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Data exclusivity: a tool to sustain market monopoly

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Abstract

There has been a general downgrading of patent from its touted original has position of being the unique economic tool to promote innovation. The rhetoric of innovation which has long served as a platform to nestle “patents” have been challenged in all countries. For the pharmaceutical industry, the linking of patents—however unfairly—as the woe affecting pricing of life-saving medication in the developing world, the permeation of the pricing question as an election issue in the developed world, issues from secondary patents that potentially blocked further innovation, the low thresholds of biotechnology patents have all resulted in the industry assuming the avatar of defendants of patents globally. It has also resulted in the industry beginning its quest for new tools to help consolidate market exclusivity. This background has caused the pharmaceutical industry to scramble for tools to help sustain or maintain the longevity of their market monopoly. This paper will examine one such tool—data exclusivity—currently touted by the pharmaceutical industry. The focus of the paper will be on how data exclusivity can impact access to medication, specifically in developing countries. In doing so, the paper will discuss what data exclusivity is in Part II followed by an outline in Part III of the historic origins of data exclusivity. A description of Article 39 of the TRIPS agreement and its requirements are outlined in Part IV after which Part V addresses some of the controversial questions relevant to India. The Conclusion highlights the need to be cautious in adding a more TRIPS–plus form of exclusivity.

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Notes

  1. Marrakesh Agreement Establishing the World Trade Organization, Legal Instruments–Results Of The Uruguay Round, 33 I.L.M 181 (1994) [hereinafter “Marrakesh Agreement”]. See also The WTO, World Trade Organization, https://www.wto.org/english/thewto_e/thewto_e.htm.

  2. See Report of the United Nations High Level Panel Report on Access to Medicines, United Nations, (Sep. 2016), http://www.unsgaccessmeds.org/final-report/.

  3. Id. See also Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 31, 33 I.L.M. 81 (1994), reprinted in World Trade Organization, The Results of the Uruguay Round of Multilateral Trade Negotiations 365 (1995) [hereinafter “TRIPS Agreement”]. See Doha Declaration, infra note 75.

  4. See Ed Silverman, Hepatitis C Drugs Remain Unaffordable in Many Countries, Says WHO Study, Pharmalot, (May 31, 2016), https://www.statnews.com/pharmalot/2016/05/31/gilead-hepatitis-drug-prices-who/. See also Over 1 Million Treated With Highly Effective Hepatitis C Medicines, World Health Organization, (Oct. 27, 2016), http://www.who.int/mediacentre/news/releases/2016/hepatitis-c-medicines/en/.

  5. See generally Development Agenda for WIPO, World Intellectual Property Organization, http://www.wipo.int/ip-development/en/agenda/.

  6. Brook Baker, et al., Justifying India’s Patent Position to the United States International Trade Commission and Office of United States Trade Representative 7 Indian J. Intell. Prop. Law 1 (2015). See also Andrew Goldman, Colombia Issues Public Interest Declaration To Lower Price of Glivec, KEI Online, http://keionline.org/node/2601 (Jun. 14, 2016); See also Ministerio De Salud Y Protección Social, Resolución Numero 00002475/(Jun. 14, 2016), https://www.minsalud.gov.co/Normatividad_Nuevo/Resoluci%C3%B3n%202475%20de%202016.pdf.

  7. Kimberly Leonard, Can the Government Already Control Drug Prices?, U.S. News (Jan. 11, 2016), http://www.usnews.com/news/articles/2016/01/11/congressional-democrats-urge-nih-to-act-on-drug-prices.

  8. Bernie Sanders, Cummings Send Letter on ARIAD's Staggering Price Increases (Oct. 20, 2016), https://www.sanders.senate.gov/newsroom/press-releases/sanders-cummings-send-letter-on-ariads-staggering-price-increases.

  9. See H.R. 1223-115th Congress (2017-2018); Peter Maybarduck, Pharma Power Stumbles on FDA User Fee Vote, Public Citizen (Aug. 4, 2017), https://www.citizen.org/media/press-releases/pharma-power-stumbles-fda-user-fee-vote.

  10. G. Lee Skillington & Eric M. Solovy, The Protection of Test and Other Data Required by Article 39.3 of the TRIPs Agreement, 24 NW. J. Int’L L. & Bus. 1 at 6 (2003) [hereinafter, Skillington & Solovy].

  11. See 21 USC § 355 (b)(1) and (b)(2) under which applications for a new chemical entity can receive 5 years of exclusivity. See also Frequently Asked Questions on Patents and Exclusivity, U.S. Food and Drug Administration, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm#howlongexclusivity.

