Brazil's BRPTO Publishes Draft Guidelines for Patent Applications on New Uses of Known Products: A Critical Analysis for Pharmaceutical Practitioners

The Brazilian Patent and Trademark Office (BRPTO/INPI) has recently opened a public consultation period (ending September 26, 2025) for proposed amendments to its Chemistry examination guidelines, specifically addressing patent applications for new uses of known products. These proposed changes represent a significant tightening of requirements for pharmaceutical patent protection in Brazil and warrant careful consideration by practitioners in the biotechnology and pharmaceutical sectors.

The Scope and Intent of the Proposed Guidelines

The updated guidelines specifically target inventions where the primary innovation is the new use of a known product, rather than merely a secondary use of a new product. This clarification aims to address a persistent problem in Brazilian patent examination: examiners mistakenly applying new use provisions to accessory use inventions where they are inappropriate. The BRPTO emphasizes that for these guidelines to apply, the product itself must already be known in the prior art, with novelty residing solely in its new purpose or application.

Notably, the guidelines reinforce that use claims should be treated as process claims, reflecting the Brazilian approach to medical use inventions, which must be drafted in the Swiss-type format: "use of compound X characterized by being for the manufacture of a medicament for treating disease Y".

Key Restrictions and Requirements

Novelty and Inventive Step Assessment

The proposed guidelines better define and exemplify the steps for novelty and inventive step evaluation, which must focus exclusively on the new purpose or use, assessing whether it was previously disclosed or would be obvious to a skilled practitioner. This represents a continuation of Brazil's historically strict approach to second medical use patents.

Features That Do Not Confer Novelty

The guidelines explicitly state that the following features cannot provide novelty for new use claims:

• Dosage regimen variations;

• Route of administration modifications;

• Patient group specifications (e.g., using a known product for a subset of patients, e.g., diabetics, children, elderly, is not novel); and

• Treatment schedule alterations.

This restriction, especially when applied to patient groups, contradicts established concepts of selection inventions in Brazil's General Patent Applications Examination Guidelines and disregards relevant technical aspects, such as physiological differences between age groups that impact therapeutic effects. In particular, the technical explanation on why patient groups would not be able to render a medical use novel is inconsistent with the concept of selection inventions.

Obviousness Presumptions

Claims are likely to be rejected as obvious when:

1. The mechanism of action for the new use is identical to the mechanism known for the compounds in the state of the art already used for treating the new therapeutic application;

2. The compound's mechanism of action is known and also relates to the treatment of the new condition;

3. There is structural similarity to known compounds used for the same purpose;

4. The new use is based on known side effects or symptom management already described in the art; and

5. The etiology of the new and previous indications is the same.

These criteria align with existing Brazilian practice but provide more explicit guidance on how mechanism of action considerations influence obviousness determinations.

Enablement Requirements: A Heightened Standard

In Vivo Evidence Mandate

Perhaps the most restrictive aspect of the proposed guidelines is the mandatory requirement for in vivo evidence at the time of filing. The guidelines explicitly state that:

• In vivo studies are required for enablement;

• Data from in vitro, ex vivo, or in silico studies alone are insufficient; and

• No supplemental data will be accepted, even if aimed at corroborating information already disclosed in the specification.

Although the current guidelines on new medical use inventions are quite strict and establish the necessity of in vivo data for demonstrating the new use, the current wording leaves some room for interpretation on whether in vitro data presented in the application as filed could be further corroborated by post-filed in vivo data. The proposed guidelines set in stone that validated animal models represent the minimal standard for enablement and expressly forbid post-filed data submission. This represents a significant contradiction in view of the General Patent Applications Examination Guidelines, which allow supplemental data for inventive step arguments.

Compound-Specific Support

Support will be recognized only for the exact compounds tested. Unlike compound per se patents, structural similarity extrapolations will be unacceptable for new use claims. This creates what practitioners describe as a "gap of patentable subject matter that cannot be protected", as the standards for support and inventive step become contradictory.

Claim Drafting Requirements and Restrictions

Mandatory Specificity

Claims must:

• Specify the exact compound used;

• Clearly identify the disease or condition treated;

• Avoid Markush structures or chemical classes (considered indefinite);

• Eliminate vague references (e.g., "central nervous system disorders" or "serotonin reuptake inhibition"); and

• Exclude dosage, administration methods, or patient group selections (considered indefinite).

Prohibited Claim Formats

The proposed guidelines also reinforce that claims are not allowed if they:

• Describe the direct therapeutic use (e.g., "Use of product X characterized by being in the treatment of disease Y");

• Refer to methods of treatment or use the "product for use" format (violating Article 10, VIII of the Brazilian Industrial Property Law); and

• Mix therapeutic regimens or administration modes within the use claim.

Combination Products

The guidelines permit claims for combinations of known products for new medical use, provided the combination is:

• Applied simultaneously; and

• Supported by in vivo evidence demonstrating a cause-and-effect relationship for the therapeutic effect.

Strategic Implications for Pharmaceutical Patent Practice

Portfolio Development Challenges

These proposed changes will significantly impact pharmaceutical patent portfolio strategies in Brazil. The mandatory in vivo evidence requirement, combined with the prohibition on supplemental data, means that patent applications must be filed with complete preclinical evidence packages. This creates timing challenges for pharmaceutical companies that typically file patents early in the development process.

Prosecution Strategy Adjustments

Practitioners will need to adjust their approach to Brazilian filings by:

1. Ensuring comprehensive in vivo data is available at filing;

2. Including data for as many compounds as possible at the time of filing rather than relying on broader chemical classes and structure similarity;

3. Avoiding patient subgroup or dosage regimen differentiation as sources of novelty; and

4. Carefully drafting disease/condition limitations with maximum specificity.

International Coordination Considerations

The restrictive nature of these guidelines may require separate prosecution strategies for Brazil compared to other major jurisdictions. The prohibition on structural extrapolation and requirement for compound-specific testing may necessitate more targeted filing strategies or delayed publication of early research results.

Key Takeaways for Patent Practitioners

For Immediate Action:

• Review current Brazilian patent portfolios for applications that may be affected by these new guidelines;

• Prepare comments for submission before September 26, 2024, consultation deadline; and

• Adjust filing strategies to ensure in vivo evidence is available at the time of filing.

For Long-term Strategy:

• Develop Brazil-specific prosecution approaches that account for the heightened enablement standards;

• Consider the economic impact of requiring compound-specific testing for each variation sought to be protected; and

• Evaluate the timing of Brazilian filings to ensure adequate preclinical data is available.

For Portfolio Management:

• Assess the value proposition of new use patents in Brazil, given the increased restrictions;

• Consider alternative protection strategies, such as formulation or combination patents, where the requirements may be less restrictive; and

• Coordinate with clinical development teams to ensure patent-supporting studies are appropriately designed and their publication is delayed whenever possible.

The proposed guidelines represent a significant tightening of Brazil's already restrictive approach to new use patents. While the BRPTO's stated goal of reducing examination inconsistencies is laudable, the practical effect may be to substantially limit the availability of meaningful patent protection for pharmaceutical innovations in Brazil. Practitioners should carefully consider these changes in their strategic planning and take advantage of the consultation period to provide informed feedback on the potential impacts of these proposed restrictions.

This post was written by Lisa Mueller and Rob Rodrigues, Luiza Cotia, and Yasmin Kronemberger of RNA Law.