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Brazil is positioned as the largest pharmaceutical market in Latin America, accounting for 38% of the region’s revenue in 2024. With a market estimated at $34.4 billion that year, the sector is projected to reach $42.2 billion by 2035. In addition, the country has a significant history of 89,925 agrifood patents filed since 2010.
In the industrial property scenario, the Brazilian PTO has been presenting significant operational advances:
Volume of filings: In 2025, the Brazilian PTO registered 29,557 patent filings (a growth of 6.7%, marking the best result since 2016) and granted 13,624 patents.
Backlog reduction and resumption: The backlog of pending applications was significantly reduced, but recent studies indicate that the queue has begun to grow again. A survey released in May 2026 shows that the stock of applications awaiting a preliminary examination – which had been reduced to levels around 60,000 – has started to rise again, in a context where the average time to reach a first decision remains high; for instance, it reaches 6.8 years in the
pharmaceutical sector, approximately 20% above the overall average.
Profile of foreign filings: In 2024, the sectors that led the filings by non-resident applicants were Pharmaceutical (11.2%), Fine Organic Chemistry (8.1%) and Basic Materials Chemistry (5.9%).
International dominance: Applicants from 89 countries sought protection at the Brazilian PTO in 2025. The main countries of origin were the United States (23.5%), China (10.5%), Germany (5.2%) and Switzerland (4.1%). Among the most prominent foreign companies in the areas of medicinal preparations, fine chemistry and food technology are Novartis, Nestlé, BASF and Bayer.
For the chemistry professional, patent classification functions as a vital tool for competitive intelligence and legal certainty. It defines the internal technical distribution at the Brazilian PTO (determining whether the examination will fit into divisions such as Biotechnology, Organic Chemistry or Medicines), serves as an essential instrument for the search for prior art (evaluation of novelty and inventive step) and enables the monitoring of competitors.
The Brazilian PTO adopts two complementary systems:
IPC (International Patent Classification): Mandatory and used since 1971. In 2025, the Brazilian PTO worked on the translation of 517 new groups to IPC version 2026.01, which came into force in January 2026.
CPC (Patent Cooperation Classification): Adopted as a supplementary scheme in 2013. By February 2026, Brazil had more than 862,000 filings accessible via CPC (considering patente families), streamlining cross-searches based on the EPO and USPTO.
Brazil is actively involved in the evolution of the global ranking. In 2025, Brazilian PTO acted as rapporteur for strategic projects in the area of Chemistry with the World Intellectual Property Organization (WIPO):
Guidelines to the Foreign Applicant: Since July 2025, the process has become more transparente through DIRPA Ordinance No.11/2025, which standardized classification procedures in accordance with WIPO guidelines. It should be noted that, with each annual update of the IPC, the documents may be automatically reclassified by the Brazilian PTO, which changes the visibility of the portfolio in third-party searches.
Understanding the rules of the Brazilian IP Law (BIPL) is crucial, as Brazil imposes specific restrictions that differ from other jurisdictions.
Exclusions (Non-Patentable): Therapeutic and surgical methods are not eligible for protection (Article 10 (VIII) of the BIPL. Polymorphs and salts undergo strict scrutiny as to the requirement of qualified novelty, requiring the demonstration of genuine inventive step.
Protection opportunities: Regulatory strategy requires claiming compositions, formulations, or the use of compounds. Second medical uses are accepted by the Brazilian PTO in the form of a “Swiss formula” (indirect form of protection), mandatorily written as: “use of compound X in the preparation of a drug for the treatment of Y”. Small molecules with structural novelty and proven pharmacological effect are also protectable; controlled release systems (nanoparticles,
liposomes, microencapsulation); monoclonal antibodies and biopharmaceuticals (claimed as composition or process); and prodrugs (strategy to circumvent limitations of novelty in known compounds).
Exclusions (Non-Patentable): Natural extracts per se without an innovative extraction process, are not accepted. Cosmetic properties without inventive step — such as trivial pH adjustments or simple addition of fragrances without ifferentiating technical effect — tend to be refused.
Protection Opportunities: Protection should fall on specific formulations or manufacturing processes (such as synthesis of surfactants, emulsifiers and conditioning polymers with non-obvious steps). Finished products (perfumes, sunscreens, hygiene items) with innovative mechanisms, cosmetic peptides and UV filters of organic synthesis (sector with strong filings of companies such as L’Oréal, Unilever and Shiseido) are patentable. Functional packaging with controlled dosage or active release can be safeguarded as invention patents or utility models.
