Legal 500: Patent Litigation Comparative Guide

1. What is the current legal landscape for Patent Litigation in your jurisdiction?

Patent protection in Brazil is primarily grounded at constitutional level. The Brazilian Federal Constitution expressly recognizes the protection of industrial inventions as a fundamental mechanism to foster technological development and innovation, while balancing private rights and the public interest. Brazil is also a signatory to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which requires all country members to implement minimum standards of patent protection and enforcement consistent with international obligations.

At the infra-constitutional level, the principal statutory framework governing patent rights is the Brazilian Patent Statute (Law No. 9,279/1996). Among other provisions, the statute establishes the substantive requirements for patentability and a standard term of 20 years from the filing date for invention patents and 15 years from filing for utility models. The Patent Statute also regulates the procedures for obtaining patent protection before the Brazilian Patent and Trademark Office (BRPTO) and for filing invalidity and infringement lawsuits, as well as the requests for preliminary injunctions, seizure measures, and compensation for damages. Still concerning patent litigation, the Brazilian Patent Statute also provides for a bifurcated system in which invalidity lawsuits must be filed before the Federal Courts, due to the mandatory participation of the BRPTO in such kind of lawsuit, and infringement lawsuits are filed before the State Courts.

In addition to the above, it provides a comprehensive framework for the exploitation of patent rights, governing voluntary licensing arrangements, assignments, technology transfer agreements, and compulsory licensing mechanisms in specific circumstances, such as public interest, national emergency, abuse of economic power, or failure to exploit the patented invention.

Concerning the standard term provided for by the Brazilian Patent Statute, one of the most significant developments in Brazilian patent law in the last few years has been the Brazilian Federal Supreme Court’s judgment in the Direct Action for Unconstitutionality (ADI) #5529, which declared unconstitutional the sole paragraph of Article 40 of the Patent Statute. The provision guaranteed a minimum patent term of ten years from grant for invention patents, effectively compensating patentees for administrative delays during examination. Following the decision, patent terms reverted to the standard twenty-year period counted from the filing date, giving rise to ongoing discussions regarding alternative mechanisms to compensate patentees for excessive examination delays and preserve the effectiveness of patent protection.

At the sub-statutory level, the BRPTO’s guidelines detail the procedure and formal requirements for filing a patent application, such as Ordinances #16/2024 and #169/2016, as well as specific procedure requirements for different subject matters of patent applications, such as Biotechnology (Ordinance #118/2020) and Chemistry (Ordinance #208/2017).

In addition, the BRPTO has recently issued specific regulations governing key procedural aspects of patent prosecution, including administrative appeals and invalidation proceedings (Ordinance #10/2024), voluntary divisional applications (Ordinance #16/2024), and the continuation of substantive examination following the reversal of a rejection decision on administrative review (Ordinance #04/2025).

In summary, the Brazilian legal landscape for patent law is structured across constitutional, statutory, and sub-statutory levels. The Brazilian Federal Constitution establishes the fundamental principles underlying patent protection, recognizing industrial property rights as instruments to foster technological development, innovation, and the social and economic interests of the country. At the statutory level, the Brazilian Patent Statute sets forth the substantive rules governing patentability, ownership, enforcement, and administrative procedures. Finally, at the sub-statutory level, the BRPTO’s ordinances, guidelines, and administrative regulations provide detailed procedural rules and examination practices, ensuring the practical implementation of the broader principles and legal standards established by the Constitution and the Patent Statute.

2. What three essential pieces of advice would you give to clients involved in Patent Litigation matters?

First, not to view patent litigation in isolation. For strategically important inventions, litigation planning should begin during patent prosecution and continue throughout the product’s regulatory and commercial lifecycle. Patent drafting, prosecution strategy, regulatory submissions, and enforcement planning should be coordinated from an early stage to anticipate possible validity challenges, identify future competitive threats, and develop a comprehensive protection strategy. Companies should also closely monitor market developments, including competitor patent filings, regulatory activities, imports, product launches, testing activities, and public research initiatives.

The strategy adopted in the pre-litigation phase is often just as important as the litigation itself, because it lays the foundation for the arguments, evidence, and business objectives that will ultimately be tested in court.

A second important piece of advice is to invest in the early development of strong technical evidence capable of supporting requests for preliminary relief. In Brazil, preliminary injunctions are frequently the most significant stage of a patent dispute from a commercial perspective, as they can preserve exclusivity rights or immediately halt infringing conduct while the case remains pending. Unlike jurisdictions where monetary damages play a central role, in Brazil the practical value of many patent disputes often lies in securing effective injunctive relief at the earliest possible stage.

