, and the Foundation's subsequent failure to capture the massive profits from the invention).
186. Id. at 43. "In spite of its drawbacks, especially in making comparisons between universities, royalty income is likely to remain the most commonly used measure of patent administration effectiveness . . . ." MATKIN, supra note 17, at 129, See also Albert E. Muir, Technology Transfer Office Performance Index, 4 J. ASS'N U. TECH. MANAGERS (1993), available in 〈http://www.crpc.rice.edu/autm/journal/93/performance93.html〉 (proposing an index-based system for evaluation TTO efficacy). Licensing revenues also are incomplete indicators, because they fail to reflect the many biomedical inventions that for various reasons were not patented (or commercialized) by the university. See, e.g., Lisa Eckelbecker, Technology Transfer: Guarded Patents Help Colleges Exploit Market, TELEGRAM & GAZETTE (Worcester), Mar. 3, 1996, at El (discussing the invention of the birth control pill by the Worcester Foundation for Experimental Biology, and the Foundation's subsequent failure to capture the massive profits from the invention).
187. Id. at 43. "In spite of its drawbacks, especially in making comparisons between universities, royalty income is likely to remain the most commonly used measure of patent administration effectiveness . . . ." MATKIN, supra note 17, at 129, See also Albert E. Muir, Technology Transfer Office Performance Index, 4 J. ASS'N U. TECH. MANAGERS (1993), available in 〈http://www.crpc.rice.edu/autm/journal/93/performance93.html〉 (proposing an index-based system for evaluation TTO efficacy). Licensing revenues also are incomplete indicators, because they fail to reflect the many biomedical inventions that for various reasons were not patented (or commercialized) by the university. See, e.g., Lisa Eckelbecker, Technology Transfer: Guarded Patents Help Colleges Exploit Market, TELEGRAM & GAZETTE (Worcester), Mar. 3, 1996, at El (discussing the invention of the birth control pill by the Worcester Foundation for Experimental Biology, and the Foundation's subsequent failure to capture the massive profits from the invention).
188. AUTM LICENSING SURVEY (1997), supra note 6, at 34, 43.
189. Id. at 53.
190. Id. at 15.
191. Id.
192. Id.
193. Id. at 44.
194. Id. at 26.
195. In 1988, Harvard was issued a patent for the Oncomouse, a rodent designed to be cancer-ridden, providing researchers with a reliable experimental subject Transgenic Non-Human Mammals, U.S. Patent No. 4,736,866 (Apr. 12, 1988). See Harvard University Awarded First Patent for Genetically Engineered Animal (BLR 762), 7 BIOTECH. L. REP. 107 (1988). The U.S. Patent and Trademark Office was faced with a flurry of similar patent applications on organisms and heavy opposition from various interest groups. It was almost five years before any further organism patents were granted. Marla Cone, The Mouse Wars Turn Furious, L.A. TIMES, May 9, 1993, at 1. Oncomouse, however, which was licensed to Du Pont, was not a licensing success story despite its scientific merits. Marla Cone, The Mouse Wars Turn Furious, L.A. TIMES, May 9, 1993, at 1 (explaining that Du Pont failed to properly market the Oncomouse to the scientific community).
196. In 1988, Harvard was issued a patent for the Oncomouse, a rodent designed to be cancer-ridden, providing researchers with a reliable experimental subject Transgenic Non-Human Mammals, U.S. Patent No. 4,736,866 (Apr. 12, 1988). See Harvard University Awarded First Patent for Genetically Engineered Animal (BLR 762), 7 BIOTECH. L. REP. 107 (1988). The U.S. Patent and Trademark Office was faced with a flurry of similar patent applications on organisms and heavy opposition from various interest groups. It was almost five years before any further organism patents were granted. Marla Cone, The Mouse Wars Turn Furious, L.A. TIMES, May 9, 1993, at 1. Oncomouse, however, which was licensed to Du Pont, was not a licensing success story despite its scientific merits. Marla Cone, The Mouse Wars Turn Furious, L.A. TIMES, May 9, 1993, at 1 (explaining that Du Pont failed to properly market the Oncomouse to the scientific community).
197. In 1988, Harvard was issued a patent for the Oncomouse, a rodent designed to be cancer-ridden, providing researchers with a reliable experimental subject Transgenic Non-Human Mammals, U.S. Patent No. 4,736,866 (Apr. 12, 1988). See Harvard University Awarded First Patent for Genetically Engineered Animal (BLR 762), 7 BIOTECH. L. REP. 107 (1988). The U.S. Patent and Trademark Office was faced with a flurry of similar patent applications on organisms and heavy opposition from various interest groups. It was almost five years before any further organism patents were granted. Marla Cone, The Mouse Wars Turn Furious, L.A. TIMES, May 9, 1993, at 1. Oncomouse, however, which was licensed to Du Pont, was not a licensing success story despite its scientific merits. Marla Cone, The Mouse Wars Turn Furious, L.A. TIMES, May 9, 1993, at 1 (explaining that Du Pont failed to properly market the Oncomouse to the scientific community).
