Journal of Global Trade, Ethics and Law

Vol. 1 No. 4 (2023): Journal of Global Trade, Ethics and Law
Articles

The Incentive Argument in Pharmaceutical Patent Law

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  • Aaron Sean Poynton
Aaron Sean Poynton
Harvard Business School AMP Foundation
DOI: https://doi.org/10.5281/zenodo.10529407

Published 2024-01-15

Keywords

  • Pharmaceutical Industry,
  • Patent Law,
  • Intellectual Property Protection,
  • TRIPS Agreement,
  • Patent Wavers,
  • Innovation Incentives,
  • Covid-19 Vaccines,
  • Global Health Diplomacy
    • ...More
    Less

How to Cite

Poynton, A. S. (2024). The Incentive Argument in Pharmaceutical Patent Law. Journal of Global Trade, Ethics and Law, 1(4), 1–23. https://doi.org/10.5281/zenodo.10529407

Copyright (c) 2024 Journal of Global Trade, Ethics and Law

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

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Abstract

This paper critically examines the pharmaceutical industry and the incentive argument in patent law. It begins by framing an overview of the industry and patent law, focusing on U.S. and U.K. law, and multilateral agreements, and efforts by international organizations, such as the World Trade Organization (WTO). Next, the paper considers patent incentive arguments on both sides of the issue to provide a holistic and balanced perspective. It then views the longstanding debate through the lenses of contemporary issues related to Covid-19 vaccines and the recent patent waivers considered by many countries. This paper then provides informed opinions supporting the argument that intellectual property protection is core to innovation in the pharmaceutical industry, but patent waivers may be a necessary tool in certain situations. Lastly, it concludes by recommending fixing the TRIPS compulsory licensing provision flaws and carefully finding a TRIPS waiver solution that could strike the desired balance between protecting intellectual property (IP) and providing for the common good.

