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Using Patent Data to Assess the Value of Pharmaceutical Innovation

Published online by Cambridge University Press:  01 January 2021

Aaron S. Kesselheim  and
Jerry Avorn
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Extract

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration (FDA) in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health (NIH), supports medical innovation “distinct from the process of drug development.”

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 2 , Summer 2009 , pp. 176 - 183
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

Blum, J. “FDA Approves 19 new U.S. drugs, Fewest Since '83; Glaxo Leads,” Bloomberg News, January 8, 2008, available at <http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a2MOCNVDHucs> (last visited March 25, 2009). (last visited March 25, 2009).' href=https://scholar.google.com/scholar?q=Blum,+J.+“FDA+Approves+19+new+U.S.+drugs,+Fewest+Since+'83;+Glaxo+Leads,”+Bloomberg+News,+January+8,+2008,+available+at++(last+visited+March+25,+2009).>Google Scholar
Keyhani, S., Diener-West, M., Powe, N., “Are Development Times for Pharmaceuticals Increasing or Decreasing?” Health Affairs 25, no. 2 (2006): 461–468.CrossRefGoogle Scholar
Government Accountability Office, Science, Business, Regulatory and Intellectual Property Issues Cited as Hampering Drug Development Efforts, November 2006, available at <http://oversight.house.gov/Documents/20061219094529–73424.pdf> (last visited March 25, 2009).+(last+visited+March+25,+2009).>Google Scholar
Holmer, A. F., Testimony by President and CEO of Pharmaceutical Research and Manufacturers of America on “Prescription Drug Safety and Pricing” before the Senate Committee on Health, Education, Labor, and Pensions, June 13, 2000, Congressional Record, 146, no. 73. (2000).Google Scholar
Pharmaceutical Research and Manufacturers of America, Foreign Government Pharmaceutical Price and Access Controls, July 1, 2004, available at <http://www.ita.doc.gov/td/health/phRMA/phRMA%20Response.pdf> (last visited March 25, 2009).+(last+visited+March+25,+2009).>Google Scholar
Gagnon, M. A. and Lexchin, J., “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” PLoS Medicine 5, no. 1 (2008): e1.CrossRefGoogle Scholar
Avorn, J., Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (New York: Alfred A. Knopf, 2005).Google Scholar
Tamblyn, R., Laprise, R. and Hanley, J. A. et al., “Adverse Events Associated with Prescription Drug Cost-sharing Among Poor and Elderly Persons,” JAMA 285, no. 4 (2001): 421–429; Steinman, M. A., Sands, L. P., Covinsky, K. E., “Self-Restriction of Medications Due to Cost in Seniors Without Prescription Coverage,” Journal of General Internal Medicine 16, no. 12 (2001): 793-799.CrossRefGoogle Scholar
Griliches, Z., ed., R&D, Patents, and Productivity (Chicago: University of Chicago Press, 1985).Google Scholar
Trajtenberg, M., “A Penny for your Quotes: Patent Citations and the Value of Innovations,” RAND Journal of Economics 23, no. 1 (1990): 172–187.CrossRefGoogle Scholar
Henderson, R., Jaffe, A. B. and Trajtenberg, M., “Universities as a Source of Commercial Technology: A Detailed Analysis of University Patenting, 1965–1988,” The Review of Economics and Statistics 80, no. 1 (1998): 119–127; Jaffe, A. B., Fogarty, M. S. and Banks, B. A., “Evidence from Patents and Patent Citations on the Impact of NASA and Other Federal Labs on Commercial Innovation,” Journal of Industrial Economics 46, no. 2 (1998): 183-199; Mowery, D., Sampat, B. and Zeidonis, A., “Learning to Patent: Institutional Experience, Learning, and the Characteristics of U.S. University Patents after the Bayh-Dole Act, 1981–1992”, Management Science 48, no. 1 (2002): 73-89.CrossRefGoogle Scholar
Shane, S., “Technological Opportunities and New Firm Creation,” Management Science 47, no. 2 (2001): 205–220.Google Scholar
Harhoff, D., Narin, F., Scherer, F.M. and Vopel, K., “Citation Frequency and the Value of Patented Inventions,” The Review of Economics and Statistics 81, no. 3 (1999): 511–515; Jaffe, A. B., Trajtenberg, M. and Fogarty, M. S., “Knowledge Spillovers and Patent Citations: Evidence from a Survey of Inventors,” AEA Papers and Proceedings 90, no. 2 (2000): 215-218.CrossRefGoogle Scholar
Lanjouw, J. O. and Schankerman, M., “Patent Quality and Research Productivity: Measuring Innovation with Multiple Indicators,” The Economic Journal 114, no. 495 (2004): 441–465.CrossRefGoogle Scholar
