INPI PUBLIC CONSULTATION NO. 02/2025 – CRITICAL CHANGES TO CHEMISTRY PATENT GUIDELINES

New Uses of Known Products Under Scrutiny

Deadline Extended to October 27, 2025

Executive Summary

The Brazilian Patent and Trademark Office (INPI) has launched Public Consultation No. 02/2025, proposing significant amendments to the examination guidelines for patent applications in the field of chemistry. These changes specifically target the patentability of new uses of known products, introducing stricter requirements that could fundamentally alter the Brazilian patent landscape for pharmaceutical and chemical innovations.

Simões IP strongly opposes these proposed guidelines, as they create additional barriers to legitimate innovation and further distance Brazilian patent practice from internationally accepted standards.

Key Proposed Changes

Mandatory In Vivo Data Requirement

The most restrictive aspect of the proposal mandates that patent applications must include in vivo test data at the time of filing to demonstrate the claimed use. This requirement applies to both medical and non-medical applications.

Impact: Applications lacking such data will face automatic rejection for insufficient disclosure under Article 24 of the Brazilian IP Law.

Rejection of Alternative Testing Methods

The INPI proposal explicitly states that ex vivo, in vitro, and in silico data are insufficient to meet disclosure requirements, regardless of their scientific validity or acceptance in other jurisdictions.

Rationale: The INPI argues these methods cannot adequately demonstrate efficacy due to “pharmacokinetic uncertainties.”

Limitation to Tested Compounds

For applications claiming products defined by functional or structural characteristics, only compounds explicitly tested and demonstrated in the specification will be considered sufficiently described.

Consequence: Broad claims covering chemical classes or Markush formulas will be severely restricted.

Prohibition of Post-Filing Data

Any supporting data submitted in reply to Office Actions (i.e. after the filing date) will be categorically disregarded as added subject matter under Article 32 of the Brazilian IP Law.

Strategic Implication: This eliminates even the possibility of submitting comparative tests aiming strengthening patentability arguments during examination.

Exclusion of Dosage and Patient-Specific Claims

Claims relating to dosage regimens or patient subgroups will not be accepted, as they are deemed not to confer novelty or constitute essential technical features.

Simões IP Position and Strategy

Our Opposition

We fundamentally disagree with these proposed guidelines for several critical reasons:

• International Misalignment: The proposals create significant divergence from globally accepted patent examination standards.
• Innovation Barriers: The requirements impose unrealistic burdens on legitimate pharmaceutical research and development.
• Economic Impact: These changes could discourage investment in Brazilian pharmaceutical innovation.
• Scientific Inconsistency: The rejection of established scientific methodologies contradicts modern drug development practices.

Our Action Plan

Simões IP is actively coordinating with Local pharmaceutical associations, International IP organizations and Research institutions to oppose or seek modifications to the current proposal, with the aim of aligning Brazilian practice more closely with global norms and ensuring a fair, balanced, and innovation-friendly examination of patent applications in Brazil.

 Client Advisory

We recommend that clients with pending or planned applications in this area review existing applications for establishing an action plan, especially considering expediting examination before potential guideline implementation and Engage in the consultation process to voice concerns.

Timeline and Next Steps

How Simões IP can help:

Our specialized team is prepared to:

• Draft comprehensive consultation responses on behalf of clients
• Analyze existing patent portfolios for potential impact
• Coordinate with international counsel for global filing strategies
• Monitor regulatory developments and provide timely updates

Contact Our Experts

For strategic guidance on this consultation or to discuss your patent portfolio in light of these proposed changes, contact our Chemistry and Pharmaceutical Patent team at sip@simoes-ip.com.

The stakes are high, and the deadline is firm. Act now to protect your innovations and influence Brazilian patent policy.

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