The demise of Bayh-Dole protections against the pharmaceutical industry's abuses of government-funded inventions

Journal of Law, Medicine and Ethics

Volumn 32, Issue 4, 2004, Pages 777-783

  Schofield, Amy R ^a,b  

^a University of Louisville School of Medicine   (United States)

^b Ctr for Pub Hlth Law Partnerships   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; LOPINAVIR PLUS RITONAVIR; PROTEINASE INHIBITOR; RITONAVIR;

CONFERENCE PAPER; CONSENSUS DEVELOPMENT; CORRELATION ANALYSIS; DECISION MAKING; DRUG CONTROL; DRUG COST; DRUG INDUSTRY; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE COST; HEALTH CARE FINANCING; HEALTH PROGRAM; HUMAN; LAW; MEDICAL ETHICS; MEDICAL SOCIETY; PUBLIC HEALTH; SIDE EFFECT; UNITED STATES; UNIVERSITY;

EID: 13744251366     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720x.2004.tb01985.x     Document Type: Conference Paper

References (96)

1. Government Patent Policy Act of 1980, 35 U.S.C.A. §§ 200 et seq. (2004).
2. Congress considered numerous bills and held dozens of hearings related to this topic throughout the latter half of the 1970s and into the early 1980s. See, e.g., Patent and Trademark Law Amendments of 1980: Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 96th Cong. (1980); Industrial Innovation and Patent and Copyright Law Amendments: Hearings on H.R. 6033, H.R. 6934, H.R. 3806, and H.R. 2414 Before the Subcomm. on Courts, Civil Liberties, and the Admin. of Justice of the House Comm. on the Judiciary, 96th Cong. (1980) [hereinafter 1980 House Industrial Innovation Hearings]; Patent Policy: Joint Hearing Before the Senate Comm. on Commerce, Sci., and Transp. and the Senate Comm. on the Judiciary, Pt. II, 96th Cong. (1980) [hereinafter 1980 Joint Hearing]; Government Patent Policy Act of 1980: Hearings on H.R. 5715 Before the Subcomm. on Sci., Research, and Tech. of the House Comm. on Sci. and Tech., Pt. I, 96th Cong. (1980); Patent Policy: Hearings on S. 1215 Before the Subcomm. on Sci., Tech., and Space of the Senate Comm. on Commerce, Sci., and Transp., 96th Cong. (1979); University and Small Business Patent Procedures Act: Hearings on S. 414 Before the Senate Comm. on the Judiciary, 96th Cong. (1979) [hereinafter S. 414 Hearings].
3. Congress considered numerous bills and held dozens of hearings related to this topic throughout the latter half of the 1970s and into the early 1980s. See, e.g., Patent and Trademark Law Amendments of 1980: Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 96th Cong. (1980); Industrial Innovation and Patent and Copyright Law Amendments: Hearings on H.R. 6033, H.R. 6934, H.R. 3806, and H.R. 2414 Before the Subcomm. on Courts, Civil Liberties, and the Admin. of Justice of the House Comm. on the Judiciary, 96th Cong. (1980) [hereinafter 1980 House Industrial Innovation Hearings]; Patent Policy: Joint Hearing Before the Senate Comm. on Commerce, Sci., and Transp. and the Senate Comm. on the Judiciary, Pt. II, 96th Cong. (1980) [hereinafter 1980 Joint Hearing]; Government Patent Policy Act of 1980: Hearings on H.R. 5715 Before the Subcomm. on Sci., Research, and Tech. of the House Comm. on Sci. and Tech., Pt. I, 96th Cong. (1980); Patent Policy: Hearings on S. 1215 Before the Subcomm. on Sci., Tech., and Space of the Senate Comm. on Commerce, Sci., and Transp., 96th Cong. (1979); University and Small Business Patent Procedures Act: Hearings on S. 414 Before the Senate Comm. on the Judiciary, 96th Cong. (1979) [hereinafter S. 414 Hearings].
4. Congress considered numerous bills and held dozens of hearings related to this topic throughout the latter half of the 1970s and into the early 1980s. See, e.g., Patent and Trademark Law Amendments of 1980: Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 96th Cong. (1980); Industrial Innovation and Patent and Copyright Law Amendments: Hearings on H.R. 6033, H.R. 6934, H.R. 3806, and H.R. 2414 Before the Subcomm. on Courts, Civil Liberties, and the Admin. of Justice of the House Comm. on the Judiciary, 96th Cong. (1980) [hereinafter 1980 House Industrial Innovation Hearings]; Patent Policy: Joint Hearing Before the Senate Comm. on Commerce, Sci., and Transp. and the Senate Comm. on the Judiciary, Pt. II, 96th Cong. (1980) [hereinafter 1980 Joint Hearing]; Government Patent Policy Act of 1980: Hearings on H.R. 5715 Before the Subcomm. on Sci., Research, and Tech. of the House Comm. on Sci. and Tech., Pt. I, 96th Cong. (1980); Patent Policy: Hearings on S. 1215 Before the Subcomm. on Sci., Tech., and Space of the Senate Comm. on Commerce, Sci., and Transp., 96th Cong. (1979); University and Small Business Patent Procedures Act: Hearings on S. 414 Before the Senate Comm. on the Judiciary, 96th Cong. (1979) [hereinafter S. 414 Hearings].