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References

  1. Abdela, Adil, and Marshall Steinbaum. "The United States has a Concentration Problem: Reviewing Concentration Estimates in Antitrust Markets, 2000-Present." U.S. Federal Trade Commission, September 2018.
  2. Access Campaign. "Compulsory Licenses: the TRIPS Waiver and Access to COVID-19 Medical Technologies." May 2021. https://msfaccess.org/compulsory-licenses-trips-waiver-and-access-covid-19-medical-technologies.
  3. Allen & Overy LLP. "China: Patent Law Amendment Brings Sea Change to Pharmaceutical Patent Regime." November 5, 2020. https://www.jdsupra.com/legalnews/china-patent-law-amendment-brings-sea-96748/.
  4. AstraZeneca. Annual Report 2020. https://www.astrazeneca.com/content/dam/az/Investor_ Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf
  5. BIOSIMILARS COUNCIL. "Failure to Launch: Patent Abuse Blocks Access to Biosimilars for America’s Patients." June 2019. https://www.biosimilarscouncil.org/wp-content/uploads/2019/06/Biosimilars-Council-White-Paper-Failure-to-Launch-June-2019.pdf.
  6. Congressional Budget Office (CBO). "Research and Development in the Pharmaceutical Industry." 2021. https://www.cbo.gov/publication/57126
  7. Damodaran, Aswath. [Data set 2018]. Accessed June 30, 2021. http://people.stern.nyu.edu/adamodar/New_Home_Page/data.html.
  8. Daxue Consulting. "China’s Pharmaceutical Industry Will be the Largest in Under 10 Years." 2023. https://daxueconsulting.com/pharmaceutical-industry-china/.
  9. DiMasi, Joseph, et al. "Innovation in the pharmaceutical industry: New estimates of R&D costs." Journal of Health Economics Volume 47, 2016.
  10. Dunn, Andrew. "With Boehringer Settlement, AbbVie Completes Humira Sweep." Biopharmadive, May 14, 2019. https://www.biopharmadive.com/news/abbvie-boehringer-ingelheim-settle-humira-patent-biosimilar/554729/.
  11. European Commission. "Antitrust." Accessed May 22, 2021. https://ec.europa.eu/competition-policy/antitrust_en.
  12. European Patent Office. "EPO Statistics: European Patent Applications 2020 by Field of Technology." 2020. Accessed June 3, 2021. https://documents.epo.org/projects/babylon/eponet.nsf/0/EF610C9864E63FDBC1258699004AB942/$File/european_patent_applications_per_field_of_technology_per_country_of_residence_2011-2020_en_.xlsx.
  13. European Patent Office. "G 0005/83 (Second Medical Indication) of 5.12.1984." 1984. Accessed June 3, 2021. https://www.epo.org/law-practice/case-law-appeals/recent/g830005ep1.html.
  14. Feldman, Robin. "May Your Drug Price Be Evergreen." Journal of Law and the Biosciences, Volume 5, Issue 3 (December 2018). https://academic.oup.com/jlb/article/5/3/590/5232981.
  15. Feldman, Robin, and Evan Frondorf. Drug Wars: How Big Pharma Raises Prices and Keeps Generics Off the Market. Cambridge University Press, June 2017.
  16. Ford, Jeff, et al. "Biopharma leaders prioritize R&D, technological transformation, and global market presence." Deloitte, August 24, 2020. https://www2.deloitte.com/us/en/insights/industry/life-sciences/pharmaceutical-industry-trends.html.
  17. Frank, Richard G., Leslie Dach, and Nicole Lurie. "It Was The Government That Produced COVID-19 Vaccine Success." Health Affairs Forefront, May 14, 2021.
  18. Fusco, Stefania. "Lessons from the Past: The Venetian Republic’s Tailoring of Patent Protection to the Characteristics of the Invention." 17 Nw. J. Tech. & Intell. Prop., February 9, 2019. https://ssrn.com/abstract=3331687.
  19. Golec, Joseph, and John A. Vernon. “Financial Effects of Pharmaceutical Price Regulation on R&D Spending by EU Versus US Firms.” Pharmacoeconomics, Vol. 28(8), 2010.
  20. Heller, Michael A., and Rebecca S. Eisenberg. "Can Patents Deter Innovation? The Anticommons in Biomedical Research." Science AAAS Vol 280, May 1, 1998. https://moodle.lse.ac.uk/mod/resource/view.php?id=409386.
  21. Heller, Michael A., et al. “Can Patents Deter Innovation? The Anticommons in Biomedical Research.” Science AAAS Vol 280, May 1, 1998. https://moodle.lse.ac.uk/mod/resource/view.php?id=409386.
  22. Hilts, Philip J. "AIDS Drug’s Maker Cuts Price by 20%." New York Times, September 19, 1989.
  23. Hooper, Charles. "Pharmaceuticals: Economics and Regulation." The Library of Economics and Liberty, 2023. Accessed May 23, 2023. https://www.econlib.org/library/Enc/PharmaceuticalsEconomicsandRegulation.html.
