Overview of technology development

Principles and Practice of Clinical Research

Volumn , Issue , 2007, Pages 291-314

  Goldstein, Bruce ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

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EID: 79959826955     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-012369440-9/50026-8     Document Type: Chapter

References (76)

1. In this chapter, "government" means an agency of either the federal government or a state government, including, where applicable, a university acting.
2. "Technology transfer," as the term is normally used, usually encompasses issues focused on acquiring and licensing patents, which are discussed in anot.
3. See, for example, Restatement (2d) Agency, § 322 (an agent who fails to disclose existence of agency or identity of the principal is personally liable) a.
4. See, for example, id. § 1 (definition of agency, principal, and agent), § 26 (creation of actual agency), § 140 (principal liability for the acts of.
5. See, for example, id. § 1 comment c (attorney at law) and § 14C (although individual members of the board of directors are not agents of the corporatio.
6. Id. § 27.
7. NIH has 27 subdivisions under its aegis, each of which is either an "institute" or a "center." The institutes and centers of the NIH, together with.
8. Id. § 320.
9. Gwynne P Corporate collaborations: Scientists can face publishing restraints. The Scientist 1999, 1. May 24.
10. Gwynne P Corporate collaborations: Scientists can face publishing restraints. The Scientist 1999, 6. May 24.
11. Weiss R Thyroid drug study reveals tug of war over privately financed research. Washington Post 1997, A03. April 16.
12. King R Bitter pill: How a drug firm paid for university study, then undermined it. Wall Street Journal 1997, A01. April 15.
13. Rennie D Thyroid storm [Editorial]. JAMA 1997, 277(15):1238-1243.
14. Boots Pharmaceuticals was purchased 1995, A.G. Basf (Ed.).
15. Dong BJ, et al. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA 1997, 277:1205-1213.
16. Mayor GH, et al. Limitations of levothyroxine bioequivalence evaluation: Analysis of an attempted study. Am J Ther 1995, 2:417-432. Dr. Mayor was also an associate editor of this journal at the time.
17. The Adequacy of Appropriations Act, 41 U.S.C. § 11, and the Antideficiency Act, 31 U.S.C. § 1341.
18. 31 U.S.C. § 1350: "An officer or employee of the United States Government or of the District of Columbia government knowingly and willfully violating.
19. Omnibus Budget Reconciliation Act, Public Law 105-277 (1997).
20. See 65 Fed. Reg. 14406 (March 16, 2000).
21. See, for example, Restatement (2d) Torts § 757 comment b; Roger Milgrim, Milgrim on Trade Secrets § 101 (discussing the Uniform Trade Secret Act); cf.
22. Milgrim, § 16.01[7].
23. Economic Espionage Act, 18 U.S.C. §§ 1831-32; Milgrim, § 13.03.
24. 5 U.S.C. § 552.
25. Id., § 552(b)(4). Information generated by a government scientist under a CRADA is also exempt, provided the information is such that it would be deemed.
26. Id., § 552(b)(5).
27. Id., § 552(b)(6). See also Privacy Act of 1974, 5 U.S.C. § 552a.
28. 35 U.S.C. § 205. This exemption only applies for a "reasonable time in order for a patent application to be filed.".
29. 15 U.S.C. § 3710a(c)(7). Of particular note, subparagraph (7)(B) extends the "trade secret" exemption of the Freedom of Information Act to cover dat.
30. Depending on the parties negotiating the agreement, it often, but not always, contains some additional terms. Examples of such provisions include those th.
31. See, for example, Weigh Systems South, Inc. v. Mark's Scales & Equipment, Inc., 68 S.W.3d 299 (Ark. 2002) (although the extent of measures taken to guard.
32. Federal Register Notice published on May 25, 1999 (64 FR 28205).
33. Although the Public Health Service no longer functions as a discrete subunit of the Department of Health and Human Services, the name still serves to iden.
