Brazil Revises Its Patent Examination Guidelines for New Use Inventions: Key Changes and Remaining Challenges

BRPTO’s Rule #208/2017 sets forth the Examination Guidelines for Patent Applications in the Field of Chemistry, specifically addressing, in Chapter 9, the criteria for evaluating new uses of known products – particularly new medical uses – in Brazil.

On June 30, 2026, the BRPTO published and enacted Ordinance #80/2026, amending Chapter 9 and concluding the public consultation process initiated almost one year earlier through Call for Contributions #02/2025.

Compared to the initial draft published under Call for Contributions #02/2025, the final and official text reflects the efforts of stakeholders, including Brazilian and International associations, to achieve more balanced requirements, demonstrating the importance of a transparent dialogue between the IP community and the BRPTO.

This article reviews the new Ordinance and traces the key discussions over the past year that ultimately shaped the final text.

Key development: Post-Filing Data

According to Article 24 of the Brazilian Patent Statute (enablement requirement), the specification must describe the subject matter clearly and sufficiently so as to enable a person skilled in the art to carry it out and to indicate, when applicable, the best mode of execution.

Regarding new use inventions, the BRPTO’s interpretation set out in the original Guidelines (BRPTO’s Rule #208/2017) required the presence of evidence proving the claimed new use in the specification at the time of filing. In practice, this allowed, for instance, the submission of complementary information to demonstrate an equivalence of effect whenever an application included only in vitro tests or exemplified a single compound from a Markush formula.

The first draft for Chapter 9, published by the BRPRO in July, 2025, however, firmly stated that post-filing data should not be accepted to address lack of enablement, and that the submission thereof should be regarded as addition of new matter under Article 32 of the Brazilian Patent Statute¹. Consequently, only the uses of products unequivocally and sufficiently proved in the specification as filed (for instance, by means of in vivo tests, in the case of medical use inventions) would be considered enabled.

Example: If an application claims the use of enzyme X inhibitors for manufacturing a medicament to treat disease Y, but only inhibitor 1 is tested in vivo in the specification as filed, then only the use of inhibitor 1 will meet the enablement requirement. Inhibitors 2 and 3 must be excluded from the claims due to lack of enablement.

This restriction was widely challenged by stakeholders, as generating comprehensive in vivo data at the time of filing a patent application is highly impractical, given that such filings typically occur at an early stage in the development of the underlying technology.

Fortunately, the BRPTO has stepped back from this restriction, and has amended the final text, currently published as Ordinance #80/2026, to explicitly foresee the acceptance of post-filing data.

Applicants must be aware, however, that Ordinance #80/2026 makes clear that this type of evidence will only be considered admissible when the application as originally filed contains sufficient information to render the claimed use credible, rather than merely speculative.

Specifically, for new medical uses, in vitro, ex vivo, or in silico data can be used as a basis to claim therapeutic activity, though the BRPTO still refers to in vivo data as preferable to validate such an effect. In any case, if the application includes only instructions, research plans, descriptions of incomplete studies, or trials, the medical use will not be considered enabled.

With respect to compounds defined by a Markush formula, the therapeutic activity needs only to be demonstrated for at least one representative compound of each chemical class corresponding to the different substituents encompassed by the formula. In contrast, for antibody-related inventions, enablement will be recognized only for antibodies that are expressly characterized by their complementarity-determining regions (CDRs) or variable regions and are supported by experimental data in the working examples. These requirements are, however, aligned with the examination standards already adopted by the BRPTO for their respective product claims.

Dosage Regimen and Group of Patients: BRPTO’s Longstanding Restrictive Position is Maintained

Rule #208/2017 already reflects the BRPTO’s restrictive stance on medical use claims involving therapeutic features. While reference offices such as the USPTO and EPO accept further medical use inventions differing in dosage, administration regimen, patient group, or route of administration, the BRPTO considers that these features do not confer novelty to a known use, in addition to impairing the clarity of the claims, as they would be directed to the therapeutic treatment itself.

This position runs counter to developments in neighboring jurisdictions, such as Argentina, which in March 2026 repealed guidelines that had systematically excluded entire classes of pharmaceutical patent claims, and now permits dosage and administration regimen features, provided a non-obvious technical effect or unexpected therapeutic advantage is demonstrated.

Nonetheless, despite requests from several stakeholders, the BRPTO kept Ordinance #80/2026 unchanged on this regard. Therefore, dosage regimen- and patient group- related inventions remain, in the eyes of the BRPTO, not entitled to patent protection.

Important Clarifications on Non-Medical Use Features and Accessory Use Claims

Following the public consultation process, Ordinance #80/2026 presents a disclaimer clarifying that, in non-medical fields, features relating to the mode of application, dosage, site of application, and other operational parameters may form part of the invention and, wherever appropriate, can contribute to the novelty of the claimed use. This clarification is particularly relevant to the agrochemical sector, where many inventions rely on use features, rather than a new use.

Another welcome change – already included in the first draft – is the express statement in Chapter 9 that its provisions do not apply when the claimed use constitutes an accessory aspect of a new product invention. This disclaimer is expected to reduce unnecessary technical requirements, given that examiners have frequently misapplied the provisions of this Chapter to impose claim restrictions on inventions directed to accessory uses.

Conclusions

The final text of Chapter 9 of the BRPTO’s Rule #208/2017, as amended by Ordinance #80/2026, incorporates important adjustments resulting from the public consultation process, most notably by preserving the admissibility of post-filing data when supported by a technically credible disclosure at the time of filing. These changes enhance legal certainty and address concerns that could have disproportionately affected innovation-driven sectors.

At the same time, the BRPTO has maintained its longstanding restrictive approach to therapeutic features in medical use claims, despite international trends. As a result, debates surrounding the patentability of dosage regimens, patient groups, and other treatment-related features are likely to continue.

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  Isabella Sant’anna