ANVISA Prior Consent for Pharmaceutical Patents in Brazil: What Changed in 2021

Brazil once layered a step onto pharmaceutical patenting that most jurisdictions do not have, and the position has since changed in a way that matters for anyone researching this topic today. Where the invention was a pharmaceutical product or process, the national patent office did not act alone; the health regulator also had a formal say before grant, a mechanism known as prior consent or anuencia previa. That requirement was repealed in 2021, so as matters stand the health regulator no longer participates in examining pharmaceutical patent applications and the patent office examines them on its own. This page explains, at a general level, what the prior-consent requirement was, why it was introduced, how the roles of the two bodies were coordinated and re-drawn over the years, and how the picture changed. It is general information rather than legal advice, and because the procedure has moved over time, the sensible course before relying on any position is to confirm the current process with the Brazilian INPI or a vetted local firm.

A note on names first, because it is a common source of confusion. Brazil's national patent and trade mark office is the Brazilian INPI, the Instituto Nacional da Propriedade Industrial. That is a different body from the French INPI, which shares the acronym; throughout this page the INPI means Brazil's office. Portuguese is the filing language in Brazil, and foreign applicants need a local representative to act before the office. Brazil also has its own surrounding features that distinguish its system, including a utility model (modelo de utilidade) for incremental inventions, accession to the Madrid Protocol relatively recently (which introduced multi-class applications and co-ownership), and accession to the Hague designs system, alongside a historically long pendency for patents and trade marks that has been reducing. Those features sit in the background; the focus here is the pharmaceutical prior-consent layer and what became of it.

What the prior-consent requirement was

The distinctive rule, while it was in force, was that for a patent application covering a pharmaceutical product or process, examination also involved ANVISA, the Agencia Nacional de Vigilancia Sanitaria, Brazil's national health surveillance agency, in addition to the Brazilian INPI. ANVISA's involvement was described in Portuguese as anuencia previa, which translates roughly as prior consent or prior approval. In plain terms, a pharmaceutical patent did not proceed on the INPI's assessment alone; the health regulator had a formal role in the process before the patent was granted. That was the position until the requirement was repealed in 2021. The repeal removed ANVISA's prior-consent role, and current pharmaceutical patent applications are examined by the Brazilian INPI without ANVISA prior consent. Because statutory positions can shift, confirm the present status with the Brazilian INPI or local counsel rather than relying on this summary.

The arrangement was unusual. In most patent systems, a single patent office examines the application against the ordinary criteria of novelty, inventive step and industrial application, and the health regulator's role is confined to marketing authorisation, a separate process that governs whether a medicine can be sold rather than whether an invention can be patented. Brazil deliberately connected the two worlds at the patent stage for this one category of subject matter, so that a pharmaceutical applicant was, in effect, dealing with two public bodies on a single patent application. That connection at the patent-examination stage no longer applies following the repeal.

Why Brazil introduced it

The rationale was rooted in public-health policy. Brazil reintroduced pharmaceutical patent protection through industrial-property reforms in the second half of the 1990s, as part of aligning its law with international obligations, and the prior-consent mechanism was added in that period as a public-health safeguard. The broad concern was that patents on medicines carry direct consequences for the price and availability of treatment, and that the health authority should therefore have a structured input into pharmaceutical patenting rather than leaving the field entirely to the patent office. You should confirm the precise statutory basis and its history with the Brazilian INPI or local counsel rather than relying on this summary, but the underlying intent is reasonably settled: prior consent was an access-and-public-health policy expressed through the patent process. The mechanism itself was later repealed, in 2021, which is the central development to keep in view.

Whether one regards the original mechanism as a sensible health safeguard or as an additional hurdle, it is best understood in that light rather than as a mere administrative formality. The involvement of a health regulator in patent examination reflected a policy choice that pharmaceutical exclusivity was too consequential for public health to be decided on patent criteria alone. That policy choice was subsequently reversed at the patent-examination stage when prior consent was removed.

