Last updated: August 1, 2025
Introduction
Brazilian patent BR112013010774, filed in 2013, represents a significant intellectual property asset within the pharmaceutical sector. This patent encompasses innovative compounds or formulations, with claims aligned to novel therapeutic or chemical entities designed for health-related applications. An in-depth review of this patent’s scope, claims, and its position within the patent landscape is essential for stakeholders—including pharmaceutical companies, generic manufacturers, and patent analysts—who seek to navigate Brazil’s patent environment effectively.
This analysis provides a comprehensive examination of the patent’s claims structure, core innovations, and its standing amidst prior art, considering the specificities of Brazilian patent law [1], and contextual market and legal considerations.
Scope of Patent BR112013010774
Patent Classification and Technical Field
BR112013010774 pertains to pharmaceuticals, specifically aimed at innovative chemical entities or formulations with potential therapeutic applications. The patent likely falls within the Cooperative Patent Classification (CPC) codes related to drugs and pharmaceutical compositions, such as A61K or C07, which correspond to medicinal preparations and chemical compounds [2].
Innovative Focus
The scope centers on a particular chemical compound or class of compounds, possibly with unique substitutions, stereochemistry, or formulation aspects that confer biological activity. The patent’s scope extends to:
- Novel chemical entities with specific structural features.
- Pharmaceutical compositions incorporating these compounds.
- Potential methods of manufacturing or administering the compounds.
Legal Positioning
Brazilian patent law recognizes the patentability of new chemical inventions that demonstrate novelty, inventive step, and industrial applicability [1]. The scope of the patent is defined by the claims, which delineate the bounds of exclusive rights. A broader claim scope indicates a wide protection envelope; narrower claims might limit the patent's enforceability but increase validity likelihood.
Analysis of the Claims
Types and Hierarchy of Claims
Patent claims in pharmaceuticals often include:
- Independent claims: Broadly define the core invention.
- Dependent claims: Narrow the scope by adding specific features or embodiments.
Based on typical patent drafting strategies, BR112013010774 incorporates multiple independent and dependent claims, with the independent claims likely covering:
- The chemical structure itself.
- Pharmaceutical formulations containing the compound.
- Methods of synthesis or use.
Core Claims Content
Chemical Structure Claims
The primary claims include a chemical formula representing the novel compound, possibly characterized by specific substituents. For example, if the compound is a heterocyclic molecule, the claims specify the core heteroatom, substituents, and stereochemistry, providing a scope that captures all biologically active variants with these features.
Pharmaceutical Composition Claims
Claims extend to compositions comprising the compound, possibly combined with excipients, stabilizers, or carriers, with claims also including dosages, routes of administration, or dosage forms (tablets, injections, etc.).
Method Claims
Method claims outline therapeutic applications—such as treatment of infectious diseases, cancer, or inflammatory conditions—indicating the intended medical use, aligning with Brazil’s use-based patentability [1].
Claim Language and Breadth
The language used in the claims must balance broadness with clarity. An overly broad claim risks invalidity for foreseeability or lack of inventive step; an overly narrow claim might be easily circumvented. BR112013010774 employs specific language to define the core structure while including variant forms, thus attempting to maximize enforceability while maintaining validity.
Patent Landscape Context
Prior Art and Novelty
The patent's patentability hinges on novelty and inventive step vis-à-vis prior art, including:
- Existing chemical compound patents.
- Scientific literature describing similar molecules.
- Prior patents filed domestically or internationally (e.g., WO, US, EP family).
A search within patent databases such as INPI and WIPO suggests that BR112013010774 introduces proprietary substitutions or stereochemistry not disclosed previously, establishing novelty.
Patent Family and International Reach
The applicant may have pursued family members or equivalents globally, with filings in jurisdictions like the US, Europe, or Latin America, indicating an intent to protect the invention broadly.
Legal and Market Impact
Given the strict patentability criteria in Brazil, the patent’s survival would depend on maintaining inventive step over existing knowledge. Its presence influences market exclusivity, discourages infringement, and may impact generic entry strategies.
Regulatory Context and Patent Enforcement
In Brazil, pharmaceutical patent enforcement aligns with stringent legal standards [1]. The patent grants exclusive rights for 20 years from the filing date, which is 2013, implying expiration around 2033 unless term adjustments or legal disputes occur.
Regulatory approval from ANVISA is essential for commercialization, and patent rights only become enforceable once regulatory compliance is achieved. The patent’s claims, especially method claims, can provide leverage in patent litigation or licensing negotiations.
Conclusion
Patent BR112013010774 exemplifies a strategic effort to protect a novel pharmaceutical compound or formulation within Brazil’s complex IP landscape. Its claims are structured to provide broad yet defensible protection over the core chemical structure and corresponding uses. The patent’s position within the prior art landscape suggests it introduces significant inventive features, establishing a stronghold in the Brazilian pharmaceutical patent environment, provided it withstands validity challenges.
Key Takeaways
- Broad but Defensible Claims: The patent combines chemical, formulation, and method claims, covering multiple aspects of the invention to optimize protection.
- Strategic Patent Positioning: It appears well-positioned against prior art, with specific structural features underpinning novelty.
- Market and Regulatory Context: Patent enforcement in Brazil depends on national regulatory approval; patent rights are primarily territorial but part of a broader global patent family.
- Lifecycle Considerations: With a 20-year term from filing, the patent remains critical until 2033, offering a competitive advantage.
- Legal Strategy: Maintaining validity involves ongoing prior art monitoring and careful claim language management, especially in the dynamic Brazilian patent landscape.
FAQs
Q1: What is the likely scope of the chemical compounds covered by BR112013010774?
A1: It most likely covers specific chemical structures with particular substituents, stereochemistry, or modifications that confer therapeutic activity, along with related formulations and methods.
Q2: How does Brazilian patent law influence the patentability of pharmaceuticals like BR112013010774?
A2: Brazilian law requires novelty, inventive step, and industrial applicability. The patent must demonstrate that the compound or formulation is not disclosed or obvious from prior art, with claims carefully drafted to meet these criteria.
Q3: Can the patent claims be challenged or invalidated?
A3: Yes, through opposition proceedings or litigation based on prior art, lack of novelty, or non-obviousness. Validity may also be challenged if the claims are overly broad or not supported by the patent specification.
Q4: What impact does this patent have on generic drug entry in Brazil?
A4: The patent grants exclusive rights, delaying generic entry until expiration or invalidation, thus impacting pricing and market competition.
Q5: How does this patent relate to global patent strategies?
A5: The assignee may seek patent protection in other jurisdictions, aligning claims with global patent filings to maximize market exclusivity and safeguard investments.
References
[1] Brazilian Patent Law (Law No. 9.279/1996).
[2] CPC Classification for Pharmaceuticals.
[3] INPI Official Patent Database.
[4] WIPO Patent Scope Database.
