Dear Colleagues,

Last week, the Brazilian Patent and Trademark Office (BRPTO) opened a public consultation on Chapter 9 of the Guidelines for the Examination of Patent Applications in the Chemical Field (Rule No. 208/2017), which addresses claims directed to new uses of known products. Contributions may be submitted until September 27, 2025.

The new draft covers the use of known substances, particularly for new medical uses (currently accepted in Swiss-type format), as well as new non-medical uses. It also clarifies that the criteria outlined do not apply to the use of new substances, for which the novelty and inventive step should be assessed based on the substance itself.

Although no changes have been proposed regarding the interpretation of novelty, inventive step, or clarity for medical use claims, additional examples have been included to enhance understanding. The standards set forth in the current guidelines continue to apply.

In short, novelty continues to be assessed based on the disease to be treated. For inventive step, the compound’s mechanism of action or the disease’s etiology must differ from those known in the prior art, for example. For clarity, the disease must be clearly defined; features such as dosage, administration route, or patient group remain insufficient to distinguish and to clearly define the claimed subject matter.

The most significant update in the draft concerns the sufficiency of disclosure for medical use claims. The proposed changes include:

• Only in vivo experimental data will be considered sufficient to support therapeutic use claims at filing.
• In vitro, ex vivo, in silico studies, and theoretical reasoning will no longer be accepted to demonstrate the required technical effect.
• Post-filing data, even if based on the original disclosure, will be rejected as added subject matter, in violation of Article 32 of the Brazilian IPL.
• For generic compound classes (e.g., by functional or structural features), the sufficiency of disclosure will be recognized only for those compounds that were individually tested in vivo and disclosed in the original application.

We are closely monitoring these developments and preparing our comments for submission. Should you wish to share your own contributions or need support in doing so, please feel free to contact us