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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].Google Scholar

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).Google Scholar

See, e.g., S. Rep. No. 96-480, at 3 (1979).Google Scholar

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).Google Scholar

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.Google Scholar

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. See, e.g., 1980 House Industrial Innovation Hearings, supra note 2, at 4 (statement of Philip Klutznick, Secretary of Commerce).Google Scholar

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35 U.S.C.A. § 202(b)(1)-(2).Google Scholar

35 U.S.C.A. § 203.Google Scholar

Id. at § 203(1).Google Scholar

Id. at § 201(f) (emphasis added).Google Scholar

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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.cfin?hint=1&DR_ID=23279> (last visited November 8, 2004); “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). (last visited November 8, 2004); “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 (last visited November 8, 2004).' href=https://scholar.google.com/scholar?q=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++(last+visited+November+8,+2004);+“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++(last+visited+November+8,+2004).>Google Scholar

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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.Google Scholar

See NIH NORVIR Decision, supra note 28, at 5.Google Scholar

Id. at 5–6.Google Scholar

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.Google Scholar

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 Arno, P. S. and Davis, M. H., “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 thereinafter Arno & Davis].Google Scholar

35 U.S.C.A. § 203(1)(a), supra text accompanying notes 12 and 13.Google Scholar

See, e.g., Arno, & Davis, , supra note 51, at 649–53; Letter, Brown, supra note 36.Google Scholar

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.”).Google Scholar

See NIH NORVIR Decision, supra note 28, at 5–6.Google Scholar

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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.Google Scholar

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); 126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 30,364 (statement of Sen. Bayh). 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 Rohrbaugh, M., 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); Bayh Statement, supra note 43, at 3.Google Scholar

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126 Congressional Record (Washington, D.C.: U.S. Government Printing Office, 1980): at 8,739.Google Scholar

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