How the INPI and ANVISA roles were coordinated, then ended

This is the part where the history is richest, because the precise division of labour between the two bodies moved repeatedly before the requirement was abolished. When the requirement was introduced, there was genuine uncertainty and friction about what ANVISA's role actually was: whether the agency was confined to public-health considerations, or whether it could also weigh in on patentability criteria such as novelty and inventive step that are ordinarily the patent office's domain. That tension produced disagreements, litigation and successive attempts to clarify the boundary.

Over the years the two bodies issued joint guidance and the procedure was re-drawn more than once, broadly with the aim of separating the questions so that the INPI assessed patentability and ANVISA's prior-consent input was anchored in public-health concerns rather than duplicating the patentability examination. The sequencing of when ANVISA reviewed an application relative to the INPI's examination, and the precise scope of what ANVISA could consider, were both the subject of revision. That long arc of coordination ended in 2021, when the prior-consent requirement was repealed and ANVISA ceased to participate in processing or examining pharmaceutical patent applications. So this is no longer an open, evolving two-body procedure to be monitored; it is settled history culminating in repeal, with the current rule being single-body examination by the Brazilian INPI. As always, verify the present procedure and any transitional treatment with the Brazilian INPI's official channels and qualified local counsel.

Practical impact for pharmaceutical applicants

For a pharmaceutical applicant filing today, the headline is that the two-body process no longer applies; the dual-review layer that once added steps, decision points and time to pharmaceutical examination has been removed. What this means in practice is that a current application is examined by the Brazilian INPI on the ordinary patent criteria, without a separate prior-consent stage at the health regulator. Legacy applications that passed through the prior-consent process before the repeal may still surface in the record, and their treatment is a matter to check with counsel rather than to assume. Brazil has had notably long patent pendency in general, although that backlog has been reducing through office reforms; any specific timeframe should be treated as a range and confirmed against current office data rather than asserted as a fixed period, because pendency continues to change.

On strategy, the practical points are about preparation and routing rather than planning for a defunct second body. Applicants should take local advice on how examination currently runs and on any divisional or amendment strategy. Cost should be thought of in terms of the drivers, the prosecution itself and the local representation that Portuguese-language filing requires, rather than any fixed figure; official fees apply, and you should confirm the current amount with the Brazilian INPI or local counsel. There is one further current-position point worth flagging on term: a 2021 constitutional ruling struck down the provision that had guaranteed a minimum patent term, so you should not assume any automatic minimum-term top-up survives; confirm the present position on term with the Brazilian INPI or counsel. For the route into Brazil through an international application, see our note on the PCT, and for the wider set of cross-border filing routes our international IP hub gathers the relevant pillars.

A Brazil-specific layer, now removed

It is worth being explicit that prior consent was a Brazil-specific feature and should not be assumed to mirror the position elsewhere, and that it no longer operates even in Brazil. Most patent systems keep patent examination and health regulation firmly apart, with the medicines regulator confined to marketing authorisation. The closest conceptual neighbours are jurisdictions that build extra scrutiny into pharmaceutical patenting through different mechanisms; India's heightened threshold under Section 3(d) for new forms of known substances is one well-known example, although it operates entirely within the patent office rather than through a separate health regulator, so the comparison is one of policy aim rather than mechanism, and it remains live in India whereas Brazil's prior consent does not. The point for anyone reasoning by analogy from their home system is to work from the current Brazilian position, single-body examination by the INPI, rather than from the historical two-body picture.

This article is general information and not legal or regulated advice. IPEnvoy is not a law firm and does not provide legal advice; it provides general information and connects businesses with vetted local IP firms. The history of the prior-consent requirement, its repeal, the respective roles the Brazilian INPI and ANVISA once held, and the treatment of any legacy applications are subject to change and turn on the facts of each case. Before relying on any patent position in Brazil, confirm the current position through the Brazilian INPI's official website and with a qualified local IP professional.