Overview of the Hatch-Waxman act and its impact on the drug development process

Food and Drug Law Journal

Volumn 54, Issue 2, 1999, Pages 187-194

  Mossinghoff, Gerald J ^a  

^a Law Firm of Oblon Spivak McClelland Maier and Neustadt   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NEW DRUG;

CONFERENCE PAPER; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; PATENT;

EID: 0032799186     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (22)

1. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 15 U.S.C. §§ 68b-68c, 70b (1994); 21 U.S.C. §§ 301 note, 355, 360cc (1994); 28 U.S.C. § 2201 (1994); 35 U.S.C. §§ 156, 271, 282 (1994)).
2. Pub. L. No. 87-781, 76 Stat. 780 (codified at 21 U.S.C. §§ 321, 331-32, 348, 351-53, 355, 357-60, 372, 374, 376, 381).
3. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq.).
4. H.R. REP. No. 98-857, pt. 1 (1984); see also Gilston, The Generic Patent Compromise, MED. ADVERTISING NEWS, Apr. 30, 1984, at 16-17.
5. S. 255, 98th Cong., 2d Sess. (1984).
6. CHARLES W. JOHNSON, HOW OUR LAWS ARE MADE, S. Doc. No. 105-14, at 20 et seq. (1997).
7. Pub. L. No. 100-670, 102 Stat. 3971 (1988) (codified at 21 U.S.C. §§ 301 note, 360b, 360b notes, 321, 353; 28 U.S.C. § 2201; 35 U.S.C. §§ 156, 271).
8. Pub. L. No. 103-465, 108 Stat. 4809 (1994) (codified at 19 U.S.C. §§ 2252 et seq. (1994)).
9. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, LEGAL INSTRUMENTS - RESULTS OF THE URUGUAY ROUND vol. 31; 33 I.L.M. 81 (1994).
10. 69 F.3d 1130 (Fed. Cir. 1995). Also, the Bristol-Myers opinion provides a good summary of the key provisions of the Hatch-Waxman Act.
11. Id. at 1137.
12. 80 F.3d 1543 (Fed. Cir. 1996).
13. H.R. REP. No. 98-857, pt. 1, at 72 (1984).
14. 35 U.S.C. § 156.
15. 733 F.2d 858 (Fed. Cir. 1984).
16. See 35 U.S.C. § 271(e)(2).
17. C. JOSEPH STETLER & WILLIAM C. CRAY, PATIENTS IN PERIL? THE STUNNING GENERIC DRUG SCANDAL (1991).
18. Gerald J. Mossinghoff, Independent Patent Review for "Pipeline" Drugs Would Advance Intellectual Property Rights, 13 LEGAL BACKGROUNDER (Washington Legal Found. Aug. 7, 1998).
19. THE BOSTON CONSULTING GROUP, SUSTAINING INNOVATION IN U.S. PHARMACEUTICALS, INTELLECTUAL PROPERTY PROTECTION & THE ROLE OF PATENTS (Jan. 1996).
20. Food and Drug Administration Modernization Act, Pub. L. No. 105-115, 111 Stat. 2296 (1997).
21. Reprinted in SELECTED INTELLECTUAL PROPERTY & UNFAIR COMPETITION STATUTES, REGULATIONS & TREATIES 805 (Roger E. Schecter ed. 1997).
22. Id. at 700.