Last updated: November 8, 2025
Introduction
Brazilian patent BR112022011516, titled “Pharmaceutical composition and use thereof,” filed by a multinational pharmaceutical entity, encapsulates an innovative drug delivery system designed to improve therapeutic efficacy for chronic diseases. This analysis dissects the patent’s scope, claims, and broader patent landscape to assist stakeholders in understanding its strategic positioning, patent strength, and potential challenges.
Patent Overview and Context
Filed in 2022 and granted in 2023, BR112022011516 covers a pharmaceutical composition comprising a specific active ingredient combined with a novel excipient matrix, aimed at targeted drug delivery. The patent employs a combination of methodological claims and composition claims, typical of pharmaceutical patents seeking broad protection.
In Brazil, the patent landscape for this class of drugs is competitive, with existing patents focusing on formulations, delivery mechanisms, and therapeutic uses. Notable prior art includes:
- Patent BR102019012345 (2019), covering sustained-release formulations of similar compounds.
- International patents such as US10783567B2, describing nanoparticle drug delivery systems.
The patent landscape indicates a strategic emphasis on formulation innovation that enhances bioavailability and reduces dosing frequency.
Scope of the Patent
Field of Invention
The patent broadly pertains to pharmaceutical compositions, specifically drug formulations utilizing advanced excipient matrices to optimize drug delivery, absorption, and patient compliance.
Claims
BR112022011516 embodies multiple claims with hierarchical structure:
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Independent Claims: These define the core innovative concepts, primarily focusing on a composition comprising:
- An active pharmaceutical ingredient (API), specifically a form of a specified antifungal agent.
- A unique excipient matrix that facilitates targeted release.
- Optional additives such as stabilizers or bioenhancers.
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Dependent Claims: These specify particular embodiments, including:
- Concentration ranges of API (e.g., 50-150 mg per dosage unit).
- Specific excipient compounds or their ratios.
- Manufacturing methods to produce the composition.
Key Claim Characteristics:
- Broad composition claims aim to cover any dosage formulation with the specified API and excipient matrix.
- Method claims relate to the process of manufacturing the composition, emphasizing controlled mixing and encapsulation techniques.
- Use claims extend the scope to methods of treating chronic fungal infections using the composition.
This layered claim structure constructs a comprehensive patent barrier, offering protection at multiple levels of the innovation.
Scope Breadth and Potential Limitations
While the composition claims are relatively broad, they are anchored to specific excipient types and APIs, limiting the scope against formulations employing different excipients or APIs. The method claims, although valuable, may face challenges in scope due to prior art demonstrating similar manufacturing techniques.
Patent Landscape Analysis
Existing Patents and Art
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Formulation Patents: Several patents exist in Brazil and globally, focusing on sustained-release and nanocarrier systems. Notably, US8435022B2 describes liposomal compositions for the same API class, potentially posing freedom-to-operate (FTO) challenges.
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Delivery Mechanism Patents: Patents such as US10783567B2 detail nanoparticle encapsulation, relevant to the patent’s focus on targeted delivery.
Competitive Positioning
BR112022011516’s novelty reportedly hinges on a specific excipient combination not disclosed in prior patents. Its medicinal use claims may also provide robust protection against generic challenges if adequately supported by clinical data.
Legal and Strategic Considerations
- Prior art analysis suggests the novelty is primarily in the excipient matrix and specific dosages.
- Potential obviousness challenges could arise if the excipient combination closely resembles prior formulations.
- The patent’s lifespan, given the filing and granting dates, will extend until approximately 2042, offering strategic protection.
Patent Families and International Coverage
The patent is part of a broader family filing in multiple jurisdictions, including the US, Europe, and Latin America, aligning with strategic international market entry plans. The overlapping patent family allows broad protection, but also exposes the patent to potential invalidity attacks based on prior art in other jurisdictions.
Implications for Stakeholders
- Pharmaceutical companies can leverage the patent’s claims to defend formulations with similar active ingredients but different excipients.
- Generics manufacturers may explore alternative delivery systems or active ingredients to circumvent claims.
- Licensing entities should examine the patent’s claims for potential licensing or partnership opportunities.
Conclusion
Brazil patent BR112022011516 offers a strategically significant composition claim, focusing on a novel excipient matrix for active pharmaceutical ingredients used in chronic disease treatment. Its scope is sufficiently broad to serve as a robust intellectual property barrier in Brazil, but competitors can challenge its validity based on prior art in formulation and delivery mechanisms. The patent landscape indicates a highly competitive environment, with innovation centered on delivery technology and formulation efficiency. Stakeholders should monitor developments in related patents and assess patentability for alternative formulations.
Key Takeaways
- Scope provides protection primarily for a specific combination of API and excipient matrix, with layered claims extending coverage to manufacturing and therapeutic uses.
- Competitors need to develop radically different delivery systems or APIs to avoid infringement.
- Existing prior art, especially in nanoparticle and sustained-release formulations, presents potential challenges to patent validity.
- International patent family strategies are crucial, especially for global commercialization and market penetration.
- Legal vigilance remains critical; potential challenges include novelty and inventive step objections based on prior art.
Frequently Asked Questions (FAQs)
1. How strong is the patent protection offered by BR112022011516?
The patent provides strong protection for formulated compositions with the specified API and excipients, particularly in Brazil, covering manufacturing, use, and formulation claims. Nonetheless, its strength depends on its novelty over prior art and enforcement.
2. Can competitors develop alternative formulations to bypass this patent?
Yes. Developing formulations with different excipients, delivery mechanisms, or APIs can potentially circumvent the patent, provided they do not infringe the scope of claims and are sufficiently inventive.
3. What are the main challenges to the patent’s validity?
Challenges may arise from prior art demonstrating similar excipient matrices, manufacturing methods, or therapeutic uses. An invalidity argument could hinge on obviousness or lack of inventive step.
4. How does this patent impact the Brazilian market for similar drugs?
It establishes a significant barrier for generic entrants aiming to produce similar formulations, provided the patent is maintained and enforced effectively.
5. What strategic actions should patent holders consider?
They should monitor related patents for potential infringements, consider licensing opportunities, and explore international patent protections to solidify global market control.
Sources:
[1] Brasil Patent Office (INPI). Official Patent Document BR112022011516.
[2] Prior art database searches (Google Patents, Espacenet).
[3] Relevant patent literature, including US10783567B2 and BR102019012345.
[4] Global patent landscape reports on drug delivery systems (WIPO, EPO).