198. HARVARD UNIVERSITY, supra note 67, at 2.
199. Id. at 3.
200. Dean Tosteson retired on July 1, 1997, after a 20-year term as Dean of the Harvard Medical School. His successor is Dr. Joseph Martin. Martin Named Next Dean of Faculty of Medicine, HARV. U. GAZETTE, Nov. 14, 1996, at 1.
201. Catherine Fahy, Harvard Puts Its Bio Med Researchers Under One Roof, MASS. HIGH TECH, May 6, 1996, at 4; Harvard's Plan Called Ambitious: Institutes of Medicine Raises Questions, TELEGRAM & GAZETTE (Worcester), Aug. 22, 1993, at A6.
202. Catherine Fahy, Harvard Puts Its Bio Med Researchers Under One Roof, MASS. HIGH TECH, May 6, 1996, at 4; Harvard's Plan Called Ambitious: Institutes of Medicine Raises Questions, TELEGRAM & GAZETTE (Worcester), Aug. 22, 1993, at A6.
203. Hunnewell, supra note 29, at 35.
204. Id. at 4.
205. There is, however, a historical debate whether English physician Edward Jenner might have been the first inventor. PETER FIRLE, EDWARD JENNER'S COWPOX VACCINE: THE HISTORY OF A MEDICAL MYTH (1977).
206. The patent is held jointly by Harvard and MIT.
207. Hunnewell, supra note 29, at 34.
208. Id. at 35.
209. Derek Bok, President's Report: Business and the Academy, HARV. MAG., May-June 1981, at 23.
210. Hunnewell, supra note 29, at 35.
211. See also DEREK BOK, BEYOND THE IVORY TOWER (1982).
212. Robert Frahm, Colleges Lack Funding Catalyst to Convert Research into Gold, HARTFORD COURANT, Nov. 12, 1991, at A1.
213. Gretchen Morgenson, In Pecunia Veritas?, FORBES, Nov. 28, 1988, at 204.
214. Richard A. Knox, Medical School Adopts Tighter Conflict Policy, BOSTON GLOBE, Mar. 24, 1990, at 25.
215. Dean Tosteson acknowledged that the scandal impacted his decision to bring the policy revision to completion. "I wouldn't say it was decisive, but it was certainly on my mind." Richard A. Knox, Harvard Debates Research Ethics, BOSTON GLOBE, Feb. 26, 1990, at 1.
216. HARVARD UNIVERSITY, FACULTY OF MEDICINE, FACULTY POLICIES ON INTEGRITY IN SCIENCE (1996).
217. Hunnewell, supra note 29, at 37.
218. Eliot Marshall, When Commerce and Academe Collide, SCI., Apr. 13, 1990, at 152.
219. MSP was the brainchild of Dean Tosteson. Eliot Marshall, Harvard Tiptoes into the Market, SCI., Sept. 23, 1988, at 1595; Interview with Joseph F. Lovett, General Partner, Medical Science Partners (Apr. 8, 1996).
220. MSP was the brainchild of Dean Tosteson. Eliot Marshall, Harvard Tiptoes into the Market, SCI., Sept. 23, 1988, at 1595; Interview with Joseph F. Lovett, General Partner, Medical Science Partners (Apr. 8, 1996).
221. David Stipp, Plan Could Mark New Trend By Universities to Bring Their Work to Market, WALL ST. J., Sept. 15, 1988, at 2.
222. Hunnewell, supra note 29, at 35.
223. Marshall, supra note 189, at 1595.
224. Interview with Joseph F. Lovett, supra note 189.
225. The endowment is managed by the Harvard Management Company, a university-owned corporation. Andrew Bary, Harvard's Men, BARRON'S, Dec. 2, 1996, at 31.
226. Interview with Joyce Brinton, Dir., Harv. Univ. Off. for Tech. & Trademark Licensing (Oct. 18, 1996).
227. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, ANNUAL REPORT TO THE COMMITTEE ON PATENTS AND COPYRIGHTS FISCAL YEAR 1993, at 4 (1993).
228. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, ANNUAL REPORT TO THE COMMITTEE ON PATENTS AND COPYRIGHTS FISCAL YEAR 1994, at 3 (1994).
