Life Sciences and Pharma IP Litigation 2025

BRAZIL Trends and Developments Contributed by: Eduardo Hallak, Juliana Neves, Isabella Bonisolo and Juliana Castelo Branco, Licks Attorneys

questions the allocation of 10% of the revenue earned by the BPTO to the BPTO itself, in view of understaffing and backlog issues, is pending analysis before the Appellate Court for the Fed - eral Second Circuit (TRF-2), with the trial session expected to happen in 2025 (Case # 5095710- 55.2021.4.02.5101). In 2022, the trial court rendered a decision on the merits determining that the federal government should structure a report on the inefficiency of and need for the BPTO, and allocate financial resources to the IP authority to enable the devel - opment of activities and reduce the backlog. Given the sensitive issues raised by life sciences and pharma IP cases, the sector would benefit from the success of this public civil action, as the incomings would allow the BPTO to improve the quality and delivery time of its services to applicants. Accurate and expedited analysis by BPTO examiners could prevent the need for law - suits challenging BPTO actions. The BPTO Joins the Global Patent Prosecution Highway In July 2024, the BPTO joined the Global Pat - ent Prosecution Highway (Global PPH or GPPH) programme, aiming to speed up the prosecution of patent applications by sharing examination results from any of the 35 participating offic - es, including those obtained under the Patent Cooperation Treaty (PCT), that indicate patent - able subject matter. For 2025, the BPTO issued Ordinance # 48 on 29 November 2024, which: • establishes Phase V of the PPH Pilot Project, regulating the Global PPH; • expands the participation limit to 3,200 PPH requests per year, with a maximum of 1,000

requests for the same section of International Patent Classification (IPC); and • accepts substantive examination results indicating patentable subject matter from all Global PPH participating authorities, includ - ing those examined under the PCT. This initiative may enhance Brazil’s contribution to global protection for the pharmaceutical and life sciences industries in 2025, as it encom - passes faster patent prosecution by leveraging examination results, while being cost effective. Also aiming to reduce the BPTO’s backlog, Bill # 2210/2022 proposes amendments to the BPS, to: • create a provisional patent application; • devise mechanisms for the BPTO to benefit from searches of technical examinations published by other patent offices and interna - tional organisations; and • eliminate the automatic 36-month term required for applicants to request the exami - nation of the patent application, and restrict the capability of amending the application only until the beginning of the technical examination. This proposal of restriction limits the possibility of amending the patent application and favours the conclusion of the analyses of applications in Brazil before other jurisdictions, aiming to address backlog issues at the BPTO. A new proposal, including a PTA mechanism, was pre - sented to the Senate in July 2024. The ongoing discussion in Congress must be closely moni - tored, particularly regarding the term to request examination and the possibility for the BPTO to consider searches from other patent offices.

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