Pharmaceutical companies, biotechs, startups, and research institutions developing new applications for already known products will need to review their patent protection strategies in Brazil. With the publication of Normative Ordinance BPTO/PR No. 80/2026, the Brazilian Patent and Trademark Office (BPTO) updated the examination guidelines related to what are known as new uses of known products, bringing greater clarity on patentability criteria and on the type of technical evidence expected for this type of invention.
The changes have a direct impact on sectors in which innovation does not always arise from the discovery of a new molecule, but from identifying a new application for an already existing product. Although the goal is to increase the predictability of the system and standardize the examination of applications, the update also raises important questions about R&D strategy, evidence generation, and the ideal timing for filing patents.
Why do the revised guidelines matter?
Not every innovation comes from developing a completely new technology. In many cases, the breakthrough lies in discovering that a known product can solve a problem different from the one it was originally designed to address.
This is a common scenario in the pharmaceutical industry, where a medicine may prove effective for a new therapeutic indication. Similar situations occur in the chemical and biotechnology sectors, where compounds, formulations or biological products can find entirely new industrial, agricultural or commercial applications.
For companies and research institutions, the ability to protect these discoveries is essential to attract investment, justify development costs and build competitive advantages.
What does the update bring in practice?
The main contribution of the revised guidelines is the consolidation of the criteria used by the BPTO to examine applications related to new uses.
The document provides greater detail on how requirements such as novelty, inventive step and sufficiency of disclosure will be evaluated, offering more objective parameters for both patent examiners and applicants.
In practical terms, companies, universities and researchers now have a clearer understanding of what may qualify for protection and what type of supporting evidence is likely to be required. It is worth noting that applying these criteria still depends on a case-by-case technical and strategic analysis, since each invention starts from its own set of evidence and a specific regulatory context.
At the same time, the update reinforces the importance of building patent protection on a solid technical foundation from the early stages of development.
The Impact on Innovation Strategies
The revisions reinforce a trend that has been gaining importance in recent years: the need to align research, development and intellectual property strategies more closely.
For organizations working on drug repurposing or new applications of existing technologies, the timing of a patent filing and the quality of the available evidence now play an even more important role in protection strategies.
As a result, R&D, regulatory affairs and intellectual property teams will need to work more closely together to ensure that the data generated during development can effectively support future patent claims.
Greater Focus on Technical Support for the Invention
One of the most significant aspects of the more detailed criterio concerns the need to clearly demonstrate the relationship between the known product and the new technical or therapeutic effect being claimed.
In other words, the BPTO aims to distinguish inventions that are supported by credible technical evidence from those that still rely heavily on unproven assumptions.
For companies and research institutions, this reinforces the importance of carefully planning evidence generation throughout the development process. The stronger the technical support included in a patent application, the greater the likelihood of overcoming challenges during examination.
What Does This Mean for Pharmaceutical Companies and Biotechs?
The impact is likely to be particularly relevant for organizations investing in drug repurposing initiatives.
In recent years, drug repurposing has become an increasingly important strategy because it allows companies to identify new therapeutic applications for known substances while reducing development risks and leveraging existing scientific knowledge.
With the revised parameters, protection for these innovations remains available, but applicants will need to take a more strategic approach to generating data, determining the optimal filing date and drafting patent claims. Each case must be evaluated individually, taking into account the product’s development history and the strength of the evidence already available.
For many companies, these considerations may directly influence development timelines and broader intellectual property strategies.
Universities and Startups Also Need to Adapt
The update does not affect only large corporations.
Universities, research institutes and startups are often responsible for the early-stage discoveries that give rise to new uses of known products, particularly in the fields of healthcare, biotechnology and chemistry.
In these environments, innovations frequently emerge from preliminary findings and continue to evolve as additional studies are conducted. As a result, determining the right time to file a patent application becomes an even more strategic decision.
Striking the right balance between securing protection early and generating sufficient supporting evidence is likely to be one of the key challenges for these organizations.
A point that continues to spark debate
Despite bringing greater clarity to examination criteria, the update also opens discussions about how these criteria will be applied in practice.
One particularly sensitive aspect is the absence of specific provisions addressing patent applications already filed and still awaiting examination.
This creates uncertainty for companies and institutions that developed their filing strategies based on previous examination practices and may now face assessments under a more detailed framework.
How this issue evolves over the coming years will be closely watched by patent applicants and intellectual property professionals alike.
What Should Companies Do Now?
Given the revised guidelines, organizations developing innovations based on new uses of known products should review their patent protection strategies in Brazil.
Several actions are becoming increasingly important:
- Assess the strength of the technical evidence available before filing;
- Integrate R&D, regulatory and intellectual property teams from the earliest stages of development;
- Carefully plan the timing of patent filings;
- Review pending applications to identify possible impacts of this update;
- Adapt protection strategies to align with the BPTO’s updated examination framework.
Greater Predictability for the Patent System
The revision of Chapter 9 of INPI’s Chemistry Examination Guidelines represents an important step toward greater consistency and predictability in the assessment of patent applications involving new uses of known products.
For pharmaceutical companies, biotechs, universities and startups, the key takeaway is not that protection for these innovations has become unattainable, but that securing it now requires more careful planning and closer alignment between scientific research and intellectual property strategy.
The true impact of the revised guidelines will be defined by how they are applied in practice. But one thing is already clear, understanding the BPTO’s new criteria and having specialized guidance to interpret them on a case-by-case basis will be essential for organizations seeking to turn scientific discoveries into protected and competitive innovation assets.