229. HARVARD OTTL/OTL ANNUAL REPORT FY 1995, supra note 84, at 4.
230. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, ANNUAL REPORT TO THE COMMITTEE ON PATENTS AND COPYRIGHTS FISCAL YEAR 1996, at 6 (1996).
231. Interview with Joyce Brinton, supra note 195.
232. Interview with Michael J. Astrue, Vice Pres. & Gen. Counsel, Biogen (Dec. 12, 1996).
233. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, supra note 197, at 4.
234. HARVARD UNIVERSITY, A STATEMENT OF POLICY IN REGARD TO PATENTS (1934).
235. Interview with Joyce Brinton, supra note 195. See also HARVARD UNIVERSITY, A STATEMENT OF POLICY IN REGARD TO PATENTS ON DISCOVERIES OR INVENTIONS BEARING ON HEALTH AND THERAPEUTICS 1 (1959) ("No patents primarily concerned with therapeutics or public health may be taken out by any member of the University, except with the consent of the President and Fellows; nor will such patents be taken out by the University itself except for dedication to the public.").
236. Harvard Licensing Report FY 1977-1987, supra note 84, at 1.
237. Id.
238. Id.
239. Id. at 2.
240. Id. at 3.
241. Memorandum from Joyce Brinton, Harv. Univ., Off. for Tech. & Trademark Licensing, to Members of the Comm. on Patents & Copyrights, Report of Activity Fiscal Year 1990-1991 (Oct. 21, 1991).
242. Steve Atkinson became the director of OTL, where he served until 1992 when he retired and was replaced by the current director, Nina Green. Memorandum from Joyce Brinton, Harv. Univ., Off. for Tech. & Trademark Licensing, to Members of the Comm. on Patents & Copyrights, Report of Activity Fiscal Year 1991-1992 (Oct. 26, 1992).
243. Interview with Joyce Brinton, supra note 195,
244. Interview with Nina Green, Dir., Harv. Med. School Off. of Tech. Licensing & Industry-Sponsored Research (Nov. 13, 1996).
245. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, supra note 196, at 3.
246. Half of the patents filed on inventions at the Harvard Faculty of Medicine resulted from sponsored research projects. Memorandum from Joyce Brinton, Harv. Univ., Off. for Patents, Copyrights, & Licensing, to Comm. on Patents & Copyrights, Report of PCL Activity for 1987-1988 (Oct. 5, 1988).
247. Memorandum from Joyce Brinton, Harv. Univ., Off. for Patents, Copyrights, & Licensing, to Members of the Comm. on Patents & Copyrights, Report of Activity Fiscal Year 1989-1990 (Oct. 12, 1990).
248. Id.
249. Id. See also Memorandum from Joyce Brinton, supra note 215 (finding that approximately 40% to 60% of Harvard's licensing revenue is attributable to the "medical faculty").
250. Memorandum from Joyce Brinton, supra note 216.
251. Id. It is interesting to note the potential for conflict between sponsored research and licensing operations that was manifested in this instance. See BARRY WERTH, THE BILLION DOLLAR MOLECULE 71-73 (1994).
252. Hunnewell, supra note 29, at 36.
253. Harvard Licensing Report FY 1977-1987, supra note 84.
254. Compiled and adapted from various annual reports and memoranda to members of the Harvard University Committee on Patents and Copyrights, as cited elsewhere in this article. More recent data trumped older, inconsistent information.
255. These data indicate the number of cases/inventions licensed or optioned, not the number of actual transactions entered or agreements executed.
256. Harvard University had no licensing revenue before FY 1981. Memorandum from Joyce Brinton, supra note 216.
257. HARVARD UNIVERSJTY OFFICE FOR TECHNOLOOY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, supra note 199, at 1.
258. Interview with Joyce Brinton, supra note 195.
259. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, supra note 199, at 4.
260. See generally Marjorie Sun, Part of AIDS Virus is Patented. (Protein Known as GP120), SCI., Feb. 26, 1988, at 970.
261. Eric Convey, Biogen Reaps $30 Million in Settlement, BOSTON HERALD, Oct. 1, 1996, at 23. Pharmacia previously had been a defendant against Harvard, in the University's first patent infringement suit. In 1989, Harvard had filed suit against Pharmacia for infringing Professor Tabor and Professor Richardson's patent for Sequensase. Peter G. Gosselin, Harvard Sues Swedish Firm over Patents, BOSTON GLOBE, Aug. 1, 1989, at 31.