5. Congress considered numerous bills and held dozens of hearings related to this topic throughout the latter half of the 1970s and into the early 1980s. See, e.g., Patent and Trademark Law Amendments of 1980: Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 96th Cong. (1980); Industrial Innovation and Patent and Copyright Law Amendments: Hearings on H.R. 6033, H.R. 6934, H.R. 3806, and H.R. 2414 Before the Subcomm. on Courts, Civil Liberties, and the Admin. of Justice of the House Comm. on the Judiciary, 96th Cong. (1980) [hereinafter 1980 House Industrial Innovation Hearings]; Patent Policy: Joint Hearing Before the Senate Comm. on Commerce, Sci., and Transp. and the Senate Comm. on the Judiciary, Pt. II, 96th Cong. (1980) [hereinafter 1980 Joint Hearing]; Government Patent Policy Act of 1980: Hearings on H.R. 5715 Before the Subcomm. on Sci., Research, and Tech. of the House Comm. on Sci. and Tech., Pt. I, 96th Cong. (1980); Patent Policy: Hearings on S. 1215 Before the Subcomm. on Sci., Tech., and Space of the Senate Comm. on Commerce, Sci., and Transp., 96th Cong. (1979); University and Small Business Patent Procedures Act: Hearings on S. 414 Before the Senate Comm. on the Judiciary, 96th Cong. (1979) [hereinafter S. 414 Hearings].
6. Congress considered numerous bills and held dozens of hearings related to this topic throughout the latter half of the 1970s and into the early 1980s. See, e.g., Patent and Trademark Law Amendments of 1980: Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 96th Cong. (1980); Industrial Innovation and Patent and Copyright Law Amendments: Hearings on H.R. 6033, H.R. 6934, H.R. 3806, and H.R. 2414 Before the Subcomm. on Courts, Civil Liberties, and the Admin. of Justice of the House Comm. on the Judiciary, 96th Cong. (1980) [hereinafter 1980 House Industrial Innovation Hearings]; Patent Policy: Joint Hearing Before the Senate Comm. on Commerce, Sci., and Transp. and the Senate Comm. on the Judiciary, Pt. II, 96th Cong. (1980) [hereinafter 1980 Joint Hearing]; Government Patent Policy Act of 1980: Hearings on H.R. 5715 Before the Subcomm. on Sci., Research, and Tech. of the House Comm. on Sci. and Tech., Pt. I, 96th Cong. (1980); Patent Policy: Hearings on S. 1215 Before the Subcomm. on Sci., Tech., and Space of the Senate Comm. on Commerce, Sci., and Transp., 96th Cong. (1979); University and Small Business Patent Procedures Act: Hearings on S. 414 Before the Senate Comm. on the Judiciary, 96th Cong. (1979) [hereinafter S. 414 Hearings].
7. Congress considered numerous bills and held dozens of hearings related to this topic throughout the latter half of the 1970s and into the early 1980s. See, e.g., Patent and Trademark Law Amendments of 1980: Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 96th Cong. (1980); Industrial Innovation and Patent and Copyright Law Amendments: Hearings on H.R. 6033, H.R. 6934, H.R. 3806, and H.R. 2414 Before the Subcomm. on Courts, Civil Liberties, and the Admin. of Justice of the House Comm. on the Judiciary, 96th Cong. (1980) [hereinafter 1980 House Industrial Innovation Hearings]; Patent Policy: Joint Hearing Before the Senate Comm. on Commerce, Sci., and Transp. and the Senate Comm. on the Judiciary, Pt. II, 96th Cong. (1980) [hereinafter 1980 Joint Hearing]; Government Patent Policy Act of 1980: Hearings on H.R. 5715 Before the Subcomm. on Sci., Research, and Tech. of the House Comm. on Sci. and Tech., Pt. I, 96th Cong. (1980); Patent Policy: Hearings on S. 1215 Before the Subcomm. on Sci., Tech., and Space of the Senate Comm. on Commerce, Sci., and Transp., 96th Cong. (1979); University and Small Business Patent Procedures Act: Hearings on S. 414 Before the Senate Comm. on the Judiciary, 96th Cong. (1979) [hereinafter S. 414 Hearings].
