Life Sciences and Pharma IP 2026

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

Since ADI #5529, discussions regarding the introduc ‑ tion of a specific compensation regime in Brazilian statute have gained weight and political backing. The following bills are currently being evaluated in Con ‑ gress. • Bill #2,210/2022 proposes amendments to the BPS to reduce the BRPTO’s backlog. One of the main proposals of this bill is to simplify the filing of the patent application, allowing inventors to request a priority date with no need to immediately submit complete technical documentation. The Brazil ‑ ian Senate recently presented Amendment #4, which allows PTA proceedings before the BRPTO whenever there is an unjustifiable delay attribut ‑ able to the BRPTO’s examination. In any event, adjustments may not exceed five years, and shall be proportional to the delay in the actual case. Bill #2,210/2022 is still pending approval by the Fed ‑ eral Senate. • Bill #2,056/2022 also provides for the possibility of the patentee requesting PTA (limited to a five- year maximum adjustment) based on the BRPTO’s delay in examination. Under this bill, the request for PTA would also be subjected to a five-year statute of limitations based on the expiration of the patent term (ie, PTA may be sought within the five years following the patent’s expiry). This bill is still pend ‑ ing approval by the House of Representatives. • Bill #1,471/2023 proposes three rules for extending patent terms: (a) any extension is limited to a maximum period of five additional years of patent protection; (b) eligible patents must have had ten years be ‑ tween filing and granting of the patent; and (c) only one extension per product would be avail ‑ able. This bill is also pending approval by the House of Representatives. • Bill #5,810/2025 also proposes the possibility of PTA in proportion to the BRPTO’s delay but limited to a maximum five-year extension. According to this bill, the patentee would have 60 days after the patent’s grant to request term adjustment. The bill also provides a transitional rule extending the same 60-day window for patentees that have already filed PTA lawsuits to request term adjustment (counting from the day in which the bill passed into

law). Bill #5,810/2025 is pending approval by the House of Representatives. New rules for Brazilian patent prosecution On the bright side, the BRPTO’s patent backlog and pendency issues were addressed emphatically after ADI #5529. Throughout the 2010s, patents in many fields could take upwards of ten years in examination, but the BRPTO is now making a conscientious shift to address pendency. In 2023 and 2024, the average patent age at grant was around six years. In 2025, this went down to around four years (without counting the pendency at appeal level, which still adds up to four more years to the prosecution length), and the BRPTO has stated its intention to get the average down to three years in the next few years (from the request for examination to the decision at first stage level, without the appeal stage). Between 2024 and 2025, the BRPTO introduced a series of regulatory and procedural changes as part of its internal restructuring, which were presented as being necessary to: • improve institutional efficiency; • reduce the backlog of patent examinations; and • align the agency with technological and digital governance standards. Of the changes, the following stand out. • BRPTO’s Ordinance #10/2024 has changed the administrative appeal process, as appeals are no longer subject to a full review. This ordinance has been very controversial as it effectively eliminates the “full review effect” described by Article 212 (Section 1) of the BPS and restricts the applicant’s ability to discuss other technical or legal arguments at the appeal stage other than the grounds of rejection at first instance. • BRPTO’s Ordinances #14/2024 and #16/2024 have both introduced further changes regarding voluntary divisional patent applications. The new rules stipulate that divisional applications shall only occur prior to the publication of the decision to allow or reject the original application, which goes against TRIPS provisions and the well-established

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