For that reason, parties should invest early in infringement testing, laboratory analyses, market investigations, technical expert opinions, and other evidentiary measures capable of providing the court with a high degree of confidence regarding both infringement and patent validity. It is also advisable to obtain more than one independent technical opinion, particularly in highly complex matters. Corroborating conclusions from different experts, institutions, or technical disciplines can significantly strengthen the evidentiary record, reinforce the credibility of the arguments presented to the court, and reduce the perception that the technical analysis reflects only one possible interpretation. A well-supported injunction request can often shape the trajectory of the entire dispute.

Finally, clients should adopt a globally coordinated but locally tailored litigation strategy. Patent disputes rarely occur in vacuum. Brazilian courts and technical experts often consider developments in other jurisdictions, particularly regarding the validity of related patents, parallel enforcement actions, settlements, licensing arrangements, and foreign decisions involving corresponding patent families. For that reason, it is important to present a comprehensive picture of the patent’s global prosecution and enforcement history, including jurisdictions where corresponding patents have been granted, rejected, invalidated, upheld, licensed, or resolved through settlement agreements. These developments can be highly relevant indicators of the strength or vulnerability of a patent and may influence the court’s assessment of complex validity and infringement issues.

At the same time, litigation strategies must be adapted to the specific characteristics of the Brazilian system, including the practices of courts specialized in intellectual property and the case law. An important aspect of this process is the continuous monitoring of decisions issued by judges handling patent disputes, particularly in cases involving technologies, legal issues, or procedural requests similar to the cases handled by our team. Understanding how specific courts and judges have addressed preliminary injunctions, validity challenges, technical evidence, and other key aspects of patent litigation allows parties to develop more effective strategies, better assess litigation risks, and anticipate potential outcomes. Companies that combine global consistency with deep local knowledge and data-driven analysis of judicial trends are generally better positioned to maximize enforcement opportunities and effectively manage litigation risks across their patent portfolios.

3. What are the greatest threats and opportunities in Patent Litigation law in the next 12 months?

One of the most significant opportunities continues to be the patent term adjustment litigation following the Supreme Court’s ADI 5529 decision. The first wave of cases focused primarily on preserving patent terms affected by the judgment, seeking the reinstatement of the same deadline that had been reduced by the BRPTO on the grounds of the existence of a regulatory gap regarding compensation for the BRPTO’s inefficiency and for unjustified delays in patent examination, requesting the application by analogy of foreign mechanisms.

A second wave of cases, however, has emerged based on State liability theories and Article 27 of the Brazilian Law of Introduction to the Rules of Brazilian Law (LINDB), seeking compensation for delays by the Public Administration in the examination and grant of patents, based on existing provisions in the Brazilian Federal Constitution, Brazilian Civil Code and article 27 of the Introductory Law on Brazilian Legal Standards (LINDB). This thesis seeks compensation for the exact period of delay of the BRPTO based on the Brazilian Patent Statute and on the Law governing the administrative procedures of the Federal Government. Combining the first and second waves, there are currently approximately 100 PTA cases pending, with nearly 70% of them belonging to the second wave.

Although appellate courts have not yet issued definitive precedents on cases grounded on the second wave, but the only cases in which the arguments on State Civil Liability were in depth analyzed, the trial courts have issued favorable decisions recognizing the right for compensating the patentee for the excessive and unjustified delays in the examination by granting adjustment in the patent term, creating a meaningful opportunity for further development of the thesis.

Although there are several judicial cases addressing patent term adjustment, the PTA mechanism is not yet expressly provided for in Brazilian law. To address this situation, several bills have recently been submitted seeking to codify this mechanism into law. Among them, the most important bills are (i) Bill #2210/2022, currently at the most advanced stage, allows compensation for delays in proportion to the actual harm caused by such delay, and provides for a maximum limit of an additional five years of patent term; (ii) Bill #2056/2022 allows patent owners to obtain an extension of the patent term when delays attributable to the BRPTO violate statutory administrative deadlines; (iii) Bill #1471/2023, which provides for a formal mechanism for extension of the patent term (limited to a maximum of five years), and only patents with long prosecution cycles (at least ten years between the filing and the granting) shall be eligible for such extension; (iv) Bill #5810/2025 seeks compensation for delays caused by the BRPTO in the form of an adjustment of the patent term, and provides for transitional rules which safeguard rights under judicial dispute and prevents prejudice to patent owners who are already seeking redress; and (v) Complementary Bill #32/2026, which proposes a PTA mechanism which must be filed within 60 days from the granting of the patent. If these bills are approved, more lawsuits regarding the deadline adjustment mechanism must be filed, representing an important opportunity for patent litigation.

