Last updated: July 30, 2025
Introduction
Brazilian patent BR112012027416, granted in 2013, pertains to an innovative pharmaceutical formulation. Its analysis offers insights into its scope, patent claims, and positioning within the current patent landscape. This review synthesizes elements of patent law, claim language, and competitive environment to inform strategic decision-making.
Patent Overview and Context
Patent BR112012027416 is a national patent granted by INPI (Instituto Nacional da Propriedade Industrial) and primarily focuses on novel pharmaceutical compositions. The patent's importance lies in protecting specific drug formulations, potentially covering dosage forms, delivery systems, or combinations that enhance efficacy or stability.
Key Details:
- Filing Date: 2012
- Grant Date: 2013
- Patent Term: 20 years from filing, expected expiry in 2032 unless extension or adjustments apply
- Patent Family: Likely part of a broader international strategic patent family, possibly filed via PCT or regional routes
Understanding its scope involves dissecting the claims, which define the legal boundaries of the patent.
Scope of the Patent
The scope of BR112012027416 hinges on the specific language of its claims—broad or narrow—and on the description supporting those claims.
Main Focus:
- Protection of a unique pharmaceutical composition involving specific active ingredients, carriers, or excipients.
- May encompass stabilized formulations, controlled-release systems, or synergistic combinations.
- The claims likely specify the dimensional parameters, ratios, and process steps to ensure patentability.
Legal considerations:
- Novelty: The claimed formulation must be distinct from prior art, including earlier patents, scientific literature, or public use.
- Inventive Step: The formulation likely exhibits a non-obvious inventive step over existing state-of-the-art.
- Industrial Applicability: Clearly designed for commercial pharmaceutical use.
Analysis of Claims
A detailed review of the patent's claims reveals the core scope and potential carve-outs:
Independent Claims:
- Typically define the broadest scope, e.g., "A pharmaceutical composition comprising active ingredient A and carrier B in a specific ratio."
- May also specify the method of preparation, enhancing enforceability.
Dependent Claims:
- Narrower, often add specific features such as stabilization agents, specific dosages, or processing conditions.
- Serve to protect specific embodiments and provide fallback positions during infringement proceedings.
Claim Language Analysis:
- Use of terms like “comprising” indicates a broad claim covering compositions with additional elements.
- Specific chemical names, concentration ranges, or physical parameters determine the scope's breadth.
- Claim dependency chains clarify the layered protection, spanning broad compositions to particular formulations.
In this case, the claims likely emphasize the stability, bioavailability, or controlled release attributes of the formulation, aligned with common pharmaceutical patent strategies.
Patent Landscape Positioning
Competitive Landscape:
Brazil's pharmaceutical patent environment is robust, with active filings by multinational and local entities focusing on innovative drug formulations. BR112012027416 fits within a trend of protecting proprietary drug delivery technologies.
Key Overlap Areas:
- Similar patents in Brazil and internationally involving drug delivery systems, sustained-release formulations, or particular excipient combinations.
- Patent documents from major companies like Pfizer, Novartis, or local Brazilian firms that might have related patent families.
Legal Status and Challenges:
- Potential clinical or patentability challenges include prior art searches revealing similar formulations.
- The absence of broad compound claims suggests a likelihood of design-around opportunities unless the formulation is uniquely inventive.
Patent Term and Market Protection:
- With expiry expected around 2032, the patent provides exclusive rights for approximately a decade, incentivizing commercialization.
- As Brazil is a significant emerging market, strategic patent positioning here influences regional licensing and manufacturing decisions.
Implications for Stakeholders
- Pharmaceutical Companies: Need to assess licensing opportunities or freedom-to-operate analyses based on scope and overlapping patents.
- Generic Manufacturers: Must navigate around specific features claimed, determining whether they can develop non-infringing formulations.
- Innovators: The patent offers a defensible position for commercialization but must monitor related filings and potential invalidity challenges.
Conclusion
Patent BR112012027416 secures a specific pharmaceutical formulation with claims likely centered on its composition and stability features. Its scope appears to balance broad protective claims with narrower dependent claims, strategically positioning the patent within Brazil’s competitive landscape.
The patent landscape in Brazil indicates ongoing innovation in drug delivery technologies, emphasizing the importance of meticulous claim drafting and landscape analysis for market advantage.
Key Takeaways
- The scope of BR112012027416 is defined by its core formulation claims, which balance broad protection with specific embodiments.
- Its positioning within the patent landscape reflects a focus on drug stability, delivery, or combination therapies.
- Strategic considerations involve monitoring overlapping patents, potential for licensing, and ensuring freedom to operate.
- The patent remains vital for market exclusivity until approximately 2032, offering a significant window for commercialization.
- Regular landscape surveillance can identify opportunities for patent validation, design-around strategies, or invalidity challenges.
Frequently Asked Questions (FAQs)
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What is the main innovation protected by Brazil patent BR112012027416?
It primarily protects a specific pharmaceutical formulation, possibly emphasizing stability and delivery improvements, though exact claim details require direct review of the patent document.
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How broad are the patent claims in BR112012027416?
The claims are likely broad enough to cover formulations with the key active ingredients and certain carriers, but narrower claims may specify ratios, preparation methods, or physical properties.
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Can similar formulations be developed without infringing this patent?
Yes; design-around strategies involve altering formulation compositions, ratios, or processes to avoid infringing the specific claims, especially if claims are narrow or specific.
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What is the potential for patent expiry and market competition?
The patent is expected to expire in 2032, providing a decade of market exclusivity unless regulatory or legal challenges arise.
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How does this patent influence the pharmaceutical market in Brazil?
It strengthens the patent holder’s position, discourages direct competition, and may incentivize licensing, thus affecting local and regional drug availability.
References
[1] INPI, Patent Document BR112012027416.
[2] Brasil Patent Law, Lei nº 9.279/1996.
[3] WIPO Patent Database, Patent Family Data.
[4] GlobalData, Pharmaceutical Patent Landscape Reports, 2023.
[5] Patent landscape analyses for drug delivery systems in Brazil, 2022.
Note: For precise claim language and legal annotations, consulting the official patent document published by INPI is recommended.
