The main differences between the final draft and the first proposal, published on July 29, 2025, as Call for Contributions #02/2025, are summarized below.

Post-filing data
In line with previous discussions held with the BRPTO, the final draft foresees the possibility of accepting post-filing data, provided that the original application presents sufficient elements to support the conclusion that the therapeutic activity is real and not speculative, for instance, by means of in vitro, ex vivo or in silico results.

It’s worth noting that in the BRPTO’s first proposal, only in vivo data would be deemed sufficient to meet the enablement requirement, and any type of post-filing data would be considered addition of new matter.

Additionally, for the use of compounds defined by a Markush formula, it will be sufficient to prove the therapeutic activity for at least one representative compound of each chemical class of the different substituents covered by said formula.

Dosage regimen and group of patients
The final draft reaffirms the BRPTO’s position that therapeutic features, such as dosage regimen and/or group of patients, do not confer novelty to a known use, besides impairing the clarity and precision of the claims.

Agrochemical sector
Although the final draft remains applicable to all fields, the BRPTO included a new paragraph making clear that its interpretation differs between the medical and other fields, including the agrochemical field.

In particular, according to the final draft, claims directed to the use of a known product for a known purpose, combined with additional technical features (e.g., amounts employed, dosing regimen, site of application, or other operational parameters), should be regarded as inventions relating to a method of application or treatment, and should be examined accordingly.

In other words, unlike medical uses, new features related to the application mode, dosage regimen, site of application, among others, should be considered as part of the invention, being sufficient to confer novelty to the claimed use.

Next steps
According to the BRPTO, the Guidelines for New Uses of Known Products will be published on June 23 in the BRPTO’s Official Gazette.

The final draft of the new Chapter 9 is available in Portuguese here.

Should you have any questions regarding this new proposal or require further assistance in this regard, please contact us by email at info@lickslegal.com.