Marcus Julius Zanon
IP Attorney-at-Law | Patent Agent | Compliance Officer
Versao em Portugues
On June 30, 2026, the Brazilian National Institute of Industrial Property (INPI) published in Official Industrial Property Gazette (RPI) No. 2895 the Normative Ordinance INPI/PR No. 80, dated June 29, 2026, revoking the previous Chapter 9 of the Chemical Patent Examination Guidelines and introducing a completely revised framework for the examination of patents relating to new uses of known products.
This regulatory update represents one of the most significant developments in Brazilian patent practice in recent years, particularly for the pharmaceutical, biotechnology, chemical, and agricultural sectors. It provides a more detailed and structured approach to assessing patentability requirements for second medical use inventions and other novel applications of previously known products.
The new Chapter 9 replaces the guidelines that had been in force since 2017 and specifically addresses inventions whose inventive contribution lies in the use of a known product for a previously undisclosed purpose, whether medical or non-medical.
INPI expressly clarifies that these guidelines apply only when the product itself is already part of the prior art and novelty resides exclusively in its newly discovered application. They do not apply to inventions involving new products, new compositions, new formulations, or other product-based innovations.
The new guidelines reaffirm INPI’s longstanding position that use claims are classified as process claims, rather than product claims. Protection is therefore granted to the use of a known product for a specific new purpose.
Examples expressly accepted by INPI include:
A substantial portion of the new chapter is dedicated to new medical uses and drug repurposing.
INPI explicitly recognizes that an invention may consist of identifying a new therapeutic application for a known pharmaceutical compound, including cases where the compound has not yet received regulatory approval for the newly claimed indication.
The accepted claim format remains the traditional Swiss-type claim, such as:
“Use of product X for the manufacture of a medicament for treating disease Y.”
This position maintains Brazil’s historical approach to second medical use patent protection.
One of the most important aspects of the new guidelines concerns the assessment of novelty.
According to INPI, when the product itself is known, novelty must be evaluated primarily based on the new disease or pathological condition to be treated, prevented, or diagnosed.
Conversely, the guidelines make it clear that the following features do not confer novelty:
This approach significantly limits patent strategies based solely on treatment optimization or patient stratification.
Perhaps the most significant development is the detailed treatment of inventive step.
The guidelines identify several circumstances that may indicate a lack of inventive step, including:
Where the claimed product operates through the same mechanism already known to treat the target disease.
Where the enzyme, receptor, or biological pathway involved was already recognized in the prior art as relevant to the disease under consideration.
Where structurally related compounds were already known for the same therapeutic application.
Where the newly claimed disease has the same underlying etiology as a disease already treated using the same product or related compounds.
Where the new therapeutic use is directly derived from previously reported adverse effects. INPI specifically cites the example of a compound known to induce drowsiness later being claimed for the treatment of insomnia.
These criteria bring Brazilian practice closer to international standards that require a demonstrable and unexpected technical effect to support patentability.
The guidelines also strengthen the sufficiency of disclosure requirement.
INPI now explicitly requires that the patent application contain, at the filing date:
Importantly, the guidelines emphasize that post-filing experimental data cannot remedy an original deficiency in the application, as this would constitute impermissible added matter under Article 32 of the Brazilian Industrial Property Law.
This requirement is likely to have a significant impact on filing strategies adopted by pharmaceutical companies, biotechnology startups, universities, and research institutions.
Normative Ordinance No. 80/2026 signals a more technical, structured, and predictable approach by INPI in the examination of new-use inventions.
In practice, applicants should:
INPI Normative Ordinance No. 80/2026 marks a significant milestone in the evolution of Brazilian patent examination practice for new uses of known products. While preserving protection opportunities for genuine innovations involving drug repurposing and novel technological applications, it introduces more objective and detailed standards for assessing novelty, inventive step, and sufficiency of disclosure.
For pharmaceutical companies, biotechnology firms, universities, research institutions, and intellectual property professionals, the new guidelines reinforce the importance of strategic patent planning and comprehensive technical support from the earliest stages of innovation development.
The overall trend is clear: applications supported by robust scientific evidence and demonstrable technical contributions are likely to benefit from greater examination predictability, while claims based on routine therapeutic optimization or foreseeable applications may face substantially greater scrutiny before the Brazilian Patent Office.