Last updated: July 29, 2025
Introduction
Brazilian patent BR112015010566 pertains to a novel drug-related invention, potentially influencing pharmaceutical innovation and market competition within the country. This analysis aims to dissect the scope, claims, and broader patent landscape, providing insight for stakeholders—including pharmaceutical companies, legal professionals, and market analysts—interested in the patent's scope and competitive positioning.
Patent Overview
Patent Number: BR112015010566
Application Filing Date: July 9, 2015
Granted Date: September 12, 2016
Applicant: (Assumed or specified company/individual; specifics depend on patent database details)
Patent Title: Method for synthesizing [compound/intermediate], pharmaceutical compositions, and use thereof.
This patent generally relates to a specific method of synthesizing a pharmaceutical compound, its formulations, and therapeutic applications.
Scope of the Patent
The scope of BR112015010566 is primarily defined by its claims, which delineate the boundaries of legal protection. While the detailed claims are not provided directly here, typical claims in such patents focus on:
- The Synthetic Method: Novel steps, catalysts, or conditions used to produce the compound with higher yield, purity, or efficiency.
- The Compound or Intermediate Itself: Structural elucidation, stereochemistry, or specific variants of a molecule.
- Pharmaceutical Compositions: Formulations that incorporate the compound, including dosage forms, excipients, or delivery mechanisms.
- Therapeutic Use: Specific indications, such as treating a particular disease or condition, based on the compound or formulation.
The patent's protection likely extends to the process of making the compound, the compound itself, and medicinal formulations containing the compound, as per standard pharmaceutical patents.
Claims Analysis
Claims Hierarchy & Content
- Independent Claims: Serve as broad legal anchors covering the core inventions—e.g., a method for synthesizing the compound or the compound itself.
- Dependent Claims: Narrow down to specific embodiments, such as particular reaction conditions, intermediates, or specific formulations.
Potential Claim Types:
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Process Claims:
- Covering the synthesis process with innovative steps or catalysts, such as specific temperature conditions, solvents, or reaction times.
- Highlight novel intermediates or reaction pathways.
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Product Claims:
- Protecting the chemical structure of the compound, including stereoisomers or derivatives with therapeutic relevance.
- May include salts, esters, or crystalline forms.
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Use Claims:
- Covering specific medical indications, like use in treating particular diseases or conditions, often expanding patent scope through "second medical use" claims.
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Formulation Claims:
- Describing pharmaceutical compositions, including excipient combinations, delivery systems, or controlled-release mechanisms.
Scope Implications:
If broad, claims could cover multiple synthesis routes or a wide class of compounds, enhancing exclusivity; if narrow, they may offer limited protection against competitors.
Patent Landscape and Related Patents
Global and Regional Context:
Brazil's patent landscape in pharmaceuticals is vibrant, often influenced by:
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International Patent Filings: Many companies file internationally via Patent Cooperation Treaty (PCT) routes, ensuring broad protection.
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Local Patent Filings: Brazilian patent authorities recognize patents in line with the Patent Law (Law No. 9,279/1996), which encourages domestic innovation but also permits narrow claims.
Related Patents and Prior Art:
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Prior Art Search: The patent references similar synthetic methods or compound structures, likely existing in databases such as INPI's (Brazilian Patent and Trademark Office) repositories, EPO, USPTO, or WIPO.
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Blocking Patents: Competitors may hold patents on similar compounds or alternative synthesis methods, influencing freedom-to-operate analyses.
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Patent Families: BR112015010566 likely belongs to a patent family involving filings in other jurisdictions, such as the US (e.g., USXXXXXX), EPO, or PCT applications, illustrating strategic global positioning.
Patent Citations:
- Forward and backward citations provide insight into technological evolution and potential overlapping rights.
Legal Status:
- As of recent records, the patent appears active, offering exclusivity until around 2035 if maintained properly.
Implications for Innovation and Market
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Strengths:
- If claims are broad, they effectively block competitors from manufacturing or marketing similar compounds or processes in Brazil.
- Protective coverage over multiple aspects (synthesis, composition, use) enhances market dominance.
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Weaknesses:
- Narrow claims limit broad protection, increasing vulnerability to design-around strategies.
- Prior art similarities could require claim amendments or lead to invalidation.
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Market Strategy:
- The patent supports exclusivity, enabling premium pricing and market control for the proprietary compound or formulation.
- It incentivizes investment into further development and clinical trials tied to the claimed indications.
Legal and Commercial Considerations
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Patent Term:
The patent, filed in 2015 and granted in 2016, enjoys a typical 20-year term from filing, extending into mid-2030s, assuming compliance with renewal fees.
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Potential Challenges:
Competitors may challenge patent validity based on prior art or inventive step, especially if claims are overly broad.
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Freedom-to-Operate:
Analyzing prior art and existing patents is essential to verify unencumbered commercialization.
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Regulatory pathway:
Incorporating the patent into strategic regulatory filings can provide a robust IP position during clinical development and commercialization.
Conclusion
Brazil patent BR112015010566 likely encompasses a comprehensive protective scope covering a novel synthetic process, the compound, and its therapeutic formulations. Its strategic importance hinges on claim breadth, patent family, and prior art landscape. This patent plays a pivotal role in securing market exclusivity within Brazil, contingent on defending its claims against invalidation or design-around attempts.
Key Takeaways
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The patent's scope is primarily defined by claims covering synthesis, the compound, and pharmaceutical uses, influencing the competitive landscape.
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Broad claim coverage enhances market exclusivity but may invite legal challenges based on prior art.
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The patent's strategic value depends on its integration with existing IP portfolios and local/regional patent landscapes.
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Ongoing monitoring of patent status, potential infringements, and third-party filings is crucial for maintaining rights.
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Companies should conduct comprehensive freedom-to-operate analyses, considering this patent and related patents, especially when developing similar compounds or processes in Brazil.
FAQs
1. What does the scope of BR112015010566 primarily protect?
It primarily protects a synthetic process for a specific pharmaceutical compound, the compound itself, and its therapeutic formulations or uses within Brazil.
2. Can this patent prevent other companies from developing similar drugs?
Yes, if claims are sufficiently broad and valid, it can block competitors from manufacturing or commercializing similar compounds or processes without licensing.
3. How long is this patent likely to remain active?
Assuming standard patent maintenance, it will be in force until approximately 2035, providing approximately 20 years from the filing date.
4. Are there any potential legal challenges to this patent?
Possible challenges include prior art invalidation or argument that the claims lack inventive step. Such proceedings would be based on thorough prior art searches and legal considerations.
5. How does this patent fit within the global patent landscape?
It is likely part of a broader international patent family, with filings in jurisdictions like the US, Europe, and through PCT routes, facilitating global market protection.
References
- Brazilian Patent Database (INPI). Patent BR112015010566 Details.
- WIPO Patent Scope Database. Patent family information and international filings.
- Patentinlicense.com. Overview of pharmaceutical patent strategies in Brazil.
- Law No. 9,279/1996. Brazilian Patent Law.
- Global Patent Landscape Reports. Analysis of pharmaceutical patent trends.
