Brazil has entered a new phase in the legal treatment of deposits of biological material for patent procedures. The change is particularly relevant to biotechnology, pharmaceutical, diagnostic, agricultural and industrial microbiology portfolios.
What is the Budapest Treaty?
The Budapest Treaty establishes international recognition of microorganism deposits for patent procedure. Instead of requiring separate deposits in each country, Contracting States recognize a single deposit made with an International Depositary Authority (IDA).
In practice, the system is used not only for microorganisms but also for biological materials accepted by individual IDAs, including cells, tissue cultures, fungi and plasmids.
The Brazilian timeline
Brazil deposited its instrument of accession with WIPO on October 20, 2025. According to the official notification, the Treaty entered into force for Brazil on January 20, 2026.
On June 9, 2026, Decree No. 13,011 promulgated the Budapest Treaty and its Regulations in Brazil, consolidating its incorporation into the domestic legal framework.
Why biological deposits matter
A patent application must disclose the invention clearly and completely enough for a person skilled in the art to carry it out. For some biotechnology inventions, a written description and drawings may not be sufficient to reproduce the biological material involved.
A deposit with a qualified institution may supplement the description. The authority preserves viable, uncontaminated material and furnishes samples under the applicable treaty, regulations and national law.
Practical consequences for Brazilian applications
Accession strengthens the legal framework for recognizing deposits made with IDAs in Brazilian patent procedures. The PCT Applicant’s Guide for Brazil provides that deposits may be made with institutions holding international depositary authority status and identifies the information expected by the Office.
Brazilian institutions may now be nominated to seek IDA status, but accession itself does not automatically create a Brazilian IDA. Each institution must meet the Treaty requirements and complete the international procedure.
- Assess whether a deposit is needed to supplement disclosure.
- Confirm that the selected IDA accepts the relevant material.
- Coordinate deposit timing with priority and filing dates.
- Provide deposit details and available material characteristics.
- Review sequence listings and other INPI technical requirements.
Impact on biotechnology and life sciences
The new framework should reduce uncertainty and bring Brazilian practice closer to the international system used for biotechnology portfolios. It may be relevant to microorganisms, bioprocesses, biological inputs, cellular platforms, vectors and genetic materials.
The Treaty does not replace substantive patentability analysis under Brazilian law. Novelty, inventive step, industrial application, sufficiency of disclosure and statutory exclusions remain subject to INPI examination.
Next steps for rights holders and foreign associates
New applications and families approaching Brazilian national phase entry should be reviewed early. IDA receipts, accession numbers, viability information and submissions in other jurisdictions can be important to a consistent Brazilian strategy.
Foreign associates should provide Brazilian counsel with complete deposit documentation and the relevant international prosecution history so the local approach can be coordinated with the wider portfolio.
Each patent application requires an individual assessment of the material, deposit timing, disclosure, sequence listings and applicable INPI requirements. This article is informational and does not constitute legal advice.