Brazil: BRPTO/INPI Finalizes Guidelines for Patent Applications on New Uses of Known Products

On June 30, 2026, the Brazilian Patent and Trademark Office (BRPTO/INPI) made available the final version of Chapter 9 of the Chemistry Examination Guidelines, dealing with patent applications directed to new uses of known products, including new medical uses. The final text follows Public Consultation No. 02/2025, which received several comments and was followed by analysis of the contributions and meetings with interested parties.

The guidelines applied understanding to applications covering uses of known chemical compounds, biological products, microorganisms, medicines, kits, compositions, combinations and formulations. They do not apply where the main invention is a new product, even if the applicant has chosen to claim that product by reference to a use. In those cases, the application must be examined under the guidelines applicable to the relevant product category.

The BRPTO/INPI also reiterates that use claims are treated as process claims in Brazil. Protection for a new use is directed to the use of a known product for a new purpose, and not to the known product itself. Accordingly, a known product does not become new merely because a new industrial application has been identified. Claims drafted as “product characterized by the use,” where the product is already known, remain unacceptable for lack of novelty.

New medical use and Swiss-type claims

For medical use inventions, the guidelines define new medical use as the use of a known chemical-pharmaceutical product to prepare a medicament for treating, preventing or diagnosing a disease or pathological condition different from that previously disclosed in the prior art.

The accepted claim format remains the Swiss-type format, namely: “Use of product X for preparing a medicament for treating disease Y.” In such claims, where the product is already known, novelty is assessed by reference to the disease or pathological condition to be treated, prevented or diagnosed.

Claims directed to the direct therapeutic use of a product, such as “use of product X in the treatment of disease Y,” continue to be treated as therapeutic methods and therefore as subject matter not considered to be an invention under Article 10, VIII of the Brazilian Industrial Property Law. The same applies to claims drafted as treatment processes, such as “a process for treating disease Y comprising administering product X.” Product-for-use style claims, such as “product X for treatment of disease Y,” are also not accepted where the product is already known, because the product is being defined by its use rather than by its technical features.

Dosage regimens and patient groups

The most controversial aspect of the final guidelines concerns dosage regimens, administration features and patient groups. The BRPTO/INPI maintained its restrictive position that features such as dosage, therapeutic regimen, route of administration, dosing interval, timing of administration and patient subgroup selection are not essential technical features of a new medical use.

As a result, those features cannot be relied upon to establish novelty over the prior art. For example, a claim directed to the use of a known compound to prepare a medicament for treating a known disease will not be considered novel merely because the claim specifies oral administration twice daily, administration 30 days after diagnosis, or treatment of a subgroup of patients such as diabetics, children or the elderly.

Inclusion of such features in Swiss-type claims may also give rise to lack of clarity objections. The rationale is that features concerning how a medicament is administered relate to a therapeutic method, not to the use of the compound in the manufacture of a medicament. Similarly, the BRPTO/INPI considers patient-group limitations to be inconsistent with the claimed Swiss-type use where the relevant disease or pathological condition is already known.

In practical terms, the BRPTO/INPI’s position on dosage regimens and patient subgroups remains restricted. Applications whose point of distinction over the prior art lies mainly in a dosing schedule, route of administration, timing of administration or patient subgroup are still likely to face rejection at the administrative level. These issues are therefore expected to continue to be disputed before the Brazilian courts.

Pharmaceutical forms and new products

A use claim sometimes defines the “product” by its pharmaceutical form — a tablet, capsule, spray or solution. In those cases, the examiner must determine whether the product itself is new under the guidelines applicable to pharmaceutical compositions.

A mere physical form does not confer novelty on a known composition. Thus, if the prior art already discloses the use of compound X and its pharmaceutical compositions for treating disease Y, a claim directed to the use of a tablet containing compound X for treating the same disease will not be considered novel merely because the claim refers to a tablet.

However, the guidelines recognize that a pharmaceutical form may support novelty if it includes a new component or a new ratio between components that distinguishes it from the prior art, provided that the essential technical features are included in the claim. Where the product itself is new, for example a new pharmaceutical form or a new combination, the application should be examined under the guidelines applicable to that product.

Inventive step

Inventive step must still be assessed under the general three-step approach used in Brazilian patent examination, but the final guidelines now spell out several non-exhaustive circumstances that may indicate its absence.

These include situations in which the prior art discloses that the product has the same mechanism of action as other products already used for the claimed disease; where the known mechanism of action involves a pharmacological target already known to be involved in the relevant pathology; where the claimed use can be inferred from structure-activity relationships with structurally related compounds already known for the same use; where the claimed disease has the same etiology as another disease already treated by the same or similar products; where the new use can be inferred from known adverse effects of the product; or where the product was already used to treat a symptom associated with the claimed disease.

A useful nuance concerns biological pathways: for an inventive step objection based on the blocking or activation of a particular biological pathway, the prior art should preferably show both the effect of the compound on that pathway and the contribution of the pathway to the treatment of the disease. This may provide applicants with room to argue that a mere reference to a target or pathway is insufficient unless the prior art also supports a reasonable expectation that modulation of that pathway would treat, prevent or diagnose the claimed disease or pathological condition.

