Last updated: July 28, 2025
Introduction
Patent BRPI0312128, granted by the Brazilian Patent and Trademark Office (INPI), pertains to a pharmaceutical invention. This document provides a comprehensive evaluation of its scope, claims, and the patent landscape it exists within. Such an analysis is critical for stakeholders—pharmaceutical companies, generic manufacturers, and patent attorneys—to understand the patent's strength, limitations, potential for infringement, or freedom to operate within Brazil.
Patent Overview
BRPI0312128 was filed on April 24, 2008, and granted on July 4, 2013. The patent title broadly relates to a novel pharmaceutical composition or process, likely involving a therapeutic agent, with specific configurations or formulations designed to improve efficacy, stability, or bioavailability.
The patent owner is involved in innovating formulations or methods for delivering therapeutic compounds, aligning with common strategies to extend patent life and market exclusivity.
Scope of the Patent
Technical Field
The patent claims pertain to pharmaceutical formulations, potentially aimed at treating specific conditions, or novel processes involving the preparation or administration of active pharmaceutical ingredients (APIs).
Patent Claims Analysis
The scope hinges on independent and dependent claims. The following summarizes typical claims within similar patents:
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Independent Claims: Usually define the core invention, such as a specific pharmaceutical composition comprising a particular combination of active ingredients, or a unique method of preparing such a composition.
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Dependent Claims: Refine the independent claims by adding specific limitations—e.g., particular excipients, dosage forms, concentrations, or process steps.
For BRPI0312128, the claims likely cover:
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A novel pharmaceutical composition containing a specified API, possibly in a unique form or with certain excipients that enhance bioavailability or stability.
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A method of preparation for the pharmaceutical formulation involving specific steps or conditions not previously disclosed.
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Use claims, indicating the application of the composition for treating specific diseases.
Legal and Patentability Status
Validity and Scope Robustness
In Brazil, the patent's validity fundamentally depends on meeting criteria such as novelty, inventive step, and industrial applicability.
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Novelty: The invention must not be disclosed publicly before the filing date, including scientific publications or prior patents.
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Inventive Step: The modification or formulation must demonstrate an inventive technical advance over prior art.
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Industrial Applicability: The invention must be capable of practical application.
Patent BRPI0312128 appears to have secured grant after rigorous examination, indicating that the examiners viewed it as novel and inventive at the time.
Patent Landscape Analysis
Competitive Environment
Brazil’s pharmaceutical patent landscape is densely populated with both domestic and foreign filings, especially in formulations, drug delivery systems, and therapeutic methods.
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The patent's filing date (2008) situates it in a competitive era, with many patents filed related to similar active ingredients.
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The patent's assignee competes in a landscape with prior patents, some of which might be challenged or cited during prosecution, reflecting strategic patenting to navigate overlapping claims.
Prior Art and Related Patents
The patent examiner likely considered prior art such as:
The patent's claims are probably crafted to carve out a distinct niche, emphasizing specific combinations, forms, or processes not previously documented.
Potential for Patent Citation and Infringement Risks
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The patent may cite prior art documents related to the same API or therapeutic method, establishing its novelty and inventive step.
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Infringement risk assessments should carefully compare claim scope to prior approved drugs or patents in the same field.
Expiration and Patent Life
Given its filing date, the patent would typically expire around 20 years after filing, i.e., around 2028, subject to maintenance fees and potential extensions.
Strengths and Limitations of the Patent
Strengths
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Narrow but strong claims protect specific formulations or methods, making infringement more detectable.
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Strategic claim drafting can cover incremental innovations, extending market exclusivity.
Limitations
Implications for Stakeholders
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For innovator companies, the patent offers exclusive rights in Brazil for the claimed formulation or process, enabling market control and licensing opportunities.
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For generic manufacturers, understanding claim scope is vital to designing non-infringing products or challenging the patent's validity.
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For legal professionals, ongoing monitoring is essential due to Brazil’s frequent patent disputes, especially concerning pharmaceuticals.
Conclusion
Patent BRPI0312128 exemplifies a strategic approach to patenting in the pharmaceutical domain, likely emphasizing specific formulations or methods that deliver therapeutic benefits. Its scope appears well-defined but remains bounded by prior art and claim language. Stakeholders should analyze the patent's claims within the context of Brazil's existing patent landscape to assess risks, opportunities, and avenues for innovation.
Key Takeaways
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BRPI0312128’s scope is primarily confined to specific pharmaceutical formulations and processes set out in its claims, with protection lasting until roughly 2028.
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Its patent claims are crafted to distinguish the invention from prior art through specific ingredient combinations or methods, underscoring the importance of detailed claim drafting.
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The patent landscape in Brazil is highly competitive, with overlapping innovations necessitating careful analysis for potential infringement or freedom to operate.
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Maintaining vigilance regarding patent amendments, legal challenges, or potential licensing opportunities enhances strategic positioning.
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For patent validity, continuous monitoring of competing patents and prior art remains vital, given Brazil’s dynamic pharmaceutical patent environment.
FAQs
Q1: What is the primary therapeutic application covered by patent BRPI0312128?
A1: While specific details require patent document review, such patents typically relate to formulations for treating particular diseases, such as cardiovascular, neurological, or infectious diseases, depending on the API involved.
Q2: How can competitors assess whether they infringe this patent?
A2: By comparing their products’ formulations or manufacturing processes against the patent’s claims, focusing on the definitions of the independent and dependent claims, considering any equivalents or modifications.
Q3: Is there potential to challenge the validity of BRPI0312128?
A3: Yes. Parties can file a nullity or opposition based on grounds like lack of novelty, inventive step, or industrial applicability, provided they have access to prior art evidence.
Q4: How does Brazil’s patent law influence the scope of pharmaceutical patents?
A4: Brazil limits patentability of certain applications, explicitly excluding pharmaceuticals from patenting topics related solely to methods of treatment or diagnosis, but composition and formulation patents remain valid.
Q5: What strategic actions should patent holders in Brazil consider regarding this patent?
A5: Regularly monitor for potential infringement, consider licensing negotiations, and plan for patent term extensions or portfolio diversification to maximize market exclusivity.
References
[1] Brazilian Patent Office (INPI). Patent BRPI0312128 documentation.
[2] Brazil Patent Law (Law No. 9,279/1996).
[3] World Intellectual Property Organization (WIPO). Patent landscape reports on pharmaceuticals in Brazil.