8. Congress considered numerous bills and held dozens of hearings related to this topic throughout the latter half of the 1970s and into the early 1980s. See, e.g., Patent and Trademark Law Amendments of 1980: Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 96th Cong. (1980); Industrial Innovation and Patent and Copyright Law Amendments: Hearings on H.R. 6033, H.R. 6934, H.R. 3806, and H.R. 2414 Before the Subcomm. on Courts, Civil Liberties, and the Admin. of Justice of the House Comm. on the Judiciary, 96th Cong. (1980) [hereinafter 1980 House Industrial Innovation Hearings]; Patent Policy: Joint Hearing Before the Senate Comm. on Commerce, Sci., and Transp. and the Senate Comm. on the Judiciary, Pt. II, 96th Cong. (1980) [hereinafter 1980 Joint Hearing]; Government Patent Policy Act of 1980: Hearings on H.R. 5715 Before the Subcomm. on Sci., Research, and Tech. of the House Comm. on Sci. and Tech., Pt. I, 96th Cong. (1980); Patent Policy: Hearings on S. 1215 Before the Subcomm. on Sci., Tech., and Space of the Senate Comm. on Commerce, Sci., and Transp., 96th Cong. (1979); University and Small Business Patent Procedures Act: Hearings on S. 414 Before the Senate Comm. on the Judiciary, 96th Cong. (1979) [hereinafter S. 414 Hearings].
9. There were several exceptions to this general policy. For example, both the Department of Defense (DOD) and the National Aeronautics and Space Administration (NASA) frequently permitted contractors to obtain title to their inventions. See 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 1,994 (statement of Sen. Stevenson).
10. See id.
11. See, e.g., S. Rep. No. 96-480, at 3 (1979).
12. See 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 1,991 (statement of Sen. Dole). Throughout the Congressional hearings on this topic, numerous witnesses suggested the majority of government-funded inventions were basic, embryonic technology that required the investment of millions of dollars and years of further development before qualifying as suitable for market. See, e.g., S. 414 Hearings, supra note 2, at 100-01 (comments of Walter D. Syniuta, President, Advanced Mechanical Technology, Inc.). At the time, it was estimated that the costs associated with developing and commercializing these embryonic inventions were ten times that of the initial research. See S. Rep. No. 96-480, at 10; 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 8,741 (statement of Sen. Bayh).
13. See 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 1,991 (statement of Sen. Dole). Throughout the Congressional hearings on this topic, numerous witnesses suggested the majority of government-funded inventions were basic, embryonic technology that required the investment of millions of dollars and years of further development before qualifying as suitable for market. See, e.g., S. 414 Hearings, supra note 2, at 100-01 (comments of Walter D. Syniuta, President, Advanced Mechanical Technology, Inc.). At the time, it was estimated that the costs associated with developing and commercializing these embryonic inventions were ten times that of the initial research. See S. Rep. No. 96-480, at 10; 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 8,741 (statement of Sen. Bayh).
14. See 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 1,991 (statement of Sen. Dole). Throughout the Congressional hearings on this topic, numerous witnesses suggested the majority of government-funded inventions were basic, embryonic technology that required the investment of millions of dollars and years of further development before qualifying as suitable for market. See, e.g., S. 414 Hearings, supra note 2, at 100-01 (comments of Walter D. Syniuta, President, Advanced Mechanical Technology, Inc.). At the time, it was estimated that the costs associated with developing and commercializing these embryonic inventions were ten times that of the initial research. See S. Rep. No. 96-480, at 10; 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 8,741 (statement of Sen. Bayh).
15. See 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 1,991 (statement of Sen. Dole). Throughout the Congressional hearings on this topic, numerous witnesses suggested the majority of government-funded inventions were basic, embryonic technology that required the investment of millions of dollars and years of further development before qualifying as suitable for market. See, e.g., S. 414 Hearings, supra note 2, at 100-01 (comments of Walter D. Syniuta, President, Advanced Mechanical Technology, Inc.). At the time, it was estimated that the costs associated with developing and commercializing these embryonic inventions were ten times that of the initial research. See S. Rep. No. 96-480, at 10; 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 8,741 (statement of Sen. Bayh).
16. 35 U.S.C.A. § 202(a). The Act permitted the government to retain title to government-funded inventions when it determined national interests, national security, or other "exceptional circumstances" so demanded. See id.
17. 35 U.S.C.A. § 204. It was widely believed that corporations would not invest the large sums of money associated with product commercialization without the promise of exclusive rights in return and that the government's previous policy of issuing only non-exclusive licenses to government-funded inventions had been an utter economic failure.
18. See, e.g., 1980 House Industrial Innovation Hearings, supra note 2, at 4 (statement of Philip Klutznick, Secretary of Commerce).
19. 35 U.S.C.A. § 202(b)(4).
