This Monday, April 6, The Brazilian Patent and Trademark Office (BRPTO) held a public event to discuss the main comments received in response to Call for Contributions #02/2025, which proposed a revised version of the Patent Examination Guidelines for New Uses of Known Products. During the event, the BRPTO also presented the key amendments expected to be incorporated into the final version of the Guidelines as a result of the consultation process, which are summarized below.

Post-filing data

Following the consultation process, the BRPTO stepped back from the proposed restriction and decided to maintain its current position of accepting post-filing data, provided that such data aims to support technical effects that were already presented as plausible in the application as originally filed.

Therefore, the presence of in vivo data at the filing date, as initially proposed by the BRPTO, will no longer be required to demonstrate the technical effect of new medical uses, nor will data with statistical relevance be demanded (which had been referred to by the BRPTO during the event as the “gold standard”).

The BRPTO also confirmed that its established practice of allowing extrapolation of a technical effect from a tested compound to other compounds covered by the same Markush formula will be maintained, as long as equivalence of effect is proven during examination.

Dosage regimen and group of patients

Although the BRPTO acknowledged that features related to dosage regimen or groups of patients may represent a technical advance, the Office reaffirmed that its position will remain unchanged: such features do not confer novelty to a known use.

Agrochemical sector

Of particular relevance to the agrochemical industry, the BRPTO clarified that its interpretation of new uses differs between the medical and agrochemical fields. According to the Office, new uses of known agrochemicals for an already known purpose remain allowable when supported by modified conditions of application, for instance, use at a specific phenological stage. The BRPTO confirmed that this distinction will be expressly reflected in the revised Guidelines.

Next steps

During the event, participants representing associations such as ABPI, ABAPI and CropLife Brasil requested an additional round of comments on the revised version of the Guidelines, as soon as it is made available to the public.

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