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The History and Political Economy of the Hatch-Waxman Amendments
26/26 checkable references clean · checked 2026-08-27
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The 26 checked references that resolve
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Larisa (nunc in eodem museo ac n. 288 supra). Tit. sep. Hieronis, s. II/IIIp.
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High Technology, Consumer Privacy, and U.S. National Security: Hearing Before the Subcomm. On Commerce, Manufacturing, and Trade of the H. Comm. On Energy and Commerce, 113th Cong., September 17, 2014 (Remarks by Professor Laura K. Donohue, Geo. U. L. Center)
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PIPOTHIAZINE PALMITATE: depot antipsychotic now introduced in the UK by May and Baker
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Geographic Distribution of Federal Funds, Fiscal Year 1982: [United States]
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Delphi. Syll.³ 546 A 6 suppl. id. dubitanter l. c. 9 ὁ δεῖνα Ἀγ[γειάτ]α[ς]
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YOUNG ADULT OFFENDERS (17–20 YEARS)****See note to Appendix I
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Tort Law. Civil Liability for Criminal Acts. Illinois Expands Civil Liability of Drug Traffickers. Drug Dealer Liability Act, Pub. Act 89-293, 1995 Ill. Legis. Serv. 3156 (West) (To Be Codified at Ill. Comp. Stat. Ch. 740, Section 57/1-85 (1994))
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no DOI — not checked) (proposing patent term restoration for animal drugs and biologics, pesticides, and chemicals regulated under TSCA)
no DOI — not checkedThey did not have leverage after that loss and when I was chairman of the subcommittee
no DOI — not checkedLANGUAGE]; see also PMA's Engman and GPIA's Haddad Will Explain Patent Restoration/ANDA Compromise at Rep. Kastenmeier's Hearing June 6
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no DOI — not checkedBut the legislative history does not suggest either precedent was considered. The Commissioner of Patents later reported that the number was arbitrary. Mossinghoff, supra note 24, at 191. An economist involved in the discussions reports "folklore" that Haddad "at hearings put up a poster showing that many leading products had a life of 14 years before being largely supplanted by brand competition and that was the basis" for the 14-year limit. Email from Henry Grabowski to Erika Lietzan
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no DOI — not checkedWaxman asked 'unanimous consent' that the compromise amendment be considered as read, and then plunged into an explanation of the legislation before Luken could make a point of order assertion. Dingell then ruled that Luken had not made his point of order in a timely manner, and then cmte
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no DOI — not checkedThe FDA testified at this hearing. 357 Innovation and Patent Law Reform, supra note 201, at 422 (Rep. Sawyer: "I was just going to say, in the 8 years that I have been here, I have never seen a compromise that wasn't a delicately balanced compromise, which is code for 'Keep your damn hands off it
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no DOI — not checkedThe change from 18 to 30 months was a change that brought on the dissident groups within the PMA and has brought us to a package now that we can say with confidence is opposed by no one and backed by all of the groups concerned
no DOI — not checkedROBSON STATEMENT, supra, at 427. Because the stay had been based on data integrity concerns, this should have ended the matter. The FDA still declined to lift the stay for three more years, however, insisting on the hearing. See 46 Fed
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no DOI — not checkedIsoflurane as a General Anesthetic: Will it Displace All Other Volatile Anesthetics
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no DOI — not checkedreprinted in PRIVATE PATENT LEGISLATION, supra note 120, at 83. 405 Id. 406 PRIVATE PATENT LEGISLATION, supra note 120, at 83; see
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no DOI — not checkednoting that prescription drug coverage was limited both for Medicare beneficiaries and for patients insured through private insurance companies). Congress did not add an outpatient prescription drug benefit for Medicare beneficiaries until 2003. Medicare Prescription Drug, Improvement, and Modernization Act
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no DOI — not checkedThe facts of life are that a generic drug manufacturer will await, as a practical matter, until the decision of a court on a patent challenge before that manufacturer markets a generic drug
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no DOI — not checkedThis leaves the ultimate question: how did seven years of policy discussions and full engagement by both affected industries result in legislation that clearly benefitted one group rather than the other? The legislative process turned out the way it did because the generic companies benefitted from a classic "Baptists and bootleggers" alliance. Professor Yandle first articulated the Baptists and bootleggers theory of regulation in 1983. 456 Both groups had vigorously supported Sunday Blue Laws, which closed bars and liquor stores on Sundays in southern states. 457 Baptists supported the blue laws on moral grounds, while bootleggers supported them for economic reasons (they had exclusive sales on Sundays). 458 Yandle's theory holds
no DOI — not checked461 The generic companies argued that their proposed policy changes would increase and accelerate the supply of less expensive drugs. They urged these policy changes because they would be selling the drugs in question and would profit from the legislation's passage. But, just as the patent owners had done with respect to patent term restoration, they invoked the public's interest-here, in cheaper drugs. As a result, they received strong support from the public sector
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no DOI — not checkedgenerally in support of measures to facilitate earlier generic drug entry-did not play a meaningful role in the political process that led to enactment of the Hatch-Waxman Amendments. It had been deeply involved in development of a model state law to guide generic drug substitution, but it did not engage in the discussions relating to patent term restoration or the generic drug bill. The FTC did not have the reputation and influence then that it has today. After a series of hostile oversight hearings in 1979 and 1980 and unambiguous comments from members of Congress that it had "overstepped its bounds
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