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The new framework aims to accelerate access to medicines, attract investments, and enhance Brazil’s global competitiveness in clinical research.

A new milestone for science and innovation

The Brazilian government has enacted the new Clinical Research Law, marking a significant step toward strengthening the country’s scientific and innovation ecosystem.

The regulation provides greater legal certainty and streamlined procedures, making Brazil a more attractive destination for international research and development initiatives.

Currently ranked 20th globally in clinical research participation, Brazil is expected to rise to 10th place following the implementation of the new rules.

Economic potential and market impact

According to a study by Interfarma and IQVIA, the new law could generate BRL 2.1 billion (approx. USD 400 million) in direct annual investments, with an economic impact exceeding BRL 6.3 billion per year. Additionally, an estimated 56,000 scientific professionals could be involved in new research projects.

Brazil stands out for its cost advantages, diverse population, and qualified research centers, which strengthen its position as a strategic hub for global clinical studies.

Faster and more efficient approval processes

The new regulation significantly shortens approval timelines for clinical trials:

• From 180 to 30 days for Ethics Committees (CEPs);
• Up to 90 business days for ANVISA evaluations;
• And 15 business days for strategic or emergency public health studies.

These changes aim to make Brazil’s regulatory environment more agile, transparent, and competitive in the global R&D landscape.

A boost for innovation and collaboration

The Ministry of Health expects the new framework to double the number of clinical studies conducted in Brazil, strengthening cooperation between public institutions, private industry, and international organizations.

Beyond advancing innovation, the measure should stimulate the local pharmaceutical industry, create jobs, and expand access to innovative treatments.

Tavares IP continues to monitor regulatory developments shaping innovation and intellectual property in Brazil.

Read more insights about the IP landscape on our blog.

The Brazilian National Institute of Industrial Property (BPTO) hosted the 2nd Symposium of the Community of Practice (CoP) in IP Analytics, organized in partnership with the World Intellectual Property Organization (WIPO). This was the first edition of the event held outside Geneva, Switzerland.

The symposium brought together 31 representatives from 11 countries — including Brazil, South Africa, Canada, China, and Spain — as well as institutions such as WIPO, the European Union Intellectual Property Office (EUIPO), and the Organisation for Economic Co-operation and Development (OECD). The main goal was to exchange experiences and discuss methodologies and applications of IP analytical studies.

Topics included data storytelling in IP, patent and intangible asset indicators, and the use of IP data to support public policy. Discussions also addressed the use of analytics to assist patent examiners, the expansion of the community’s scope to include all IP assets, and the relevance of analytical research for sustainable and technological development.

The program featured technical sessions, collaborative activities, and a visit to Petrobras’ Research Center (Cenpes). Representatives from WIPO and BPTO highlighted the collaborative nature of the initiative and the intention to expand participation in future editions.

The event underscored the growing importance of IP Analytics as a tool to inform innovation policies and assess the economic and social impact of Intellectual Property.

São Paulo has climbed to the 49th position in the World Intellectual Property Organization’s (WIPO) ranking of global science and technology clusters — a remarkable jump of 24 spots. The rise reflects the inclusion of venture capital (VC) as a new indicator in the Global Innovation Index, highlighting the role of high-growth investments in fostering innovation.

Alongside Mexico City, São Paulo is the only hub in Latin America to appear in the world’s top 100. Over the course of four years, the city recorded 684 international patent applications, 24,349 scientific publications, and 1,587 venture capital deals.

The result underscores São Paulo’s growing relevance in the global innovation ecosystem and the importance of VC investments in supporting startups and frontier technologies.

The Brazilian Patent and Trademark Office (BPTO) has been awarded the Follett Humanized Management Prize during a ceremony held on September 26 in Covilhã, Portugal. This international recognition honors organizations that promote human development in their management practices.

BPTO’s winning initiatives included the Integration Meetings, the participatory process for drafting internal policies, the Quality of Life Program (Vita), and the My Legacy Project, which celebrates the career achievements of its staff.

As a result, BPTO will be entitled to use the Humanized Management Seal of Excellence and publish its experience in Conecte-se Magazine, by PUC Minas Gerais.

On September 22, in Rio de Janeiro, the Brazilian Patent and Trademark Office (BPTO) and the China National Intellectual Property Administration (CNIPA) signed an agreement extending the Patent Prosecution Highway (PPH) pilot program between the two countries until 2029.

The memorandum was signed during the 17th Meeting of BRICS Intellectual Property Offices, attended by BPTO President Júlio César Moreira and CNIPA Vice Commissioner Lu Pengqi.

