Brazil: Understanding the New Bioinputs Regulation and Patent Landscape


Brazil's agricultural sector has consistently been a key player in the global economy, significantly impacting both international and domestic markets. In 2022, Brazil ranked as the fourth largest grain producer and the second largest exporter worldwide, with agribusiness products representing nearly half of the nation's total exports by 2024. Innovation is crucial for the sector's advancement, particularly regarding bioinputs—biological products that boost productivity and sustainability in agriculture, aquaculture, and forestry. Recently, the Brazilian Congress introduced a regulatory framework for bioinputs, while the Brazilian Patent and Trademark Office (INPI) published studies on patent trends and challenges in protecting these technologies. Law #15,070/2024, enacted on December 23, 2024, establishes comprehensive regulations for the production and use of bioinputs, addressing previous regulatory gaps. A significant aspect of this law is the allowance for on-farm production, enabling farmers to create tailored bioinputs on-site. However, this practice raises concerns about potential misuse, including the risk of ineffective products and infringement on intellectual property rights. The law permits on-farm production solely for personal use and mandates simplified registration for production units, while prohibiting the commercialization of bioinputs. Further provisions require adherence to good manufacturing practices and transport protocols, ensuring traceability and safety. Additionally, the law outlines the roles of various agencies, including ANVISA and IBAMA, in the registration process for new bioinputs, while exempting those intended solely for export from registration requirements. To foster the bioinputs sector, the law introduces incentives for research and development, particularly benefiting small-scale producers and traditional communities. In summary, this new legislation represents a significant advancement in establishing a robust legal framework for bioinputs in Brazil, promoting innovation and sustainability while addressing key regulatory concerns. However, the practical application of these provisions will depend on subsequent regulations from the Ministry of Agriculture and Livestock, which will be vital in defining the operational landscape for bioinputs.



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