Brazil’s patent shakeup: How pharma is handling a new reality

A 2021 Supreme Court ruling changed how patent terms are calculated, forcing pharma companies to rethink their IP strategies. Juliana Neves of Licks explains the key changes, upcoming reforms, and how companies can protect their portfolios effectively.

Pharmaceuticals and IP in Brazil have been anything but quiet since a landmark 2021 Supreme Court ruling shook up patent term extensions.

The decision sent ripples through the pharma (and other) sectors, sparking litigation, influencing filing strategies, and putting pressure on Brazil’s Congress and the Brazilian Patent and Trademark Office (BRPTO) to update.

Companies in Brazil are already focusing on strengthening applications, making early amendments, and proactively managing portfolios, while those considering entry are looking at how to align filings with marketing approval timelines to secure effective protection.

LSIPR sat down with Juliana Neves, partner at Licks, ahead of LSPN North America Fall 2025—where she will be speaking on this topic—to find out more about Brazil’s IP and hear her tips for pharma companies looking to nail this region.

LSIPR: What are some of the most significant recent IP changes in Brazil?

Neves: A lot has been going on since a major trial at the Supreme Court in 2021 (ADI 5529).

That was the first very important IP-related trial there, and it declared the sole paragraph of Article 40 of our patent law unconstitutional.

This provision had an automatic mechanism to compensate for delays at the BRPTO in prosecuting patents. It established that any application granted after 10 years of prosecution—which unfortunately was very common—would receive 10 years of protection from the grant date.

After this trial, that provision was revoked and declared unconstitutional. Since then, all patents are granted with a 20-year term of protection counted from filing.

But Justice Rapporteur Dias Toffoli modulated the decision to determine that pharmaceutical patents would be impacted retroactively. As a result, a number of patents had their terms reduced or even expired immediately.

Beyond affecting patent strategy, this also created pressure in Congress to amend the Brazilian Patent Law, and on the BRPTO to revise its internal guidelines to expedite examination.

Several companies began filing judicial lawsuits seeking Patent Term Adjustment (PTA), arguing that the delays caused by both the BRPTO and the Brazilian Health Regulatory Agency (ANVISA) should justify a restoration of the protection period lost due to the removal of the automatic extension mechanism.

What changes can we expect on the horizon?

We have a couple of bills pending in Congress that aim to streamline the process at the BRPTO and amend the Patent Law to reduce deadlines at certain stages, as well as eliminate steps that the drafters believe contribute to the backlog we face today.

The PTO is also reviewing its guidelines to streamline procedures, with the goal of reaching a point where all patent applications are fully examined and decided within a maximum of four years. Currently, the average is eight or nine years, so it’s a very ambitious target.

The most important bill pending in Congress right now is Bill 2210/2022. The proposal eliminates the 36-month deadline for requesting examination.

Instead, examination would be requested automatically at the time the applicant files the application. If not, the PTO would assume that after the 18-month publication, the application would be ready to proceed.

This is problematic because it limits the period during which applicants are allowed to amend the claim set and refine the application.

Under the proposal, Article 32—which currently allows amendments—would be revised to establish that amendments are only permitted until the examination request. But since examination would be automatic, applicants would no longer have an opportunity to amend their claims later.

The proposal also responds to growing pressure from the private sector to address examination delays.

As a result, industry associations have strongly advocated for the inclusion of a PTA mechanism in the bill which would allow up to five years of compensation in cases of unjustified delays by the BRPTO.

This provision is seen as essential to restore legal certainty and competitiveness in Brazil’s innovation landscape.

How did the industry react to the Supreme Court’s decision?

After the 2021 Supreme Court trial we saw almost 70 lawsuits filed in Brazil seeking compensation for reduced patent terms.

This was especially significant because around 100,000 patents in force at the time were affected—many had their terms reduced, and some even expired immediately.

The impact on the industry was enormous, with companies rethinking their strategies for operating in Brazil.

That said, we didn’t see companies leaving or refraining from entering the Brazilian market, which is a positive point.

Instead, they are trying to adapt to the trial’s outcome, often working through associations and engaging in advocacy to push for the bill that includes the PTA provision.

Litigation is still active, and new PTA-related lawsuits are being filed. The industry is responding positively, not by withdrawing, but by pursuing multiple strategies to strengthen portfolios and obtain patents as quickly as possible.

Another effect of the 2021 decision has been an increase in litigation over fast-track examination, as applicants seek judicial intervention to overcome administrative delays and secure timely patent protection for strategic technologies.

We are already seeing more lawsuits asking the courts to order the PTO to expedite the examination of patent applications. This is also a direct consequence of the changes in the law.

How have changes affected both international companies considering Brazil and those already operating there?

The alternative to leaving Brazil or avoiding the market is to pay closer attention to patent portfolios here—strengthening applications and making amendments as early as possible.

The idea is that when the application reaches examination, it is already in a condition to be granted without major discussion and without too many office actions.

This also means working in line with the PTO’s new guidelines. The PTO is reviewing and updating its rules to streamline and accelerate the process.

Staying up to date with these changes is crucial to avoid problems during prosecution. One of the key updates in the guidelines is the limit on what applicants can raise at the appellate level.

The PTO now understands that only the issues raised by the examiner at first instance can be discussed on appeal. Because of this, it is very important to reach a first-instance decision with an application that is already in the best possible condition for grant.

For now, the best strategy is to manage portfolios proactively in Brazil: strengthen applications early, anticipate possible objections, and aim to secure grants with as few obstacles as possible.

What mistakes do you see companies making most when approaching IP in Brazil?

The most common mistake I see is companies delaying the decision to file in Brazil. Unlike some other countries, Brazil does not have a linkage between the ANVISA and the Brazilian PTO, so regulatory approval by ANVISA does not depend on the patent status at the BRPTO, which can lead to situations where products are launched without enforceable IP rights.

A smart strategy would be to coordinate filings with both agencies, taking into account the timelines for marketing approval and patent prosecution.

Sometimes companies file for marketing approval, but it takes years for the PTO to grant the patent.

While patent rights are retroactive to the filing date, due to statutory timelines and limitations on enforcement, the effective period of protection can be significantly reduced.

In practice, if you receive marketing authorisation long before the patent is granted, you can end up operating in the market without IP protection for an extended period, which is obviously not ideal. This is the industry’s most common strategic mistake.

It’s very important to monitor key decisions from specialised IP courts, as these rulings often shape enforcement strategies and influence how future cases are decided. Also, building a strong relationship with local counsel ensures that your portfolio management is both legally sound and strategically aligned with Brazil’s evolving IP landscape.

LSPN North America Fall 2025 takes place October 21-22 at the Hyatt Regency in San Francisco.

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