262. Eric Convey, Biogen Reaps $30 Million in Settlement, BOSTON HERALD, Oct. 1, 1996, at 23. Pharmacia previously had been a defendant against Harvard, in the University's first patent infringement suit. In 1989, Harvard had filed suit against Pharmacia for infringing Professor Tabor and Professor Richardson's patent for Sequensase. Peter G. Gosselin, Harvard Sues Swedish Firm over Patents, BOSTON GLOBE, Aug. 1, 1989, at 31.
263. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, supra note 199, at 3; Stanley Ziemba, Abbott Settles With Biotech Firm, CHI. TRIB., Sept. 18, 1996, at 1 (noting that Abbott Laboratories settled by paying Cambridge Biotech $3,250,000 for a nonexclusive sublicense to use Cambridge's HIV-related diagnostic technology).
264. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, supra note 199, at 3; Stanley Ziemba, Abbott Settles With Biotech Firm, CHI. TRIB., Sept. 18, 1996, at 1 (noting that Abbott Laboratories settled by paying Cambridge Biotech $3,250,000 for a nonexclusive sublicense to use Cambridge's HIV-related diagnostic technology).
265. HARVARD UNIVERSITY OFFICE FOR TECHNOLOGY AND TRADEMARK LICENSING, HARVARD MEDICAL SCHOOL OFFICE OF TECHNOLOGY LICENSING AND INDUSTRY SPONSORED RESEARCH, supra note 199, at 7.
266. Id.
267. Id. at 4.
268. Other universities have also benefited from Harvard's growing pains. See, e.g., Christopher Anderson, UC Goes Where Harvard Feared to Tread, SCI., Dec. 18, 1992, at 1875.
269. HARVARD UNIVERSITY, supra note 67, at 3.
270. Silicon Valley Fever, CAL. LAW., June 1995, at 28.
271. Timothy J. Mullaney, Gallo May Benefit UMAB Commercially, BALTIMORE SUN, May 27, 1995, at 19C.
272. See generally ANNALEE SAXENIAN, REGIONAL ADVANTAGE: CULTURE AND COMPETITION IN SILICON VALLEY AND ROUTE 128 (1994); Homa Bahrami & Stuart Evans, Flexible Re-Cycling and High-Technology Entrepreneurship, CAL. MGMT. REV., Mar. 22, 1995, at 62.
273. See generally ANNALEE SAXENIAN, REGIONAL ADVANTAGE: CULTURE AND COMPETITION IN SILICON VALLEY AND ROUTE 128 (1994); Homa Bahrami & Stuart Evans, Flexible Re-Cycling and High-Technology Entrepreneurship, CAL. MGMT. REV., Mar. 22, 1995, at 62.
274. Cheryl Ajluni, Microsensors Move into Biomedical Applications, ELECTRONIC DESIGN, May 28, 1996, at 75.
275. The first two Stanford inventions licensed also were biomedical: dehydroprogesterone and an interferon-related compound. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING, TOTAL POSITIVE INCOME FROM 1974 TO THE PRESENT IN TOTAL DOCKET ORDER (1996). Prior to the formation of its OTL, Stanford University had received a miniscule amount of revenue from patents it had outsourced to a patent management agency. MATKIN, supra note 17, at 71 (noting that Stanford had received less than $5000 in overall royalty income from patents licensed via an outsourcing agency in the period 1954 to 1967).
276. Eric Grunwald, OTL Turns 25 But Doesn't Get a Break on Insurance, STANFORD TECH. BRAINSTORM, Summer 1996, at 1.
277. STANFORD UNIVERSITY NEWS SERVICE, PRESS RELEASE (Nov. 14, 1972).
278. Id. (noting that equity was accepted from Dynaspec, Inc. of Mountain View, CA). Currently, Stanford holds equity in 25 companies. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING, 1996 REPORT 3 (1996).
279. Grunwald, supra note 242, at 1.
280. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING, supra note 241.
281. Irene Johnston Petrick & Michael M. Reischman, Strategic Development of Engineering Policies for Patenting and Licensing, SRA J., Mar. 1, 1996, at 13 (finding that rigid policies have had a deleterious impact on technology transfer).
282. Eliot Marshall, When Commerce and Academe Collide, SCI., Apr. 13, 1990 at 152.
283. Id.
284. STANFORD UNIVERSITY SENATE OF THE ACADEMIC COUNCIL, STANFORD UNIVERSITY FACULTY POLICY ON CONFLICT OF COMMITMENT AND INTEREST (1994).
285. A good telling of the tale was authored by Niels Reimers, former director of Stanford's OTL. Niels Reimers, Tiger by the Tail, 7 J. ASS'N U. TECH. MANAGERS 1 (1995), available in 〈http://www.crpc.rice.edu/ autm/journal/95/TBT95.html〉.
