Brazil adheres to the Budapest Treaty: what changes for biotechnological patents

On June 10, 2026, Decree No. 13.011, of June 9, 2026, was published in the Official Gazette, promulgating Brazil’s accession to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. The treaty was originally signed in Budapest on April 28, 1977, and modified on September 26, 1980.

Brazil’s accession follows a rite that began with approval by the National Congress (Legislative Decree No. 174, of June 23, 2025), followed by the deposit of the instrument of accession with the World Intellectual Property Organization (WIPO) on October 20, 2025. In terms of external legal effect, the treaty was already in force for Brazil since January 20, 2026. Now, with its promulgation by Decree 13.011, the treaty produces effects in Brazilian domestic law.

What is the Budapest Treaty

The Budapest Treaty solves a practical problem of the international patent system: when an invention involves a microorganism (a bacterium, fungus, yeast, or cell line), the written description is not sufficient for a third party to reproduce the invention. It is necessary to deposit a viable sample of the microorganism in a recognized depository institution.

Before the treaty, this had to be done in each country where the patent application was filed — an expensive, slow, and logistically complex process. The Budapest Treaty simplifies this by establishing that:

The deposit of a microorganism with a single International Depositary Authority (IDA) is recognized for all purposes of patent procedure in all signatory countries.

Today, there are 48 IDAs in operation around the world, in countries such as the United States (ATCC), Germany (DSMZ), the United Kingdom (NCIMB), Japan (NITE), and China (CGMCC).

The three pillars of the treaty

The Budapest Treaty has three fundamental objectives, as per the text promulgated by Decree 13.011/2026:

What changes for the Brazilian depositor

In the short term, nothing changes in INPI procedures. As the Institute itself highlighted in its official note, the Examination Guidelines already require that the deposit of biological material be made with a recognized IDA — and these IDAs are currently all abroad. Accession to the treaty does not alter current procedures.

In the medium term, the change is significant. As a signatory to the Treaty, Brazil can now seek recognition for national institutions with WIPO to act as International Depositary Authorities (IDAs). Institutions such as Embrapa and Fiocruz are already mobilizing for this recognition.

When Brazil has a recognized IDA:

• Brazilian researchers will be able to deposit their samples in national territory, eliminating international shipping costs, customs fees, and logistical risks associated with transporting biological material abroad
• National institutions (such as Embrapa, Fiocruz, university culture collections) will be able to obtain new sources of revenue from providing deposit, storage, and sample supply services
• The scientific community will have faster access to deposited biological material for research purposes — IDAs are obliged to provide samples to third parties under the conditions stipulated in the treaty

Implications for the innovation ecosystem

Agricultural biotechnology

Embrapa, with its vast collection of microorganisms of agricultural interest, is particularly well-positioned to become an IDA. This would directly benefit:

• Agricultural biotechnology startups that develop inoculants, biofertilizers, and bioinputs
• Genetic improvement programs that depend on patented strains
• Research with microorganisms from Brazilian biodiversity — a strategic asset

Health biotechnology

Fiocruz, with its culture collections and biosecurity infrastructure, is a natural candidate for an IDA. For the pharmaceutical sector:

• Patents for biological and immunobiological medicines involving cell lines
• Development of vaccines and diagnostic kits
• Research with microorganisms from Amazonian biodiversity and other biomes

Regulatory impact

Accession to the Treaty also aligns with other ongoing regulatory agendas:

• The Biodiversity Law (Law 13.123/2015) and the rules for access to genetic heritage
• The Legal Framework for Biotechnology and discussions on intellectual property of genetic sequences
• The INPI’s guidelines for biotechnological patent examination, which have been updated since the 2023 review

The path so far

Brazil’s accession to the Budapest Treaty did not happen overnight. The process involved:

Lessons for startups and deep techs

For companies operating in biotechnology, the message is clear:

1. Brazil is integrating into international IP systems. After joining the Madrid Protocol (trademarks, 2019) and the PCT system (patents, already consolidated), accession to the Budapest Treaty completes the framework for international protection of biotechnological inventions.

2. The Brazilian IDA will reduce costs and deadlines. Companies that currently send samples abroad (ATCC, DSMZ) will be able to make deposits locally — with simpler logistics and potentially lower costs.

3. Monitor the recognition of Brazilian IDAs. Embrapa and Fiocruz are at the forefront, but other institutions — university culture collections, state research centers — may also claim the status. Each new IDA is an alternative deposit option for the national depositor.

Below, a lecture by my advisor, Prof. Dr. Tatiana Duque Martins, on the Budapest Treaty and its importance for Brazilian biotechnology.

Read also:

• The INPI backlog is over — but not for drug patents
• ADI 5.529: the STF’s decision that shortened drug patents in Brazil
• LPI at 30 years: INPI releases report with proposals for improvement of the Industrial Property Law

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