34. Black's Law Dictionary 1990, 1586-1589. 6th ed.
35. See also Corbin A. Corbin On Contracts, § 14 (single-volume edition).
36. Williston S. Williston On Contracts 3d § 1364C (buyer's consequential damages under the Uniform Commercial Code), § 1394 (general consequential damage.
37. 41 U.S.C. § 11.
38. 31 U.S.C. § 1341.
39. 31 U.S.C. § 1350.
40. See the Web page of the Association of University Technology Managers at www.autm.net.
41. 21 C.F.R. § 310.305 and § 312.32.
42. 21 C.F.R. §§ 312.50 (general duties of sponsor), 312.53 (selecting investigators and monitors).
43. See, for example, 21 C.F.R. § 312.47(meetings with FDA), § 312.50 (general duties of sponsor), § 312.58 (FDA inspection of sponsor's records), and.
44. 21 U.S.C. §§ 335a, 335b.
45. 45 C.F.R. Part 46, Subpart A.
46. 42 U.S.C. § 282(c) ("substances and living organisms").
47. See Executive Order No. 10096 (1952), as amended.
48. The Federal Technology Transfer Act, P.L. 99-502 (1986) (amending 15 U.S.C. § 3710a).
49. The National Technology Transfer and Advancement Act, P.L. 104-113 (1995) (amending 15 U.S.C. § 3710a).
50. To be sure, not every agency of the U.S. government views the minimum degree of "collaboration" equally. The only case pertaining to this point is Che.
51. See, for example, NIH Policy Manual No. 2300-320-03 (the NIH Visiting Program).
52. Some confusion occasionally arises between a "cooperative agreement" (15 U.S.C. § 3706), which is a mechanism analogous to a grant by which federal.
53. 15 U.S.C. § 3710a(c)(4).
54. Id. § 3710a(c)(4)(B).
55. Id.; see also 35 U.S.C. § 204.
56. Although rarely exercised, in instances posing an apparent (but not actual) conflict of interest, the NIH institute has the power to elect to waive that c.
57. 15 U.S.C. § 3710a(b)(1).
58. 15 U.S.C. § 3710a(b)(1, 2).
59. 15 U.S.C. § 3710a(c)(5).
60. Because OTT and OGC have representatives on the CRADA Subcommittee, issues that OTT and OGC have about a CRADA are typically raised as an integral part of.
61. On a case-by-case basis, the Subcommittee will consider Materials CRADAs for materials that are commercially available but that are so exorbitant that the.
62. Federal Register 1999, (64 FR 72090), but it does not entirely answer this conundrum., (64 FR 72090), but it does not entirely answer this conundrum.
63. 17 U.S.C. § 101 (definitions), § 102 (subject matter of copyright), § 103 (compilations and derivative works), and § 106 (core rights of copyright.
64. BellSouth Advertising & Publ. Corp. v. Donnelley Information Publ., Inc., 999 F.2d 1436 (11th Cir., 1993), cert. denied, 501 U.S. 1101 (1994).
65. Kregos v. Assoc. Press, 937 F.2d 700 (2d Cir., 1991); Eckes v. Card Prices Update, 736 F.2d 859 (2d Cir., 1984).
66. West Publishing Co. v. Mead Data Corp., 799 F.2d 1219 (8th Cir., 1986).
67. 17 U.S.C. § 106 (core rights of copyright owner), § 106A (rights of attribution and integrity), and §§ 601-603 (importation).
68. A major exception to this right is the "first sale" doctrine. In essence, if I buy a book from a store, I can do whatever I want with that book, inclu.
69. 17 U.S.C. § 107.
70. 17 U.S.C. § 105. The only twist to this rule is that the government may accept assignment of a copyright from a private party, but this is rarely done.
71. State Street Bank & Trust Co. v. Signature Financial Gp., Inc., 149 F.3d 1368 (Fed. Cir., 1998), cert. denied, 119 S.Ct. 851 (1999).
72. For example, a chapter in a medical textbook that broadly teaches about an area of health might be a legitimate outside activity for an NIH physician, but.
73. See Id.; TMEP § 1207.
74. Trademark Manual of Examining Procedure § 1209.01(c) (TMEP).
75. TMEP § § 1209.01(b).
76. See 15 U.S.C. § 1052. Other marks that cannot be protected include those that are deceptively misdescriptive, are purely geographical references, are a.