286. Katherine Ku, Licensing DNA Cloning Technology, LES NOUVELLES, June 1983, at 14.
287. Reimers, supra note 251.
288. For information on Gordon Research Conferences, see Gordon Research Conferences, ORC Homepage (visited Sept. 30, 1997) 〈http://www.grc.uri.edu〉.
289. Stanley Cohen & Herbert Boyer et al., On Transfer of Animal DNA Fragment into E. coli Plasmid, PROC. NAT'L. ACAD. SCI., Nov. 1973, at 3240.
290. Lita Nelsen estimates that Stanford and UC lost 50% of the potential revenue from the Cohen-Boyer discovery because of their inability to obtain foreign patent rights. Nelsen, supra note 57, at 51.
291. Reimers, supra note 251.
292. Id.
293. Id.
294. Id.
295. Id.
296. 447 U.S. 303 (1980).
297. Id. See also Gale R. Peterson, Introduction to the Field of Biotechnology Law, in UNDERSTANDING BIOTECHNOLOGY LAW, supra note 57, at 21 n.20 (noting prior patents on living organisms).
298. Patent No. 4,237,224. The product patent was issued some four years later, almost a decade after the original application was filed. Patent No. 4,468,464. Cohen-Boyer Patent on Spliced Genes Finally Issues to Stanford University (BLR 275), 3 BIOTECH. L. REP. 183 (1984).
299. Larry Light & Joan Hamilton, Finance: Rewriting the Rules of Venture Capital, BUS. WK., July 19, 1993, at 70.
300. Ku, supra note 252, at 14.
301. Grunwald, supra note 242, at 1.
302. Ku, supra note 252, at 14.
303. Stanford even developed a standard licensing form that "could be accurately used even by individuals unfamiliar with the terms of the complex licensing document." Stanford Issues Form for Calculating Royalties Due under Cohen-Boyer License (BLR 119), 2 BIOTECH. L. REP. 35 (1983).
304. "Since these products are 'closest' along the chain of manu facture to the claims of the patent, they have the highest royalty." Ku, supra, note 252, at 14.
305. Id.
306. Insulin was the first rDNA product, introduced by Eli Lilly under the brand name Humulin. Id.
307. Id.
308. Id.
309. Grunwald, supra note 242, at 1. Stanford had suffered prior revenue losses on the expiration of the University's second-largest patent (for FM music synthesis) and a number of successful biomedical licenses, including the CAT scanner. Id.
310. Id.
311. Compiled and adapted from various Stanford memoranda and reports (cited elsewhere in this article). More recent data trumped older, inconsistent information.
312. Grunwald, supra note 242, at 1.
313. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING REPORT, supra note 244, at 3.
314. Interview with Kathy Ku, Dir., Stanford Univ., Off. of Tech. Licensing (Mar. 25, 1997).
315. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING, CONNECTIONS 4 (1993).
316. COUNCIL ON GOVERNMENTAL RELATIONS, supra note 13, at 6.
317. Nelsen, supra note 9, at 41.
318. Interview with Kathy Ku, supra note 280.
319. Interview with Allegra Helfenstein, Legal Counsel, Molecular Probes, Inc. (Mar. 17, 1997).
320. Interview with Kathy Ku, supra note 280.
321. STANFORD UNIVERSITY OFFICE OF TECHNOLOGY LICENSING REPORT, supra note 244, at 3.
322. STANFORD UNIVERSITY OFFICE FOR TECHNOLOGY LICENSING, STRATEGIC PLAN (1997), available in 〈http:// www-leland.stanford.edu/group/OTL/strategic.html〉.
323. Interview with Kathy Ku, supra note 280.
324. Peter Hadekel, Montreal 2000; Mutual Funds and Prudent People, MONTREAL GAZETTE, Apr. 21, 1996, at A7.
325. MIT has a well-deserved reputation in the business community as being a reasonable and reliable partner. The Institute was a pioneer in forming official links with industry. In 1948, MIT founded its Industrial Liaison Program as a "mutually beneficial communications link between the faculty and staff at the Institute and the research, management, and operational activities of more than 300 diverse research-oriented industrial organizations." Massachusetts Institute of Technology, President's Office, 5.50 Industrial Liaison Program (ILP) (visited Sept. 30, 1997) 〈http://web.mit.edu:1962/tiserve.mit.edu/9000/23727.html〉. ILP is part of MIT's Office of Corporate Relations. Massachusetts Institute of Technology, MIT Office of Corporate Development (visited Sept. 30, 1997) 〈http://ilp.mit.edu/corpdev〉.