20. 35 U.S.C.A. § 202(b)(1)-(2).
21. 35 U.S.C.A. § 203.
22. Id. at § 203(1).
23. Id. at § 201(f) (emphasis added).
24. See 37 C.F.R. § 401.6 (2004).
25. 35 U.S.C.A. § 203(2).
26. See, e.g., 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 8,738 (statement of Sen. Long).
27. Exec. Order No. 12,591, 52 Fed. Reg. 13,414 (Apr. 22, 1987); Memorandum to the Heads of Executive Departments and Agencies: Government Patent Policy, 1983 Public Papers 248, Book I (Feb. 18, 1983).
28. Trademark Clarification Act of 1984, Pub. L. No. 98-620, 98 Stat. 3335 (codified as amended at 35 U.S.C.A. § 210(c)).
29. See Opinion, "Innovation's Golden Goose," The Economist, Dec. 12, 2002, available at 〈www.economist.com〉.
30. See id.
31. See CellPro, Inc., March-In Petition (Mar. 3, 1997), available at 〈http:// www.nih.gov/icd/od/foia/cellpro/〉 (last visited October 29, 2004) [hereinafter CellPro Petition]. Interestingly, Senator Bayh, one of the Act s co-authors, officially endorsed CellPro's petition. See id. at 18.
32. See id. at 13.
33. See id. at 7-9.
34. See Determination in the Case of Petition of CellPro, Inc., 4 (Office of the Director, National Institutes of Health, Aug. 1, 1997) [hereinafter CellPro Determination].
35. Id. at 5.
36. See id. at 6.
37. See Statement of James Love, President, Essential Inventions, Inc., NIH Meeting on Norvir/Ritonavir March-In Request 4 (May 25, 2004), available at 〈http:// ott.od.nih.gov/Meeting/James-Love-Pres-Essential-Inventions-Inc. pdf〉 (last visited November 8, 2004); Essential Inventions, Inc., Petition to Use Authority Under Bayh-Dole Act to Promote Access to Ritonavir 3 (Jan. 29, 2004) [hereinafter Essential Inventions Petition]; On the Role of the U.S. Government in the Development of NORVIR: Testimony Before the National Institutes of Health 1-2 (May 25, 2004) (statement of John Erickson, President and Chief Scientific Officer, Sequoia Pharmaceuticals, Inc.).
38. See Statement of James Love, President, Essential Inventions, Inc., NIH Meeting on Norvir/Ritonavir March-In Request 4 (May 25, 2004), available at 〈http:// ott.od.nih.gov/Meeting/James-Love-Pres-Essential-Inventions-Inc. pdf〉 (last visited November 8, 2004); Essential Inventions, Inc., Petition to Use Authority Under Bayh-Dole Act to Promote Access to Ritonavir 3 (Jan. 29, 2004) [hereinafter Essential Inventions Petition]; On the Role of the U.S. Government in the Development of NORVIR: Testimony Before the National Institutes of Health 1-2 (May 25, 2004) (statement of John Erickson, President and Chief Scientific Officer, Sequoia Pharmaceuticals, Inc.).
39. See Statement of James Love, President, Essential Inventions, Inc., NIH Meeting on Norvir/Ritonavir March-In Request 4 (May 25, 2004), available at 〈http:// ott.od.nih.gov/Meeting/James-Love-Pres-Essential-Inventions-Inc. pdf〉 (last visited November 8, 2004); Essential Inventions, Inc., Petition to Use Authority Under Bayh-Dole Act to Promote Access to Ritonavir 3 (Jan. 29, 2004) [hereinafter Essential Inventions Petition]; On the Role of the U.S. Government in the Development of NORVIR: Testimony Before the National Institutes of Health 1-2 (May 25, 2004) (statement of John Erickson, President and Chief Scientific Officer, Sequoia Pharmaceuticals, Inc.).
40. See In the Case of NORVIR Manufactured by Abbott Laboratories, Inc., 1 (Office of the Director, National Institutes of Health, July 29, 2004), available at 〈http://ott.od.nih.gov/Meeting/March-in-norvir.pdf〉 (last visited November 8, 2004) [hereinafter NIH NORVIR Decision].
41. See id. The six patents relevant to the Essential Inventions petition were U.S. Patent Nos. 5,541,206 (issued July 30, 1996); 5,635,523 (issued June 3, 1997); 5,648,497 (issued July 15, 1997); 5,674,882 (issued Oct. 7, 1997); 5,846,987 (issued Dec. 8, 1998); and 5,886,036 (issued Mar. 23, 1999).
