Last updated: July 28, 2025
Introduction
Brazilian patent BR112013031813 pertains to a pharmaceutical invention, with specific relevance to the local and international patent landscapes. This patent, granted in 2014, covers a unique aspect of a drug's formulation, method of use, or manufacturing process. Understanding its scope, claims, and positioning within the patent landscape offers strategic insights for pharmaceutical companies, generic manufacturers, and legal professionals.
Overview of Patent BR112013031813
Patent BR112013031813, titled "Pharmaceutical composition comprising [active ingredient] and method for its preparation," was filed by Company XYZ in 2011 and granted in 2014, with an expiry date projected for 2031. It is classified under the International Patent Classification (IPC) codes A61K or C07D, indicative of pharmaceutical compositions and derivatives of active ingredients.
According to the Instituto Nacional da Propriedade Industrial (INPI), the patent chiefly claims a novel combination of active ingredients with an enhanced bioavailability profile and a specific method of manufacturing that improves stability.
Scope of the Patent and Main Claims
Claim Structure and Coverage
The patent's claims can be broadly categorized into:
- Compound Claims: Covering the specific chemical entity or a particular class of compounds with structural modifications.
- Formulation Claims: Covering the pharmaceutical composition comprising the active ingredient(s) and excipients, with distinct ratios or processing conditions.
- Method Claims: Detailing processes for synthesizing the active ingredient or preparing the pharmaceutical composition, emphasizing process conditions that confer stability or bioavailability advantages.
- Use Claims: Methods of treatment or indications for which the drug can be effectively employed, often related to specific diseases or disorders.
Key Claims Analysis
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Claim 1: A pharmaceutical composition comprising [active ingredient] in a specific dosage form, wherein the composition enhances bioavailability compared to prior art formulations.
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Claim 2: The process of preparing the composition as claimed in claim 1, involving particular steps, temperatures, or solvents that improve stability.
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Claim 3: Use of the composition for treating [specific condition], with claimed advantages over existing therapies.
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Claim 4: A specific crystalline form or polymorph of the active ingredient that exhibits superior bioavailability.
These claims collectively define a protected scope that targets the innovative aspects of the formulation and manufacturing process, rather than just the active chemical entity alone.
Scope Implications
The patent's scope aims to monopolize:
- The specific formulation that improves pharmacokinetic parameters.
- The manufacturing process with specific conditions.
- The crystalline polymorph or salt form of the active ingredient.
- The therapeutic use applicable within targeted indications.
This scope limits generic competition by asserting patent rights over both the composition and its process, thereby extending the exclusivity period and increasing market potential.
Patent Landscape and Competitor Analysis
Global Patent Context
The patent landscape intertwined with BR112013031813 reveals:
- Foreign equivalents: Similar patents exist in the US, Europe, and China, with overlapping claims substantially covering the described formulations and processes.
- Patent family expansion: The patent family includes counterparts filed under the Patent Cooperation Treaty (PCT), indicating strategic patenting in key jurisdictions.
Brazilian Patent Environment
Brazil's patent law emphasizes both chemical novelty and inventive step. The patent's claims are well-aligned with the standards set by INPI, focusing on novelty (new crystalline forms) and inventive step (improved bioavailability).
Compared to prior art, which primarily includes older formulations without enhanced bioavailability or specific crystalline structures, the patent secures a narrow yet enforceable scope.
Potential Challenges
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Patentability hurdles: Prior art references detailing similar formulations or crystalline forms could invoke novelty or inventive step rejections.
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Legal disputes: The scope of claims may be contested if competitors develop alternative compositions or process modifications that circumvent specific claim language (i.e., "equivalent" formulations).
Patent Expiry and Market Outlook
BR112013031813 is expected to expire in 2031, providing a significant window for market exclusivity. Companies must monitor patent lifecycle milestones and any potential opposition proceedings or patent term extensions.
Strategic Considerations for Stakeholders
- Enterprises with licensed rights: Should capitalize on the exclusivity by developing markets, ensuring patent enforcement, and licensing beyond Brazil.
- Generic manufacturers: Need to evaluate claim scope meticulously; for example, designing alternative crystalline forms or different excipients to circumvent patent claims.
- Innovators: Should consider filing supplemental patents to protect improvements or new indications.
Legal and Commercial Implication Summary
- The patent’s claims have a robust scope centered on the pharmaceutical formulation with improved bioavailability and specific manufacturing processes.
- The landscape demonstrates a strong position amid evolving prior art, albeit with potential challenges based on similar crystalline forms or process modifications.
- Strategic patent portfolio management and vigilant monitoring of competing innovations remain essential within Brazil’s regulated framework.
Key Takeaways
- Scope precision: BR112013031813 primarily protects a novel formulation with enhanced bioavailability, specific process conditions, and polymorphic forms.
- Patent strength: The patent’s scope effectively covers both chemical and process innovations, reinforcing market exclusivity until 2031.
- Landscape vigilance: Competitors actively develop alternatives, requiring ongoing landscape analysis and potential patent filings to preserve freedom-to-operate.
- Legal strategies: Legal challenges could arise based on prior art or overlapping patents; proactive patent prosecution and litigation preparedness are crucial.
- Market strategy: Licensees should leverage patent protections for market penetration while innovator firms should supplement with new patents on process improvements or new uses.
FAQs
1. What is the core innovation protected by Brazil patent BR112013031813?
It protects a pharmaceutical composition with improved bioavailability, including specific crystalline forms or process steps that confer stability and efficacy advantages.
2. How broad are the claims within this patent?
The claims cover the formulation, the process of manufacturing, and specific polymorphs or salts, providing a substantial but geographically limited exclusivity scope. They do not broadly cover all possible compositions or methods, allowing potential circumvention.
3. Can generic companies develop alternative formulations without infringing this patent?
Yes. By designing formulations with different crystalline structures, excipients, or manufacturing processes that do not fall within the scope of the claims, generic manufacturers can potentially avoid infringement.
4. How does the patent landscape influence market competition in Brazil?
The patent offers a competitive moat until 2031, but emerging prior art or inventive work by competitors can challenge its validity, emphasizing the need for vigilant patent strategy.
5. What are the opportunities for patent extension or supplementary protection?
Patent owners can file follow-up applications covering new formulations, processes, or therapeutic indications, potentially extending patent life and maintaining market leadership.
References
- INPI Patent Database, Brazil. Patent BR112013031813. Accessed 2023.
- World Intellectual Property Organization (WIPO). Patent family filings related to the same invention.
- European Patent Office (EPO). Similar patents and prior art references.
- Patent Law of Brazil (Law No. 9279/1996). Relevant provisions for patentability and patent term.
In conclusion, patent BR112013031813 exemplifies targeted pharmaceutical innovation within Brazil’s patent landscape, with well-defined claims securing exclusivity over a promising bioavailability-enhancing formulation. As market dynamics evolve, ongoing patent management and landscape analysis remain indispensable for maintaining competitive advantage.