Exclusions (Non-Patentable): Natural food products, fruits, grains and unprocessed inputs are prohibited. Cultivars and plant varieties are protected by a different legal regime (Cultivars Protection Law 9.456/97) managed by the Ministry of Agriculture and Livestock (MAPA), and not by the Brazilian PTO.
Protection Opportunities: Protection falls on the processing, transformation processes and the resulting compositions. These include extraction technologies, flavor encapsulation, innovative fermentation techniques, as well as applied enzymes, modified starches and fat substitutes. Probiotics, prebiotics and fortified foods with proven physiological action are patentable, as well as food contact materials with active functions (antimicrobial, antioxidant or freshness
indicators).
The protection strategy requires attention to mandatory sectoral regulators that act in parallel with the Brazilian PTO:
| Area | Regulator | Main Standards |
|---|---|---|
| Pharmaceutical | ANVISA + Brazilian PTO | BIPL 9.279/96 · Law 14.195/2021 · RDC ANVISA |
| Hygiene & Cosmetics | ANVISA | RDC 752/2022 · RDC 07/2015 · Law 15.154/2025 |
| Food & Beverage | ANVISA + MAPA | RDC 429/2020 (labeling) · Cultivars Law 9.456/97 · IN MAPA |
| Biocides and agrochemicals | MAP + ANVISA + IBAMA | Law 7.802/89 · Decree 4.074/02 |
| Synthesis ingredients | ANVISA | Category-specific RDC · Brazilian Pharmacopoeia |
End of prior consent (Law 14.195/2021): Since August 27, 2021, pharmaceutical patente examinations have been processed directly and exclusively at the Brazilian PTO, failing to undergo prior evaluation by ANVISA. The measure resulted in the immediate unblocking of more than 1,134 applications.
RDC 752/2022 (Cosmetics): Defines the criteria and degrees of risk for Personal Hygiene, Perfumery and Cosmetics (HPCs) products, directly impacting the substantiation of claims for specific effects in patents.
Law 15.154/2025 (Artisanal Exemption): Grants artisanal cosmetics the exemption from registration with ANVISA, however, they remain bound and subject to the patent system of the Brazilian PTO if they intend protection.
Plant breeding and biotechnology: Genetically modified plant varieties go to MAPA via Law 9.456/97, but the biotechnological processes used to obtain them remain patentable at Brazilian PTO.
WIPO Standard ST.26: Since July 2022, the application of the ST.26 standard has been mandatory for the presentation of amino acid or nucleotide sequences in biotechnological filings for pharmaceutical or food use.
For the chemical and pharmaceutical divisions, Brazilian PTO provides prioritization tools capable of reducing the regular analysis time (6 to 8 years) to periods between 9 and 16 months
CNV offers specialized support to international companies in the technical management of assets with the Brazilian PTO:
Strategic claims: Drafting and precise adjustment of the set of claims to eliminate challenges related to non-patentable matters or reach-through claims clauses.
Post-examination amendments (Article 32 of the BIPL): Legislation limits voluntary amendments to the period prior to the request for examination, permitting—after that stage—only amendments that clarify or better define the application, without introducing new subject matter or expanding the scope of the claims, as well as restrictive adjustments accepted by the Brazilian PTO under current administrative practice. In these scenarios, the CNV acts strategically and in strict adherence to the Industrial Property Law, structuring clarifying and restrictive amendments aligned with Brazilian PTO guidelines to strengthen the applicant’s position during examination, without creating unnecessary risks of future cancellation (nullity) or inquiry regarding compliance with Article 32.
Technology transfer and contracts: Recordal and registration of license agreements with Brazilian PTO, consultancy on the rule of ownership of improvements (which belong to those who developed them), in addition to the preparation of NDAs (Confidentiality and Non-Competitiveness Agreements) and Patent Distribution and Commercial Representation Agreements.
Acceleration and intelligence: Documentary audit for classification in priority examination pathways (Fast-Track), technological monitoring of competitors and market surveillance to protect R&D or challenge blockages, in addition to corporate training focused on practical distinctions between the Brazilian system and other international jurisdictions.