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Review for Innovation and Patent System in the Pharmaceutical Sector

  • Minn, Mari (Department of Law and Technology, Scuola Superiore Sant'Anna)
  • Published : 2017.06.30
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Abstract

This study analyzes patenting practices in the pharmaceutical industry and the impacts of sequential innovation. The main argument of the research is that strategic patenting is common in the pharmaceutical sector and it is legal within the context of patent law. However, when these practices have negative effects on the competition process post-grant, the practices that are legal under patent law may come into conflict with antitrust laws, which are not applied. The study brings into question whether sequential patenting practices characteristic of the pharmaceutical industry encourage or discourage innovation, and moreover, the overall functionality of the patent system. Ultimately, the functionality of the patent system creates market incentives that neglect consumer, i.e., patient, welfare; potential solutions to deal with the shortcomings are discussed.

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References

  1. Bechtold, S. (2016). Innovation heuristics: Experiments on sequential creativity in intellectual property. Indiana Law Journal, 91(4), 1250-1307.
  2. Bessen, B. & Meurer, M.(2008) Patent failure: How judges, bureucrats and lawyers put innovators at risk. Princeton: Princeton University Press.
  3. Buccafusco, C., & Masur, J. S. (2014). Innovation and incarceration: An economic analysis of criminal intellectual property law. Southern California Law Review, 275(87), 275-334.
  4. Burdon, M. & Sloper, K. (2003).The art of using burden secondary patents to improve protection. International Journal of Medical Marketing, 3(3), 226-238. https://doi.org/10.1057/palgrave.jmm.5040125
  5. Burke, P. F., & Reitzig, M. (2007). Measuring patent assessment quality-analyzing the degree and kind of (in) consistency in patent offices' decision making. Research Policy, 36(9), 329-355.
  6. Cohen, W. M., & Merrill, S. A. (2002) Patents in the knowledge -based economy. Washington: The National Academies Press.
  7. Domeij, B. (1990). Pharmaceutical Patents in Europe. Sweden: Kluwer Law International.
  8. European Commission (2009). Pharmaceutical sector inquiry final report. Retrieved from: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf.
  9. European Commission (2011). Study on the quality of the patent system in Europe. Retrieved from: http://ec.europa.eu/internal_market/indprop/docs/patent/patqual02032011_en.pdf.
  10. European Federation of Pharmaceutical Inustries and Associations (EFPIA). (2017). The pharmaceutical industry in figures 2016. Retrieved from https://www.efpia.eu/uploads/Modules/Documents/the-pharmaceutical-industry-in-figures-2016.pdf
  11. European Patent Office (EPO). (2015). Annual report 2015 statistics at a glance. Retrieved from http://documents.epo.org/projects/babylon/eponet.nsf/0/4C30F69F33211B6EC1257F6A0049308F/$File/at_a_glance_en.pdf
  12. EvaluatePharma (2015). Orphan drug report 2015 3rd edition. Retrieved from http://info.evaluategroup.com/rs/607-YGS-364/images/EPOD15.pdf
  13. Farrell, J., & Shapiro, C. (2008). How strong are weak patents? American Economic Review, 98(4), 1347-1369. https://doi.org/10.1257/aer.98.4.1347
  14. Feldman, R. (2008). Patent and antitrust: Differing shades of meaning. Virginia Journal of Law and Technology, 5(1), 1-20.
  15. Feldman, R. (2012). Rethinking patent law. USA: Harvard university press.
  16. Gilbert, J. (2003). Rebuilding big pharma business model. USA: Windhower.
  17. Gilbert, R., & Shapiro, C. (1990). Optimal patent breadth and length. RAND Journal of Economics, 21(1), 106-112. https://doi.org/10.2307/2555497
  18. Gilbert, R., & Shapiro, C. (1996). An economic analysis of unilateral refusals to license intellectual property. Proceedings of the national academy of sciences of the United States of America, 93, 12749-12755. Retrieved from http://www.pnas.org/content/93/23/12749.full.pdf https://doi.org/10.1073/pnas.93.23.12749
  19. Hall, B. H., Thomas, G., & Torrisi, S. (2009). Financial patenting in Europe. European Management Review, 6(1), 45-63. https://doi.org/10.1057/emr.2009.3
  20. Hara, T. (2003). Innovation in the pharmaceutical industry: The process of drug discovery and development. UK: Elgar Publishing.
  21. IMS institute for Healthcare Informatics. (2013). The global use of medicines: Outlook through 2017. Retrieved from: http://www.imshealth.com/files/web/IMSH%20Institute/Reports/US_Use_of_Meds_2013/IIHI_Global_Use_of_MedsReport_2013.pdf
