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Flexibilities Under Article 39.3 of the TRIPS Agreement: Protection of Pharmaceutical Test Data and the Case of Brazil

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Abstract

This article focuses on the Lundbeck v. ANVISA case to analyze the flexibilities regarding the protection of pharmaceutical test data under Article 39.3 of the TRIPS Agreement. It argues that ANVISA’s granting of marketing approval for generic medicines on the basis of bioequivalence studies does not breach Brazil’s obligations under the TRIPS Agreement. This abbreviated process of approval is an important tool in fostering an industry for generic medicines. The text of Article 39.3 needs to be interpreted flexibly and in light of the objective to promote access to medicines for all.

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Notes

  1. 1.

    For a detailed account of the process of clinical trials and marketing approval see: Correa (2002a, b).

  2. 2.

    KEI Research Note 2014:3.

  3. 3.

    Dimasi et al. (2016), pp. 20–33.

  4. 4.

    This is certainly a generalization as notable exceptions exist in both ends of the spectrum. While an increasingly large number of developing countries have agreed to exclusivity periods for test data as a result of their participation in Free Trade Agreements (FTAs), the Canadian Court of Appels ruled in favor of a flexible interpretation of TRIPS Article 39.3 in Bayer Inc v. Canada (Attorney General), 3 November 1998.

  5. 5.

    de Carvalho (2014), p. 573.

  6. 6.

    WTO, P/C/W/296, 20 June 2001.

  7. 7.

    For a detailed account of the negotiations of the TRIPS Agreement from a developmental perspective, see: Yu (2004), pp. 324–442.

  8. 8.

    MERCOSUR (2002).

  9. 9.

    As Health Minister (1998–2002), Serra created ANVISA and threatened to use compulsory licencing as a bargaining chip in price negotiations with pharmaceutical companies.

  10. 10.

    Brazil. Federal Senate Diary (2001), pp. 22–312.

  11. 11.

    Jucá and Mattos (2006).

  12. 12.

    Brazil. TRF 1st Region (2011).

  13. 13.

    Brazil. TRF 1st Region (2011).

  14. 14.

    CADE, Administrative Process (2012).

  15. 15.

    Brazil. Superior Justice Tribunal (2011).

  16. 16.

    Zavaski passed away in January, 2017.

  17. 17.

    Brazil. Higher Federal Court. Reclamação 13882. Lundbeck v. ANVISA (Interim measures), 21 December 2012.

  18. 18.

    World Trade Organization (2013).

  19. 19.

    Jucá and Mattos (2006).

  20. 20.

    Admittedly, the scope of “exploit” could present a problem, but it was not central to the debates in the Brazilian courts.

  21. 21.

    The absence of a footnote was meant to allow for flexibilities in the development of generic medicines, as will be discussed.

  22. 22.

    Correa (2002a, b), p. 32.

  23. 23.

    UNCTAD (2011), p. 163.

  24. 24.

    Stoll et al. (2009), p. 653.

  25. 25.

    IP/C/W/296, supra note 6.

  26. 26.

    […] no person other than the person that submitted [undisclosed test data for marketing approval of pharmaceutical products] may, without the latter’s permission, rely on such data in support of an application for product approval during a reasonable period of time [not less than five years] after their submission.” (added highlights).

  27. 27.

    Part C, Section C.08.004.1 of the Canadian Food and Drug Regulations. “Where a manufacturer (…) relies on data contained in the information or materials filed by the innovator, the Minister shall not issue a notice of compliance (…) earlier than five years”.

  28. 28.

    Canada, Federal Court of Appeal, Bayer Inc. v. Canada (Attorney General), 3 November 1998.

  29. 29.

    Section C.08.004.1 (Revised).

  30. 30.

    de Carvalho (2014), pp. 572–573.

  31. 31.

    Ibid. p. 593.

  32. 32.

    Correa (2002a, b), p. 29.

  33. 33.

    Ibid. p. 25.

  34. 34.

    Stoll; Malbon et al. (2014), pp. 587–588.

  35. 35.

    Ibid., p. 654.

  36. 36.

    Stoll; Malbon et al. (2014), p. 653.

  37. 37.

    Yu (2009), p. 813.

  38. 38.

    Panel Report, EC-Trademarks and Geographical Indications, WT/DS/174/R, adopted 15 March 2005, para. 7.210.

  39. 39.

    Panel Report, Canada-Pharmaceutical Patents, WT/DS114/R, adopted 7 April 2000, para. 7. 24.

  40. 40.

    Yu (2009), p. 815.

  41. 41.

    See Gervais (2010), para 58. Available at: http://www.smoke-free.ca/trade-and-tobacco/Resources/Gervais.pdf. Accessed 1 Mar 2016.

  42. 42.

    Correa (2002a, b), p. 44.

  43. 43.

    WO/PBC/18/22, para. 487.

  44. 44.

    These documents of the TRIPS Council are quoted by de Carvalho (2014), p. 560.

  45. 45.

    Ibid. p. 554.

  46. 46.

    de Carvalho (2014), p. 559.

  47. 47.

    Ibid. p. 560.

  48. 48.

    Ibid. p. 567.

  49. 49.

    Ibid. p. 567.

  50. 50.

    Ibid. p. 567.

  51. 51.

    de Carvalho (2014), p. 568.

  52. 52.

    Watal (2001), p. 204.

  53. 53.

    WT/DS171/3.

  54. 54.

    Ibid. para. 9.

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Authors and Affiliations

  1. Brazilian Ministry of Foreign Affairs, Brasilia, Brazil

    Letícia Frazão Leme

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  1. Letícia Frazão Leme
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  1. International and Compared Law, University of São Paulo Law School, São Paulo, Brazil

    Alberto do Amaral Júnior

  2. University of São Paulo Law School, São Paulo, Brazil

    Luciana Maria de Oliveira Sá Pires

  3. International Relations Institute, University of São Paulo, São Paulo, Brazil

    Cristiane Lucena Carneiro

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Frazão Leme, L. (2019). Flexibilities Under Article 39.3 of the TRIPS Agreement: Protection of Pharmaceutical Test Data and the Case of Brazil. In: do Amaral Júnior, A., de Oliveira Sá Pires, L.M., Lucena Carneiro, C. (eds) The WTO Dispute Settlement Mechanism. Springer, Cham. https://doi.org/10.1007/978-3-030-03263-0_22

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