INPI publishes update to the Examination Guidelines for Patent Applications in the Field of Chemistry
On Tuesday, June 30, 2026, INPI (Brazilian Patent and Trademark Office) published Normative Ordinance INPI/PR No. 80, dated June 29, 2026, updating the Examination Guidelines for Patent Applications in the Field of Chemistry regarding the chapter on new uses of known products. Given the importance of the subject, we present a structured summary below:
1. Scope of the guidelines
The guidelines address inventions where the main subject matter is the use of an already known product (e.g., a chemical compound) for a new purpose, covering both new medical uses (the primary focus) and new non-medical uses.
These guidelines do not apply when (i) the product is new (examination follows product rules), or (ii) the “new use” is merely an ancillary part of another invention.
2. Legal nature of the claims
Use claims are considered process claims, with protection extending to the use of the known product for a new purpose. However, the mere new use of a known product does not guarantee novelty.
3. Novelty requirement
A new use is considered novel when the purpose (e.g., a newly treated disease) has not been disclosed in the state of the art.
The following do not confer novelty:
- dosage, therapeutic regimen, or route of administration;
- dosage interval;
- timing of administration;
- specific patient group;
- simple form (e.g., tablet) when already known.
For medical use, novelty is assessed primarily based on the disease or condition being treated.
4. Inventive step
The assessment considers whether the new use is non-obvious to a person skilled in the art.
Indications of a lack of inventive step include:
- the same mechanism of action already known for treating the same disease;
- a mechanism of action associated with a target already known in the pathology;
- structural similarity to compounds already used for the same purpose;
- same etiology as the disease treated by known products;
- new use inferable from known side effects;
- use derived from treating the disease’s symptoms.
5. Sufficiency of disclosure
The application must (i) clearly describe the new use; (ii) present sufficient experimental evidence at the time of filing—with the INPI indicating a preference for *in vivo* data and requiring the presentation of *in vitro* tests; (iii) enable reproduction by a person skilled in the art.
Important rule: adding new data after filing is not permitted (as the INPI considers this an addition of subject matter); any subsequent data may only confirm what was already described or could be inferred from the information contained in the specification at the time of filing.
For broad chemical classes (e.g., Markush structures), the use must be demonstrated for at least some representatives of those classes.
6. Clarity and precision of claims
Claims must clearly define (i) the product (chemical compound) and (ii) the specific purpose of the use (e.g., a specific disease).
Claims are not accepted if they:
- use generic terms (e.g., “central nervous system disorders”);
- define only a mechanism of action (e.g., “receptor inhibitor”);
- describe generic classes without specifying compounds;
- include a therapeutic regimen or patient group (e.g., use of compound X in diabetic patients);
- define the product by its use.
The preferred claim format is the “Swiss-type” claim, as shown in the example below:
use of compound X for the preparation of a medicament for treating disease Y.
Why is this update important?
INPI reinforces its restrictive stance, particularly regarding new medical uses; it maintains its position that dosage regimens are unpatentable and raises the evidentiary bar for claimed technical effects by requiring clinical trial data—data often treated as confidential information.
The Life Sciences & Healthcare team of Souto Correa Advogados is available to answer questions at patents@soutocorrea.com.br