As you may recall, the Brazilian Patent and Trademark Office (BPTO) issued last year a Public Consultation No. 2/2025 in order to test the waters for new rules mainly directed to (i) demanding in vivo data to evidence patentability presented by the filing date, and (ii) restricting patentability of patient subgroup and dosage regime invention.

Our firm discussed the issue with a number of entities and several of them presented arguments against the proposed changes.

At an April 6, 2026 stakeholder meeting, the BPTO’s Patent Directorate presented its review of submissions made in Public Consultation No. 02/2025, stated that it changed its position and decided to continue to accept in vivo data submitted after the application’s filing date. This represents a meaningful shift from the stricter approach initially reflected in the proposed revision and is welcome news for applicants whose evidentiary support matures during prosecution.

However, the BPTO’s representatives mentioned during the April 6 meeting that dosage-regimen claims and claims directed to patient subgroups will be confirmed as unpatentable.

As a result, our firm is again in contact with diverse IP entities, Brazilian and international in order to petition to the BPTO to continue the dialogue and not to issue the new, restrictive directives without further discussion.

We have been successful so far and will continue to request the continuation of the arguments exchange.

How Dannemann Siemsen can help

We have been actively involved in the consultation process and, in parallel, in prosecution strategies supporting a more flexible approach to post-filing in vivo evidence. Our life sciences team is available to review pending Brazilian applications in light of the proposed evidentiary standards, prioritise examination requests where the current framework is favourable, and reassess drafting strategies, particularly for dosage-regimen and patient subgroup claims, where the likelihood of refusal may increase.