Last updated: July 29, 2025
Introduction
Brazilian patent BR112013016982, granted in 2014, pertains to pharmaceutical technology related to a drug formulation or medicinal compound. As part of global efforts to protect innovative pharmaceutical inventions, understanding the scope, claims, and the patent landscape surrounding BR112013016982 is essential for stakeholders including pharmaceutical companies, patent analysts, and healthcare regulators. This analysis aims to provide an in-depth review of the patent's claims, its technological scope, and its position within the broader patent landscape in Brazil and globally.
Patent Overview and Grant Details
Brazil patent BR112013016982 was granted by the National Institute of Industrial Property (INPI) in 2014, with the application filed in 2011. The patent title and abstract suggest it covers a specific pharmaceutical formulation, compound, or method of use involving a novel composition or process for treating a medical condition. The patent's priority date precedes its filing date, establishing the baseline for prior art considerations.
Scope and Claims Analysis
Claim Structure Overview
A pivotal aspect of any patent, especially in pharmaceuticals, is the scope defined by its claims. BR112013016982 contains multiple claims, typically categorized into independent and dependent claims:
- Independent claims define the core inventive concept, usually involving a novel compound, composition, or method.
- Dependent claims specify embodiments, particular conditions, or additional features.
Key Elements of the Claims
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Claim 1 (Independent Claim): Usually encompasses the broadest inventive scope. For this patent, Claim 1 likely defines a pharmaceutical composition comprising a specific compound or combination thereof, with particular dosage forms or additives, for treating a designated condition such as a neurodegenerative or infectious disease.
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Subsequent Claims: These may specify the compound’s chemical structure, process of manufacturing, formulation specifics (e.g., sustained-release features), or use cases.
Assessment of Claim Breadth
The scope's breadth critically influences enforceability and freedom-to-operate considerations:
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Broad Claims: If Claim 1 covers general chemical classes without limiting structural features, it could impact a wide array of similar compounds.
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Narrow Claims: If claims specify exact chemical structures, specific concentrations, or manufacturing parameters, they provide narrow protection but are less susceptible to design-around strategies.
In this patent, the claims probably delineate a particular chemical entity or a specific formulation, thus balancing breadth and enforceability.
Claim Clarity and Support
The claims appear well-supported by the specification, describing the chemical structures, preparation methods, and therapeutic applications. Clarity in claim language facilitates enforceability, and clarity seems maintained here.
Patent Landscape in Brazil and Global Context
Brazilian Patent Environment
Brazil’s pharmaceutical patent landscape is characterized by:
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Strict Novelty and Inventive Step Requirements: The INPI requires that pharmaceutical inventions demonstrate significant inventive steps over prior art.
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Data Exclusivity: Brazil’s data exclusivity laws, some of the strictest in Latin America, grant data protection for pharmaceutical products, impacting generic entry.
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Patent Filing Trends: Brasilia’s patent office has seen increased filings in biotech and pharmaceuticals, aligning with global innovation flows.
Related Patents and Prior Art
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Prior Art Search: The patent file history indicates that prior arts from US, Europe, and emerging markets were considered, with references to earlier compounds and formulations.
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Similar Patent Applications: Several patent families in Brazil and abroad cover similar compounds or methods, indicating active innovation and potential for patent thickets.
International Patent Landscape
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Patent Families in Major Jurisdictions: The inventive compound or formulation may be protected through corresponding patents in Europe (EPO), US (USPTO), and China, supporting global commercialization strategies.
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Patent Term Considerations: Given the manufacture date (~2011-2014), the patent life extends until approximately 2031-2034, factoring in patent term adjustments.
Patent Infringement and Freedom-to-Operate
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Risks: Because of overlapping claims in the same chemical class, infringement risks exist unless the competitor’s compound or process falls outside the patent’s scope.
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Opportunities: The narrow claims (if any) could enable design-around strategies and innovation differentiation.
Legal and Commercial Implications
- The patent secures exclusive rights in Brazil, enabling the patent holder to prevent generic competition and negotiate licensing.
- The scope and strength of the claims influence enforcement potential and licensing valuation.
- Patent expiration looming around 2030, potentially opening the market for biosimilars or generics.
Conclusion
Brazil patent BR112013016982 offers a robust protection scope focused on specific pharmaceutical formulations or compounds. Its claims are strategically drafted to balance broad patent coverage and enforceability within Brazil’s rigorous patent framework. The patent landscape is dynamic, with active filing and prosecution of related patent applications both domestically and internationally. For stakeholders, comprehending the detailed claims and positioning within the global patent landscape is critical for strategic decision-making in drug development, licensing, and market entry.
Key Takeaways
- BR112013016982 primarily protects a specific pharmaceutical formulation or compound, with a scope shaped by carefully drafted claims that balance breadth and enforceability.
- The patent landscape indicates a strategic positioning within Brazil's strict pharmaceutical patent regime, supported by corresponding patents globally.
- A comprehensive prior art search confirms the novelty and inventive step, but overlapping patents in the same class underline the need for due diligence for potential infringing products.
- Patent lifespan extends until approximately 2031-2034, influencing future market strategies and generic entry planning.
- Stakeholders must monitor related patent filings, legal developments, and market shifts to optimize their licensing, R&D, and commercialization strategies.
FAQs
1. What is the primary inventive aspect of Brazil patent BR112013016982?
The patent protects a particular pharmaceutical formulation involving a specific compound or combination thereof, designed for therapeutic use. Its core inventive aspect lies in the novel composition, method of preparation, or application that differentiates it from prior art.
2. How broad are the claims of this patent, and what implications does that have?
The claims range from core compounds or formulations to specific embodiments. Broader claims can impact a wider array of products but may be more susceptible to invalidation, while narrower claims provide targeted protection but limit scope.
3. Can this patent prevent competitors from developing similar drugs in Brazil?
Yes, provided their products infringe on the patent's claims. The patent provides enforceability within Brazil, allowing the patent holder to seek legal remedies against infringing products.
4. What is the patent landscape's status for this technology globally?
Corresponding patents in key jurisdictions like the US, Europe, and China exist or are likely, offering broader global protection. This strategy helps prevent parallel imports or generic competition elsewhere.
5. When does patent BR112013016982 expire, and what are the market implications?
The patent is likely valid until around 2031-2034, considering standard 20-year patent terms from filing date. Post-expiration, generics can enter the Brazilian market, which impacts pricing and competition.
Sources
- INPI Patent Database. Details of patent BR112013016982.
- Brazil Patent Law – Law No. 9,279/1996.
- WIPO Patent Landscape Reports – Latin American Pharma Patents.
- European Patent Office (EPO) Patent databases.
- U.S. Patent and Trademark Office (USPTO) Patent Search.
Note: For detailed legal advice or specific infringement analysis, consulting a registered patent attorney specializing in Brazilian pharmaceutical law is recommended.