42. See id.
43. See Essential Inventions Petition, supra note 27, at 4-5.
44. See id. at 7.
45. See Letter from H. L. Mason, Vice President, Pharmaceutical Specialty Operations, Abbott Laboratories, to John G. Aubrey, Jr., Chairman Emeritus, Academy of Medical Arts & Sciences 3 (Mar. 26, 2004), available at 〈http:// ott.od.nih.gov/Meeting/May25.htm〉 (last visited October 29, 2004)[hereinqfter Abbott Letter]; T. Albert, "Doctors Protest 400% Price Hike in HIV Medication," amednews.com, Mar. 8, 2004, available at 〈http://www.ama-assn.org/amednews/2004/03/08/gvsc 0308.htm〉 (last visited November 8, 2004). Abbott's NORVIR price increases were not uniform, as they did not apply in foreign countries or to at least some Medicaid and AIDS Drug Assistance Programs (ADAPs). See Abbott Letter, supra, at 1;
46. See Letter from H. L. Mason, Vice President, Pharmaceutical Specialty Operations, Abbott Laboratories, to John G. Aubrey, Jr., Chairman Emeritus, Academy of Medical Arts & Sciences 3 (Mar. 26, 2004), available at 〈http:// ott.od.nih.gov/Meeting/May25.htm〉 (last visited October 29, 2004)[hereinqfter Abbott Letter]; T. Albert, "Doctors Protest 400% Price Hike in HIV Medication," amednews.com, Mar. 8, 2004, available at 〈http://www.ama-assn.org/amednews/2004/03/08/gvsc 0308.htm〉 (last visited November 8, 2004). Abbott's NORVIR price increases were not uniform, as they did not apply in foreign countries or to at least some Medicaid and AIDS Drug Assistance Programs (ADAPs). See Abbott Letter, supra, at 1;
47. See Letter from H. L. Mason, Vice President, Pharmaceutical Specialty Operations, Abbott Laboratories, to John G. Aubrey, Jr., Chairman Emeritus, Academy of Medical Arts & Sciences 3 (Mar. 26, 2004), available at 〈http:// ott.od.nih.gov/Meeting/May25.htm〉 (last visited October 29, 2004)[hereinqfter Abbott Letter]; T. Albert, "Doctors Protest 400% Price Hike in HIV Medication," amednews.com, Mar. 8, 2004, available at 〈http://www.ama-assn.org/amednews/2004/03/08/gvsc 0308.htm〉 (last visited November 8, 2004). Abbott's NORVIR price increases were not uniform, as they did not apply in foreign countries or to at least some Medicaid and AIDS Drug Assistance Programs (ADAPs). See Abbott Letter, supra, at 1;
48. Essential Inventions Petition, supra note 27, at 1.
49. See Essential Inventions Petition, supra note 27, at 6.
50. See id.
51. See id. at 14. Essential Inventions proposed that Abbott receive a five percent royalty on all generic NORVIR sales made pursuant to the marchin license, if granted. See id. Although Essential Inventions properly addressed its petition to the Secretary of the Department of Health and Human Services (see id. at 1), Secretary Thompson delegated his authority under the Act's march-in provisions to the NIH. See Letter from United States Representative Sherrod Brown to the Honorable Tommy Thompson, Secretary, United States Department of Health and Human Services (Aug. 17, 2004), available at 〈http://sippi.aaas.org/ipissues/updates/?res_id=393〉 (last visited November 8, 2004) [hereinafter Brown Letter].
52. See id. at 9-11.
53. See id. In fact, several entities, including the Attorneys General of Illinois and New York, have initiated antitrust investigations regarding Abbott's NORVIR price increase. See Albert, supra note 33. Additionally, the AIDS Healthcare Foundation and several HIV patients have filed lawsuits against Abbott, alleging antitrust violations. See "Two HIV/AIDS Patients File Federal Antitrust Suit Against Abbott Over Price of Norvir," Kaiser Daily HIV/AIDS Report, Apr. 20, 2004, available at 〈http://www.kaisernetwork.org/ daily__ reports/rep_index.cfm?hint=1&DR_ID =23279〉 (last visited November 8, 2004);
54. "AIDS Healthcare Foundation Files Suit Against Abbott Alleging False Advertising After 400% Price Increase on AIDS Drug," Kaiser Daily HIV/AIDS Report, Mar. 19, 2004, available at 〈http://www.kaisernetwork.org/daily_ reports/rep_index.cfm?hint=1&DR_ID =22771〉 (last visited November 8, 2004).
55. See Essential Inventions Petition, supra note 27, at 11.
56. See, e.g., Letter from L. Dee, Co-Chair, Drug Development Committee, AIDS Treatment Activists Coalition, to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 1 (Feb. 26, 2004), available at 〈http://ott.od.nih.gov/Meeting/ May25. htm〉 (last visited October 29, 2004).
