The Brazilian Patent and Trademark Office (BPTO) published a draft amendment to the guidelines for patent applications involving new uses of known products. The consultation runs until September 26, 2025, with significant potential impact, especially on biotec/pharmaceutical applications.

Key Impact

The two most critical changes are:

• post-filing experimental data will no longer be accepted to demonstrate the technical effect of an invention. Applications will only be sufficiently disclosed if they already contain conclusive in vivo results at the time of filing. This stricter standard is expected to make prosecution more challenging;

• exclusion of novelty for claims directed to dosage regimens, administration routes, treatment schedules, patient groups or timing.

Other relevant issues include:

• Presumption of obviousness in certain scenarios, such as inferences from known mechanisms of action or structure–activity relationships;

• Stricter requirements for clarity and precision, with rejection of generic disease terms or broad functional definitions.