  22. Kapczynski, A., Park, C., & Sampat, B. (2012). Polymorphs and prodrugs and salts: An empirical analysis of "secondary" pharmaceutical patents. PLOS one, 7(12), e49470. doi: 10.1371/journal.pone.0049470
  23. Kaplow, L. (1983). The patent antitrust intersection: A reappraisal (Harward Law School Discussion Paper No. 2). Retrieved from http://www.law.harvard.edu/programs/olin_center/papers/pdf/Kaplow_2.pdf
  24. Katz, M. L. (1985). On the licensing of innovations. RAND Journal of Economics, 16(4), 504-520 . https://doi.org/10.2307/2555509
  25. Kesan, J. P., & Ball, G. G. (2006). How are patent cases resolved? An empirical analysis of the adjudication and settlement of patent disputes. Washington University Law Review, 84(2), 237-312.
  26. Kitch, E. W. (1977). The nature and function of the patent system. Journal of Law and Economics, 20(2), 265-290. https://doi.org/10.1086/466903
  27. Leffler, K. & Leffler, C. (2003). The probabilistic nature of patent rights: In response to Kevin McDonald. Antitrust, 17(77), 1-39.
  28. Lemley, M. A. (1997). The economics of improvement in intellectual property law, Texas Law Review, 75, 989. Available at SSRN: https://ssrn.com/abstract=1274199
  29. Lemley, M. A. (2001). Rational ignorance at the patent office. Northwestern university law review, 95(4), 1497-1532.
  30. Lemley, M. A. (2003). Ex ante versus ex post justifications for intellectual property (Research Paper Series, No. 144). University of Chicago Law Review, 71, 129. Available at SSRN: https://ssrn.com/abstract=494424 or http://dx.doi.org/10.2139/ssrn.494424
  31. Lemley, M. A., & Moore, K. A. (2004). Ending abuse of patent continuations. Boston University Law Review, 84(1), 63-126.
  32. Lemley, M. A., & Shapiro, C. (2005). Probabilistic patents. Journal of Economic Perspectives, 19(2), 75-98. https://doi.org/10.1257/0895330054048650
  33. Lemley, M. A., & Shapiro, C. (2007). Patent holdup and royalty stacking. Texas Law Review, 85, 1991-2049.
  34. Leslie, C. R. (2012). Antitrust and patent law as component parts of innovation policy. Journal of Corporation Law, 34(4), 1259-1289.
  35. Levin, R. C., Klevoric, A. K., Nelson, R. R., & Winter, G. S. (1987). Appropriating the returns from industrial research and development (Brookings Papers on Economic Activity, 3). Retrieved from https://www.brookings.edu/wp-content/uploads/1987/12/1987c_bpea_levin_klevorick_nelson_winter_gilbert_griliches.pdf
  36. Merges R. P., & Nelson, R. R. (1990). On the complex economics of patent scope, Columbia Law Review, 839(90), p. 839-916.
  37. Moore, K. A. (2009). Judges, juries and patent cases - an empirical peek inside the black box. Michigan Law Review, 99, 365.
  38. Nordhaus, W. D. (Ed.) (1969). Invention, growth and welfare: A theoretical treatment of technological change. Cambridge: MIT Press.
  39. Nordhaus, W. D. (1972). The optimum life of a patent, The American Economic Review, 62(3), 428-431.
  40. Parchomovsky, G., & Polk Wagner, R. (2005). Patent portfolios. Pennsylvania Law Review, 154(1). 1-77. https://doi.org/10.2307/25047582
  41. Paul, S. M., Mytelka D. D., Dunwiddie, C. T., Persinger, C. C. Munos, B. H., Lindborg, S. R., Schacht, A. (2010). How to improve R&D productivity: The pharmaceutical industry's grand Challenge. Nature Reviews Drug Discovery, 9, 203-214. https://doi.org/10.1038/nrd3078
  42. Pharmaceutical Research and Manufacturers of America (phRMA). (2012). Title unknown. Source is deleted as of July 12, 2017.
  43. Pires de Carvalho, N. (2008). The TRIPS regime of antitrust and undisclosed information. Hague: Kluwer Law.
  44. Scherer, F. M. (2014). First mover advantages and optimal patent protection (Harvard University research working paper series RWP14-053). Available at https://www.hks.harvard.edu/research-publications/publications#heading_02
  45. Scotchmer, S. (1991). Standing on the shoulders of giants: Cumulative research and the patent law. Journal of Economic Perspectives, 29(5). 29-41.
  46. Shapiro, C. (2001). Navigating the patent thicket: Cross licenses, patent pools, and standard setting. Innovation Policy and the Economy, 1, 119-150.
  47. Shapiro, C. (2003). Antitrust limits to patent settlements. RAND Journal of Economics, 34(2), 391-411. https://doi.org/10.2307/1593724
  48. Tahir, A. & Kesselheim, A. S. (2012). Secondary patenting of branded pharmaceuticals: A case study of how patents on two HIV drugs could be extended for decades. Health Affairs, 31(10). 2286-2294. https://doi.org/10.1377/hlthaff.2012.0107
  49. TRIPS agreement, WIPO treaties, Retrieved from: https://www.wto.org/english/tratop_e/tripse/t_agm3c_e.htm#5, Also available at http://www.cptech.org/ip/wto/trips-art31.html.
  50. World Intellectual Property Organization (WIPO). (2016). Paris convention for the protection of industrial property. WIPO Treaties. Retrieved from http://www.wipo.int/ treaties/en/text.jsp?file_id=288514