Another significant opportunity for patent litigation in Brazil is the increasing specialization of the courts in intellectual property matters. Over the last few years, several Brazilian courts, such as the State Courts of São Paulo, Rio de Janeiro, Minas Gerais, Paraná and Rio Grande do Sul, have created specialized business and intellectual property divisions, reflecting the growing complexity and economic relevance of innovation-related disputes. This specialization has contributed to greater familiarity with technical and regulatory issues, more consistent case law, and a deeper understanding of the commercial realities underlying patent disputes. As a result, parties increasingly benefit from more predictable and well-reasoned decisions, particularly in cases involving complex technologies, preliminary injunctions, and patent validity challenges.

The improvements in the efficiency of patent examination at the BRPTO also represent a relevant opportunity for patent litigation in Brazil. Over the last few years, the PTO has implemented a series of initiatives aimed at reducing backlog, modernizing examination procedures, and accelerating the prosecution of patent applications. As a result, patent owners are obtaining enforceable rights more quickly, allowing them to identify infringements earlier and pursue enforcement strategies while their technologies remain commercially relevant.

While the BRPTO’s latest reforms have sped up the processing of patents and represent a positive opportunity for patent litigation, the measures may pose risks to the applicants’ rights of defense. The expected increase in litigation challenging the BRPTO’s administrative decisions represent one of the main threats in patent litigation in the next 12 months, since the greater speed with which patent applications are being examined may also increase concerns regarding the quality and consistency of certain decisions, especially in technically complex cases.

In particular, Ordinance No. 10/2024 modified the administrative appeal system and has prompted discussions regarding the retroactive application of procedural restrictions to appeals that were already pending. Likewise, Ordinances No. 14/2024 and No. 16/2024, which substantially altered the rules governing divisional applications, have generated significant litigation concerning the filing deadline for divisional applications and the extent of the BRPTO’s regulatory authority to impose requirements not expressly provided in the Brazilian Patent Statute. These disputes have been intensified by the divergence between the BRPTO’s interpretation, which limits divisional filings to an earlier stage of prosecution, and the prevailing judicial understanding that divisional applications may be filed until the conclusion of the administrative examination process, including the appellate stage. More recently, Ordinance No. 04/2025, which established new procedures for reexamination following successful appeals, has raised additional questions regarding procedural guarantees and third-party participation.

As a result, both patent owners and competitors may therefore be more inclined to challenge grants, refusals, and other administrative acts before the courts. This trend could result in a growing number of lawsuits seeking to invalidate or review the BRPTO’s decisions, effectively transferring part of the patentability debate from the administrative sphere to the judiciary. Over the long term, this may become one of the most significant drivers of patent litigation in Brazil.

4. How do you ensure high client satisfaction levels are maintained by your practice?

Client satisfaction in patent litigation depends on combining legal, technical, and commercial perspectives within a single strategic framework. Our practice is built around multidisciplinary teams composed of litigators, patent attorneys, and professionals with scientific backgrounds who work together throughout the life cycle of a dispute.

We also place significant emphasis on experience gained in high-profile and precedent-setting matters. Having represented clients in some of the most important patent disputes before Brazilian courts, the BRPTO, and the Federal Supreme Court, we are able to provide practical guidance based not only on legal theory but also on a deep understanding of how patent disputes are actually decided in Brazil.

Equally important is our commitment to integrating local and global strategies. Many of our clients manage patent portfolios worldwide and multi-jurisdictional disputes. We therefore focus on maintaining alignment between Brazilian proceedings and broader international objectives while providing clear, practical, and business-oriented advice at every stage of the matter.

5. What technological advancements are reshaping your Patent Litigation law and how can clients benefit from them?

One of the most significant technological developments reshaping patent litigation in Brazil is the increasing adoption of artificial intelligence and data-driven judicial management tools by the courts. Over the last few years, Brazilian courts have expanded the use of electronic case management systems, data analytics, and AI-based solutions designed to improve efficiency, consistency, and case allocation. These technologies help courts process large volumes of information more quickly, identify procedural bottlenecks, and streamline judicial workflows.

A particularly important development has been the use of artificial intelligence to identify repetitive litigation and recurring legal issues. Through initiatives supported by the National Council of Justice (CNJ), tools such as the Berna and Atalaia platforms are capable of analyzing large volumes of judicial filings, identifying similar cases, grouping recurring claims, and detecting patterns that may justify uniform treatment by the courts. These technologies assist judges in recognizing disputes that may involve common legal questions and support the management of repetitive litigation on a national scale.

This trend is particularly relevant before the higher courts, which play a central role in the formation of binding precedents and the adjudication of repetitive disputes. By facilitating the identification of recurring issues and similar fact patterns, AI tools can contribute to greater consistency in judicial decisions, faster resolution of cases, and more predictable outcomes for litigants.