Sapsalis, E., van Pottelsberghe de la Potterie, B. and Navon, R., “Academic Versus Industry Patenting: An In-Depth Analysis of What Determines Patent Value,” Research Policy 35, no. 10 (2006): 1631–1645.CrossRefGoogle Scholar
National Bureau of Economic Research, The NBER US Patent Citations Data File, available at <http://www.nber.org/patents> (last visited March 27, 2009).+(last+visited+March+27,+2009).>Google Scholar
Hall, B. H., Jaffe, A. B. and Trajtenberg, M., “The NBER Patent Citations Data File: Lessons, Insights, and Methodological Tools,” NBER Working paper 8498, October 2001, available at <http://www.nber.org/papers/w8498.pdf> (last visited April 10, 2009).CrossRef+(last+visited+April+10,+2009).>Google Scholar
Hall, B. H., Jaffe, A. B. and Trajtenberg, M., “Market Value and Patent Citations: A First Look,” Institute of Business and Economic Research, Paper E00'277 (May 2000), available at <http://repositories.cdlib.org/cgi/viewcontent.cgi?article=1036&context=iber/econ#> (last visited March 27, 2009). (last visited March 27, 2009).' href=https://dx.doi.org/10.3386/w7741>CrossRef (last visited March 27, 2009).' href=https://scholar.google.com/scholar?q=Hall,+B.+H.,+Jaffe,+A.+B.+and+Trajtenberg,+M.,+“Market+Value+and+Patent+Citations:+A+First+Look,”+Institute+of+Business+and+Economic+Research,+Paper+E00'277+(May+2000),+available+at++(last+visited+March+27,+2009).>Google Scholar
United States Patent and Trademark Office, Classification Definitions, January 2005, available at <http://www.uspto.gov/go/classification/uspc424/defs424.htm) (last visited March 27, 2009).Google Scholar
Trajtenberg, M., Henderson, R. and Jaffe, A., “University Versus Corporate Patents: A Window on the Basicness of Invention,” Economics of Innovation and New Technology 5, no. 1 (1997): 19–50.CrossRefGoogle Scholar
National Science Foundation, “U.S. Industrial R&D Performers Report Increased Expenditures for 2004,” December 2006, available at <http://www.nsf.gov/statistics/infbrief/nsf07304/nsf07304.pdf> (last visited March 27, 2009).+(last+visited+March+27,+2009).>Google Scholar
Loscalzo, J., “The NIH Budget and the Future of Biomedical Research,” New England Journal of Medicine 354, no. 16 (2006): 1665–1667.CrossRefGoogle Scholar
Jaffe, A. B. and Trajtenberg, M., “Flows of Knowledge from Universities and Federal Laboratories: Modeling the Flow of Patent Citations over Time and Across Institutional and Geographic Boundaries,” Proceedings of the National Academy of Sciences 93, no. 23 (1996): 12671–12677.CrossRefGoogle Scholar
Berndt, E. R., Cockburn, I. M. and Grépin, K. A., “The Impact of Incremental Innovation in Biopharmaceuticals: Drug Utilization in Original and Supplemental Indications,” Pharmacoeconomics 24, supplement 2 (2006): 69–83.CrossRefGoogle Scholar
Kesselheim, A. S., Fischer, M. A. and Avorn, J., “Extensions of Intellectual Property Rights and Delayed Adoption of Generic Drugs: Effects on Medicaid Expenditures,” Health Affairs 25, no. 6 (2006): 1637–1647.CrossRefGoogle Scholar
Jaffe, A. B. and Lerner, J., Innovation and its Discontents (Princeton, NJ: Princeton University Press, 2004).CrossRefGoogle Scholar
U.S. Congressional Budget Office, How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry, July 1998, available at <http://www.cbo.gov/ftpdocs/6xx/doc655/pharm.pdf> (last visited March 27, 2009).+(last+visited+March+27,+2009).>Google Scholar
Markel, H., “Patents Could Block the Way to a Cure,” New York Times, August 24, 2001: at A19.Google Scholar
Sobolski, G. K., Barton, J.H. and Emanuel, E. J., “Technology Licensing: Lessons from the US Experience,” JAMA 294, no. 24 (2005): 3137–3140.CrossRefGoogle Scholar
Catlin, A., Cowan, C., Hartman, M. and Heffler, S., “National Health Spending in 2006: A Year of Change for Prescription Drugs,” Health Affairs 27, no. 1 (2008): 14–29; Levit, K., Smith, C., Cowan, C., Lazenby, H. and Martin, A., “Inflation Spurs Health Spending in 2000,” Health Affairs 21, no. 1 (2002): 172-181.CrossRefGoogle Scholar
Vernon, J. A., “Simulating the Impact of Price Regulation on Pharmaceutical Innovation,” Pharmaceutical Development and Regulation 1, no. 1 (2003): 55–65.CrossRefGoogle Scholar
Goozner, M., The $800 Million Pill: The Truth Behind the Cost of New Drugs (Berkeley, CA: University of California Press, 2004).CrossRefGoogle Scholar