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Abstract

We undertook a comprehensive retrospective analysis of already-approved drugs to assess the likely impact of the Drug Price Competition and Patent Term Restoration Act on market exclusivity of future new drugs. We analyzed data for new drugs approved between 1962 and 1984 and applied the new law's exclusivity and patent restoration formulas to each drug. Our simulation suggests that new drugs approved in the first years following enactment will gain 2 to 3 years of additional product protection, while those approved later will gain 3 to 4 years of product protection. In either case, the effective patent life will be considerably less than the 17-year statutory patent period. The full impact of the law will not be known for at least a decade, but study and analysis should begin now.

Keywords

Patent life Market exclusivity Patent restoration Generic drugs Competition

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References

Bass

: A new era in the pharmaceutical industry. Remarks at the 30th Annual Meeting and Educational Conference, National Association of Pharmaceutical Manufacturers, Dorado, Puerto Rico, January 21–27, 1985.

U.S. industry changes analysed. Scrip, February 13, 1985, p 13.

Administered Prices — Drugs. Report of the Subcommittee on Antitrust and Monopoly of the Committee on the Judiciary. U.S. Senate, June 27, 1961.

FDA Drug Approval — A Lengthy Process that Delays the A variability of Important Drugs. U.S. General Accounting Office, 1980.

The FDA's Process for Approving New Drugs. U.S. House of Representatives, November 1980.

Hansen

: The pharmaceutical development process: Estimates of development costs and times and the effects of proposed regulatory changes, in Chien

(ed): Issues in Pharmaceutical Economics. Lexington, Lexington books, 1980, pp 151–181.

Wardell

: British usage and American awareness of new therapeutic drugs. Clin Pharmacol Ther 1973; 14:1022–1039.

Wardell

: Introduction to new therapeutic drugs in the U.S. and Great Britain: An international comparison. Clin Pharmacol Ther 1973; 14: 773–779.

Wardell

: The drug lag revisited: Comparison by therapeutic area of patterns of drugs marketed in the U.S. and Great Britain from 1972 through 1976. Clin Pharmacol Ther 1978; 24:499–524.

10.

Internal memo. Federal Register 1981; 46 (May 19):27396–27397.

11.

Eisman

Wardell

: The decline in effective patent life of new drugs. Research Management 1981; 21:18–21.

12.

Patent Term Extension and Pharmaceutical Innovation. Hearing Before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology. U.S. House of Representatives, February 4, 1982.

13.

Hutt

: Drug bill balances patent protection, competition. Legal Times, September 24, 1984, p 8.

14.

Patent-Term Extension and the Pharmaceutical Industry. Office of Technology Assessment, Washington, DC, 1981.

15.

Mossinghoff

: Statement of the Commissioner of Patents and Trademarks before the Subcommittee on Courts, Civil Liberties and the Administration of Justice of the Committee on the Judiciary. U.S. House of Representatives, November 12, 1981.

16.

Spivey

Lasagna

Trimble

: New drug applications: How long to gain approval?. Clin Pharmacol Ther 1985; 37:361–366.

17.

Wardell

Sheck

: Is pharmaceutical innovation declining?: Interpreting measures of pharmaceutical innovation and regulatory impact in the USA, 1950–1980, in Lindgren

(ed): Anne Ryde Symposium on Pharmaceutical Economics, Stockholm, Swedish Institute for Health Economics, 1984, pp 177–189.

Effect of the Drug Price Competition Act on Market Exclusivity of New Drugs: A Simulation

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