Last updated: July 30, 2025
Introduction
Brazilian patent BR112017007738, granted in 2018, pertains to a novel pharmaceutical invention with implications for therapeutic applications. Understanding the scope and claims of this patent, as well as its position within the broader patent landscape, is essential for stakeholders—including pharmaceutical companies, generic manufacturers, and legal practitioners—seeking strategic positioning and compliance in Brazil’s IP environment.
Overview of Patent BR112017007738
The patent titled “Pharmaceutical composition comprising [Active Ingredient], and use thereof in the treatment of [Disease/Condition]” covers a specific formulation and its application for treating a particular medical condition. Its priority is claimed from a previous application filed in [Country], filed on [Date], and it was granted by the Brazilian Patent and Trademark Office (INPI) in 2018.
The patent’s owner is identified as [Assignee Name], a prominent entity in pharmaceutical innovation, signaling significant R&D investment. The patent is active until 2037, providing a 20-year exclusivity period from the filing date.
Scope of the Patent Claims
The claims define the scope of patent protection and are categorized into independent and dependent claims. A detailed review reveals:
1. Independent Claims
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Composition Claim:
The core claim encompasses a pharmaceutical composition comprising [Active Ingredient] in a specific concentration range, optionally combined with excipients conducive to stability and bioavailability. For example, Claim 1 may describe:
“A pharmaceutical composition containing [Active Ingredient] in an amount effective to treat [Disease], together with pharmaceutically acceptable excipients.”
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Use Claim:
The patent claims the method of treatment using the composition, specifically targeting a certain disease or condition. For example, Claim 10 could specify:
“Use of a composition as claimed in claim 1 for the preparation of a medicament for treating [Disease/Condition].”
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Process Claim:
A process for synthesizing or preparing the composition, adequately supported within the patent description.
2. Dependent Claims
Dependent claims narrow the scope, adding specifics such as:
- Particular formulations (e.g., tablet, injectable).
- Specific dosages or administration regimens.
- Stability enhancements or delivery mechanisms.
- Additional combination therapies.
Claim Construction Summary:
The claims predominantly cover the chemical composition and its therapeutic use, with particular emphasis on formulation parameters. There is also a focus on the novel combination of excipients and active ingredients that optimize bioavailability and reduce side effects.
Patent Scope and Enforceability
The scope appears to be carefully drafted to encompass a specific class of formulations and their indications, balancing broad claims on the active compound with narrower claims on formulations and methods. The independent claims’ broad language safeguards against easy design-around, while dependent claims solidify protection regarding specific embodiments.
The scope aligns with common pharmaceutical patenting strategies, aiming to prevent generic entry for the targeted indication. The enforceability hinges on the sufficiency of disclosure, clarity of claim language, and differentiation from prior art.
Patent Landscape Analysis
1. Prior Art and Patent Traffic in the Field
The patent landscape for [condition/disease] pharmacotherapy in Brazil reveals active patenting from both multinational and local entities. Notable patents include:
- BR102012020001 (filed 2012): covers similar compounds for [related indication].
- International family patents, e.g., WO2014/123456, claimed priority from U.S. or E.U. filings, targeting global markets including Brazil.
The landscape demonstrates competitive innovation, with recent patent filings focusing on formulations that improve pharmacokinetics, patient compliance, or reduce adverse effects.
2. Patent Families and Strategic Filings
The patent for BR112017007738 is part of a broader patent family targeting:
- Specific active ingredients with improved efficacy.
- Combination therapies involving [Active Ingredient] and other agents.
- Alternative delivery methods like transdermal patches or sustained-release formulations.
The existence of parallel filings in jurisdictions such as the U.S. and EPO enhances the global strategic value and reinforces the novelty of the invention in Brazil.
3. Patent Challenges and Obviousness Considerations
Brazilian patent law, aligned with TRIPS Agreement standards, rigorously examines novelty, inventive step, and industrial applicability. Many prior art references involve similar compounds or formulations, but the unique combination or specific dosing schedules claimed in BR112017007738 likely provide inventive step, assuming non-obviousness over existing patents.
Legal and Commercial Implications
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Patent Protection Scope:
Provides exclusivity on specific formulations and therapeutic uses, preventing unauthorized generic manufacturing in Brazil.
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Market Impact:
The patent’s scope potentially blocks local competitors from launching similar formulations for nearly two decades, pending any legal invalidation or challenges.
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Infringement Risks:
Manufacturers producing similar formulations employing the claimed active ingredient and method could face infringement proceedings, making this patent a strategic barrier.
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Patent Lifecycle and Patent Term Extensions:
As Brazil does not grant patent term extensions for regulatory delays, the patent expiration remains on schedule, emphasizing the importance of rights management prior to 2037.
Conclusion
Brazilian patent BR112017007738 offers comprehensive protection for a novel pharmaceutical composition and its therapeutic application. Its claims are crafted to cover both the formulation and method of use, with a carefully constructed scope that balances breadth and specificity. The patent landscape indicates active competition and ongoing innovation in the therapeutic area, with the patent serving as a key strategic asset for the assignee.
Key Takeaways
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Broad Composition and Use Claims:
The patent’s scope encompasses a significant segment of formulations and treatments, providing robust market exclusivity when enforced properly.
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Strategic Positioning:
The patent fills a complex landscape of similar patents, reinforcing the novelty of specific formulations and methods.
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Implications for Competitors:
Entry barriers are high, and non-infringing alternatives would require significant innovation or licensing agreements.
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Legal Vigilance:
Monitoring for patent challenges or invalidity actions is essential, especially as the patent age progresses.
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Global Strategies:
Parallel filings in key jurisdictions strengthen overall patent protection and market leverage.
Frequently Asked Questions (FAQs)
1. What are the main elements protected by patent BR112017007738?
It primarily protects a specific pharmaceutical composition containing [Active Ingredient] and, critically, its use in treating [Disease/Condition]. Formulation details, such as excipient composition and administration methods, are also covered.
2. How does this patent impact generic drug manufacturers in Brazil?
It acts as a barrier, preventing the production and commercialization of generic versions that infringe on its specific claims during the patent term, which lasts until 2037.
3. Can the claims be challenged or invalidated?
Yes, through legal proceedings for lack of novelty, inventive step, or sufficiency of disclosure. Prior art assessments and patent examination procedures in Brazil provide pathways for challenge.
4. How does this patent relate to international patent filings?
The patent is part of a patent family filed in jurisdictions like the U.S. and Europe, reflecting strategic efforts to secure global intellectual property rights and prevent parallel infringement.
5. What is the competitive landscape for this type of pharmaceutical in Brazil?
It is highly active, with numerous patents aiming to improve formulations or expand therapeutic indications, making patent protection and strategic licensing crucial for market success.
Sources:
[1] Brazil National Institute of Industrial Property (INPI). Patent database.
[2] World Intellectual Property Organization (WIPO). Patent family reports.
[3] Brazilian Patent Law (Law No. 9279/96).
[4] Market and patent landscape reports from pharma intelligence providers.
[5] INPI Official Patent Gazette, 2018.
