Influence and convergence to higher standards: The dual examination of pharmaceutical patents in Brazil

What the paper says

Abstract Between 2001 and 2021, pharmaceutical patent applications filed in Brazil were examined by the patent office (INPI) and the national health regulator (Anvisa). This paper investigates how health regulators can contribute to patent examination by shifting the set of criteria cited as grounds for 2589 negative decisions from both entities. Initially, the INPI focused on the traditional criteria of novelty, inventiveness and industrial applicability, while Anvisa adopted a more diverse approach and cited invention description most often. Over time, the entities converged to higher citation rates, with more criteria being considered relevant, indicating greater examination rigour. The most significant shift was the INPI's decisions becoming closer to Anvisa's than to its own previous decisions, and this paper provides concrete evidence of Anvisa influencing changes in the INPI's guidelines. Once Anvisa's main contribution became non‐binding opinions, this policy's stability and enforcement were strengthened, and having both entities became almost symbiotic or mutually nutritious. Still, the lack of clarity about shared responsibilities and the intense debate that ensued have made implementing this multi‐entity policy even more complex. Thus, this paper provides lessons about the dual examination system and similar policies as flexibilities within the Trade‐Related Aspects of Intellectual Property Rights (TRIPS) Agreement.