  24. Hopkins, Jared S., and Dean Seal. "Pfizer Expects Drop in Revenue as Covid Vaccine Demand Wanes." The Wall Street Journal, Updated Jan. 31, 2023, 2:49 pm ET.
  25. IMAK. "America’s Best Selling Drugs of 2019." 2019. Accessed June 3, 2021. https://www.i-mak.org/2019-bestselling/.
  26. IMAK. "Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving Up Drug Prices." Public comments to the U.S. Federal Trade Commission. August 2018.
  27. IQVIA. 2020. “Medicine Spending and Affordability in the United States.”
  28. Johnson, Eric E. "Intellectual Property and the Incentive Fallacy." Florida State University Law Review Vol 39:623. 2012. https://ir.law.fsu.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1027&context=lr
  29. J-PAL Policy Briefcase. "Incentives for Immunization." Abdul Latif Jameel Poverty Action Lab, Cambridge, MA, 2011.
  30. Kennedy, Joe. "The Link Between Drug Prices and Research on the Next Generation Cures." Information Technology & Innovation Foundation, September 9, 2019. https://itif.org/publications/2019/09/09/link-between-drug-prices-and-research-next-generation-cures.
  31. Le Deu, Franck, and Jorge Santos da Silva. "Biotech in Europe: A strong foundation for growth and innovation." McKinsey Consulting, August 23, 2019. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/biotech-in-europe-a-strong-foundation-for-growth-and-innovation.
  32. Lee, Samuel, Jr. "Composition of Bilious Pills." U.S. Patent 1796.
  33. Mansfield, Edwin. “Patents and Innovation: An Empirical Study.” 32 MGMT.SCI.173, 175 (1986).
  34. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).
  35. Mikulic, Matej. "Total global spending on pharmaceutical research and development from 2014 to 2028." Statista. Published October 6, 2023. Accessed October 6, 2023. https://www.statista.com/statistics/309466/global-r-and-d-expenditure-for-pharmaceuticals/.
  36. Moir, Hazel, and Deborah Gleeson. "Explainer: Evergreening and How Big Pharma Keeps Drug Prices High." The Conversation. November 5, 2014. https://theconversation.com/explainer-evergreening-and-how-big-pharma-keeps-drug-prices-high-33623.
  37. Nayak, Malathi. "Cost of Patent Infringement Litigation Falling Sharply." Bloomberg Law, August 11, 2017. https://biglawbusiness.com/cost-of-patent-infringement-litigation-falling-sharply.
  38. Organisation for Economic Co-operation and Development. 2017. Health at a Glance 2017: OECD Indicators. Paris: OECD Publishing. https://doi.org/10.1787/health_glance-2017-en.
  39. Pammolli, Fabio, et al. "The Productivity Crisis in Pharmaceutical R&D." 10 Nature Resv.Drug Discovery 428, 428 (June 2011).
  40. PharmExec. "What Happens When a Product Loses Its Patent?" May 1, 1998. https://www.pharmexec.com/view/what-happens-when-product-loses-its-patent.
  41. PhRMA. "PhRMA Statement on WTO TRIPS Intellectual Property Waiver." May 5, 2021. https://www.phrma.org/en/Press-Release/PhRMA-Statement-on-WTO-TRIPS-Intellectual-Property-Waiver.
  42. PhRMA. "The Economic Impact of the U.S. Biopharmaceutical Industry: 2017 National and State Estimates." December 2019. https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/D-F/Economic-Impact-US-Biopharmaceutical-Industry-December-2019.pdf.
  43. Pistilli, Melissa. "Pharmaceutical Industry Overview: Top International Regions for Drug Companies." Investing News, 2023. https://investingnews.com/daily/life-science-investing/pharmaceutical-investing/top-pharmaceutical-regions/.
  44. Qian, Yi. “Do national patent laws stimulate domestic innovation in a global patenting environment? A cross-country analysis of pharmaceutical patent protection, 1978-2002." The Review of Economics and Statistics. 89 (3): 436–453.
  45. Richman, Barak, et al. “Pharmaceutical M&A Activity: Effects on Prices, Innovation, and Competition.” Loyola University Chicago Law Journal Volume 48, 2017.
  46. Rosenberg, Tina. “HIV Drugs Cost $75 in Africa, $39,000 in the U.S. Does it Matter?” New York Times, September 9, 2018. https://www.nytimes.com/2018/09/18/opinion/pricing-hiv-drugs-america.html.
  47. Scherer, Frederic M. "A Note on Global Welfare in Pharmaceutical Patenting." FRB of Philadelphia Working Paper No. 03-11, https://ssrn.com/abstract=568264, August 2, 2014.
  48. Sengar, Geetanjali, and Pranab Tripathy. “Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development.” Pharmatutor, June 27, 2012. https://www.pharmatutor.org/articles/pharmaceutical-regulatory-agencies-and-organizations-around-world-scope-challenges-in-drug-development.
