Senator Jacques Wagner is the leader of the government coalition in the Senate, and an important Senator of the government party. He has previously served as Chief of Staff for President Dilma Rousseff (successor to President Lula) during her second term. In April 2024, Senator Wagner introduced a substitute Bill (Link) to amend the Brazilian Patent Statute (#9.279/1996), changing Articles 32 and 33. This proposal seeks to abolish the deferred examination process in the Brazilian Patent System, a practice that dates back to 1971. Under the current deferred examination system, applicants are granted a period of 36 months (from filing or priority) to request substantive examination, a practice that aligns with most countries in Europe, Latin America, and Asia.

The Bill was already approved by the House under #10.920/2018, and will be voted both in the Senate's Committee on Foreign Affairs and National Defense (CRE) and the Committee on Science, Technology, Innovation, Communication, and IT (CCT). In this sense, Senator Wagner's Opinion and the substitute bill represent a major upgrade to the likelihood of approval for Bill 2210/2022, in a context where the majority of bills pertaining to IP are neither approved nor considered.

Bill #10.920/2018 was initially submitted to the House in October 2018, focusing exclusively on trademark issues, given the context of Brazil's accession to the Madrid Protocol, enacted by Decree #10.033/2019. However, the content of the bill was fully amended by Congressman Efraim Filho (Democrat Party). The amendments removed all proposals related to changes in the trademark system and introduced changes to the patent system, including the creation of the provisional patent application.

Senator Jacques Wagner's proposed Substitute Bill brings about significant changes to the existing Bill once again. It eliminates some of the proposals included in the House-approved version, such as the provisional patent application and the allowance for filing documents in a foreign language. Furthermore, it reintroduces provisions that solely address trademark matters.

One of the key changes is the amendment to Article 33, which essentially reverses the existing approach of the Brazilian Patent Statute towards the examination of patent applications. As per the current system, applicants have a 36-month period from the application filing date to request the technical examination.

This 36-month period plays a crucial role for inventors and investors, providing them with the opportunity to assess the market viability of the invention disclosed in the application. If the invention lacks market potential, money and time are saved by avoiding the examination fee and preventing unnecessary workload for the BRPTO's patent examiners. Further, the 36 months are important to update the claims of the application, in light of the original disclosure.

Under the procedure proposed by the Bill, the examination would begin immediately upon filing, and applicants would retain the option to request a deferred examination within the same 36-month timeframe.

Combined with the changes to Article 32, also proposed in the Substitute Bill, the deadline for making voluntary changes to patent applications would be shifted for the beginning of the examination process, which would occur within an undefined timeframe.

The amendments to Articles 32 and 33, as presented in the Substitute Bill, contradicts the interests of the majority of participants of the Invitation for Public Comments #1, published by the BRPTO on September 15, 2023, which sought comments on potential regulatory changes to the procedures and deadlines stipulated in Articles 32 and 33. In this regard, 86.49% of the participants (representing approximately 100% of the patent applicants, as the BRPTO permitted non-users to participate in the invitation for public comments) expressed their preference for maintaining the 36-month deadline for submitting the request for examination. This preference is due to the opportunity to make voluntary amendments to the application up until the request. The suggestion of the BRPTO found support only within the Brazilian pharmaceutical generic industry.

Furthermore, there's a lack of harmonization of the Bill with the Brazilian Patent Statute, particularly in relation to the request for examination. Under the existing system, both the applicant and any interested party can request the examination. However, the Bill establishes that only the applicant can request the deferred examination, potentially leading to confusion among both local and international applicants. Additionally, the bill does not address the 18-month secrecy period established by Article 30, nor does it consider the timeframe for PCT applicants to initiate the Brazilian national phase.

Effectively, considering the patent owner community's negative response to the proposed changes to Articles 32 and 33, it's likely that most, if not all, patent applications will opt for the deferral of the application, rendering the amendment useless.

The government proposal indicates a patent policy that is all focused on supporting the Brazilian generic pharmaceutical industry, very much aligned with the “Nova Indústria Brasil” government Action Plan, which seeks to stimulate the country’s development through incentives for innovation and sustainability, with measures such as creating an online list, updated with expiring pharmaceutical patents, and the development of a platform containing data on pharmaceutical patent applications filed since 2000 to identify sector trends and gaps, which led to a Technical Cooperation Agreement between the government and the Association of National Capital Pharmaceutical Industries (FarmaBrasil), an association known for representing anti-patent interests.

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