Resumo

VODANOVIC UNDURRAGA, Eduardo. Conceptual Analysis of Patent System Flexibilities. Isonomía [online]. 2025, n.62, pp.116-148.  Epub 26-Jan-2026. ISSN 1405-0218.  https://doi.org/10.5347/isonomia.62/2025/752.

Because of their high prices, patented drugs are becoming increasingly difficult to acquire by individuals and health budgets. Faced with this access problem, flexibilities of the patent system are commonly cited as a plausible legal tool to be used, especially by developing countries.Two aspects of these flexibilities are usually highlighted. On the one hand, they comprise a set of mechanisms (such as compulsory licenses, parallel imports or the definition of patenting requirements) aimed at tempering the outcomes of patent law in various ways. On the other hand, there is also the common idea that it is the national member states of the World Trade Organization who should define the requirements entailed by each mechanism. However, in addition to these features, it is not sufficiently clear what else they have in common and what distinguishes each mechanism.The paper shows the advantage of carrying out a theoretical-conceptual analysis of the flexibilities of the patent system by understanding most of them as exceptions of the enforcement of rights.

The paper provides a conceptual framework based on a specific understanding of patent rights and the analysis of norms that give a greater clarity to a topic that has been under-theorized.

Palavras-chave : flexibilities; TRIPS agreement; pharmaceutical patents; exceptions.

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