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Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination

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  • Michael D. Frakes
  • Melissa F. Wasserman

Abstract

We explore how the Patent Office may improve the quality of issued patents on “secondary” drug features by giving examiners more time to review drug-patent applications. Our findings suggest that current time allocations are causing examiners to issue low quality secondary patents on the margin. To assess the merits of expanding ex ante scrutiny of drug-patent applications at the agency, we set forth estimates of the various gains and losses associated with giving examiners more time, including reduced downstream litigation costs and added personnel expenses, along with both the static gains and dynamic innovation losses associated with earlier generic entry.

Suggested Citation

  • Michael D. Frakes & Melissa F. Wasserman, 2020. "Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination," NBER Working Papers 27579, National Bureau of Economic Research, Inc.
    • Handle: RePEc:nbr:nberwo:27579
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    1. DiMasi, Joseph A. & Grabowski, Henry G. & Hansen, Ronald W., 2016. "Innovation in the pharmaceutical industry: New estimates of R&D costs," Journal of Health Economics, Elsevier, vol. 47(C), pages 20-33.
    2. Henry Grabowski & Carlos Brain & Anna Taub & Rahul Guha, 2017. "Pharmaceutical Patent Challenges: Company Strategies and Litigation Outcomes," American Journal of Health Economics, MIT Press, vol. 3(1), pages 33-59, Winter.
    3. G. M.P. Swann, 2009. "The Economics of Innovation," Books, Edward Elgar Publishing, number 13211.
    4. Lei, Zhen & Wright, Brian D., 2017. "Why weak patents? Testing the examiner ignorance hypothesis," Journal of Public Economics, Elsevier, vol. 148(C), pages 43-56.
    5. Lee Branstetter & Chirantan Chatterjee & Matthew J. Higgins, 2016. "Regulation and welfare: evidence from paragraph IV generic entry in the pharmaceutical industry," RAND Journal of Economics, RAND Corporation, vol. 47(4), pages 857-890, November.
    6. Bronwyn H. Hall & Adam B. Jaffe & Manuel Trajtenberg, 2001. "The NBER Patent Citation Data File: Lessons, Insights and Methodological Tools," NBER Working Papers 8498, National Bureau of Economic Research, Inc.
    7. Bognar, Katalin & Romley, John A. & Bae, Jay P. & Murray, James & Chou, Jacquelyn W. & Lakdawalla, Darius N., 2017. "The role of imperfect surrogate endpoint information in drug approval and reimbursement decisions," Journal of Health Economics, Elsevier, vol. 51(C), pages 1-12.
    8. Eric Helland & Seth A. Seabury, 2016. "Are Settlements in Patent Litigation Collusive? Evidence from Paragraph IV Challenges," NBER Working Papers 22194, National Bureau of Economic Research, Inc.
    9. Ernst R. Berndt & Rena M. Conti & Stephen J. Murphy, 2017. "The Landscape of US Generic Prescription Drug Markets, 2004-2016," NBER Working Papers 23640, National Bureau of Economic Research, Inc.
    10. Bruno Van Pottelsberghe & Pierre M. Picard, 2011. "Patent office Governance and Patent System Quality," Working Papers ECARES ECARES 2011-007, ULB -- Universite Libre de Bruxelles.
    11. David Dranove & Craig Garthwaite & Manuel I. Hermosilla, 2020. "Expected Profits and The Scientific Novelty of Innovation," NBER Working Papers 27093, National Bureau of Economic Research, Inc.
    12. Daron Acemoglu & Joshua Linn, 2004. "Market Size in Innovation: Theory and Evidence from the Pharmaceutical Industry," The Quarterly Journal of Economics, President and Fellows of Harvard College, vol. 119(3), pages 1049-1090.
    13. Bhaven Sampat & Heidi L. Williams, 2019. "How Do Patents Affect Follow-On Innovation? Evidence from the Human Genome," American Economic Review, American Economic Association, vol. 109(1), pages 203-236, January.
    14. Eric Budish & Benjamin N. Roin & Heidi Williams, 2015. "Do Firms Underinvest in Long-Term Research? Evidence from Cancer Clinical Trials," American Economic Review, American Economic Association, vol. 105(7), pages 2044-2085, July.
    15. Rebecca Henderson & Iain Cockburn, 1996. "Scale, Scope, and Spillovers: The Determinants of Research Productivity in Drug Discovery," RAND Journal of Economics, The RAND Corporation, vol. 27(1), pages 32-59, Spring.
    16. Sampat, Bhaven N. & Shadlen, Kenneth C., 2017. "Secondary pharmaceutical patenting: A global perspective," Research Policy, Elsevier, vol. 46(3), pages 693-707.
