Life Sciences and Pharma IP 2026

BRAZIL Trends and Developments Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys

interpretation of the courts over the legislation and international agreements over the practice. • BRPTO’s Ordinance #4/2025 has introduced a new procedure for the examination of remanded appli ‑ cations after a successful appeal, when the Board of Appeals reverses a rejection and remands the case to the first instance for further examination. This new ordinance from the BRPTO gave rise to a few concerns, such as: (a) third-party technical submissions in remanded cases are prohibited; (b) divisional applications are not allowed in remanded cases unless the division is recom ‑ mended by the BRPTO; and (c) there is no prioritisation of remanded cases, which may cause further delay in prosecution. Even though these proposed regulations give rise to some concerns, they endorse the notion that the BRPTO is looking for ways to modernise the patent system and streamline examination. Of course, there are challenges in looking to overcome systematic pen ‑ dency problems, and these challenges are conducive to growing pains. In any case, Brazilian courts are available to aid patentees in guaranteeing their rights to a full defence and a revaluation of administrative decisions if they are unduly restrictive of applicants’ rights. The ongoing fight for the BRPTO’s financial independence One of the main causes of the BRPTO’s historic pen ‑ dency problems is the patent offices’ constraints in managing their own revenue. Although the BRPTO accrues considerable yearly amounts in revenue, its financial autonomy is considerably limited by the fed ‑ eral administration’s budget allocation. In 2024, for example, despite accruing BRL850 million in yearly revenue (approximately USD160 million), the pat ‑ ent office was only allowed to spend BRL250 mil ‑ lion (approximately USD46 million) to finance its own activity. In recent years, there has been much discourse regarding the need to allow the BRPTO to manage its own resources. This conversation is particularly important as a stepping stone towards overcoming the patent office’s well-known pendency issues.

To address this issue, the Brazilian Intellectual Proper ‑ ty Association, or ABPI (the Brazilian arm of the Inter ‑ national Association for the Protection of Intellectual Property, or AIPPI), made efforts in 2025 to spread awareness of this issue and to discuss the matter with key stakeholders in government. Moreover, legislative proposals such as Bill #143/2019 look to remove these financial constraints from the BRPTO, with the express purpose of allowing the pat ‑ ent office to bolster its activity and aid in overcoming its historical pendency problem. Although the bill is still being processed in the House of Representatives and requires a higher number of votes to pass (as it refers to the national budget), efforts like those spear ‑ headed by the ABPI bring light to this issue, and are commendable attempts to improve the Brazilian pat ‑ ent system. Upcoming rules concerning patents for dosage regimens and new medical uses Another highly relevant discussion for life sciences and pharma cases in Brazil concerns the patentability of dosage regimens. Due to the potential of innova ‑ tive dosage regimens to increase patient adherence to drug treatments, dosing regimen patents are par ‑ ticularly useful in order to claim the way to administer an already known drug, specifying the amount (dose), frequency, duration, route of administration or sched ‑ ule for a specific treatment. The BRPTO often interprets this kind of patent as being barred by Article 10 (VIII) of the BPS, which states that “surgical methods and techniques, as well as therapeutic or diagnosis methods for application in the human or animal body”, are not deemed to be inventions under Brazilian patent law. This statutory limitation invites a discussion on wheth ‑ er this requirement would rule out patents related to new uses or dosage regimens. According to the BRPTO’s restrictive interpretation, although it is pos ‑ sible to allow such patents, some restrictions to their language are required. This places Brazil in opposition to many countries wherein such types of invention are allowed more broadly. For example:

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