Brazil: An Unregulated “Pharmaceutical Orange Book”? New patent-intelligence cooperation has a story to tell

Brazil’s Ministry of Health and ABIFINA, the association representing local biosimilar and generic companies, have signed a patent-intelligence cooperation agreement aimed at improving the use of patent information within the Unified Health System (SUS).

Signed on 25 November 2025, the agreement (Agreement No. 3/2025)1creates a dedicated channel for consolidated access to patent-related intelligence on strategic health products. From the framework published so far, it appears that ABIFINA will develop a structured list of patents and pharmaceutical products comparable, in spirit, to the US FDA’s Orange Book.

Scope of the cooperation

The arrangement is intended to give the Ministry of Health access to a Patent Monitoring System maintained by ABIFINA, which currently consolidates around 20,000 patent documents filed in Brazil, covering medicines, biotechnology and pharmaceutical inputs.

This includes a study of active pharmaceutical ingredients (APIs) and medicines with patents expiring by 2030, as well as several ongoing patent-monitoring programs (MPPs) that track patent filings relating to:

·       agricultural crop-protection products (MPP Agro);

·       biodiversity-based medicines (MPP Bio);

·       cannabis-derived products (MPP Cannabis);

·       pharmaceuticals registered with the US FDA, including biosimilars with corresponding Brazilian patents (MPP FDA and MPP FDA Biosimilars);

·       animal health (MPP Saúde Animal); and

·       pharmaceutical products of particular interest to SUS (MPP SUS).

Under the cooperation, the Ministry may designate up to twelve official representatives to interact with ABIFINA and submit technical queries to intellectual property specialists, with a view to:

·       identifying emerging technologies and new therapeutic targets;

·       mapping technological-development pathways;

·       analyzing patent-protection scenarios; and

·       supporting decisions with greater legal certainty and market awareness.

In return, if the Ministry uses MPP outputs in technical or official documents, it must refer to the MPP as an “ABIFINA product.”

The cooperation is structured under Brazil’s general regime for partnerships with civil-society organizations (Law 13.019/2014, as amended by Law 13.204/2015). There is no transfer of funds or assets between the parties. Each side bears its own costs and remains solely responsible for its personnel and infrastructure. The agreement is initially valid for 48 months from publication and may be extended once, for an equivalent period, by addendum.

Federal actions announced at the plenary

During the plenary session in which the agreement was signed, the Ministry of Health also announced a package of federal measures to strengthen the Health Economic-Industrial Complex (CEIS), including:

·       R$ 15 billion in investments to expand domestic production, with 31 new Productive Development Partnerships (PDPs);

·       R$ 3.2 billion for the acquisition of 84,600 items of equipment under the “Agora Tem Especialistas” (Now We Have Specialists) program, which aims at reducing waiting times for specialized medical care within SUS;

·       R$ 6 billion for the operationalization of the Complexo Industrial de Biotecnologia em Saúde (CIBS/Fiocruz);

·       R$ 25 million for implementing the AnvisAI project, aimed at modernizing regulatory assessments; and

·       investments in advanced research at CNPEM to develop new active pharmaceutical ingredients.

These measures frame the cooperation with ABIFINA as one element of a broader industrial-policy effort focused on technological upgrading and local manufacturing capacity.

Policy backdrop

The cooperation fits within the broader National Strategy for the Development of the Health Economic-Industrial Complex (CEIS), established by Decree 11.715/2023. That strategy seeks to reduce Brazil’s technological and productive dependence in health, including by promoting technology-transfer partnerships (the PDPs).

These initiatives naturally require robust information on intellectual property, particularly for projects involving technology transfer, local manufacturing and the introduction of biosimilars into SUS.

However, ABIFINA’s active role in patent-invalidity lawsuits raises questions about whether this cooperation is the right institutional choice for the Ministry of Health, especially considering there is still no legislation or regulation establishing an official patent-listing framework in Brazil.

By plugging ABIFINA’s patent-monitoring capabilities into the Ministry’s internal decision-making, the government is effectively relying on the expertise of an association that frequently seeks to challenge patent protection in Brazil.

For pharmaceutical, biotechnology and fine-chemical companies – both domestic and foreign – the signal is that SUS-related policy and procurement decisions will increasingly be informed by systematic patent intelligence.

Over the next four years, the effectiveness of this arrangement will depend on how actively SCTIE/MS officials use these tools in public decision-making and how well the patent data are translated into actionable guidance for policymakers and procurement teams.

It also remains to be seen whether any resulting patent list will come to be used as evidentiary support in patent-infringement proceedings, in a way similar to how the US Orange Book and Paragraph IV certification framework shape litigation in the United States.

• 1https://abifina.org.br/acontece-na-abifina/abifina-firma-acordo-com-o-ministerio-da-saude-durante-plenaria-do-geceis/.