  12. Id.

  13. Id.

  14. See Test Data Protection for Medical Inventions, KEI (Aug. 8, 2017), https://www.keionline.org/testdata. See also Determination in the Case of Fabrazyme, https://www.ott.nih.gov/sites/default/files/documents/policy/March-In-Fabrazyme.pdf

  15. See James Love, 2010 Fabrazyme March-in Request, KEI (Aug.2, 2010), https://www.keionline.org/fabrazyme (Aug. 8, 2017).

  16. See Srividhya Ragavan, The Significance of the Data Exclusivity Debate and its Impact on Generic Drugs, 1:1 JIPS 131 (2017).

  17. See Kristina Lybecker, When Patents aren’t Enough: The Case for Data Exclusivity for Biologic Medicines, IP Watchdog (Jul. 9, 2014), http://www.ipwatchdog.com/2014/07/09/patents-arent-enough-data-exclusivity-for-biologic-medicines/id=50318/; See generally, What Does The TPP Say About Data Exclusivity And Biosimilars?, Managed Care, https://www.managedcaremag.com/focus/what-does-tpp-say-about-data-exclusivity-and-biosimilars.

  18. See Test Data Protection for Medical Inventions, supra note 14.

  19. See Drug Price Competition and Patent Term Restoration Act of 1984, 35 U.S.C. § 156 (1984) [hereinafter Hatch–Waxman Act]. See also 21 C.F.R. 314.108.

  20. Novo Nordisk A/S, et al. v. Caraco Pharmaceutical Laboratories, Ltd., et al., 601 F. 3d 1359; 1359 (Fed. Cir) 2010 rev'd; 1325 S. Ct. 1670 (2012).

  21. Paris Convention for the Protection of Industrial Property, Mar. 20, 1883, as last revised Jul. 14, 1967, 21 U.S.T. 1583, 828 U.N.T.S. 305 at art. 10 [hereinafter “Paris Convention”].

  22. Id.

  23. Id.

  24. Paris Convention, supra note 21, art. I0bis(2).

  25. World Trade Organization, supra note 1.

  26. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 31, 33 I.L.M. 81 (1994), reprinted in World Trade Organization, The Results of the Uruguay Round of Multilateral Trade Negotiations 365 (1995) [hereinafter “TRIPS Agreement”].

  27. Id., at Article 39.

  28. Paris Convention, supra note 21, at art. 10bis(2).

  29. See Art. 39.1 of TRIPSS Agreement; See also Skillington & Solovy, supra note 10, at 8–10.

  30. See TRIPS, supra note 26, at Article 39.

  31. See Overview: The TRIPS Agreement, https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm#tradesecrets. See generally Uniform Trade Secrets Act, 14 U.L.A. 539–40 (Commissioners' Prefatory Note) (1980).

  32. See Skillington & Solovy, supra note 10, at 8–10.

  33. See Approaches to the Protection of Trade Secret, Enquiries Into the Economic Impact of Trade Secret, OECD Publications, 2015 at 128, https://www.oecd.org/sti/ieconomy/Chapter3-KBC2-IP.pdf.

  34. See Trade Secret: Internal Market, Industry, Entrepreneurship and SMEs, https://ec.europa.eu/growth/industry/intellectual-property/trade-secrets_en.

  35. Protection of Undisclosed Know-how and Business Information (trade secrets) Against Their Unlawful Acquisition, Use and Disclosure, Directive (EU) 2016/943, European Parliament, (8 Jun., 2016), http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016L0943.

  36. Id.

  37. See TRIPS, supra note 26, at Article 3.

  38. Id.

  39. Id.

  40. See generally 35 USC § 101–130.

  41. Wael Armouti & Mohammad F.A. Nsour, Data Exclusivity for Pharmaceuticals: Was It the Best Choice for Jordan Under the U.S.—Jordan Free Trade Agreement?, 17 Oregon Rev. Int’ l. 258, 260, (2016), https://law.uoregon.edu/images/uploads/entries/Nsour.pdf.

  42. See Encouragement of New Clinical Drug Development: The Role of Data Exclusivity, International Federation of Pharmaceutical Manufacturers Associations, FN 8 at 16 Protection of Undisclosed Information and Control of Anti-Competitive Practices, APEC TRIPS Seminar: 17–19 May 1995, Presentation by New Zealand, http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf.

  43. Id.

  44. Id.

  45. Id.

  46. Id.

  47. Carlos Maria Correa, Unfair Competition Under the TRIPs Agreement: Protection of Data Submitted for the Registration of Pharmaceuticals, 3 CHI. J. INT’L. L. 69, 72-73 (2002) [hereinafter Correa, Unfair Competition]; see also Srividhya Ragavan & Moushami Joshi, Backdoor Patents Could Hurt Patents, Business Line, (Dec. 27, 2016):.