  49. Sertkaya, Aylin, et al. "Examination of Clinical Trial Costs and Barriers for Drug Development." U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, July 25, 2014.
  50. Shapiro, Carl. “Navigating the Patent Thicket: Cross Licenses, Patent Tools, and Standard Setting.” In Innovation Policy and the Economy 1. National Bureau of Economic Research, MIT Press, 2000. Accessed June 5, 2021. http://faculty.haas.berkeley.edu/shapiro/thicket.pdf.
  51. Shiffrin, SV. “The Incentives Argument for Intellectual Property Protection.” In Gosseries A., Marciano A., Strowel A. (eds) Intellectual Property and Theories of Justice. Palgrave Macmillan, London. Accessed June 5, 2021. https://doi.org/10.1057/978-0-230-58239-2_5.
  52. Smith, Adam. The Wealth of Nations. Oxford, England: Bibliomania.com Ltd, 2002.
  53. Thambisetty, Siva. "Swiss Use Claims." LL435E: Lecture 11 slides. London School of Economics and Political Science, 2022.
  54. Thambisetty, Siva. "The Legal Protection of Technology – Introduction." LL435E: Lecture 1 slides. London School of Economics and Political Science, 2022.
  55. The Business Research Company. 2021. “Pharmaceuticals Global Market Report 2021: COVID-19 Impact and Recovery to 2030.”
  56. U.S. Congressional Research Service. "Drug Pricing and Pharmaceutical Patenting Practices." February 11, 2020. https://fas.org/sgp/crs/misc/R46221.pdf.
  57. U.S. Food and Drug Administration (FDA). 2022. “International Counterparts.” https://www.fda.gov/about-fda/cvm-offices/international-counterparts.
  58. U.S. Food and Drug Administration (FDA). 2023. “FDA Fundamentals.” https://www.fda.gov/about-fda/fda-basics/fda-fundamentals.
  59. U.S. Food and Drug Administration (FDA). "2020-06 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic XLS." Accessed June 5, 2021. https://www.fda.gov/media/139082/download.
  60. U.S. Food and Drug Administration (FDA). "Frequently Asked Questions on Patents and Exclusivity." Accessed June 4, 2021. https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity.
  61. U.S. Food and Drug Administration (FDA). "Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices." Accessed June 5, 2021. https://www.fda.gov/media/133509/download.
  62. U.S. Patent and Trademark Office (USPTO). "General Information Concerning Patents." Accessed May 22, 2021. https://www.uspto.gov/patents/basics.
  63. United States Code. 35 U.S.C. § 112(a) (1953).
  64. United States Code. 35 U.S.C. § 271(e)(1).
  65. Van Norman, Gail A. “Drugs and Devices: Comparison of European and U.S. Approval Processes.” JACC: Basic to Translational Science Volume 1, Issue 5 (August 2016). https://www.sciencedirect.com/science/article/pii/S2452302X16300638.
  66. Warner-Lambert Company LLC v. Novartis (Singapore) Pte Ltd, [2017] SGCA 45.
  67. Workman, Daniel. 2022. “Drugs and Medicine Exports by Country.” World’s Top Experts. https://www.worldstopexports.com/drugs-medicine-exports-country/.
  68. World Health Organization (WHO). "Global Health Estimates 2019: Deaths by Cause, Age, Sex, by Country and by Region, 2000-2019." Accessed June 6, 2021. https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/ghe-leading-causes-of-death.
  69. World Health Organization (WHO). "The Doha Declaration." Accessed May 30, 2021. https://www.who.int/medicines/areas/policy/doha_declaration/en/.
  70. World Health Organization (WHO). "WHO and the TRIPS Agreement." Accessed May 30, 2021. https://www.who.int/medicines/areas/policy/wto_trips/en/.
  71. World Intellectual Property Organization (WIPO). "Patent Law Harmonization." Accessed May 22, 2021. https://www.wipo.int/patent-law/en/patent_law_harmonization.htm.
  72. World Trade Organization (WTO). "Ministerial Decision on the TRIPS Agreement" (adopted on June 17, 2022). WT/MIN(22)/30, WT/L/1141, June 22, 2022. See WTO, "Ministerial Conferences," at https://www.wto.org/english/thewto_e/minist_e/ minist_e.htm.
  73. World Trade Organization (WTO). "Part II — Standards concerning the availability, scope and use of Intellectual Property Rights." In Uruguay Round Agreement: TRIPS, Sections 5 and 6. Accessed June 5, 2021. https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm.
  74. Yahoo Finance. Accessed June 5, 2021.
  75. Zafar, Osman, and Sophie Lawrance. “Competition Law, IP and the Pharmaceutical Sector.” London School of Economics and Political Science, March 7, 2014.