Legal shift in biotechnology: Brazil joins the Budapest Treaty

On June 24, 06, Legislative Decree No. 2025 was published, formalizing Brazil's accession to the Budapest Treaty. As of this date, with this measure, the country formally joins the international system that facilitates the patent protection of biotechnological inventions, especially those based on microorganisms, eliminating operational barriers and raising the level of competitiveness of scientific research and national industry. The new legislation represents a significant advance for the Brazilian intellectual property system, with direct impacts on several industrial sectors, particularly agriculture (biodefensives and bioinputs).

A patent application requires a complete description of the invention that is sought to be protected. The instructions must be clear enough so that a technician in the field can reproduce the commercial product or production process without unnecessary or excessive effort. In cases where the invention involves biological material - microorganisms - the written description is not considered sufficient to meet this objective, and it is therefore necessary, in addition to the text of the patent application, to deposit samples of the microorganisms in a reference center.

In recent years, Brazil has made progress on important legislative fronts related to patent protection in biotechnology, with emphasis on the discussion surrounding Legislative Decree Project (PDL) No. 466/2022, aiming at the country's entry into the Budapest Treaty.

This topic has direct implications for the legal protection of biological innovations, especially those involving the use of microorganisms. A proper understanding of this scenario is essential for researchers, companies, universities and consulting firms that work with Intellectual Property in Brazil.

What is the Treaty of Budapest and why does it matter to Brazil?

The Budapest Treaty, created in 1977 and administered by the World Intellectual Property Organization (WIPO), establishes that the deposit of microorganisms with an International Depositary Authority (IDA) is recognized by all of the current 90 signatory countries for patent purposes. Thus, a deposit with one of these authorities is valid for all signatories.

Until then, Brazil was not yet a signatory to this treaty, which forced Brazilian companies and researchers to send samples of microorganisms to centers abroad, involving extremely high costs, complex logistical requirements and long deadlines.

Furthermore, Brazil's accession to the treaty paves the way for national institutions, such as the Brazilian Agricultural Research Corporation (Embrapa), the Oswaldo Cruz Foundation (Fiocruz), the Federal University of Rio de Janeiro (UFRJ) and the Rio de Janeiro Cell Bank, to become recognized IDAs, enabling deposits in the country. There are currently 52 foreign IDAs certified by the treaty. The best known are the American Type Culture Collection (ATCC), located in the USA, and the German Collection of Microorganisms and Cell Cultures (DSMZ), located in Germany. In Latin America, there are only two IDAs: the Chilean Collection of Microbial Genetic Resources (CChRGM), in Chile, and the Collection of Microorganisms of the National Center for Genetic Resources (CM-CNRG), in Mexico.

There is an urgent need to reduce bureaucracy, streamline and reduce costs

In 2010, Embrapa needed to send three plasmids of the Escherichia coli bacteria to the ATCC in the USA. To do so, it hired a specialized transport company for biological material, responsible for collecting the samples in the laboratory and taking them to the international airport in Brasília. The shipment required complex procedures, including specific packaging, technical forms and the payment of an additional fee to the airline. In the USA, it was necessary to contact a local attorney to clear the material through customs and deliver it to the ATCC, which currently charges US$2.500,00 per microorganism (more than R$12), an amount that covers receipt, viability testing and conservation of the material for 30 years.

Another direct benefit of joining the Budapest Treaty is the time saved in applying for and processing biotechnology patents. Currently, inventors can only file an application with the INPI after depositing the biological material in an IDA abroad, which involves long shipping, customs and health control times. Since microorganisms have a limited shelf life, delays can make them unviable. This is what happened to Embrapa when sending E. coli plasmids in 2010: on the first attempt, the materials arrived dead in the US, forcing the entire process to be repeated, with doubled costs and time. The existence of a depository center in Brazil would avoid this type of setback, accelerating the innovation cycle.

Practical examples

Sectoral impacts of accession to the Budapest Treaty

Adhesion will bring significant benefits to several sectors.

Agribusiness and agricultural biotechnology:

• The main use of microorganisms in Brazil today is in agriculture, with bioinputs.

• Facilitates the protection of bioinputs, such as growth-promoting microorganisms and biological control agents.

• It encourages research and development (R&D) in sustainable agriculture and the strengthening of production chains based on national innovation.

Pharmacist and health:

• Allows full patentability of probiotics, vaccines, antibiotics and innovative therapies based on microorganisms.

• Reduces barriers for startups and biomedical research centers in Brazil.

Environment and genetic resources:

• It values ​​Brazilian biodiversity by allowing formal protection involving endemic or symbiotic microorganisms.

• It requires solid mechanisms for sharing benefits and combating biopiracy, promoting the sustainable and sovereign use of natural resources.

Academia and public research:

• Democratizes access to the patent system for researchers, universities and public research institutions.

• It transforms Brazil into a possible regional reference in the protection of microbiological assets.

Chemical industry:

• It stimulates the development of fermentation products and processes, industrial enzymes and patentable biotransformations.

• Increases the international competitiveness of Brazilian products based on biotechnology.

Conclusion: decisive moment and window of opportunity

The approval of the PDL and its conversion into a legislative decree, incorporating Brazil into the Budapest Treaty, is a historic milestone for the country's patent system, with the potential to generate gains in efficiency, technological sovereignty and global competitiveness. We are facing a strategic window to foster innovation, expand the protection of biological assets and support the different links in the national production chain. In addition, adherence to the Treaty tends to significantly reduce the time and costs of international submissions and procedures abroad, promoting speed and direct financial savings for Brazilian researchers, companies and institutions that work with biotechnology.

By Pedro Moreira, pharmacist and industrial property agent