326. MIT has a well-deserved reputation in the business community as being a reasonable and reliable partner. The Institute was a pioneer in forming official links with industry. In 1948, MIT founded its Industrial Liaison Program as a "mutually beneficial communications link between the faculty and staff at the Institute and the research, management, and operational activities of more than 300 diverse research-oriented industrial organizations." Massachusetts Institute of Technology, President's Office, 5.50 Industrial Liaison Program (ILP) (visited Sept. 30, 1997) 〈http://web.mit.edu:1962/tiserve.mit.edu/9000/23727.html〉. ILP is part of MIT's Office of Corporate Relations. Massachusetts Institute of Technology, MIT Office of Corporate Development (visited Sept. 30, 1997) 〈http://ilp.mit.edu/corpdev〉.
327. For example, Professor Klibanov helped Genzyme bring in its CEO, Henri Termeer.
328. Ronald Rosenberg, Academic Entrepreneur MIT's Anthony Sinskey Nurtures Young Biologists and Young Companies, BOSTON GLOBE, Jan. 12, 1994, at 37.
329. Ann Harrison, Vest Warns of Doom for MIT's R&D, MASS. HIGH TECH, Nov. 11, 1996, at 1.
330. Massachusetts Institute of Technology, MIT Facts 1997 - Research at MIT (visited Sept. 30, 1997) 〈http://web.mit.edu/resdev/www/mitfacts.html#Heading10〉.
331. Richard O. Hynes, Center for Cancer Research, MIT Reports to the President 1995-96 (visited Sept. 30, 1997) 〈http://web.mit.edu/communications/pres96/13.12.html〉. See generally Massachusetts Institute of Technology, MIT Centerfor Cancer Research Home Page (visited Sept. 30, 1997) 〈http://web.mit.edu/ccrhq/ www〉.
332. Richard O. Hynes, Center for Cancer Research, MIT Reports to the President 1995-96 (visited Sept. 30, 1997) 〈http://web.mit.edu/communications/pres96/13.12.html〉. See generally Massachusetts Institute of Technology, MIT Centerfor Cancer Research Home Page (visited Sept. 30, 1997) 〈http://web.mit.edu/ccrhq/ www〉.
333. See generally Massachusetts Institute of Technology, Human-Machine Systems Laboratory (visited Sept. 30, 1997) 〈http://web.mit.edu/hmsl/www/index.html〉.
334. Massachusetts Institute of Technology, The Media Laboratory (visited Sept. 30, 1997) 〈http:// www.media.mit.edu/〉.
335. Letter from Lita Nelsen, Dir., Tech. Licensing Off., Massachusetts Inst. of Tech., to Kenneth Sutherlin Dueker (Apr. 17, 1997) (on file with author).
336. Id.
337. See generally Harvard University-Massachusetts Institute of Technology, Division of Health Sciences and Technology, HMS-MIT Division of Health Sciences and Technology (visited Sept. 30, 1997) 〈http:// www.hvd.mit.hst.med.harvard.edu〉.
338. Harvard University-Massachusetts Institute of Technology, Division of Health Sciences and Technology, Division of Health Sciences and Technology History (visited Sept. 30, 1997) 〈http://www.hvd.mit.hst.med. harvard.edu/GenInfo/Other/HST_history.html〉.
339. Mr. Whitehead originally offered Duke University funds to establish the Whitehead Institute, but his offer was rejected. MATKIN, supra note 17, at 43.
340. Whitehead Institute, History: An Experiment in Science (visited Sept. 30, 1997) 〈http://www.wi.mit.edu/ news/about/his.html#history〉.
341. Id.
342. See generally Whitehead Institute for Biomedical Research/MIT Center for Genome Research, Welcome to the Whitehead Institute Center for Genome Research (visited Sept. 30, 1997) 〈http://www-genome.wi.mit.edu/〉.
343. Whitehead Institute, supra note 304.
344. Massachusetts Institute of Technology, supra note 295.
345. MIT's total operating budget for FY 1996 was $1,359,800,000. Massachusetts Institute of Technology, MIT Facts 1997 - Financial Data (visited Sept. 30, 1997) 〈http://web.mit.edu/resdev/www/ mitfacts.html#Heading26〉.
346. Maggie Farley, Matching Investors With Inventions at MIT, BOSTON GLOBE, Aug. 16, 1992, at B12.
347. Interview with Lita Nelsen, Dir., Tech. Licensing Off., Massachusetts Inst of Tech. (Aug. 15, 1996).
348. Id.
349. Farley, supra note 310, at B12.
350. Laura Jereski, Patent Profit. (Massachusetts Institute of Technology Working More Closely with Companies Based on New Technology), FORBES, May 2, 1988, at 104.