  48. Armouti &. Nsour, supra note 41.

  49. See Small Business Assistance: FAQ for New Drug Product Exclusivity, (Nov. 2, 2016), www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance/ucm069962.htm.

  50. See Federal Food, Drug, and Cosmetic Act, 1938, § 505(b); 21 USC § 355; But see, Role of Exclusivity, supra note 40.

  51. See Encouragement of New Clinical Drug Development: The Role of Data Exclusivity , supra note 42.

  52. See Wael & Nsour, supra note 41; See also 4 Jordan Food & Drug Administration, http://www.jfda.jo/Default.aspx.

  53. Megan Kendall & Declan Hamill, A Decade of Data Protection for Innovative Drugs in Canada: Issues, Limitations, and Time for a Reassessment, Biotech. L. Reporter 1; 35(6): 259–267 (2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5178005/.

  54. See also Canadian Food & Drug Regulations, C.R.C., c. 870, C.08.004.1(1).

  55. Epicept Corporation v. Canada (Health), 2010 F.C. 956 [Epicept].

  56. Celgene Inc. v. Canada (Health), 2012 F.C. 154 [Celgene, FC]; Canada (Health) v. Celgene Inc., 2013 F.C.A. 43 [Celgene, FCA]. Kendall & Hamill, supra note 53.

  57. Aparna Nemlekar, et al., FDA is Evolving On Qualifications For 'New Chemical Entity, Law360, (Sep. 7, 2016), http://www.pepperlaw.com/publications/fda-is-evolving-on-qualifications-for-new-chemical-entity-2016-09-07/.

  58. Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013).

  59. G. Lee Skillington & Eric M. Solovy, The Protection of Test and Other Data Required by Article 39.3 of the TRIPs Agreement, 24 NW. J. Int’l L. & Bus. 1, 2–6 (2003).

  60. See Amouti & Nsour, supra note 41.

  61. See Kristina Lybecker, When Patents Aren’t Enough: The Case for Data Exclusivity for Biologic Medicines, IPWatchdog (Jul. 9, 2014), http://www.ipwatchdog.com/2014/07/09/patents-arent-enough-data-exclusivity-for-biologic-medicines/id=50318/.

  62. See Test Data Protection for Medical Inventions, Knowledge Ecology International, https://www.keionline.org/testdata.

  63. See Drugs & Cosmetics Act, 1940, at § 122E (amended, 1995) (India).

  64. Id.

  65. See Argentina Law on the Confidentiality of Information and Products, No. 24,766, Articles 4 & 5; See also Data Exclusivity: Encouraging Development of New Medicines, International Federation of Pharmaceutical Manufacturers Assn, 10-11, (2011).

  66. Id.

  67. Correa, supra note 47.

  68. See Amouti & Nsour, supra note 41.

  69. See Patent Linkage in Asian countries Compared to the US, Mirandah (Apr. 26, 2012), https://www.mirandah.com/pressroom/item/340-patent-linkage-in-asian-countries-compared-to-the-us/.

  70. The Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (as amended), https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/patented-medicines/notice-compliance-regulations.html.

  71. See generally, Kristina Lybecker, Intellectual Property Rights & Bio-pharmaceutical Industry: How Canada Measures Up, Fraser Institute, (Jan. 2017), https://www.fraserinstitute.org/sites/default/files/intellectual-property-rights-protection-and-the%20biopharmaceutical-industry.pdf.

  72. Bayer Corp. v. Union of India, WP(C) No.7833/2008; See also Bayer Corporation & Another v. Union of India & Others, Bayer Corp. v. Union of India, WP(C) No.7833/2008.

  73. Id.

  74. Indian Patents Act, 1970 (as amended in 2005), Section 107A.

  75. World Trade Organization, Ministerial Declaration of November 14, 2001, ¶ 17, WT/MIN(01)/DEC/1, 41 I.L.M. 746 (2002) [hereinafter “Doha Declaration”].

  76. Id.

  77. Xavier Seuba, Pharmaceutical Test Data Protection & Human Rights, in Reshaping Intellectual Property Law Through a Human RIghts Lens (Peter K. YU ed., 2017) (extensively discussing access to medication issues from data exclusivity).

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  1. School of Law, Texas A&M University, Fort Worth, TX, USA

    Srividhya Ragavan

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Srividhya Ragavan—Professor of Law.

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Ragavan, S. Data exclusivity: a tool to sustain market monopoly. Jindal Global Law Review 8, 241–260 (2017). https://doi.org/10.1007/s41020-017-0050-2

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