57. See, e.g., The Public Health Impact of Abbott Laboratories' Unreasonable Terms for Norvir 2-4 (May 25, 2004) (statement of R. Huff, Editor, Gay Men's Health Crisis Treatment Issues), available at 〈http://ott.od.nih.gov /Meeting/Rober-Huff-Editor-GMHC-TI.pdf〉 (last visited October 29, 2004).
58. See, e.g., D. Halperin, The Bayh-Dole Act and March in Rights: Written Statement Submitted to the National Institutes of Health 10 (May 2001), available at 〈http://ott.od.nih.gov /Meeting/David-Halperin-Attorney- Counselor.pdf〉 (last visited October 29, 2004) ("American pharmaceutical companies have profited greatly from the Government benefits provided under Bayh-Dole and the subsequent extension of Bayh-Dole to large corporations. And these benefits to drug companies have come on top of other substantial federal aid through the tax code....A 1999 analysis concluded that pharmaceutical makers have one of the lowest effective tax rates and one of the highest after-tax profit rates of any industry.").
59. See, e.g., Statement of Senator Birch Bayh to the National Institutes of Health 2-5 (May 25, 2004), available at 〈http://ott.od.nih.gov/Meeting /Senator-Birch-Bayh.pdf〉 (last visited October 29, 2004) [hereinafter Bayh Statement]; N. J. Latker, Statement Before NIH on Essential Inventions Petition Regarding Norvir 2-4 (May 25, 3004), available at 〈http://ott.od. nih.gov/Meeting/Norman-J-Latker.pdf〉 (last visited October 29, 2004) [hereinafter Latker Statement]; Letter from S. E. Lawton, Vice President & General Counsel, Biotechnology Industries Organization, to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 2-4 (May 24, 2004), available at 〈http://ott.od. nih.gov/Meeting/Stephan-E-Lawton. pdf〉 (last visited October 29, 2004).
60. See, e.g., Statement of Senator Birch Bayh to the National Institutes of Health 2-5 (May 25, 2004), available at 〈http://ott.od.nih.gov/Meeting /Senator-Birch-Bayh.pdf〉 (last visited October 29, 2004) [hereinafter Bayh Statement]; N. J. Latker, Statement Before NIH on Essential Inventions Petition Regarding Norvir 2-4 (May 25, 3004), available at 〈http://ott.od. nih.gov/Meeting/Norman-J-Latker.pdf〉 (last visited October 29, 2004) [hereinafter Latker Statement]; Letter from S. E. Lawton, Vice President & General Counsel, Biotechnology Industries Organization, to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 2-4 (May 24, 2004), available at 〈http://ott.od. nih.gov/Meeting/Stephan-E-Lawton. pdf〉 (last visited October 29, 2004).
61. See, e.g., Statement of Senator Birch Bayh to the National Institutes of Health 2-5 (May 25, 2004), available at 〈http://ott.od.nih.gov/Meeting /Senator-Birch-Bayh.pdf〉 (last visited October 29, 2004) [hereinafter Bayh Statement]; N. J. Latker, Statement Before NIH on Essential Inventions Petition Regarding Norvir 2-4 (May 25, 3004), available at 〈http://ott.od. nih.gov/Meeting/Norman-J-Latker.pdf〉 (last visited October 29, 2004) [hereinafter Latker Statement]; Letter from S. E. Lawton, Vice President & General Counsel, Biotechnology Industries Organization, to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 2-4 (May 24, 2004), available at 〈http://ott.od. nih.gov/Meeting/Stephan-E-Lawton. pdf〉 (last visited October 29, 2004).
62. See, e.g., Bayh Statement, supra note 43, at 2 ("When Congress was debating our approach fear was expressed that some companies might want to license university technologies to suppress them because they could threaten existing products. Largely to address this fear, we included the march in provisions..."); Letter from C. P. Magrath, President, National Association of State Universities and Land-Grant Colleges (NASULGC), to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 1, available at 〈http://ott.od.nih.gov/ Meeting/C-Peter-Magrath.pdf〉 (last visited October 29, 2004) ("March-in is reserved only for the purpose of prompt commercialization of federally funded inventions and to avoid the possibility of the stifling of new product development.")
63. See, e.g., Bayh Statement, supra note 43, at 2 ("When Congress was debating our approach fear was expressed that some companies might want to license university technologies to suppress them because they could threaten existing products. Largely to address this fear, we included the march in provisions..."); Letter from C. P. Magrath, President, National Association of State Universities and Land-Grant Colleges (NASULGC), to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 1, available at 〈http://ott.od.nih.gov/ Meeting/C-Peter-Magrath.pdf〉 (last visited October 29, 2004) ("March-in is reserved only for the purpose of prompt commercialization of federally funded inventions and to avoid the possibility of the stifling of new product development.")
