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

  • Letícia Frazão LemeEmail author


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.


Pharmaceutical test data Access to medicines Lundbeck 


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© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Brazilian Ministry of Foreign AffairsBrasiliaBrazil

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