Intellectual property policy in the pharmaceutical sciences: The effect of inappropriate patents and market exclusivity extensions on the health care system

AAPS Journal

Volumn 9, Issue 3, 2007, Pages

  Kesselheim, Aaron S ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Health care costs; Innovation; Intellectual property; Patent

Indexed keywords

ACETYLSALICYLIC ACID; AMLODIPINE BESYLATE; ATORVASTATIN; CLOPIDOGREL; DRUG; ESOMEPRAZOLE; GENERIC DRUG; LORATADINE; OMEPRAZOLE; PAROXETINE;

ARTICLE; CLINICAL PRACTICE; COMMERCIAL PHENOMENA; COOPERATION; COST CONTROL; DRUG ADMINISTRATION; DRUG COST; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE ACCESS; HEALTH CARE COST; HEALTH CARE DELIVERY; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HUMAN; INFORMATION DISSEMINATION; LEGAL ASPECT; LICENSING; MEDICAID; MEDICAL DECISION MAKING; MEDICAL RESEARCH; PATENT; PATIENT CARE; UNITED STATES;

DELIVERY OF HEALTH CARE; DRUG INDUSTRY; HUMANS; INTELLECTUAL PROPERTY; PATENTS; UNITED STATES;

EID: 34547903647     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj0903033     Document Type: Article

References (34)

1. US Const, Art I, § 8, cl 8.
2. Government Patent Policy Act of 1980, Pub L No. 96-517, 94 Stat 3015 (1980).
3. Jaffe AB, Lerner J. Innovation and Its Discontents. Princeton, NJ: Princeton University Press; 2004.
4. Cohen WM, Nelson RR, Walsh JP. Protecting their intellectual assets: appropriability conditions and why US manufacturing firms patent (or not). National Bureau of Economic Research Working Paper 7552. Cambridge, MA: NBER. February 2000.
5. National Bureau of Economic Research. The NBER US Patent Citations Data File. Available at: http://www.nber.org/patents. Accessed March 15, 2007.
6. Kesselheim AS, Avorn J. University-based science and biotechnology products: defining the boundaries of intellectual property. JAMA. 2005;293:850-854.
7. Heller MA, Eisenberg RS. Can patents deter innovation? The anticommons in biomedical research. Science. 1998;280:698-701.
8. Congressional Budget Office. Research and development in the pharmaceutical industry. Available at: http://www.cbo.gov/ftpdocs/76xx/ doc7615/10-02-DrugR-D.pdf. Accessed December 9, 2006.
9. Kesselheim AS, Avorn J. Biomedical patents and the public health: is there a role for eminent domain? JAMA. 2006;295:434-437.
10. Patent Act 35 USC §101 (2006).
11. Utility Examination Guidelines, 66 Fed Regist 1092 (2001).
12. Patent Act 35 USC §101 (2006).
13. Diamond v Chakrabarty, 447 US 303 (Sup Ct 1980).
14. Diamond v Diehr, 470 US 175 (Sup Ct 1981).
15. Allen R, Stabler S, Lindenbaum J, inventots. University Patents Inc., assignee. Assay for sulfhydryl amino acids and methods for detecting and distinguishing cobalamin and folic acid deficiency. US patent 4 940 658. July 10, 1990.
16. Metabolite Laboratories v Laboratory Corporation of America. 370 F3d 1354 (FCCA 2005)
17. Laboratory Corporation of America v Metabolite Laboratories. 126 SCt 2921 (2006).
18. Kesselheim AS, Mello MM. Medical process patents - monopolizing the delivery of health care. N Engl J Med. 2006;355:2036-2041.
19. Baltimore D, Sen R, Sharp P, Singh H, Staudt L, Lebowitz J, Baldwin A, Clerc R, Corcoran L, Baeuerle P, Lenardo M, Fan C, Maniatis T, inventors. President & Fellows of Harvard College, Massachusetts Institute of Technology, Whitehead Institute for Biomedical Research, assignees. Nuclear factors associated with transcriptional regulation. US patent 6 410 516. June 25, 2002.
20. Patent Act 35 USC §103 (2006).
21. Ault A. Combo pills may help patients - and are sure to help drug firms. The Washington Post. Feb 17, 2004. Health Tab:01.
22. Patent Act 35 USC §103 (2006).
23. Federal Trade Commission. To promote innovation: the proper balance of competition and patent law and policy. October 2003. Available at: http://www.ftc.gov/os/2003/10/innovationrpt.pdf. Accessed December 6, 2006.
24. Sakraida v AG Pro Inc, 435 US 273 (Sup Ct 1976).
25. NIHCM Foundation. Prescription drugs and intellectual property protection. August 2000. Available at: http://www.cptech.org/ip/health/ econ/nihcm-drugs&ipp.pdf. Accessed March 22, 2007.
26. Schering v Geneva Pharmaceutical. 339 F3d 1373 (FCCA 2003).
27. Kesselheim AS, Fischer MA, Avorn J. Extensions of intellectual property rights and delayed adoption of generic drugs: effects on Medicaid spending. Health Aff. 2006;25:1637-1647.
28. Federal Trade Commission. Generic Drug Entry Prior to Patent Expiration. July 2002. Available at: http://www.ftc.gov/os/2002/07/ genericdrugstudy.pdf. Accessed December 9, 2006.
29. Shuchman M. Delaying generic competition - corporate payoffs and the future of Plavix. N Engl J Med. 2006;355:1297-1300.
30. Drug Competition Act of 2001 (S 754).
31. Hale VG, Woo K, Lipton HL. Oxymoron no more: the potential of nonprofit drug companies to deliver on the promise of medicines for the developing world. Health Aff. 2005;24:1057-1064.
32. Kapczynski A, Chaifetz S, Katz Z, Benkler Y. Addressing global health inequities: an open licensing approach for university innovations. Berkeley Technol Law J. 2005;20:1031-1114.
33. Check E. Universities urged to do more for poor nations. Nature. 2006;444:412-413.
34. Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York, NY: Alfred A. Knopf; 2004.