On Wednesday, June 11, the Brazilian Federal Senate approved Brazil’s accession to the Budapest Treaty, which establishes the international recognition of the deposit of microorganisms as part of the patent application process. The Legislative Decree Bill (PDL 466/2022) now moves forward to promulgation.
The proposal had already been approved by the Foreign Relations Committee (CRE) with a favorable report by Senator Nelsinho Trad (PSD-MS), presented on the Senate floor by Senator Hamilton Mourão (Republicanos-RS).
Signed in 1977 and administered by the World Intellectual Property Organization (WIPO), the Budapest Treaty currently includes over 80 signatory countries. Brazil’s accession represents a strategic step forward in the field of biotechnology, with significant impact for inventors, innovative companies, and scientific institutions.
What Changes with Brazil’s Accession to the Treaty?
- Brazil will be able to designate national institutions as International Depositary Authorities (IDAs), such as Embrapa’s Cenargen (Genetic Resources and Biotechnology Center), eliminating the need to send biological materials abroad.
- Lower costs and fewer technical hurdles for Brazilian applicants, who currently rely on depositary centers located in Mexico and Chile.
- Increased legal certainty for patent applications involving microorganisms, particularly regarding sufficiency of disclosure.
- Strengthening of Brazil’s national intellectual property system and better integration of Brazilian researchers into global innovation ecosystems.
To be recognized as an IDA, an institution must meet specific criteria, such as having adequate technical infrastructure, ensuring appropriate levels of security and confidentiality, and being able to issue receipts and preserve samples. Accession to the Treaty also fosters a regulatory environment favorable to innovation and bioeconomy development.
Political Context: The proposal was approved by the Chamber of Deputies in November 2024 and has now passed the Senate with the technical support of the Ministry of Foreign Affairs. According to the official justification, this measure is part of a broader national strategy to boost biotechnology, including initiatives such as the creation of the Biological Resource Centers Network (Rede CRB).
Our Perspective: From an intellectual property standpoint, Brazil’s accession to the Budapest Treaty fills a longstanding regulatory gap and may significantly accelerate the development of technologies involving living organisms. From a government affairs perspective, this move is consistent with Brazil’s broader effort to reposition itself globally in the areas of scientific and technological innovation. It is not expected to face opposition in the Senate Plenary.
Our team will continue to monitor developments in Congress and the practical implications for clients in the biotechnology, healthcare, agribusiness, and pharmaceutical sectors.
Please feel free to contact us with any questions or to explore how this change might benefit your business.