351. Interview with Lita Nelsen, supra note 311.
352. MATKIN, supra note 17, at 133.
353. Morgenson, supra note 183, at 204. See generally MATKIN, supra note 17, at 157-59.
354. MATKTN, supra note 17, at 133.
355. History is repeating itself. In 1996, Niels Reimers, who had been serving as a consultant after retiring from Stanford in 1991, was brought in to be the first director of a new Office of Technology Management at the UC at San Francisco (UCSF). Carl T. Hall, Tech Pioneer Reimers to Sell UCSF Discoveries, S.F. CHRON., Mar. 7, 1996, at D1.
356. See, e.g., EDMUND P. LEARNED ET AL., EXECUTIVE ACTION (1951).
357. Craig Justice, The Business of Technology Transfer, PAC. N.W. EXECUTIVE, Jan. 1, 1988, at 2.
358. Interview with Lita Nelsen, supra note 311.
359. Udayan Gupta, How an Ivory Tower Turns Research Into Start-Ups, WALL ST., J., Sept. 19, 1989, available in 1989 WL-WSJ 473259.
360. The entrepreneurial spirit at MIT permeates all affiliates of the Institute. The apex of this phenomenon occurred when MIT maintenance worker Paul DeSantis developed a medical device to solve a congenital stomach defect that his daughter had since birth. After consultation with his family doctor and an engineering professor at MIT, DeSantis took the invention to the TLO. The device currently is being marketed in MIT's license portfolio. Reuters, Plumber at MIT Invents Medical Device. His Daughter's Problem Was Inspiration, SUN-SENTINEL (Ft. Lauderdale Fla.), Jan. 6, 1996, at 11A.
361. BANKBOSTON, MIT: THE IMPACT OF INNOVATION 2 (1997). It is the author's opinion that the economic impact of the other two universities in this article (Stanford and Harvard) would be comparable to MIT, but as yet there has not been an effort to quantify such data. "The [MIT] study is the first effort made to measure the national job creation impact of a single research university . . . ." Id. There was, in fact, an earlier version of this report. BANK OF BOSTON, MIT: GROWING BUSINESSES FOR THE FUTURE (1989). MIT also conducted its own econometric research. Pressman, supra note 8, at 49. It is interesting to note that, of MIT start-ups in the biomedical industry, only 18% were founded by life-science graduates, while 40% of the founders were engineers. BANKBOSTON, supra, at 22. This is likely attributable to the historical preponderance of engineering students at MIT.
362. BANKBOSTON, MIT: THE IMPACT OF INNOVATION 2 (1997). It is the author's opinion that the economic impact of the other two universities in this article (Stanford and Harvard) would be comparable to MIT, but as yet there has not been an effort to quantify such data. "The [MIT] study is the first effort made to measure the national job creation impact of a single research university . . . ." Id. There was, in fact, an earlier version of this report. BANK OF BOSTON, MIT: GROWING BUSINESSES FOR THE FUTURE (1989). MIT also conducted its own econometric research. Pressman, supra note 8, at 49. It is interesting to note that, of MIT start-ups in the biomedical industry, only 18% were founded by life-science graduates, while 40% of the founders were engineers. BANKBOSTON, supra, at 22. This is likely attributable to the historical preponderance of engineering students at MIT.
363. Massachusetts Institute of Technology, supra note 130.
364. Id.
365. Id.
366. Id.
367. Id.
368. Id.
369. Id.
370. Letter from Dr. Kingsley Taft, to Kenneth Sutherlin Dueker (Apr. 22, 1997) (on file with author) (Dr. Taft received his Ph.D. in chemistry from MIT in 1994 and his J.D. from Harvard in 1997.).
371. Nicole Ruedige, A Daring Science Career: Start Your Own Company, SCI., Sept. 6, 1996, at 1433; Jim Timpane, Life Science Jobs in a Global Market: Careers in Biotechnology and Pharmaceuticals, SCI., Feb. 12, 1993, at 1003. MIT also is experiencing that trend. BANKBOSTON, supra note 325, at 5 (noting that "the rate of formation of new companies by MIT graduates appears to be accelerating").
372. Nicole Ruedige, A Daring Science Career: Start Your Own Company, SCI., Sept. 6, 1996, at 1433; Jim Timpane, Life Science Jobs in a Global Market: Careers in Biotechnology and Pharmaceuticals, SCI., Feb. 12, 1993, at 1003. MIT also is experiencing that trend. BANKBOSTON, supra note 325, at 5 (noting that "the rate of formation of new companies by MIT graduates appears to be accelerating").
