INPI Ordinance No. 80/2026 and Second Medical Use Patents

INPI Ordinance No. 80/2026, published on June 30, 2026, in the Official Gazette No. 2895, revised Chapter 9 of the Guidelines for Examination of Patent Applications in the Field of Chemistry, previously established by Resolution No. 208/2017, by providing more detailed criteria for the examination of new uses of known products.

Although the underlying principles remain unchanged, the new Ordinance makes it clear that the examination of this subject matter will be conducted under a more rigorous standard.

Below are the main points of comparison between Ordinance No. 80/2026 and former Resolution No. 208/2017, particularly referring to the new medical uses.

What Has Remained Unchanged?

Second medical use inventions remain patentable

The BRPTO maintains its position that a new use of a product already known in the prior art may be patentable, provided that the requirements of novelty, inventive step, and sufficiency of disclosure are satisfied.

Swiss-type claims remain as the acceptable claim format

Claims drafted as “Use of compound X, characterized in that it is in the manufacture of a medicament for the treatment of disease Y,” continue to be the accepted format for claiming second medical uses.

Novelty continues to be assessed based on the new therapeutic use

The new use of a known product is considered novel when the disease or pathological condition to be treated, prevented, or diagnosed has not been disclosed in the prior art.

What Has Changed?

Higher evidentiary requirements at the filing date

With respect to sufficiency of disclosure, the Ordinance establishes that the patent application must contain, as of the filing date, evidence capable of supporting the claimed second medical use, preferably through in vivo studies. Results obtained from in vitro, ex vivo, or in silico studies may provide indications of the claimed therapeutic use but will be assessed on a case-by-case basis. In practice, applications based solely on hypotheses or preliminary results are now more likely to be considered insufficiently described.

Express recognition that treatment-related features do not establish novelty

The Ordinance expressly provides that therapeutic regimens including dosages, route of administration, and patient groups—do not, by themselves, confer novelty on a second medical use claim. Although this interpretation had already been reflected in the BRPTO examination practice, it is now formally incorporated into the Patent Examination Guidelines.

More practical examples

Whereas Resolution No. 208/2017 contained relatively concise guidance, Ordinance No. 80/2026 includes numerous practical examples addressing lack of novelty, lack of inventive step, insufficiency of disclosure, and lack of clarity. While these examples may enhance consistency and predictability in patent examination, they also leave less room for interpretative flexibility.

In practical terms, patent applications directed to second medical uses will require even more robust technical support and strategic planning from the filing date, reducing the possibility of remedying deficiencies during prosecution.

For more information on the content of this newsletter, feel free to contact:  Priscila Kashiwabara (priscila.kashiwabara@kasznarleonardos.com) and Lívia Figueiredo (livia.figueiredo@kasznarleonardos.com).