The influence of market exclusivity on drug availability and medical innovations

AAPS Journal

Volumn 9, Issue 3, 2007, Pages

  Glover, Gregory J ^a  

^a Pharmaceutical Law Group PC   (United States)

Author keywords

ANDA; FDA; Generic drugs; Hatch Waxman; Intellectual property; Market exclusivity; Orphan drug exclusivity; Patent term restoration; Patents; Pediatric exclusivity

Indexed keywords

GENERIC DRUG; NEW DRUG; ORPHAN DRUG;

ARTICLE; BIOMEDICINE; COMMERCIAL PHENOMENA; COMPETITION; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG INFORMATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; ECONOMIC DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; GENETIC ENGINEERING; HUMAN; LAW; LEGAL ASPECT; MEDICAL RESEARCH; PATENT; PATIENT CARE; UNITED STATES;

DRUG INDUSTRY; DRUG THERAPY; HEALTH SERVICES ACCESSIBILITY; HUMANS; PATENTS; UNITED STATES;

EID: 34547869291     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj0903034     Document Type: Article

References (28)

1. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. Health, United States. 2006. Table 27. 2006; Available at: http://www.cdc.gov/nchs/ data/hus/tables/2003/03hus027.pdf. Accessed November 22, 2006.
2. Cech TR. Fostering innovation and discovery in biomedical research. JAMA. 2005;294:1390.
3. Pharmaceutical Research and Manufacturers of America (PhRMA). Pharmaceutical Industry Profile 2005. Available at: www.phrma.com. Accessed November 22, 2006.
4. US Const, Art 1 §8 cl 8.
5. Patent Act 35 USC §271(a) (2006).
6. Pub L No 98-417, 98 Stat 1585 (1984) (codified at Commerce and Trade, 15 USC §686-68c, §70b (1984)). Federal Food, Drug, and Cosmetic Act, 21 USC §301 note, §355, §260(cc), (1984), Judiciary and Judicial Procedure: Creation of Remedy, 28 USC §2201 (1984), Extension of Patents, 35 USC §156, §271, §282 (1984).
7. DiMasi JA. New drug development in the United States from 1963 to 1999. Clin Pharm Ther. 2001;69:286.
8. PhRMA. Delivering on the Promise of Pharmaceutical Innovation: The Need to Maintain Strong and Predictable Intellectual Property Rights. Available at: www.ftc.gov/os/comments/intelpropertycomments/ phrma020422.pdf. Accessed November 22, 2006.
9. Waxman H. Hearing on Affordable Pharmaceuticals. Available at: http://www.house.gov/waxman/news_files/ news_statements_afford_drugs_5_8_02.htm. Accessed November 28, 2006.
10. FDA/CDER. Guidance for Industry: Applications Covered by Section 505(b)(2). 1999; Available at: http://www.fda.gov/CDER/GUIDANCE/ 2853dft.htm. Accessed November 22, 2006.
11. Federal Food, Drug, and Cosmetic Act, 21 USC §355(b)(1).
12. Federal Food, Drug, and Cosmetic Act, 21 USC §355(b)(2).
13. Federal Food, Drug, and Cosmetic Act, 21 USC §355(j).
14. Federal Food, Drug, and Cosmetic Act, 21 USC §355(j)(2)(A)(vii).
15. Federal Food, Drug, and Cosmetic Act, 21 USC §355(b)(2)(A).
16. Federal Food, Drug, and Cosmetic Act, 21 USC §355(j)(2)(B).
17. Federal Food, Drug, and Cosmetic Act, 21 USC §355(c)(3)(C).
18. Federal Food, Drug, and Cosmetic Act, 21 USC §355(j)(5)(B)(iii).
19. Federal Food, Drug, and Cosmetic Act, 21 USC §355(c)(3)(E)(ii).
20. Federal Food, Drug, and Cosmetic Act, 21 USC §355(c)(3)(E)(iii).
21. Integra LifeSciences Ltd v Merck KgaA, 331 F3d 860 (Fed Cir 2003).
22. Mueller JM. No "Dilettante Affair": Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools. 76 Wash L Rev. 2001;1:10.
23. Merck KGaA v Integra LifeSciences Ltd, 545 US 193 (Sup Ct 2005).
24. FDA. Final Rule, 21 CFR 316. Orphan Drug Regulations 57 FR 62076 December 29, 1992. Available at: http://www.fda.gov/orphan/designat/ apply.htm. Accessed November 22, 2006.
25. FDA. How to Apply for Designation as an Orphan Product. Available at: http://www.fda.gov/orphan/designat/apply.htm. Accessed December 10, 2006.
26. OOPD Program Overview. Available at: http://www.fda.gov/orphan/ progovw.htm. Accessed December 10, 2006.
27. FDA/CDER. Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act (1998). Available at: http://www.fda.gov/cder/guidance/2414fnl.htm. Accessed November 22, 2006.
28. Danzon P, Furukawa MF. Prices and Availability of Pharmaceuticals: Evidence From Nine Countries. Health Affairs Web exclusive. Available at: http://www.healthaffairs.org/WebExclusives/ Danzon_Web_Excl_102903.htm. Accessed October 27, 2006.