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:

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:

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:

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

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Regarding the biotechnology sector, some of the most relevant proposals include:

The full text containing the INPI’s suggestions for improving intellectual property legislation is available here (in Portuguese).

If you have any questions, the team is available at patents@soutocorrea.com.br.

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The main new development is that, as of July 19, 2026, consultations addressed to MAPA must be submitted exclusively through the Electronic Filing system (SEI). Requests made by email, telephone, or any other channels will no longer be answered.

The Ordinance aims to improve the Ministry’s regulatory governance by establishing a structured, transparent, and predictable workflow for processing and responding to consultations submitted by regulated entities.

In addition, the initiative is aligned with the guidelines of the Act of Introduction to the Rules of Brazilian Law (LINDB), which guides the actions of the Public Administration toward promoting greater legal certainty in the application of regulations, including through consistent responses to inquiries from regulated parties.

The Life Sciences & Healthcare team at Souto Correa Advogados remains available to clarify any questions on the matter.

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In recent years, there has been a growing number of reports of physicians being required to return part of their compensation as a condition for obtaining or keeping a position, or to pay percentages of their shifts to groups that control access to the labor market. The rapporteur of the rule, federal councilor Francisco Eduardo Cardoso Alves, emphasized the seriousness of the issue by stating that there are groups demanding 15% to 30% of a physician’s compensation in exchange for access to shifts.

In practice, the resolution prohibits physicians from demanding, offering, paying, receiving, or accepting any amount or benefit, whether direct or indirect, that may influence the hiring, admission, or maintenance of employment or professional relationships, regardless of the contractual model adopted. The prohibition also extends to the recommendation or referral of healthcare services, tests, procedures, reports, audits, and expert examinations, meaning that receiving any advantage to refer a particular laboratory or clinic, or paying to secure a shift schedule, now constitutes an ethical violation subject to accountability before the professional oversight system of medicine.

The rule also targets practices that, although known in the sector, are often presented with a veneer of formality to disguise their true nature. Participating in, intermediating, facilitating, or benefiting from arrangements that make professional relationships or clinical decisions conditional upon any financial compensation likewise constitutes an ethical violation, even if such compensation is presented as an administrative fee, commission, bonus, award, cashback, contribution to a group or digital platform, or any other designation that conceals its true purpose. The resolution makes clear that the legal form adopted does not remove ethical liability, covering cooperatives, intermediary companies, digital platforms, and any other institutional arrangements used to enable these practices.

Physicians who hold positions of technical direction, team coordination, or healthcare management are ethically liable not only for directly engaging in the prohibited conduct, but also for tolerating it or allowing it to occur within their unit.

The rule does, however, preserve payments formally agreed upon for the actual and proven provision of administrative or management services, which remain permitted provided that they are not linked to any privilege in access to positions or to forms of professional favoritism. This distinction is important because it preserves legitimate management arrangements while eliminating the space for structures created solely to disguise the payment of undue advantages under the appearance of legality.

The Life Sciences & Healthcare team at Souto Correa Advogados remains available to clarify any questions on the matter.

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To become an IDA, an institution must be located in a State Party to the Budapest Treaty and obtain accreditation from WIPO (World Intellectual Property Organization).

Brazil’s accession to the treaty is expected to encourage national institutions to qualify as IDAs, thereby making it easier and more cost-effective for Brazilian innovators in the biotechnology sector to protect their patents.

Should you have any questions, please feel free to contact us at patents@soutocorrea.com.br.

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Recognised Practice Areas

The firm was recognised in the following practice areas:

Individual Recognitions

In this edition, the following professionals were recognised:

The full results for the cycle are available on the firm’s Chambers profile, here.

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This recognition celebrates the technical excellence and dedication of our Media & Entertainment team, composed of Leticia Provedel, Eurico Barreto, Gabriela Freire, João Harres, Luiza Alkaim, and Mariana Vicentini Taylor. The ceremony was attended by partners Eduardo Peukert Mascarenhas Lopes and Rafael Alves, who represented the firm and accepted the award on behalf of the team.

We congratulate our professionals on this achievement and reaffirm our commitment to quality, innovation, and leadership in the legal Media & Entertainment sector.

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Fabrine joins the firm with a solid career, bringing extensive experience in the maritime, offshore, and oil & gas industries. She is a member of the Chartered Institute of Arbitrators (MCIArb), is listed as an arbitrator at the Brazilian Center for Mediation and Arbitration (CBMA), holds an LL.M in International Commercial Law from the University of Aberdeen with a focus on international arbitration, and an MBA from Fundação Getúlio Vargas.

Her practice includes negotiations and drafting of complex contracts, litigation strategies, and alternative dispute resolution methods (ADR). Additionally, Fabrine serves as Secretary-General of the Maritime and Port Law Commission of the OAB/RJ and is a member of the Women’s International Shipping & Trading Association (WISTA).

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Our partner Frederico Hilzendeger also maintained his individual ranking in the same category, reaffirming his excellence and leadership in the field.

Congratulations to Frederico and the entire Private Wealth & Succession Planning team for their outstanding work and continued dedication that led to this important recognition!

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Industries & Sectors

Recognized Practices:

Individual Recognitions:

Regions

In the Regions ranking, we reached the highest category in four areas in Rio Grande do Sul: Corporate/Commercial, Dispute Resolution, Labour & Employment, and Real Estate. Our partners Guilherme Rizzo Amaral, Jorge Cesa, and Fábio Baldissera were also distinguished in the top category for their respective specialties.

Práticas reconhecidas:

Reconhecimento individual:

These results reflect the unity, commitment, and dedication of each professional and practice area at our firm.

Check out the full results here.

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