Pharmaceutical patent examination in developing countries: lessons from Brazil

Eduardo, Mercadante Santino de Oliveira (2025) Pharmaceutical patent examination in developing countries: lessons from Brazil. PhD thesis, London School of Economics and Political Science.

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Abstract

Since the enactment of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), almost every country in the world has introduced patent protection for pharmaceutical inventions. However, there is considerable variation in the implementation of policies that address developmental and public health challenges. There is a wide agreement that developing countries should implement preventive (ex ante) measures to strengthen patent examination and promote balance in the public and private incentives in the patent system instead of relying on corrective (ex post) measures to address the negative consequences of lax examination. This thesis draws lessons about flexibilities in patent policy from the Brazilian experience of implementing pharmaceutical patenting since conforming to TRIPS in the late 1990s. In 2018, Brazil started basing the examination in Brazil on reports published by other offices for applications covering the same invention, in a wide movement that seeks to simplify examination to expedite prosecution and reduce the backlog of pending applications. Chapter 2 shows that this has significantly increased the grant rate, and examiners tend to make fewer objections before issuing a grant. Combining these results with a comparison of grant rates with 14 other offices, the analysis concludes this approach has reduced the standard for granting patents in Brazil and produced more negative side effects than its intended goals. Brazil also abolished the dual examination system where the patent office and the health regulator both had to examine pharmaceutical applications from 2001 to 2021, with the changing arrangements. Analysing the many arrangements for this system over two decades, Chapter 3 shows how the entities converged to high patenting standards and raised the scrutiny of all patentability criteria, especially invention description, despite the intense conflict over each entity's jurisdiction. Therefore, the regulator’s non-binding opposition to strategic applications contributed significantly to examination in an almost symbiotic relationship. Lastly, Chapter 4 investigates the Brazilian government’s history of Hepatitis C drug procurement to assess the repercussions of these policies outside the patent office. Based on an understanding that the recommended treatments were equally effective and therefore great substitutes, the government shifted procurement to centralised tenders and induced competition by having originators of different drugs compete, regardless of each drug’s patent exclusivity status. Given the high patenting standard and originator’s commercial strategies, generic manufacturers could join those tenders, significantly boosting the government’s bargaining power. However, and tying together the three chapters, pressuring examiners to decide faster based on other patent offices’ reports and removing the dual examination system has led newer drugs to obtain patents more often, threatening the potential future benefits for the government of using this strategy of induced competition. This thesis shows that Brazil has successfully explored policy flexibilities to strengthen examination but should be wary of policies that simplify examination to expedite prosecution, given the importance of promoting the balanced stimuli in patenting that generate positive externalities for public health strategies.

Item Type:	Thesis (PhD)
Additional Information:	© 2025 Eduardo Mercadante Santino de Oliveira
Library of Congress subject classification:	H Social Sciences > HD Industries. Land use. Labor T Technology > T Technology (General)
Sets:	Departments > International Development
Supervisor:	Kenneth C., Shadlen and Bhaven N., Sampat
URI:	http://etheses.lse.ac.uk/id/eprint/4845

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