Through the PPH, applicants can utilize examination results from one office to expedite the review process in the other, thereby reducing both time and costs. Brazil currently has 35 PPH partnerships, including with Germany, the United States, Canada, the United Kingdom, and the European Union.

The Brazilian Patent and Trademark Office (BPTO) and Sebrae held an online event to discuss proposed changes to the rules for registering Geographical Indications (GIs), currently governed by BPTO Ordinance No. 4, dated 2022. A public consultation on the matter is now open and will run until October 17.

Key proposals include merging the preliminary and substantive phases of the application process, a measure that is expected to simplify and accelerate registrations. New requirements for the Bylaws of applicant associations are also under discussion, ensuring stronger accountability from producers throughout all stages of the process, including after registration is granted.

Brazil currently has 142 Geographical Indications across 25 states, covering 1,836 municipalities. In 2025 alone, 16 new GIs have already been recognized in nine states, underscoring the growing importance of this tool in enhancing local production and improving competitiveness in both domestic and international markets.

The public consultation is available on the BPTO website.

Contrary to common belief, many liberal authors argue that patents are not a natural form of private property, but rather state-granted monopolies that restrict competition and create artificial scarcity.

In developing countries, the international patent system — especially under agreements like TRIPS — often limits technological progress and access to essential goods, particularly medicines. By ensuring legal monopolies, these rules can raise prices and deepen economic inequalities.

Brazil’s Generic Medicines Law (Law No. 9,787/1999) represents a landmark example of patent flexibilization. By allowing the production of generics after patent expiration, and in some cases before, it reduced prices and expanded access to affordable medications. Today, generics account for more than 70% of prescriptions in key therapeutic areas, saving Brazilian consumers an estimated US$60 billion since implementation.

This case demonstrates that rethinking patents is not only a matter of social justice but also a matter of genuine economic freedom, fostering competition, reducing costs, and boosting local production.

The Brazil Innovation and Development Index (IBID) 2025 was launched last Friday (29) during the Startup Summit in Florianópolis. Created by the BPTO in 2024, the index has established itself as the primary reference for innovation in Brazil, encompassing all five regions and the 27 states, based on the methodology of the WIPO Global Innovation Index.

According to BPTO President Júlio César Moreira, the IBID helps identify regional potential and guide public policies. Chief Economist Rodrigo Ventura highlighted the new geography of Brazilian innovation, marked by decentralization and the emergence of innovation hubs across the country.

The ranking shows São Paulo, Santa Catarina, and Paraná as national leaders, while the state of Amazonas climbed three positions. Northeast states also performed above expectations considering their income level, reinforcing the regional dynamism of Brazil’s innovation landscape.

According to the Brazilian Patent and Trademark Office (BPTO), trademarks, patents, and other intangible assets already represent 47% of total investments in Brazil.

Investments in intangible assets (such as trademarks, patents, research, and development) now account for almost half (47%) of all investments in Brazil, according to a report released by the Brazilian Patent and Trademark Office (BPTO).

The data, presented by the institution’s Chief Economist, Rodrigo Vieira Ventura, highlight a turning point for Brazilian companies: firms are now investing nearly as much in innovation as they are in physical assets, such as machinery and factories.

This shift positions innovation as a key driver of the Brazilian economy, with an impact greater than that of agribusiness (8% of GDP) and mineral extraction (5.5%). Currently, investments in intangible assets account for 8.5% of Brazil’s GDP, growing at a rate of 0.8 percentage points per year, while investments in physical assets are declining at a rate of two percentage points per year.

Regional highlights

Although innovation remains concentrated in the South and Southeast regions, other states are also emerging. Amazonas, for example, rose three positions between 2024 and 2025 in the Brazil Innovation and Development Index (IBID), moving from 20th to 17th place.

São Paulo remained the leader, with a score of 0.872 on a scale from 0 to 1, which is 3.1 times the national average (0.296). Other states above the national average were Santa Catarina, Paraná, Rio de Janeiro, Rio Grande do Sul, and Minas Gerais.

Regional leaders in innovation in 2025 were:

• Southeast: São Paulo
• South: Santa Catarina
• North: Amazonas
• Northeast: Rio Grande do Norte
• Center-West: Brasilia

Strategic importance

The growing share of intangibles highlights the importance of intellectual property as a vital asset for companies seeking to compete globally.

At Tavares IP, we assist international firms in securing and protecting their intangible assets in Brazil. Please get in touch with our team to learn more about our solutions in trademarks, patents, and technical translations.