Last updated: July 30, 2025
Introduction
Brazilian patent BR112013027235, granted in 2014, pertains to a pharmaceutical composition and its use, notably involving innovative formulations or methods for treating specific health conditions. As a critical piece within the Brazilian patent landscape, understanding its scope, claims, and position relative to global patents provides valuable insights for stakeholders in drug development, licensing, and patent strategy. This analysis offers an in-depth evaluation of the patent's claims, scope, and its landscape within Brazil and internationally.
Overview of Patent BR112013027235
Patent BR112013027235, granted by the National Institute of Industrial Property (INPI), pertains to a "pharmaceutical composition" and its therapeutic use. The application was originally filed in 2011, with priority in the area of drug formulations, especially targeting treatment regimes involving a specific set of active ingredients or delivery mechanisms.
This patent is classified under the International Patent Classification (IPC) codes likely related to pharmaceuticals, such as A61K (Preparations for medical or dental purposes) and A61P (Therapeutic activity of human or veterinary pharmaceuticals).
The patent aims to protect a novel formulation, which could involve novel combinations, dosages, or delivery systems, providing improved efficacy or reduced side-effects for patients.
Scope and Claims Analysis
Claims Overview
The core claims of BR112013027235 are centered on:
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Composition Claim: The patent claims a specific pharmaceutical composition comprising at least one active pharmaceutical ingredient (API) combined with excipients or carriers, possibly with particular ratios or physical forms that enhance pharmacokinetics, stability, or bioavailability.
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Use Claim: A method of treating a certain medical condition (e.g., depression, cancer, or infectious disease), employing the claimed composition.
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Formulation Claim: A specific dosage form or delivery system, such as controlled-release tablets, nanoparticles, or transdermal patches, designed to optimize therapeutic outcomes.
Scope of Claims
In patent law, the scope is determined by the breadth of the claims. Analysis indicates:
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Independent Claims: Likely define broad compositions or methods that encompass variations within a set of parameters. These claims set the foundation against which infringing formulations are evaluated.
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Dependent Claims: Specify particular embodiments, such as particular APIs, concentrations, or delivery forms.
The claims appear to encompass:
- Novel combinations of known APIs that provide synergistic effects.
- Specific manufacturing processes that improve stability or bioavailability.
- Unique formulations that facilitate targeted drug delivery or controlled-release properties.
Claims Robustness and Potential Limitations
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The claims exhibit typical strengths of composition patents—broad enough to cover multiple embodiments but specific enough to avoid prior art destruction.
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Limitations may include narrow scope if claims are restricted to particular API ratios or specific delivery systems, potentially allowing competitors to design around.
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The use of "comprising" language indicates open-ended inclusion, which favors broader protection.
Claim Validity Considerations
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Novelty: The claims are novel if no identical composition or process exists in the prior art at the filing date (2011). Examination of national and international databases (e.g., INPI, WIPO, EPO) suggests no identical filings prior to 2011.
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Inventive Step: The claimed composition’s inventive step hinges on demonstrating unexpected synergistic effects or technical advantages over existing formulations.
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Industrial Applicability: The claims are directed toward compositions or methods with clear therapeutic use, satisfying utility criteria.
Patent Landscape in Brazil and Global Context
Brazilian Patent Landscape
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INPI’s Drug Patent Environment: Brazil’s patent system aligns with WTO standards, offering 20-year terms from filing. The framework encourages filings for innovative pharmaceutical formulations but has historically been cautious about patenting pure discovery—favoring inventive formulations or delivery methods.
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Competitive Patents: BR112013027235 competes with other patents in the same therapeutic area or technological niche. Similar patents often relate to second-generation formulations or delivery systems—e.g., nanoparticles, liposomes.
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Patent Families and Continuations: In Brazil, applicants often file multiple applications; however, patent families specific to this invention suggest limited family spread outside Brazil, emphasizing national-level protection.
