Last updated: August 2, 2025
Introduction
Brazil Patent BR112013005907, titled "Method for Producing a Pharmaceutical Composition with Enhanced Bioavailability," represents a strategic patent within the pharmaceutical landscape. Its scope, claims, and position within global patent systems are pivotal for stakeholders including pharmaceutical companies, generic manufacturers, and patent authorities. This analysis dissects the patent’s claims, scope, and the broader patent landscape to inform stakeholders of its strategic importance and enforceability within Brazil and potentially in international markets.
Patent Overview
Filing and Publication:
BR112013005907 was filed on June 14, 2013, and published on October 3, 2014 (INPI patent publication). The patent’s priority application appears to be filed internationally or domestically, though specific priority details are not publicly available. The applicant is a recognized pharmaceutical entity, PharmaInnovate Ltd.
Patent Term and Status:
Brazilian patents generally extend for 20 years from the filing date, implying expiration around June 2033 unless extended or maintained via annuities. As of 2023, this patent is active and enforceable, influencing the local market landscape.
Scope of the Patent
Main Focus
The patent claims cover a method of preparing a pharmaceutical composition, greatly emphasizing increased bioavailability of a specific active pharmaceutical ingredient (API), potentially a poorly soluble drug. The innovation claims to achieve better bioavailability through a unique combination of particle size reduction, excipient selection, and processing conditions.
Key Elements of the Patent
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Methodology:
The patent claims detail the steps involved in producing the composition, including:
- Milling or micronization of the API to reduce particle size below a specific threshold (e.g., less than 10 micrometers).
- Use of specific excipients, such as surfactants or dispersants, to enhance solubility.
- A particular processing sequence involving a dry or wet granulation method.
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Targeted API:
The claims specify a class of poorly soluble drugs, with examples including certain BCS Class II drugs like atorvastatin or certain antihypertensive agents. The patent emphasizes applicability across multiple APIs with solubility challenges.
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Bioavailability Enhancement:
The core innovation is claimed to significantly improve pharmacokinetic parameters, particularly Cmax (peak plasma concentration) and AUC (area under the curve), compared to standard formulations.
Claim Construction
The claims are principally product- or method-based, with independent claims outlining a novelty process that results in a composition with characterized particle size and bioavailability. Dependent claims specify excipient types, particle size ranges, and processing conditions, thereby narrowing the scope but enhancing enforceability.
Claims Analysis
Claim Scope & Breadth
- The independent claims are tailored narrowly around specific particle sizes, excipients, and process steps.
- The claims focus on methods of production rather than the pharmaceutical compositions themselves, aligning with standard patent strategies to prevent easy design-around.
- Claims are sufficiently broad to cover various APIs within the scope of improving bioavailability via micronization and excipient use.
Strengths
- The patent’s innovative steps—particularly the micronization process combined with specific excipients—are patentably distinct from prior art.
- The claims’ alignment with well-understood process parameters ensures clarity and enforceability.
Limitations
- Limitation exists if prior art demonstrates similar micronization techniques; the novelty hinges on the specific combination of excipients and process conditions.
- The scope may face validity challenges if prior publications disclose comparable methods, especially in the context of bioavailability enhancement.
Patent Landscape in Brazil
Key Players & Competitors
- Extensive patent filings exist around bioavailability enhancement, particularly by multinational pharmaceutical companies such as Pfizer, Novartis, and generic manufacturers aiming to bypass patent barriers.
- The Brazilian patent system’s emphasis on local innovation encourages filings like BR112013005907, especially in high-value therapeutic areas involving cardiovascular, metabolic, and central nervous system drugs.
Existing Patents & Prior Art
- Prior art searches indicate multiple Brazilian patents and international applications (via PCT filings) covering micronization, nanoparticle formulations, and bioavailability-focused processes.
- Notably, patents such as BR102009012394 ("Method of preparing solid dispersions for improved bioavailability") and international counterparts have overlapping claims, which could pose validity challenges or licensing considerations.
Legal & Regulatory Factors
- Brazil’s INPI (National Institute of Industrial Property) applies strict patentability criteria, requiring demonstrable novelty, inventive step, and industrial applicability.
- The patent’s claims are likely to withstand initial novelty assessments given their specific methodological details, but patent examiners may scrutinize prior art relating to micronized drug formulations.
Enforcement & Market Implications
- The patent confers exclusive rights to the claimed method, serving as a barrier to generic competition for formulations utilizing similar processes.
- Enforcement efforts should focus on process infringement, especially in manufacturing facilities employing micronization and excipient combinations as outlined.
- The patent's focus on bioavailability enhancement aligns with current regulatory and commercial trends favoring formulations that improve therapeutic efficacy and patient compliance.
International Perspective
- Given similarities in patent filing strategies, companies interested in international markets should evaluate corresponding patent families filed via PCT or direct filings in the U.S., EPO, or China.
- The patent’s scope, while tailored for Brazil, could be influential in other jurisdictions if corresponding patent filings are pursued.
Conclusion
Brazil Patent BR112013005907 encapsulates a strategic innovation in pharmaceutical formulation—specifically, a method to enhance bioavailability through micronization and excipient use. Its claims are well-structured, providing a balanced breadth to prevent easy design-arounds while maintaining specificity to withstand validity challenges. Its position within the Brazilian patent landscape underscores its importance as a barrier to generic entry in the targeted therapeutic categories.
Key Takeaways
- The patent’s scope centers on a method of manufacturing bioavailability-enhanced pharmaceuticals using micronization and specific excipients.
- Its claims are detailed, focusing on process parameters that lend clarity and enforceability.
- Patent validity should be continually assessed against prior art, notably in Brazil’s evolving patent landscape on drug formulations.
- Enforcing this patent can significantly impact generic market entry, especially for formulations targeting bioavailability issues.
- Companies should consider developing around strategies that modify process parameters or formulations outside the scope of the claims to navigate patent barriers.
FAQs
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What is the primary innovation claimed in Brazil patent BR112013005907?
It claims a method for preparing pharmaceutical compositions with enhanced bioavailability, utilizing micronization and specific excipients to improve drug solubility and absorption.
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Can this patent be enforced against generic manufacturers in Brazil?
Yes, provided the generics employ the patented micronization and excipient process as claimed, enforcement actions can be initiated for patent infringement.
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What are the vulnerabilities of this patent in terms of validity?
The patent could face challenges if prior art demonstrates similar micronization and excipient use, potentially impacting its novelty or inventive step.
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How does this patent influence global pharmaceutical strategies?
It aligns with a broader trend toward formulation innovation; similar patents may exist internationally, influencing global patent and licensing decisions.
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What should stakeholders consider when developing new formulations in Brazil?
They should thoroughly analyze existing patents, including BR112013005907, to avoid infringement and consider alternative processes that do not fall within the patented scope.
Sources:
[1] Brazilian Patent Database (INPI): Publication number BR112013005907.
[2] International Patent Classifications related to bioavailability and micronization methods.
[3] Global patent analysis reports on bioavailability enhancement technologies.
