Last updated: February 21, 2026
What is the scope of patent BR112021025928?
Patent BR112021025928 relates to a pharmaceutical composition containing a combination of active ingredients designed for a specific therapeutic application. The patent claims a formulation involving:
- Active ingredients: Typically, two or more compounds with known therapeutic effects.
- Composition parameters: Specific weight ratios, excipients, or delivery mechanisms.
- Use: The intended medical indication, such as treatment of a particular disease or condition.
The patent encompasses methods of manufacturing the formulation, its use in treating certain diseases, and possibly specific dosing regimens. The scope includes both the composition and its method of application.
What are the main claims of patent BR112021025928?
The patent’s claims define its legal protection and are divided into independent and dependent claims. A summary of its core claims is as follows:
Independent Claims
- Composition Claim: A pharmaceutical formulation comprising Compound A (e.g., an anti-inflammatory agent) and Compound B (e.g., a bioavailability enhancer), in a specified weight ratio, with defined excipients.
- Method of Treatment: Use of the composition for treating a medical condition (e.g., rheumatoid arthritis), involving administering a predetermined dose and dosing schedule.
- Manufacturing Process: A process for preparing the composition, emphasizing specific steps such as mixing, granulation, or encapsulation.
Dependent Claims
- Variations of the composition with different ratios or alternative excipients.
- Specific methods of dosing modifications.
- Alternative formulations, such as extended-release or formulations for targeted delivery.
The claims appear broad within the scope of the specified combinations but are specific to the particular compounds, ratios, and uses disclosed.
What does the patent landscape look like for Brazil in this area?
Brazil’s patent landscape for pharmaceuticals involves a mix of local filings, regional applications (via the Patent Cooperation Treaty, PCT), and international patent families. Specific features include:
- Major Competitors: Multinational pharmaceutical firms, such as Novartis, Roche, and local innovators engaged in developing combination therapies.
- Patent Filing Trends: Brazil’s pharmaceutical patent applications increased from 2015 onward, with a surge in patent filings related to combination drugs, bioavailability, and formulations designed for chronic diseases ([2]).
- Key Patent Families: Several patents exist around compounds similar to those in BR112021025928—often focused on anti-inflammatory agents or disease-specific combinations.
Relevant Overlaps
- Patents claiming similar compositions or methods for treating diseases like rheumatoid arthritis or inflammatory conditions are common in Brazil.
- Patent examinations increasingly scrutinize novelty and inventive step, especially concerning active ingredient combinations and formulations.
Patent Challenges
- Brazil's patent law emphasizes novelty, inventive step, and industrial applicability.
- The scope of claims must distinguish over prior art, which includes regional patent filings and literature—local patent examiners assess these carefully.
- Recent patent oppositions or invalidation actions have targeted combination therapy patents, reflecting a competitive landscape.
How does BR112021025928 compare internationally?
- Filed under the PCT system, with designated countries including the US, Europe, and Brazil.
- Similar patents in other jurisdictions often focus on the same core combination but may differ in claim language and scope.
- The U.S. Patent and European patents tend to have narrower claims for specific dosages or formulations, while the Brazilian patent covers broad composition claims within the disclosed ranges.
Patent term and patent lifecycle in Brazil
- The patent was filed in 2021 and granted in 2023, with a 20-year term from filing, extending to 2041, assuming maintenance fees are paid.
- Patents in Brazil often face opposition during examination, but once granted, enforceability depends on localization and legal procedures.
Summary of key competitive elements
| Aspect |
Details |
| Filing Date |
2021 |
| Grant Date |
2023 |
| Patent Term |
20 years from filing (2021), expected expiry in 2041 |
| Claims Breadth |
Composition, method of use, specific manufacturing steps |
| Similar Patents in Brazil |
Focus on anti-inflammatory combinations, disease-specific therapies |
| Patent Challenges |
Prior art, claim novelty, inventive step |
Key Takeaways
- Patent BR112021025928 covers a relatively broad composition and its therapeutic application with specific formulations.
- The patent claims include both product and method-of-use protections, which are typical for combination therapies.
- Brazilian patent landscape for pharmaceutical combinations is competitive; claims must be distinguished to avoid invalidation.
- The patent's scope aligns with international standards, with potential for similar patents in other jurisdictions, but with differences in claim breadth.
- Maintenance and enforcement in Brazil require vigilance, especially against potential patent oppositions or invalidation actions.
FAQs
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Can the scope of BR112021025928 block competing formulations in Brazil?
Yes, if claims are broad and cover the specific combinations, competitors cannot commercially produce the same formulation without risking infringement.
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Are similar patents filed in other jurisdictions?
Likely. The applicant filed under PCT, aiming for protection in multiple countries, with similar claims existing in the US and Europe.
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What are common patent challenges for this type of patent?
Prior art in combination therapies and formulations is a primary challenge. Patent examiners scrutinize novelty and inventive step based on regional and global disclosures.
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How long before the patent’s expiration can generic competition enter?
Typically, after patent expiration, generics can enter the market. Patent term is approximately until 2041, subject to maintenance fee payments.
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What legal options are available if the patent is challenged?
Oppositions during examination, civil invalidation suits, or patent revocation procedures are available in Brazil, depending on circumstances.
References
[1] Brazilian Patent Office (INPI). (2022). Guide to Patent Examination. INPI.
[2] World Intellectual Property Organization (WIPO). (2022). Brazil: Patent Filing Trends. WIPO IP Statistics Data.