    17. Michael D. Frakes & Melissa F. Wasserman, 2017. "Is the Time Allocated to Review Patent Applications Inducing Examiners to Grant Invalid Patents? Evidence from Microlevel Application Data," The Review of Economics and Statistics, MIT Press, vol. 99(3), pages 550-563, July.
    18. Henry Grabowski & Carlos Brain & Anna Taub & Rahul Guha, 2017. "Pharmaceutical Patent Challenges: Company Strategies and Litigation Outcomes," American Journal of Health Economics, University of Chicago Press, vol. 3(1), pages 33-59, Winter.
    19. Wesley M. Cohen & Richard R. Nelson & John P. Walsh, 2000. "Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not)," NBER Working Papers 7552, National Bureau of Economic Research, Inc.
    20. Rena M. Conti & Ernst R. Berndt, 2014. "Specialty drug prices and utilization after loss of U.S. patent exclusivity, 2001-2007," NBER Working Papers 20016, National Bureau of Economic Research, Inc.
    21. Geoffrey F. Joyce & Neeraj Sood, 2016. "Why Medicare Price Negotiation Is The Wrong Prescription For Rising Drug Spending: Response To Rena Conti," Journal of Policy Analysis and Management, John Wiley & Sons, Ltd., vol. 35(4), pages 970-972, September.
    22. Keith M. Drake & Martha A. Starr & Thomas McGuire, 2014. "Do "Reverse Payment" Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitive Pay for Delay?," NBER Working Papers 20292, National Bureau of Economic Research, Inc.
    23. Danzon, Patricia M. & Nicholson, Sean (ed.), 2012. "The Oxford Handbook of the Economics of the Biopharmaceutical Industry," OUP Catalogue, Oxford University Press, number 9780199742998.
    24. Darius Lakdawalla & Tomas Philipson, 2012. "Does Intellectual Property Restrict Output? An Analysis of Pharmaceutical Markets," Journal of Law and Economics, University of Chicago Press, vol. 55(1), pages 151-187.
    25. Danzon, Patricia M & Chao, Li-Wei, 2000. "Does Regulation Drive out Competition in Pharmaceutical Markets?," Journal of Law and Economics, University of Chicago Press, vol. 43(2), pages 311-357, October.
    26. Jena Anupam B & Calfee John E. & Mansley Edward C & Philipson Tomas J, 2009. "`Me-Too' Innovation in Pharmaceutical Markets," Forum for Health Economics & Policy, De Gruyter, vol. 12(1), pages 1-21, November.
    27. Cesare Righi & Timothy Simcoe, 2017. "Patent Examiner Specialization," NBER Working Papers 23913, National Bureau of Economic Research, Inc.
    28. Craig L. Garthwaite, 2012. "The Economic Benefits of Pharmaceutical Innovations: The Case of Cox-2 Inhibitors," American Economic Journal: Applied Economics, American Economic Association, vol. 4(3), pages 116-137, July.
    29. David Besanko & David Dranove & Craig Garthwaite, 2016. "Insurance and the High Prices of Pharmaceuticals," NBER Working Papers 22353, National Bureau of Economic Research, Inc.
    30. Hemphill, C. Scott & Sampat, Bhaven N., 2012. "Evergreening, patent challenges, and effective market life in pharmaceuticals," Journal of Health Economics, Elsevier, vol. 31(2), pages 327-339.
    31. Kolstad, Charles D & Ulen, Thomas S & Johnson, Gary V, 1990. "Ex Post Liability for Harm vs. Ex Ante Safety Regulation: Substitutes or Complements?," American Economic Review, American Economic Association, vol. 80(4), pages 888-901, September.
    32. Fiona M. Scott Morton, 1999. "Entry Decisions in the Generic Pharmaceutical Industry," RAND Journal of Economics, The RAND Corporation, vol. 30(3), pages 421-440, Autumn.
    33. Panattoni, Laura E., 2011. "The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms," Journal of Health Economics, Elsevier, vol. 30(1), pages 126-145, January.
    34. Fiona M. Scott Morton, 1999. "Entry Decisions in the Generic Pharmaceutical Industry," Yale School of Management Working Papers ysm119, Yale School of Management.
    35. Grabowski, Henry G & Vernon, John M, 1992. "Brand Loyalty, Entry, and Price Competition in Pharmaceuticals after the 1984 Drug Act," Journal of Law and Economics, University of Chicago Press, vol. 35(2), pages 331-350, October.
    36. Lakdawalla, Darius & Sood, Neeraj, 2009. "Innovation and the welfare effects of public drug insurance," Journal of Public Economics, Elsevier, vol. 93(3-4), pages 541-548, April.
    37. de Ree, Joppe & Alessie, Rob, 2011. "Life satisfaction and age: Dealing with underidentification in age-period-cohort models," Social Science & Medicine, Elsevier, vol. 73(1), pages 177-182, July.
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    More about this item

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health
    • O34 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Intellectual Property and Intellectual Capital

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