Navigating Brazil patent delays: acceleration opportunities for Japanese applicants in life sciences

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Navigating Brazil patent delays: acceleration opportunities for Japanese applicants in life sciences

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Eduardo Hallak, Rafaella Oliveira, and Roberto Carapeto of Licks Attorneys explain how the Patent Prosecution Highway/Global Patent Prosecution Highway framework and the fast-track programme can reduce examination time and secure earlier protection

The backlog reduction initiative and its results

In 2019, the Brazilian Patent and Trademark Office (BRPTO) launched an ambitious Backlog Reduction Plan aimed at reducing patent examination pendency from approximately ten years to just two years. Since then, the BRPTO has implemented a series of measures to improve examination efficiency, including:

  • The introduction of preliminary office actions, through which prior-art documents cited in corresponding foreign applications are identified, giving applicants an opportunity either to amend their claims in line with an allowed or granted counterpart or to submit arguments supporting the patentability of the invention in light of the cited prior art;

  • The revision of examination rules and procedures;

  • The recruitment of additional patent examiners;

  • The outsourcing of prior-art searches; and

  • The incorporation of AI tools into examination-related activities.

Despite the significant progress achieved under this initiative, the objective of obtaining a final examination decision within two years has not yet been achieved. The current average patent examination pendency, considering all technical fields, remains approximately six years, as shown in Figure 1.

Figure 1.png
Figure 1: Average pendency time from filing to issuance of the decision in the first instance

For biotechnology and pharmaceutical patent applications, examination delays remain particularly significant. Data from the past 12 months indicates that applicants have waited nearly eight years, on average, to receive a first-instance decision from the BRPTO, calculated from the filing date.

In addition, whenever a patent application is rejected at first instance, the administrative appeal proceedings may add approximately five years to the overall pendency, as can be seen from Figure 2. Consequently, the total time from filing to a final administrative decision may reach approximately 13 years before the BRPTO.

Figure 2.png
Figure 2: The procedural stages of the appeal system with corresponding average time

These prolonged examination delays have become particularly relevant following the 2021 decision of the Brazilian Supreme Court declaring unconstitutional the sole paragraph of Article 40 of the Brazilian Patent Statute (Law No. 9,279/1996). Before its invalidation, this provision ensured that patentees would enjoy at least ten years of patent protection from the grant date whenever patent prosecution exceeded ten years. Consequently, the mechanism functioned as a safeguard against excessive administrative delays. In the absence of such protection, extended examination periods may substantially erode the effective period of market exclusivity available to patentees.

Applicants should therefore carefully consider the accelerated examination routes available before the BRPTO, as these mechanisms may substantially shorten prosecution timelines and mitigate the adverse effects of prolonged examination.

Acceleration routes available

It is possible to request expedited examination before the BRPTO either by using the examination result of a partner office in the Patent Prosecution Highway (PPH)/Global Patent Prosecution Highway (GPPH) programme or through the fast-track programme under specific circumstances, as established in the BRPTO’s Ordinance No. 79/2022.

PPH/GPPH programme

According to the BRPTO’s Ordinance No. 48/2024, a patent application is eligible to participate in the PPH/GPPH programme when a counterpart (sharing the same priority) has already received a favourable opinion from a partner office during the international or national phase.

Since 2025, after the BRPTO joined the GPPH, the number of partner offices has increased from 23 to 35, including the JPO, CNIPA, USPTO, and EPO. A full list may be found on the BRPTO’s website and in Figure 3.

Figure 3.png
Figure 3: Partner offices – PPH/GPPH programme

The applicant, however, must bear in mind that:

  • Participation in the PPH/GPPH programme may be requested until the beginning of examination, which includes the publication of a preliminary office action; and

  • At the time of filing the PPH/GPPH request, the claimed scope must be identical to or more restricted than the one considered patentable by the partner office.

Acceptance into the PPH/GPPH programme results in the prioritisation of all acts within the administrative sphere of the BRPTO. In 2025, the average time to receive a decision in the first instance counted from the PPH or GPPH request was around five months, according to the BRPTO’s statistics.

Figure 4 presents the BRPTO’s statistics on PPH or GPPH requests in Brazil in 2025, classified according to the origin of the corresponding patent families. The dataset comprises 1,775 requests. The US accounts for the largest number of cases, with 892 requests, representing approximately 50.3% of the total, followed by Europe, with 345 requests, or 19.4%. China ranks third, with 183 requests, corresponding to approximately 10.3% of the dataset, and Japan ranks fourth, with 117 requests, corresponding to approximately 6.6%.

