The publication of the final version of Chapter 9 of the Patent Examination Guidelines for the Field of Chemistry, together with Technical Note No. 02/2026, reinforces the BPTO’s understanding regarding the examination of claims involving new uses of known products.

Among the main clarifications, the Institute maintains that features such as dosage regimen, frequency, route of administration, and specific patient groups are considered aspects of therapeutic methods and therefore do not constitute patentable subject matter under the Brazilian Industrial Property Law.

At the same time, the final version of the guidelines introduced important refinements in relation to the proposal submitted to public consultation, preserving the possibility of using different types of technical evidence, including in vitro, ex vivo, in silico studies, as well as supplementary data submitted after filing, provided that the legal requirements are met.

This update provides greater predictability for applicants, while also keeping in focus an important debate for innovation-intensive sectors, particularly in personalized medicine, pharmacogenomics, and biotechnology, where the distinction between therapeutic discoveries and patentable inventions will continue to require careful technical analysis.

Our team is closely monitoring the evolution of these Guidelines and their impact on innovation protection strategies in Brazil.