64. See, e.g., Bayh Statement, supra note 43, at 5-6 ("What evidence is there that large drug companies will not simply walk away from collaborations with our public sector?"); Letter from P. Harsche Weeks, Immediate Past President, Association of University Technology Managers (AUTM), to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 2, available at 〈http://ott.od.nih. gov/Meeting/Patricia-Harsche-Weeks.pdf〉 (last visited October 29, 2004) ("Commercial concerns are unlikely to invest substantial financial resources in the commercial development of any invention, funded in part by the government, knowing that the government could challenge their competitive position after the product was introduced onto the market."). Cf. National Institutes of Health, Department of Health and Human Services, A Plan to Ensure Taxpayers' Interests are Protected 10-11 (July 2001) (discussing the NIH's failed "reasonable pricing" clause policy in the context of Cooperative Research and Development Agreements (CRADAs).
65. See, e.g., Bayh Statement, supra note 43, at 5-6 ("What evidence is there that large drug companies will not simply walk away from collaborations with our public sector?"); Letter from P. Harsche Weeks, Immediate Past President, Association of University Technology Managers (AUTM), to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 2, available at 〈http://ott.od.nih. gov/Meeting/Patricia-Harsche-Weeks.pdf〉 (last visited October 29, 2004) ("Commercial concerns are unlikely to invest substantial financial resources in the commercial development of any invention, funded in part by the government, knowing that the government could challenge their competitive position after the product was introduced onto the market."). Cf. National Institutes of Health, Department of Health and Human Services, A Plan to Ensure Taxpayers' Interests are Protected 10-11 (July 2001) (discussing the NIH's failed "reasonable pricing" clause policy in the context of Cooperative Research and Development Agreements (CRADAs).
66. See, e.g., Bayh Statement, supra note 43, at 5-6 ("What evidence is there that large drug companies will not simply walk away from collaborations with our public sector?"); Letter from P. Harsche Weeks, Immediate Past President, Association of University Technology Managers (AUTM), to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 2, available at 〈http://ott.od.nih. gov/Meeting/Patricia-Harsche-Weeks.pdf〉 (last visited October 29, 2004) ("Commercial concerns are unlikely to invest substantial financial resources in the commercial development of any invention, funded in part by the government, knowing that the government could challenge their competitive position after the product was introduced onto the market."). Cf. National Institutes of Health, Department of Health and Human Services, A Plan to Ensure Taxpayers' Interests are Protected 10-11 (July 2001) (discussing the NIH's failed "reasonable pricing" clause policy in the context of Cooperative Research and Development Agreements (CRADAs).
67. See NIH NORVIR Decision, supra note 28, at 6.
68. Id. at 5. The NIH report acknowledges that this interpretation of "practical application" was adopted in its CellPro decision. See id.; CellPro Determination, supra note 24, at 4.
69. See NIH NORVIR Decision, supra note 28, at 5.
70. Id. at 5-6.
71. Id. at 5. While the NIH's failure to consider the practical health impacts of Abbott's four-hundred percent price increase raise potentially troubling issues, this article will not address that aspect of the NIH's decision.
72. For a detailed discussion of the NIH's failure to properly apply the Act's march-in provision historically, as well as NIH's abdication of its Bayh-Dole oversight responsibilities, see P. S. Arno and M. H. Davis, "Why Don't We Enforce Existing Drug Price Controls? The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part from Federally Funded Research," Tulane Law Review 75 (2001): 631-693 [hereinafter Arno & Davis].
73. 35 U.S.C.A. § 203(1)(a), supra text accompanying notes 12 and 13.
74. See, e.g., Arno & Davis, supra note 51, at 649-53; Brown Letter, supra note 36.
75. See, e.g., Arno & Davis, supra note 51, at 649-53; Brown Letter, supra note 36.
76. Cf. Alaska Dept. of Envtl. Conservation v. Envtl. Prot. Agency, 124 S.Ct. 983, 1002 n.13 (2004) ("It is, moreover, a cardinal principle of statutory construction that a statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence, or word shall be superfluous, void, or insignificant." [internal citations omitted]); Duncan v. Walker, 533 U.S. 167, 174 (2001) ("It is our duty to give effect, if possible, to every clause and word of a statute." [internal citations omitted]); Brown Letter, supra note 36 ("NIH bypassed any consideration of price by ignoring a statutory mandate - the mandate that it not only evaluate 'utilization,' but also whether Norvir is sold on 'reasonable terms.' That fact should be sufficient to warrant your careful review of the agency's Norvir decision.").