Figure 4.png
Figure 4: Top 10 countries of origin of the corresponding patent families of PPH/GPPH requests before the BRPTO in 2025

For Japanese applicants, these figures are particularly significant. The data shows that Japan is already one of the main origins of patent families using the PPH/GPPH before the BRPTO, ahead of Germany, France, South Korea, the UK, India, and Brazil. This indicates that Japanese patent owners have increasingly considered Brazil as part of their global prosecution strategies. In this context, the PPH/GPPH may serve as an important mechanism to accelerate examination in Brazil, provided that the corresponding requirements are met and that the Brazilian claims are properly aligned with those allowed or considered patentable by a partner office.

Fast-track examination

Beyond the PPH/GPPH programme, BRPTO Ordinance No. 79/2022 provides additional avenues for accelerated examination. Of particular interest to pharmaceutical and biotechnology applicants, patent applications directed to the diagnosis, prevention, or treatment of AIDS, cancer, rare diseases, or neglected diseases may qualify for fast-track examination irrespective of foreign prosecution status. The same benefit is available for inventions related to public health emergencies of national importance, as defined by Decree No. 7,616/2011, and public health emergencies of international concern declared by the World Health Organization. This mechanism has become an important tool for reducing prosecution timelines in strategically sensitive areas of healthcare innovation.

Other grounds for requesting accelerated examination may likewise be relevant depending on the applicant’s business strategy. Notably, fast-track status may be granted where there is evidence of infringement of at least one claim pending in Brazil, as well as where the related technology has already been made available in the Brazilian market. In both scenarios, the rationale is to provide greater legal certainty to inventions that are already generating commercial value or facing competitive challenges.

Like the PPH/GPPH programme, the granting of fast-track status entails the prioritisation of all acts within the administrative sphere of the BRPTO. In 2025, the average time to receive a decision in the first instance counted from the fast-track request was around seven months.

While the PPH/GPPH programme remains the most frequently used acceleration mechanism by foreign applicants, fast-track examination may offer important strategic advantages. Unlike the PPH framework, it does not require a favourable examination result abroad, does not require claim harmonisation with a counterpart application, and may be requested at any time during examination, including appeal, or even during a post-grant opposition, before the BRPTO.

Figure 5 presents the BRPTO’s statistics on fast-track requests in Brazil in 2025, classified according to the origin of the corresponding patent families.

Figure 5.png
Figure 5: Top 10 countries of origin of the corresponding patent families of fast-track requests before the BRPTO in 2025

The dataset comprises 1,232 requests. Brazil accounts for the largest share, with 985 cases, corresponding to approximately 80% of the total, which is expected given that several modalities were designed for Brazilian residents, companies, or institutes. Japan, in contrast, ranks two positions lower than in the PPH/GPPH data and is in sixth place, with only four cases.

It should be emphasised that neither participation in the PPH/GPPH programme nor the granting of fast-track status guarantees patent allowance in Brazil. The BRPTO remains responsible for conducting an independent substantive examination in accordance with Brazilian patent law. Even so, recent statistics reveal a notably high success rate for Japanese-origin applications. During the last 12 months, the average allowance rate in the life sciences sector was 61.89%, whereas applications derived from Japanese patent families achieved an allowance rate of approximately 75%.

Figure 6.png
Figure 6: Comparative allowance rates before the BRPTO in the life sciences sector – Japanese-origin applications versus all-origin applications (last 12 months)

An even higher allowance rate is observed for applications examined under the PPH/GPPH framework based on claims granted by the JPO, where approximately 94% of cases ultimately proceed to allowance in Brazil. Such a high success rate suggests a significant degree of substantive alignment between the patentability standards applied by the JPO and those employed by the BRPTO.

Conclusion

For Japanese innovators, Brazil should no longer be viewed as a jurisdiction where lengthy examination delays are unavoidable. Although significant pendency challenges remain, particularly in the pharmaceutical and biotechnology sectors, the combination of PPH/GPPH access through the JPO and the increasingly robust fast-track examination framework for pharmaceutical- and biotechnology-related applications offers practical and effective pathways to obtaining earlier patent protection.

Companies that integrate these tools into their global filing strategies are likely to secure not only faster prosecution outcomes but also greater commercial value from their Brazilian patent portfolios.

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