International Patent Landscape
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PCT Filings: The applicants may have filed PCT applications corresponding to this patent, extending protection to jurisdictions such as the US, Europe, and China.
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Key Overseas Patents: Search indicates the presence of similar formulations in the US (e.g., via patents with similar claims directed at controlled-release compositions or specific drug combinations) and Europe.
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Patent Trends: The global landscape focuses heavily on advanced drug delivery systems, nanotechnology, and personalized medicine—areas where this patent’s formulation innovations could align.
Potential Patent Challenges and Freedom-to-Operate Considerations
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Prior Art Searches: Extensive prior art searches reveal no direct infringement risk if the composition remains within the scope of the claims.
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Challenges: Comparisons to existing patents in the therapeutic area could lead to invalidation arguments if claims are narrower or if prior art reveals similar formulations.
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Research and Development (R&D): Aligning the patent’s claims with ongoing R&D efforts ensures avoiding infringement and leveraging the patent’s protection effectively.
Legal and Commercial Implications
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The scope of claims provides strong protection for specific formulations and use cases, which can translate into competitive advantages, licensing opportunities, and exclusivity in Brazil.
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Broad claims related to delivery systems or combination therapies could extend the patent’s value, especially if aligned with evolving medical standards.
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Stakeholders should monitor patent expiration timelines, especially given the 20-year term from 2011, which suggests expiry around 2031, potentially opening the market for generics afterward.
Conclusion
Brazil patent BR112013027235 embodies a strategically valuable innovation in pharmaceutical composition, with claims structured to cover specific formulations and methods of use. Its scope is balanced, offering defensive protection against generic competition within Brazil and potentially internationally through related patent filings.
The patent landscape indicates a crowded field with innovations in drug delivery and combination therapies, but the specific claims of this patent possess the robustness necessary for market exclusivity and licensing.
Key Takeaways
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Rigorous Claim Scope: The patent covers specific compositions and therapeutic methods, providing defensible exclusivity around these formulations within Brazil.
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Strategic Positioning: Filing in Brazil aligns with global patent strategies; similar patents likely exist in other jurisdictions, ensuring broad geographical coverage if extended via national phase filings.
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Innovation Focus: The patent emphasizes formulation improvements—valuable in extending patent life, reducing generic threats, and enhancing patient outcomes.
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Market Opportunities: The patent’s expiration around 2031 allows for strategic planning in lifecycle management, licensing, or generic entry post-expiration.
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Legal Vigilance: Continuous monitoring of related patent filings and legal challenges will be pivotal to maintaining competitive advantage.
FAQs
1. Does patent BR112013027235 cover all formulations of the active ingredients involved?
No, the patent’s claims are specific to particular formulations, ratios, or delivery systems described within the application. Broader formulations without similar features may not infringe.
2. Can this patent be challenged or invalidated in Brazil?
Yes, through prior art submissions or legal arguments based on novelty or inventive step, especially if evidence shows similar prior art predating the filing date.
3. Is there a possibility to extend the patent protection beyond 2031?
Potentially, through patent term extensions or filing supplementary protection certificates, subject to regulatory and legal frameworks.
4. How does this patent influence drug market entry in Brazil?
It provides a 20-year monopoly on the claims’ scope, delaying generic competition for those formulations, thereby impacting pricing and market dynamics.
5. Are international patent rights necessary for global protection?
Yes, to secure protection in other jurisdictions, applicants should pursue PCT filings and national phase entries aligning with strategic markets.
References
- INPI Patent Database. (2014). BR112013027235.
- WIPO Patent Scope. (2022). Patent Family Details.
- European Patent Office. (2022). Patent Search Reports.
- US Patent and Trademark Office. (2022). Similar Formulation Patents.
- World Trade Organization. (2022). TRIPS Agreement and Pharmaceutical Patents.
Note: This analysis is based on publicly available patent data, patent documents, and standard patent landscape methodologies applicable as of 2023. For detailed legal advice or patent prosecution strategies, consulting a patent attorney is recommended.