373. AUTM LICENSING SURVEY (1997), supra note 6, at 34, 43.
374. Nelsen, supra note 9, at 59.
375. Id. at 64-65.
376. Interview with Joseph F. Lovett, supra note 189. See generally Terrance P. McGuire, A Blueprint for Growth or a Recipe for Disaster? State Sponsored Venture Capital Funds for High Technology Ventures, 7 HARV. J.L. & TECH. 419 (1994).
377. Ron Karten, OSU Keeps Spinning, OR. BUS., Mar. 1, 1989, at 53.
378. MASSACHUSETTS INSTITUTE OF TECHNOLOGY, GUIDE TO THE OWNERSHIP, DISTRIBUTION AND COMMERCIAL DEVELOPMENT OF MIT TECHNOLOGY, at pt. 4.1, available in 〈http://web.mit.edu./tlo/www/guide.4.html〉.
379. Massachusetts Institute of Technology, supra note 130.
380. Patrick L. Porter, Preston in Venture Role, MASS. HIGH TECH, Jan. 22, 1996, at 10.
381. Interview with Lita Nelsen, supra note 311.
382. Id. Faculty from MIT and other schools occasionally are drawn away to industry, even those highly-ensconced in their university. For example, in September 1991 Bristol-Myers Squibb recruited Dr. Leon Rosenberg away from his seven-year tenure as Dean of Yale University School of Medicine (and twenry-nine-year research career) to become President of Bristol-Myers Squibb Pharmaceutical Research Institute, based in Princeton, New Jersey. Business Development Reconnaissance Project: Bristol-Myers Squibb, BIOVENTURE VIEW, June 1, 1996, available in 1996 WL 8332330. By contrast, federal laboratories have experienced an exodus of their researchers to industry. Lisa Malloy Nardini, Dishonoring the Honorarium Ban: Exemption for Federal Scientists, 45 AM. U.L. REV. 885, 886 (1996) (citing overregulation and poor internal incentive programs as explanatory of this phenomenon).
383. Id. Faculty from MIT and other schools occasionally are drawn away to industry, even those highly-ensconced in their university. For example, in September 1991 Bristol-Myers Squibb recruited Dr. Leon Rosenberg away from his seven-year tenure as Dean of Yale University School of Medicine (and twenry-nine-year research career) to become President of Bristol-Myers Squibb Pharmaceutical Research Institute, based in Princeton, New Jersey. Business Development Reconnaissance Project: Bristol-Myers Squibb, BIOVENTURE VIEW, June 1, 1996, available in 1996 WL 8332330. By contrast, federal laboratories have experienced an exodus of their researchers to industry. Lisa Malloy Nardini, Dishonoring the Honorarium Ban: Exemption for Federal Scientists, 45 AM. U.L. REV. 885, 886 (1996) (citing overregulation and poor internal incentive programs as explanatory of this phenomenon).
384. Nelsen, supra note 9, at 49, See also MASSACHUSETTS INSTITUTE OF TECHNOLOGY, supra note 340.
385. Letter from Lita Nelsen, Dir., Tech. Licensing Office, Massachusetts Inst. of Tech., to Kenneth Sutherlin Dueker (Apr. 22, 1997) (on file with author).
386. Pressman, supra note 8, at 49, 54.
387. Compiled and adapted from various MIT reports and memoranda (cited elsewhere in this article).
388. Quoted in Lynne Jordan Bowers & Vickie Leon, Patent Policies of 65 Educational Institutions: a Comparison, SRA JOURNAL, Mar. 22, 1994, available in 1994 WL 13595732.
389. COUNCIL ON GOVERNMENTAL RELATIONS, supra note 13, at 1.
390. Id. at 2.
391. Id.
392. 1 AUTM TTPM, supra note 63, at II-1-2.
393. But see Julia Porter Liebeskind & Amalya Lumermn Oiver, From Handshake to Contract: Trust, Intellectual Property, and the Social Structure of Academic Research, forthcoming in TRUST WITHIN AND BETWEEN ORGANIZATIONS (Cristel Land & Rheinard Bachmann eds. 1997) (noting that prior academic norms of trust have been formalized subsequent to contact with industry).
394. For a discussion of the organizational theory aspects of university behavior and development, see Nicholas Argyres & Julia Liebeskind, Privatizing the Intellectual Commons: Universities and the Commercialization of Biotechnology (1997) (unpublished manuscript, on file with author).
395. KORNBERG, supra note 110, at 248.
396. Id. (emphasis in original).
397. For example, NSF has restructured its graduate training grants programs to "enable graduates to pursue a broader range of options . . . [to] emphasize interdisciplinary training and promote opportunities for students to work with industry." Andrew Lawler, Smoother Road for R&D Spending, SCI., Feb. 14, 1997, at 918. See also National Science Foundation, supra note 27.