Last updated: August 10, 2025
Introduction
Brazilian patent BR112013005792, filed in 2013, pertains to a pharmaceutical invention, identified within the scope of inventive advancements in drug composition or manufacturing processes. This analysis offers a comprehensive review of its scope, claims, and the patent landscape, serving as a strategic tool for pharmaceutical companies, patent attorneys, and R&D stakeholders aiming to navigate the Brazilian patent environment effectively.
Patent Overview and Bibliographic Data
- Patent number: BR112013005792
- Filing date: August 28, 2013
- Publication date: August 7, 2014
- Applicant/Assignee: [Specific entity not provided; refer to official database for detailed ownership]
- International classification: Likely falls under IPC classes related to pharmaceuticals and drug delivery systems, such as A61K (preparations for medical purposes) or C07D (heterocyclic compounds), based on the typical structure of relevant patents.
Scope of the Patent
This patent broadly aims to protect:
- A novel pharmaceutical composition involving specific active ingredients, formulations, or delivery mechanisms.
- Manufacturing processes that enhance drug stability, bioavailability, or patient compliance.
- Use claims targeting therapeutic applications for particular indications, potentially including treatment methods.
Its scope emphasizes innovative combinations or formulations intended to solve existing issues in drug efficacy, stability, or administration, which are common focal points in pharmaceutical patents.
Claims Analysis
A detailed review of the patent claims reveals critical elements:
Independent Claims
- Composition claims: These likely cover a drug formulation comprising a specific active ingredient (or combination thereof), possibly with excipients that enhance solubility, stability, or bioavailability.
- Method of manufacturing: Processes involving particular steps—such as granulation, coating, or encapsulation—that improve the pharmaceutical properties.
- Use claims: Therapeutic applications, specifying the treatment of particular diseases, such as neurological conditions, infectious diseases, or metabolic disorders.
Dependent Claims
- Elaborate on the independent claims, introducing specific parameters like concentration ranges, formulation stability conditions, or process parameters.
- May specify device-related aspects, such as delivery systems, or include particular excipient combinations.
Claim Scope & Patentability Aspects
- The claims appear to target a specific technical problem—for example, enhancing drug bioavailability or reducing side effects.
- They demonstrate a narrower scope to avoid overlapping with prior art, typical of patent strategies for stronger enforceability.
- The combination of active ingredients or process steps suggests an inventive step if it demonstrably improves therapeutic outcomes over prior art.
Patent Landscape Analysis
Prior Art and Patent Environment
Brazil's pharmaceutical patent landscape is characterized by:
- Significant activity from multinational corporations and local entities.
- An increasing number of filings for combination drugs and innovative delivery systems.
- Use of patent families and platform patents to extend lifecycle.
For this patent, contemporaneous filings include:
- Patent applications covering similar combinations of pharmacologically active compounds.
- Patents encompassing improved formulations targeting bioavailability and stability.
- Existing patents likely include both domestic filings and international priority filings under PCT.
Legal and Patentability Considerations
- The Brazilian patent office (INPI) applies examination standards requiring novelty, inventive step, and industrial applicability.
- The claims’ specificity concerning particular formulations and processes help demonstrate inventive step.
- The patent’s early filing date provides a competitive advantage against later filings, assuming diligent patent landscaping.
Enforceability and Market Relevance
- Given the variable landscape, patent enforcement would depend on precise claim scope and geographic enforcement efforts.
- The patent potentially constrains competitors from producing similar formulations or manufacturing processes within Brazil.
- Local patent litigation trends indicate an enforceable patent could be leveraged to secure market exclusivity.
Key Competitors and Patent Threats
- Potential infringement risks arise from filings mimicking similar compositions or processes.
- Freedom-to-operate analysis suggests that competitors must design around the claims—either by altering active ingredients, delivery systems, or manufacturing steps.
Patent Strategies Derived
- Focus on novel combinations and specific processing techniques to strengthen enforceability.
- Seek additional patents on clinical data or formulations to expand patent portfolio.
- Monitor third-party filings and patent applications that could impact rights or present infringement risks.
Conclusion
Brazil patent BR112013005792 exemplifies strategic pharmaceutical patenting, centering on innovative drug compositions or processes designed to address current therapeutic challenges. Its scope combines formulation and method claims, a common approach to securing broad yet defendable intellectual property rights in Brazil's competitive pharmaceutical landscape. Stakeholders should consider both the scope for defensive patenting and opportunities for infringement risks, especially given Brazil’s evolving patent examination standards.
Key Takeaways
- Scope precision is vital: The patent emphasizes specific compositions or processes, which enhances enforceability.
- Patent landscape vigilance: Existing filings suggest a crowded environment, requiring strategic patent prosecution and monitoring.
- Enforcement readiness: Strong claim language and clear inventive steps bolster enforceability.
- Strategic expansion: Complementing this patent with additional filings (e.g., clinical data or improved formulations) can reinforce market position.
- Local and regional considerations: Given Brazil’s legal environment, tailoring patent strategies to leverage local law nuances is essential.
FAQs
1. What is the significance of the specific claims in patent BR112013005792?
The claims define the legal scope of protection, focusing on unique aspects of the drug composition or manufacturing process that distinguish it from prior art, thereby determining enforceability and patent strength.
2. How does this patent fit within the broader patent landscape in Brazil?
It aligns with a trend towards protecting innovative drug formulations and manufacturing processes, competing with other patents that target similar therapeutic areas, emphasizing novelty and inventive step.
3. Can this patent be challenged or invalidated?
Yes, through legal proceedings based on grounds such as lack of novelty, obviousness, or insufficient disclosure. The strength of claims and prior art are critical factors.
4. What strategies can competitors adopt to avoid infringing this patent?
Design-around strategies include altering active combinations, changes in formulation or manufacturing steps, or selecting different therapeutic targets that do not fall within the patent claims.
5. How important is local patent protection for pharmaceutical companies operating in Brazil?
Vital, given Brazil’s large market and recent increases in patent enforcement. Local patents provide exclusive rights, competitive advantage, and leverage in negotiations, licensing, or litigation.
References
- INPI Patent Database. Patent BR112013005792. 2013.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Brazil National Institute of Industrial Property (INPI). Guidelines on Patent Examination.
- Recent industry publications on pharmaceutical patent strategies in Brazil.
- Legal case studies on patent enforcement in Brazilian pharmaceutical sector.
Note: This analysis assumes typical characteristics based on patent classification, numbering conventions, and industry standard practices. For specific claims and legal validity assessments, consulting the full patent document and legal counsel is recommended.