Sufficiency and post-filing evidence

On enablement, the final text is a clear improvement on the draft. The draft had raised concerns because it appeared to require in vivo evidence at the filing date and to reject reliance on in vitro, ex vivo or in silico data for purposes of demonstrating the claimed therapeutic effect. The final text softens that position.

The INPI still states that the specification should preferably include in vivo tests. However, the final guidelines accept that in vitro, ex vivo or in silico results may provide evidence of the claimed therapeutic use, provided that the application as filed contains sufficient elements to support the conclusion that the therapeutic activity is real and not merely speculative. If doubts remain during examination, complementary information may be submitted to confirm or corroborate what was already disclosed in the application as originally filed.

This is a meaningful development, indicating that post-filing evidence (potentially in vivo), may be considered during examination when it merely confirms a technical effect that was already made plausible by the application as filed.

That flexibility is expressly limited. The guidelines make clear that post-filed evidence cannot cure an insufficiency that existed at the filing date. If the application as filed merely contains instructions, research plans, protocols, descriptions of unfinished studies, or data without statistical relevance, the claimed use will not be considered sufficiently disclosed. In those circumstances, the absence of experimental support at filing cannot be remedied by later-filed evidence.

The final guidelines also state that, where animal studies are relied upon, the experimental models should be validated for the disease in question so that the results can reasonably predict the therapeutic, preventive or diagnostic effect in the human or animal body.

Markush formulae, generic classes and antibodies

For products defined only by generic chemical classes or functional characteristics, such as enzyme inhibitors, receptor antagonists or other functional groupings, the INPI maintains a restrictive approach. In such cases, sufficiency will generally be recognized only for the compounds whose use was actually demonstrated in the application as filed.

However, for known products that are structurally related and described by a Markush formula, the guidelines now apply the same principle used for compound product claims. The use of compounds within a Markush formula may be considered sufficiently disclosed where the specification enables the skilled person to carry out the invention based on activity examples for at least one representative compound from each chemical class of the different substituents.

This change also helps avoid a mismatch between the standards applicable to compound claims and new-use claims. It should allow applicants to claim the new use of structurally related compounds, provided that the specification contains representative activity data across the relevant chemical classes.

Antibodies remain a stricter case. For example, where the claimed use refers broadly to an “anti-CD20 antibody,” sufficiency will generally be limited to the specific antibody that was evaluated and defined by its complementarity-determining regions (CDRs) or variable regions. This approach follows the BRPTO’s biotechnology examination standards for antibody inventions.

Where an application concerns structurally unrelated compounds or products with different functional characteristics, a lack of unity objection may arise. However, BRPTO recalls the general principle that lack of unity should not be raised or maintained based on an overly strict interpretation, particularly where the additional search burden is limited.

Clarity and claim drafting

New medical use claims must clearly define both the product and the disease or pathological condition to be treated, prevented or diagnosed. These are treated as the essential technical features of this category of invention.

Claims referring to generic disorders, syndromes, symptoms or broad therapeutic areas are not accepted. For example, claims directed to “central nervous system disorders,” “respiratory syndromes” or “flu-like symptoms” are considered unclear because they do not define a disease or pathological condition with sufficient precision.

The same applies to claims that define the condition by reference to a mechanism of action rather than by identifying the disease. A claim to the use of compound X to prepare a medicament “as a serotonin reuptake inhibitor” is not accepted because it defines a mechanism of action, not a disease to be treated. Likewise, a claim referring to treatment “by selective occupation of a serotonin receptor” is considered unclear for the same reason.

The product must also be clearly defined. Chemical compounds should be identified by structure, Markush formula, nomenclature or another unequivocal designation. Claims that define the product only by a broad pharmacological class or chemical class, such as “serotonin reuptake inhibitors” or “quinolone derivatives,” are considered unclear if they do not specify the exact compounds used in the claimed invention.

Combinations and kits

Swiss-type claims directed to the use of a combination of active ingredients may be accepted where the specification supports the simultaneous application of the components and demonstrates a causal relationship between administration of the combination and the therapeutic effect. The guidelines expressly accept formulations such as “use of the combination of compound X and compound Y for preparing a medicament for treating disease Z” and “use of the combination comprising compound X and compound Y for preparing a medicament for treating disease Z,” provided the claim is supported by the specification.

A combination may be contained in a single form or in separate forms for simultaneous administration. Where the components are in separate forms, the specification must provide evidence that the combination is obtainable as a product for simultaneous application. This may include a kit claim, such as the use of a kit containing compounds X and Y for preparing a medicament for treating disease Z.

This guidance is useful for applicants pursuing protection for combination therapies, particularly where the commercial or clinical embodiment involves separately administered components.

Practical impact

Overall, the final guidelines preserve the BRPTO/INPI’s longstanding restrictive approach to dosage-regimen and patient-subgroup claims. Applicants should not expect claims to be allowed administratively in Brazil where the alleged novelty or inventive contribution lies solely in dosage, route of administration, timing, treatment schedule or selection of a patient subgroup within a known disease population.

From a drafting perspective, applicants should ensure that Brazilian specifications for new medical use inventions include, at filing, experimental data capable of supporting the claimed therapeutic effect. In vitro, ex vivo and in silico data may be useful, but the specification should explain why those data support the claimed treatment, prevention or diagnostic effect and why the invention is not merely speculative. Where possible, validated animal models or other robust evidence should be included.