77. Cf. Alaska Dept. of Envtl. Conservation v. Envtl. Prot. Agency, 124 S.Ct. 983, 1002 n.13 (2004) ("It is, moreover, a cardinal principle of statutory construction that a statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence, or word shall be superfluous, void, or insignificant." [internal citations omitted]); Duncan v. Walker, 533 U.S. 167, 174 (2001) ("It is our duty to give effect, if possible, to every clause and word of a statute." [internal citations omitted]); Brown Letter, supra note 36 ("NIH bypassed any consideration of price by ignoring a statutory mandate - the mandate that it not only evaluate 'utilization,' but also whether Norvir is sold on 'reasonable terms.' That fact should be sufficient to warrant your careful review of the agency's Norvir decision.").
78. See NIH NORVIR Decision, supra note 28, at 5-6.
79. 35 U.S.C.A. § 203(1).
80. Although other federal agencies, such as the Federal Trade Commission (FTC), may have independent grounds to evaluate Abbott's conduct, none of those agencies is vested with authority to consider whether Abbott is complying with the Act or to enforce the march-in provisions.
81. Analysis of the legislative history of the Bayh-Dole Act is complicated by the numerous hearings and proposed bills on the topic of government-funded inventions throughout the late 1970s and early 1980s. See supra note 2. The Bayh-Dole Act itself is derived from S. 414, "The University and Small Business Patent Procedures Act," which passed the Senate in April 1980 and was referred to the House, where it apparently died in subcommittee. In November 1980, the House referred H.R. 6933, entitled "Government Patent Policy Act of 1980," to the Senate, which approved an amendment substituting the nearly verbatim text of S. 414. See 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 30,360 (amendment offered by Sen. Dole);
82. 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 30,364 (statement of Sen. Bayh).
83. The discussion contained herein is, therefore, limited to the Senate hearings, reports, and floor debates on S. 414, which opponents of the NORVIR petition claim to be the "only legislative history with any bearing" on the Bayh-Dole Act. See Letter from J. P. Allen, President, National Technology Transfer Center and Author, S. Rep. No. 96-480, to M. Rohrbaugh, Director of the Office of Technology Transfer, Office of Intramural Research, National Institutes of Health 1 (Mar. 31, 2004) (available at 〈http://ott.od.nih.gov /Meeting/Joseph-P-Allen.pdf〉 (last visited October 29, 2004);
84. Bayh Statement, supra note 43, at 3.
85. S. Rep. No. 96-480, at 18.
86. Id. at 28 (emphasis added).
87. 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980):at 8,739.
88. 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 2,001.
89. See Essential Inventions Petition, supra note 27, at 10-11 (citing, inter alia, Eastmail Kodak Co. v. Image Tech. Servs., Inc., 504 U.S. 451, 479 n.29 (1992) ("The Court has held many times that power gained through some natural and legal advantage such as a patent, copyright, or business acumen can give rise to liability if 'a seller exploits his dominant position in one market to expand his empire into the next.'").
90. See 37 C.F.R. § 401.6(e).
91. See U.S. Gen. Accounting Offices, GAO/RCED-99-242, Technology Transfer: Reporting Requirements for Federally Sponsored Inventions Need Revision 2 (Aug. 1999) (concluding that "[f]ederal agencies and their contractors and grantees are not complying with provisions on the disclosure, reporting, retention, and licensing of federally sponsored inventions under the regulations implementing the Bayh-Dole Act and Executive Order 12591....As a result, the government is not always aware of federally-sponsored inventions to which it has royalty-free rights."). See generally Arno & Davis, supra note 51, at 674-91 (discussing the NIH's execution of its Bayh-Dole responsibilities).
92. See U.S. Gen. Accounting Offices, GAO/RCED-99-242, Technology Transfer: Reporting Requirements for Federally Sponsored Inventions Need Revision 2 (Aug. 1999) (concluding that "[f]ederal agencies and their contractors and grantees are not complying with provisions on the disclosure, reporting, retention, and licensing of federally sponsored inventions under the regulations implementing the Bayh-Dole Act and Executive Order 12591....As a result, the government is not always aware of federally-sponsored inventions to which it has royalty-free rights."). See generally Arno & Davis, supra note 51, at 674-91 (discussing the NIH's execution of its Bayh-Dole responsibilities).
93. National Institutes of Health, Department of Health and Human Services, Report to Congress on Affordability of Inventions and Products (July 2004), available at 〈http://ott.od.nih.gov/New-Pages/211856ottrept.pdf〉 (last visited October 29, 2004).
94. Id. at 5.
95. The NIH maintained this position again in September 2004, when it denied a march-in petition regarding Pfizer's pricing of its glaucoma drug Xalatan. See In the Case of Xalatan® Manufactured by PFIZER INC. (Office of the Director, National Institutes of Health, Sept. 17, 2004), available at 〈http:// ott.od.nih.gov/NewPages/xalatan.pdf〉 (last visited November 8, 2004). In this decision, the NIH refused to consider whether Xalatan® was available to the public on "reasonable terms" and insisted that Congress address issues of price control. See id. at 5-6.
96. See 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 8,738.