30 years of the Brazilian IP Statute: developments and challenges faced in patent practice over three decades

By Silvia Boechat and Ana Carolina Corrêa

Introduction 

The year 2026 marks the thirtieth anniversary of the Brazilian Industrial Property Statute (Law No. 9279/1996). Enacted on May 14, 1996, the Statute represented a landmark advance in patent protection, particularly for the pharmaceutical sector, by ending the exclusion of chemical and pharmaceutical products from eligibility for patent protection. To implement a TRIPS-compliant patent regime, the Brazilian Industrial Property Statute introduced the patent protection for substances, materials, or products obtained through chemical means or processes, as well as substances, materials, mixtures, or food products, chemical-pharmaceuticals, and medicines of any kind, together with their respective production or modification processes.

Main Challenges along the way 

The initial challenges arising from this expansion of patent protection derived from the temporal gap between the WTO TRIPS Agreement taking effect and the Industrial Property Statute coming into force. Two distinct institutes were created to address these challenges: the ‘mailbox’ system and ‘pipeline’ patents.

The Mailbox system, as the name implies, involved the creation of a mechanism to store applications related to pharmaceutical, food and agrochemical sectors filed between January 1, 1995, and May 14, 1997, which would be ineligible from protection prior to the new Brazilian Statute. This institute was set out in Article 229, sole paragraph, of the transitory provisions of the Statute. Neither a special identification nor a dedicated examination mechanism was created for such applications; they were simply received and processed as regular applications.

The Pipeline mechanism, set out in Articles 230 and 231 of the transitory provisions, on the other hand, offered a streamlined procedure to revalidate foreign patents in those previously excluded technical fields, in Brazil, provided that some specific conditions were met. Crucially, these applications did not undergo substantive examination by the Brazilian Patent and Trademark Office (BRPTO).

Both institutes became the subject of extensive judicial disputes over the subsequent years, particularly regarding the determination of their overall term of protection.

Back in 2001, the Industrial Property Statute was modified in other to introduce the mandatory participation of the Brazilian Food and Drug Administration (ANVISA) in the allowance of pharmaceutical patent applications. With the addition of Article 229-C, such applications required not only BRPTO’s examination but also ANVISA’s prior approval to be granted. ANVISA was tasked to assess public health risks and alignment with national drug policies. Even if BRPTO found an invention patentable, ANVISA’s opinions were binding, which meant that it could block the grant. Over the years, ANVISA’s opinions sparked debates about overlapping competencies, as they touched on patentability requirements. In 2017, a joint ordinance clarified roles: ANVISA would no longer decide on patentability but instead issue technical opinions focusing on public health concerns, while BRPTO retained authority over patent criteria. From 2021 onwards, ANVISA’s role became consultative, providing non-binding opinions to INPI, that highlights public health implications, while BRPTO makes the final decision.

Another major challenge faced by Brazilian patent practitioners stems from the shifting interpretation of Article 32 of the Industrial Property Statute over the years. The prevailing administrative interpretation, enforced by the Brazilian PTO Rule No. 93/2013, strictly limits the submission of voluntary amendments and divisional applications until the request for examination has been filed. Under this restrictive reading, any post-request changes or divisionals are confined strictly to the subject matter of the specific set of claims present at the moment examination was requested, which prevents applicants from introducing broader or restructured claims, even if fully supported by the original specification.

Recent changes

Perhaps the most significant modification to the Brazilian Industrial Property Statute in recent years occurred in 2021, following the Federal Supreme Court’s (STF) landmark ruling in ADI No. 5,529. The Court declared unconstitutional the Sole Paragraph of Article 40, which guaranteed a minimum term of protection of ten years for patents of invention and seven years for utility model patents, both counted from the grant date, whenever the Brazilian PTO took too long to examine the application.

The general rule contained in the caput of Article 40 established a term of protection of 20 years for patents of invention and 15 years for utility model patents, calculated from the filing date. Previously, when severe examination backlogs compressed the effective term after grant, the Sole Paragraph functioned as an automatic compensatory mechanism.

The STF held that this mechanism generated uncertainty as to the effective term of a patent protection. According to the Court, the possibility of extending the patent term indefinitely as a consequence of administrative delays was inconsistent with the temporal nature of patent rights. The Court also found that the provision conflicted with core constitutional principles, such as the reasonable duration of proceedings, administrative efficiency, free competition, consumer protection, and the fundamental right to health, among others.

The STF ruled that the decision would apply generally ex nunc (moving forward from May 12, 2021) but established immediate and retroactive application of caput of Article 40 for patents related to pharmaceutical products and processes, and healthcare equipment and materials. In practice, patents of invention are now protected solely for 20 years, and utility model patents for 15 years, both calculated from the filing date.

Expected Changes 

Currently, several bills are pending before the Chamber of Deputies and, most of which propose compensatory mechanisms, commonly referred to as Patent Term Adjustment (PTA), for unreasonable administrative delays in patent examination.

Bills No. 5,810/2025 and No. 32/2026 seek to introduce the Patent Term Adjustment (PTA) mechanism into the Brazilian law. By measuring the BRPTO’s delay during examination, these proposals compensate the patentees by adjusting the patent term, subject to a maximum five-year extension. Unlike the mechanism under the Sole Paragraph of Article 40, this approach quantifies the time lost and applies it to the patent term, minimizing the constitutional concern regarding the term unpredictability raised by the Supreme Court.

Bill No. 2,210/2022, now before the Federal Senate, proposes redrafting Article 32 to allow amendments until the beginning of the technical examination. The bill is also expected to reflect the BRPTO current practice of granting patents without requiring the payment of the issuance fee.

Emerging challenges 

Artificial Intelligence (AI) is set to play a significant role in the future of intellectual property not only in Brazil, but around the world. Following the DABUS case, in which an artificial intelligence system was listed as inventor of a patent application, AI-assisted and AI-generated innovations and even AI models claimed as inventions are already a reality across all technical fields.

In 2025, the INPI launched Public Consultation No. 03/2025 on draft examination guidelines for patent applications involving artificial intelligence. However, the proposal remained overly broad, leaving significant uncertainty regarding how the PTO will examine such inventions. Establishing clearer guidelines would mark a significant step for users, provided that it addresses issues such as sufficiency of disclosure for AI-assisted inventions and how to treat inventions where AI was just a kick-off to reach the invention’s full development.

Another important aspect to consider is that, given the pace of technological advances, keeping rules and manuals up to date will be essential for legal certainty, ensuring clear and precise regulation throughout the entire procedure.

Conclusion 

Thirty years after its enactment, the Brazilian Industrial Property Statute remains very much a work in progress. From the transitional mailbox and pipeline mechanisms, through the STF’s rebalancing of patent terms in ADI No. 5,529, to the PTA bills and Article 32 reforms now before Congress, its framework has continually evolved. Artificial intelligence introduces a new and still-unsettled chapter in that history, one that will likely shape Brazilian patent law for years to come. The Statute adaptability through legislation, judicial review, and administrative practice remains vital to ensuring a credible and predictable patent system aligned with innovation.

To learn more about the Brazilian IP Statute, contact us at cobo@coboip.com. We will be pleased to assist you.