The Brazilian Patent and Trademark Office (BRPTO) published Call for Contributions #02/2025 on July 29. The Call concerns Chapter 9 of the Examination Guidelines for Patent Applications in the Field of Chemistry, currently governed by BRPTO’s Rule #208/2017, which establishes the criteria for the assessment of new uses of known products, particularly new medical uses. Contributions to the proposed text must be submitted to the BRPTO within 60 days, i.e., no later than September 27. The most relevant proposals are outlined below.

-The applicability not only to novel medical uses, but also to all fields

The new proposal clarifies that the Guidelines apply beyond the medical field, providing, for instance, examples of new uses in the agrochemical field, as shown below:

“Use of product X characterized by being for controlling soil nematodes in useful plant crops.”

“Use of the combination comprising compound X and compound Y characterized by being for increasing the growth of corn plants.”

- Post-filing data to prove effect of the claimed use will no longer be accepted for being considered added matter (Article 32 of the Brazilian Patent Statute)

According to the current Guidelines, only the use whose effect has been effectively demonstrated in the specification as originally filed will be considered enabled (Article 24 of the Brazilian Patent Statute). Nevertheless, such Guidelines allow for the submission of additional data, provided they serve to complement information already disclosed in the application as initially filed, in line with the Guidelines for Examination of Patent Applications (Block I). In particular, additional data may be submitted to demonstrate equivalence of effects with respect to: (i) in vitro to in vivo; (ii) animal models to the target patient; and (iii) specific compounds to other compounds encompassed within the same Markush formula.

In the new proposal, the BRPTO emphatically establishes that post-filing data will not be allowed to overcome the lack of enablement, as the submission thereof will be interpreted as added matter (Article 32 of the Brazilian Patent Statute).

Regarding new medical uses, the new proposal adopts an even more restrictive stance, imposing additional criteria to evaluate the originally submitted data. Particularly, if the patent application only presents instructions, projects, research plans, descriptions of unfinished studies or trials, or data lacking statistical significance regarding the use of a known substance for the treatment of a disease or pathological condition, the claimed use will not be considered enabled.

- Emphasis on the distinction between first and further uses

When a patent application relates to the use as an accessory to an invention of an unknown product, the new proposed Guidelines will not apply. In such cases, the use should be evaluated based on the criteria outlined in the Guidelines applicable to the corresponding product category.

Last but not least, the BRPTO reaffirms its position that therapeutic features, such as dosage regimen or route of administration, and group of patients do not confer novelty to a known use, despite recognizing that the latter could refer to a selection invention.

The 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 do not hesitate to contact us by e-mail at info@lickslegal.com.