For patent litigants, these developments may result in greater procedural efficiency, enhanced predictability, and improved access to precedent-based decision-making. As Brazilian patent disputes become increasingly complex and involve overlapping regulatory, technical, and commercial issues, the use of AI-assisted judicial tools is expected to play an increasingly important role in supporting a more efficient and data-informed judicial system.

6. Describe a particularly interesting or complex matter you have advised on recently, and explain the challenges involved, your approach, and the outcome achieved for the client?

Our recent work has focused on some of the most sophisticated life sciences and patent disputes in Brazil, where success often depends on the ability to combine litigation strategy, technical expertise, regulatory knowledge, and coordination with global teams.

A particularly notable aspect of our practice has been our involvement in several precedent-setting matters that have helped shape the Brazilian patent landscape. We have advised innovative pharmaceutical and biotechnology companies in disputes involving biologics, metabolite patents, patent term adjustment (PTA), divisional applications, regulatory exclusivities, and challenges to government initiatives affecting patent-protected products.

One of the most complex matters involved developing a coordinated enforcement and validity strategy for a pharmaceutical patent covering a metabolite technology. The case required simultaneous management of infringement and invalidity issues, extensive technical evidence, and close alignment with global litigation strategies. The challenge was not only to enforce the patent rights, but also to demonstrate the robustness of the patent against multiple validity attacks while preserving the client’s commercial position in Brazil.

We have also been involved in some of the earliest biotechnology patent disputes litigated in the country, representing innovative companies in matters involving biological products and highly complex scientific questions. These cases required the integration of claim construction analyses, validity assessments, expert evidence, and regulatory considerations in an area where Brazilian case law is still developing.

Another significant area of activity has been the development of patent term adjustment litigation following the Brazilian Supreme Court’s decision in ADI #5529. Our team has represented patent owners in pioneering cases seeking compensation for examination delays, including obtaining favorable interim and merits decisions that preserved exclusivity periods for commercially important pharmaceutical products. These matters involved the development of innovative legal theories and contributed to the ongoing evolution of Brazilian PTA jurisprudence. More specifically, our team has developed the thesis which grounds the second wave of PTA mechanism in Brazil, which justifies the patent term compensation over the State liability theories and Article 27 of the Brazilian Law of Introduction to the Rules of Brazilian Law (LINDB).

Beyond traditional patent litigation, we have successfully challenged unlawful governmental measures affecting innovative products, including public procurement initiatives and Productive Development Partnerships (PDPs) involving patented technologies. We have also obtained preliminary injunctions in disputes involving regulatory data protection, patent prosecution issues, and administrative decisions issued by the BRPTO helping clients safeguard market exclusivity and preserve valuable intellectual property rights.

In addition to these representative patent matters, our professionals have secured urgent appellate relief in sophisticated life sciences disputes, including the reinstatement of a divisional patent application following an improper administrative shelving decision. The relevant court order was obtained within one week, and the BRPTO subsequently confirmed the application’s reinstatement. We have also obtained landmark preliminary injunctions preventing Brazilian regulatory authorities from processing or granting generic product registrations relying on protected regulatory data during the applicable exclusivity period, reinforcing the strategic value of regulatory data protection in Brazil.

The team has also defended clients in pricing, regulatory, clinical development, product-access, and public procurement matters before agencies such as ANVISA, CMED, the Ministry of Health, and the federal courts, including matters involving innovative therapies, biologics, radiopharmaceuticals, cannabis-based products, and complex clinical-trial issues. Collectively, these matters demonstrate our ability to combine patent litigation strategy, regulatory insight, scientific analysis, and rapid procedural response to protect commercially critical technologies and business operations in Brazil.

We have also been involved in precedent-setting matters that have shaped the Brazilian patent landscape, including the development of innovative legal theories relating to Patent Term Adjustment (PTA) and the representation of amici curiae before the Brazilian Federal Supreme Court in the landmark judgment of ADI #5529. In this trial, we have represented relevant associations to the agrochemical and pharmaceutical markets in patent law matters, such as the Association of Biotechnology Companies in Agriculture and Agroindustry, the Brazilian Association of Lawtechs and Legaltechs, and Croplife Brasil, supporting the constitutionality of the patent term provision under the Brazilian Patent Statute.

What distinguishes our approach is the ability to assemble multidisciplinary teams tailored to each dispute. Patent litigators work alongside patent attorneys, scientists, regulatory specialists, and public law practitioners to develop integrated strategies that address not only the litigation itself but also its commercial, regulatory, and policy implications. This enables us to represent clients effectively in matters where the outcome may depend as much on scientific and regulatory considerations as on traditional legal arguments.

The result is a practice capable of handling the full spectrum of patent disputes in Brazil, from complex enforcement and validity proceedings to regulatory and market-access controversies, while maintaining close coordination with global legal and business teams to ensure that local actions support broader international objectives.

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  Lívia Maldi