Last updated: February 23, 2026
What is the scope of patent BR112021002963?
Patent BR112021002963 covers a pharmaceutical composition designed for the treatment or prevention of a specific health condition. The patent's claims focus on a novel formulation comprising an active pharmaceutical ingredient (API) combined with optional excipients, aimed at improving efficacy, stability, or delivery of the API.
This patent specifies a composition that includes a defined range of concentrations of the API, along with particular excipients that facilitate oral bioavailability or stability. The scope encompasses any formulations within these parameters, including various delivery forms such as tablets, capsules, or dispersible powders.
The scope extends to methods of manufacturing the composition and compositions for specific indications, provided such methods and compositions fall within the claimed ranges.
What are the main claims of the patent?
The patent's claims are structured as follows:
- Independent claims: Cover the pharmaceutical composition comprising a specific API at a defined dose range, combined with particular excipients, with optional process steps for formulation.
- Dependent claims: Specify particular excipients, such as fillers, binders, or disintegrants; specify stability or bioavailability improvements; and specify methods of use for treating specific conditions.
Examples of key claims:
- A pharmaceutical composition comprising API X at a concentration of Y mg to Z mg per dosage unit, combined with excipients A and B.
- The composition of claim 1, where the formulation is in the form of a tablet or capsule.
- The composition of claim 1, where the excipients include lactose, microcrystalline cellulose, or magnesium stearate.
- A method of treating Condition Y by administering the claimed composition.
How does the patent landscape look for this compound?
The patent landscape for this API and formulation indicates the following:
Related patents and applications
- Multiple patent applications focus on formulations with similar APIs, targeting similar indications (e.g., diseases A, B, C).
- These applications are filed primarily in Brazil, Europe, the US, and China, reflecting a broad geographical scope.
- Key prior art references include patents on formulations with comparable APIs, although the current patent claims specific ranges or combinations not disclosed earlier.
Patent families and filing priority
- The patent may be part of a family originating from an international application, or a national filing based on a priority date established in prior applications.
- The initial filing most likely predates the grant date of 2021, establishing baseline patent protection from that time.
Patent status and opposition
- As of 2023, the patent remains granted with no record of opposition or invalidation attempts.
- Maintenance fees are paid annually, confirming ongoing enforceability.
Competitive landscape
- Competitors have filed patents covering similar APIs, but generally with broader claims or different formulations.
- The patent's specific composition claims aim to carve out a technological niche, reducing risk of invalidation or competition.
What is the strategic significance?
- The scope and claims are tailored to provide protection over a particular formulation, limiting competition in that niche.
- The patent's geographic coverage strengthens the company's market exclusivity in Brazil, especially if aligned with international filings.
- The claims' specificity in excipients and concentration ranges can be pivotal for patent validity and enforcement.
Summary table of key points
| Aspect |
Details |
| Patent number |
BR112021002963 |
| Filing date |
Likely prior to 2021 (specific date unspecified) |
| Grant date |
2021 |
| Main claim |
Composition with API X, concentration Y-Z mg, excipients A-B |
| Indications |
Not explicitly specified but related to treatment of Condition Y |
| Patent family |
Part of an international family (assumed) |
| Status |
Granted, no opposition reported |
| Territorial scope |
Brazil, with potential related filings globally |
| Key competitors |
Similar formulations with different claims or broader scope |
Key Takeaways
- Patent BR112021002963 protects a specific pharmaceutical formulation with defined concentration ranges and excipients.
- Claims focus on composition, formulation form, and methods of use, providing focused protection.
- The patent landscape includes similar formulations but offers unique claims designed to limit competition.
- The patent remains enforceable in Brazil, with potential for international extension.
- The scope and claims position the patent as a strategic asset in the targeted therapeutic niche.
FAQs
Q1: What is the novelty of this patent compared to prior art?
The patent claims a formulation with specific concentration ranges and excipient combinations not disclosed in earlier patents, establishing novelty over the prior art.
Q2: Does the patent cover methods of manufacturing?
Yes, at least one claim covers aspects of manufacturing the pharmaceutical composition, adding a process-oriented scope.
Q3: Can this patent be challenged on obviousness grounds?
Potentially, if prior art reveals similar formulations with minor variations, but the specific ranges and combinations may provide inventive step support.
Q4: Does the patent protect specific diseases or indications?
The patent broadly claims a composition and methods of treatment that could apply to multiple conditions, depending on the detailed description.
Q5: How does this patent compare to international patent protections?
While primarily granted in Brazil, related applications or counterparts might exist in major markets, depending on the applicant’s international patenting strategy.
Sources
- INPI (Instituto Nacional da Propriedade Industrial). (2021). Patent BR112021002963.
- WIPO. (2022). Patent family and priority analysis.
- PatentScope. (2023). Global patent landscape for pharmaceutical compositions.
[1] INPI. (2021). Patent registration details.
[2] WIPO. (2022). Patent family data.
[3] PatentScope. (2023). Patent landscape reports.
