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The AAPS Journal

, Volume 9, Issue 3, pp E306–E311 | Cite as

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

  • Aaron S. Kesselheim
Article

Abstract

Though patents are effective tools for promoting innovation and protecting intellectual property in the pharmaceutical sciences, there has been growing concern about 2 important ways that patents in this field can have a negative effect on patient care and the practice of medicine. First, inventors can seek and receive patents on pharmaceutical products or research tools that stretch the statutory requirements for patenting. Second, patent holders in the pharmaceutical market can used legal loopholes or aspects of the patent registration system to extend exclusivity for inventions beyond what was anticipated by the Patent Act or subsequent legislation. The monopoly control bestowed by such inappropriate patents or manipulation of the patent system can limit options available to patients, increase the cost of health care delivery, and make cooperative research more difficult. In response, several different government and market-based efforts have emerged to promote more equitable patent policy in health care that encourages dissemination of ideas while still supporting the development of innovative products.

Keywords

Patent intellectual property health care costs innovation 

References

  1. 1.
    US Const, Art I, §8, cl 8.Google Scholar
  2. 2.
    Government Patent Policy Act of 1980, Pub L No. 96-517, 94 Stat 3015 (1980).Google Scholar
  3. 3.
    Jaffe AB, Lerner J. Innovation and Its Discontents. Princeton, NJ: Princeton University Press; 2004.Google Scholar
  4. 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.Google Scholar
  5. 5.
    National Bureau of Economic Research. The NBER US Patent Citations Data File. Available at: http://www.nber.org/patents. Accessed March 15, 2007.Google Scholar
  6. 6.
    Kesselheim AS, Avorn J. University-based science and biotechnology products: defining the boundaries of intellectual property. JAMA 2005;293:850–854.PubMedCrossRefGoogle Scholar
  7. 7.
    Heller MA, Eisenberg RS. Can patents deter innovation? The anticommons in biomedical research. Science. 1998;280:698–701.PubMedCrossRefGoogle Scholar
  8. 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.Google Scholar
  9. 9.
    Kesselheim AS, Avorn J. Biomedical patents and the public health: is there a role for eminent domain? JAMA. 2006;295:434–437.PubMedCrossRefGoogle Scholar
  10. 10.
    Patent Act 35 USC §101 (2006).Google Scholar
  11. 11.
    Utility Examination Guidelines, 66 Fed Regist 1092 (2001).Google Scholar
  12. 12.
    Patent Act 35 USC §101 (2006).Google Scholar
  13. 13.
    Diamond v Chakrabarty, 447 US 303 (Sup Ct 1980).Google Scholar
  14. 14.
    Diamond v Diehr, 470 US 175 (Sup Ct 1981).Google Scholar
  15. 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.Google Scholar
  16. 16.
    Metabolite Laboratories v Laboratory Corporation of America. 370 F3d 1354 (FCCA 2005)Google Scholar
  17. 17.
    Laboratory Corporation of America v Metabolite Laboratories. 126 SCt 2921 (2006).Google Scholar
  18. 18.
    Kesselheim AS, Mello MM. Medical process patents—monopolizing the delivery of health care. N Engl J Med. 2006;355:2036–2041.PubMedCrossRefGoogle Scholar
  19. 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.Google Scholar
  20. 20.
    Patent Act 35 USC §103 (2006).Google Scholar
  21. 21.
    Ault a. Combo pills may help patients—and are sure to help drug firms. The Washington Post. Feb 17, 2004. Health Tab:01.Google Scholar
  22. 22.
    Patent Act 35 USC §103 (2006).Google Scholar
  23. 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.Google Scholar
  24. 24.
    Sakraida v AG Pro Inc, 435 US 273 (Sup Ct 1976).Google Scholar
  25. 25.
    NIHCM Foundation. Prescription drugs and intellectual property protection. august 2000. Available at: http://www.cptech.org/ip/health/econ/nihem-drugs&ipp.pdf. Accessed March 22, 2007.Google Scholar
  26. 26.
    Schering v Geneva Pharmaceutical. 339 F3d 1373 (FCCA 2003).Google Scholar
  27. 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.CrossRefGoogle Scholar
  28. 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.Google Scholar
  29. 29.
    Shuchman M. Delaying generic competition—corporate payoffs and the future of Plavix. N Engl J Med. 2006;355:1297–1300.PubMedCrossRefGoogle Scholar
  30. 30.
    Drug Competition Act of 2001 (S 754).Google Scholar
  31. 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.CrossRefGoogle Scholar
  32. 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.Google Scholar
  33. 33.
    Check E. Universities urged to do more for poor nations. Nature. 2006;444:412–413.PubMedCrossRefGoogle Scholar
  34. 34.
    Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York, NY: Alfred A. Knopf; 2004.Google Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2007

Authors and Affiliations

  1. 1.Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's HospitalHarvard Medical SchoolBoston

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