Opening the Black Box of Pharmaceutical Patent Value: An Empirical Analysis

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Patents and patent valuation have raised tremendous concerns from the research-based pharmaceutical industry for a long time. Questions about the valuation of drug patent portfolios, the assessment of research and development (R&D) performance or innovation output, and the competitive position of different firms in the industry all tend to revolve around the basic question of phannaceutical patent valuation. This article aims to validate the impact of pharmaceutical technology characteristics on patent value and to optimize classic patent valuation methods in the drug field. We selected 913 patents in the “Orange Book” of the US Food and Drug Administration as the sample, employed established patent value indicators (EPVI) and pharmaceutical technology’ details indicators (PTDI) as key predictors for pharmaceutical patent value (the value of pharmaceutical patents), and further conducted multiple-variable analysis. It was found that PTDI significantly influences pharmaceutical patent value and, more important, enhances the quality of existing valuation methods. Moreover, the marginal effect of individual predictors on patent value is quantitatively measured. For example, new chemical entities and new dosage forms increase the value by 62% and 60%. and orphan drug and pediatric drug classification decrease the value by 7% and 10%, respectively. In addition, the potential commercial applications of this method are briefly explored in view of the eady stage, high-efficiency, and low-cost characteristics of all value predictors in this method.

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  1. 1.

    Glass G. Pharmaceutical patent challenges-time for reassessment? Nat Rev Drug Discov. 2004;3:1057–1062.

  2. 2.

    Reitzig M. Valuing patents and patent portfolios from a corporate perspective—theoretical considerations, applied needs, and future challenges. In: United Nations, ed. Intellectual Assets: Valuation and Capitalization, New York: United Nations; 2003: 66–82.

  3. 3.

    Harhoff D, Scherer FM, Vopel K. Citations, family size, opposition and the value of patent rights. Res Policy. 2002;32:1343–1363.

  4. 4.

    Smith GV, Parr RL. Valuation of Intellectual Property and intangible Assets. 3rd ed. New York: John Wiley; 2000.

  5. 5.

    Griliches Z. Patent statistics as economic indicators: a survey. J Econ Lit. 1990;28:1661–1707.

  6. 6.

    Orange Book [database online], Rockville. MD: Food and Drug Administration: 2001. Updated January 30, 2007.

  7. 7.

    Reitzig M. Improving patent valuations for man-agement purposes—validating new indicators by analyzing application rationales. Res Policy. 2004;33:939–957.

  8. 8.

    Legal Status Database [database online]. Mu-nich, Germany: International Patent Documentation Center: 2006. Updated November 1, 2007.

  9. 9.

    Patent Citations Data File database online). Cambridge. MA: National Bureau of Economic Research: 1999. Updated December 4, 2004.

  10. 10.

    The enforcement of intellectual property rights: a survey of the empirical literature. National Bu-reau of Economic Research website. Available at: Accessed September 7, 2006.

  11. 11.

    Harhoff D, Reitzig M. Determinants of opposition against EPO patent grants—the case of biotechnology and pharmaceuticals. In J Ind Organ. 2004;22:443–480.

  12. 12.

    Lerner J. The importance of patent scope: an empirical analysis. Rand J Econ. 1994;25:319–333.

  13. 13.

    The quality of ideas: measuring innovation with multiple indicators. National Bureau of Economic Research website. Available at: Accessed September 18, 2006.

  14. 14.

    Lanjouw JO, Schankerman M. Characteristics of patent litigation: a window on competition. Rand J Econ. 2001;32:129–151.

  15. 15.

    Tong X, Frame JD. Measuring national technological performance with patent claims data. Res Policy. 1992;23:133–141.

  16. 16.

    Carpenter M, Cooper M, Narin F. Linkage be-tween basic research literature and patents. Res Manage. 1980;3:30–35.

  17. 17.

    Narin F, Noma E, Perry R. Patents as indicators of corporate technological strength. Res Policy. 1987;16:143–155.

  18. 18.

    Global Blockbuster Drug Data [database online]. Shanghai. China: Pharmaceutical Digital Library, 2003. Updated December 20, 2006.

  19. 19.

    Espina MI. To Renew or Not to Renew: An Empirical Study of Patent Valuation and Maintenance by the United States Pharmaceutical Industry. New York: Rensselaer Polytechnic Institute; 2003.

  20. 20.

    Trajtenberg M. A penny for your quotes: patent citations and the value of innovations. Rand J Econ. 1990;21:172–187.

  21. 21.

    Harhoff D, Narin F, Scherer FM, Vopel K. Citation frequency and the value of patented inventions. Rev Econ Stat. 1999;81:511–515.

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Author information

Correspondence to Yitao Wang MS.

Additional information

The research reported here is based on Yuanjia Hu’s doctoral dissertation, which was submitted to the University of Macau.

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Hu, Y., Bian, Y. & Wang, Y. Opening the Black Box of Pharmaceutical Patent Value: An Empirical Analysis. Ther Innov Regul Sci 42, 561–568 (2008) doi:10.1177/009286150804200605

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Key Words

  • Empirical analysis
  • Orange Book
  • Patent
  • Pharmaceutical
  • Valuation