Written by Carolina Mazzocato* and Rafael Garutti**
Deposit of Biological Materials: A Crucial Prerequisite
For inventions involving biological material, its deposit may be required to ensure the disclosure is sufficiently clear and complete for the invention to be performed by a person skilled in the art, especially when the biological material is not publicly accessible. If required, the deposit must be made at an institution recognized by the Brazilian PTO or designated under international agreements. This requirement is established by Art. 24 of the Brazilian Industrial Property Law (BIPL, Law No. 9.279/96) to fulfill the enablement criteria.
Although Brazil is not yet a member of the Budapest Treaty, the Brazilian PTO accepts deposits made with an International Depositary Authority (IDA). The country’s accession to this Treaty was approved by the Chamber of Deputies in November 2024 and awaits ratification by the Senate. Consequently, the country does not currently host an IDA and applications must use facilities abroad. The only IDA currently operating in Latin America is in Chile: the Chilean Microbial Genetic Resources Collection (CChRGM).
WIPO ST.26 Standard
Since July 2022, Brazil has adopted the ST.26 standard for listing biological sequences, following the WIPO global guideline. This standardized XML format replaces the previous ST.25 standard. The ST.26 format is mandatory from the beginning of the application writing, for applications involving nucleotide or amino acid sequences.
What is Patentable in Biotechnology in Brazil?
Brazil adopts a more restrictive model than countries such as the USA or Japan, although it shared significant similarities with the European Union’s approach. Consequently, not everything can be protected by patent in Brazilian territory. According to the BIPL and the Brazilian PTO guidelines:
- The following are patentable: transgenic microorganisms, vectors, plasmids, compositions with DNA/RNA, industrial methods involving microbiological processes.
- The following are not patentable: therapeutic and diagnostic methods in humans/animals, discoveries, natural living beings (or parts, even modified) found in nature or even isolated from it, including the genome or germplasm of any natural living being and natural biological processes, plants and animals, sequences isolated from nature per se.
Curiosities and Challenges of the Brazilian System
Brazil exhibits historical resistance to the patenting of living organisms, which reflects ethical, environmental and social concerns in the country.
As a signatory to the Convention on Biological Diversity (CBD) and the Nagoya Protocol, Brazil is committed to the fair and equitable sharing of benefits derived from the utilization of genetic resources. This commitment is primarily operationalized through specific domestic legislation governing access to Genetic Heritage and Associated Traditional Knowledge, such as Law no. 13.123/2015.
Non-compliance with this legislation may prevent the granting of a patent; therefore, it is essential to register access to the Brazilian Genetic Heritage and/or Associated Traditional Knowledge through the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SISGEN).
Furthermore, applicants should note the requirement to submit a Negative Declaration of Access to the Genetic Heritage to the Brazilian PTO if the patent application does not involve access to the national genetic heritage.
Conclusions and strategic considerations for foreign applicants
As previously outlined, Brazil is a country with considerable particularities; therefore, the first step is to hire a specialized intellectual property professional with a solid background in Biotechnology.
Verify if there is Brazilian Genetic Resource involved and regularize the access according to the legislation, presenting, if applicable, the negative declaration of access to the Genetic Resource and Traditional Knowledge or the deposit in an IDA.
Employ the mandatory ST.26 standard for genetic sequences from the beginning of the application writing to avoid rework and office actions.
Consider supplementary protection through the System of Cultivars or Trademark Registrations, depending on the technology.
Be aware of the normative updates, since Brazil is in constant debate about the modernization of the BIPL and the guidelines for Biotechnology.
* Carolina Mazzocato is a biologist and patent specialist at CNV IP Law Firm, with solid experience in Biotechnology, IP, and Innovation. She holds a degree in Biological Sciences (UFSCar), MBAs in ESG and Innovation & IP Management (PUC Minas and AVM), and a postgraduation degree in Biotechnology (UEM). Registered with CRBio-01 and trained by WIPO, INPI, and Brazilian Institutions. Fluent in Portuguese and English; intermediate in Spanish; basic in German and Italian.
** Rafael Garutti is a Brazilian Attorney at Law and senior partner at CNV IP Law Firm, with vast experience in IP strategy, trademarks, patents, and unfair competition. He holds an LL.M. in Business Law (FGV), an MBA in IP (UCAM), and a postgraduation degree in Data Protection (PUC Minas). Chair of INTA’s International Classification Subcommittee and recognized by IAM 300, WTR 1000, and WIPR. Fluent in Portuguese, English, and Spanish; speaks French and basic Chinese.
Source: AI-generated image (Gemini) 05/06/2025, 10:52 am
