BRPTO Updates Chemistry-Related invention Guidelines on New Use of Known Products: Here’s What Changed

For a year, patent applicants braced for the worst. In July 2025, the BRPTO floated a draft that would have made post-filing data essentially inadmissible for new use patents, treating any evidence submitted after filing as unallowable new matter. Given how early most applications are filed, alarmed pharma and chemical innovators alike. 

On June 30, 2026, the final version arrived under Ordinance No. 80/2026, amending Chapter 9 of the Examination Guidelines for Chemistry-related inventions (Rule No. 208/2017). After a year of public consultation, the BRPTO listened to the patent users and representatives, but didn’t fully retreat to the 2017 standard either. The result lands in between, and it’s worth understanding before your next filing. 

Post-Filing Data Survives, With Conditions: Applicants can still submit data after filing to support a new use claim, but only if the application as filed already makes the claimed use grounded and technically substantiated, not hypothetical. In vivo data remains preferred, but in vitro, ex vivo, or in silico evidence can anchor a claim. Pure research plans or incomplete studies still won’t meet the bar. 

For Markush formulas, enablement is satisfied when the description provides at least one representative compound for each chemical subclass of the claimed substituents. 

For Antibody claims, enablement requires CDR or variable-region characterization plus working examples.

What Didn’t Change: Dosage, administration regimen, administration route, dosing interval and patient subgroup feature still do not confer novelty on a medical use claim in Brazil.  

It is also worth noting that the BRPTO introduced a disclaimer in the new guidelines saying that, in other technical fields, claims directed to the use of a known product for a purpose already disclosed in the prior art must be examined under the general patent examination criteria applicable to method inventions, with the essential technical characteristics, including method of application or treatment, forming the basis of the analysis. 

If a Brazilian new use or second medical use filing is on your roadmap, now’s the time to revisit your disclosure strategy. Reach out to us at cobo@coboip.com, we will be glad to assist you!