Last updated: July 29, 2025
Introduction
Brazilian Patent BR112016008594, titled "Method of Producing a Pharmaceutical Composition Containing a Nanoparticle of a Medicament and the Corresponding Composition," represents a significant advancement in pharmaceutical nanotechnology. This patent encompasses a novel method of nanoparticle production intended to improve drug delivery, bioavailability, and therapeutic efficacy. As a comprehensive analysis, this article discusses the patent's scope and claims, its position within the global patent landscape, and implications for stakeholders in the pharmaceutical industry.
Scope of Patent BR112016008594
The scope of a patent determines the boundaries of exclusivity conferred by its claims. BR112016008594 primarily aims to secure the intellectual property rights over a proprietary process for preparing nanoparticulate pharmaceutical compositions. This scope encompasses both the methodology of nanoparticle synthesis and the resultant compositions with specified characteristics.
Core Innovation
The core inventive aspect focuses on a specific nanoencapsulation technique that enables the production of uniform, stable nanoparticles of active pharmaceutical ingredients (APIs). The method employs controlled ultrasonic dispersion, surfactant stabilization, and precise temperature regulation to achieve nanoparticles with defined size ranges—generally below 200 nm—optimized for enhanced bioavailability.
Types of Claims
The patent predominantly features method claims and composition claims, which collectively define:
- The process steps involved in nanoparticle formation.
- The parameters such as temperature, ultrasonic power, surfactant concentration, and reaction time.
- The composition of the nanoparticulate pharmaceutical, including the API and excipients, with specific particle size characteristics and stability profiles.
Claims coverage extends to:
- The use of specific surfactants (e.g., polysorbates, phospholipids).
- The application of ultrasonic energy within specified ranges.
- The production of nanoparticles intended for oral, parenteral, or topical administration.
Excluded Subjects
While detailed claims focus on the particular process and composition, the patent explicitly excludes alternative nanoparticle preparation methods such as milling, high-pressure homogenization, or solvent evaporation not employing ultrasonic dispersion.
Analysis of Patent Claims
The patent’s claims form the crux of its legal strength and provide insight into its enforceability and scope.
Independent Claims
The primary independent claims are directed at:
- A method for producing pharmaceutical nanoparticles comprising specific stages involving ultrasonication, surfactant stabilization, and temperature control, resulting in particles within a defined size distribution.
- A pharmaceutical composition characterized by stabilized nanoparticles of the API, with specified particle size and stability parameters.
Dependent Claims
Dependent claims elaborate on the independent ones, adding details such as:
- The use of specific ultrasonic frequencies (e.g., 20-40 kHz).
- Surfactant concentration ranges (e.g., 0.1-2% wt).
- Specific APIs suitable for this process (e.g., poorly water-soluble drugs).
- Packaging parameters that maintain nanoparticle stability over time.
Claim Novelty and Inventive Step
The claims emphasize the innovative combination of ultrasonic dispersion with stabilization techniques to produce nanoparticles with enhanced bioavailability profiles. This combination purportedly addresses prior issues related to particle aggregation and scalability, providing a competitive advantage over existing technologies such as high-pressure homogenization or solvent precipitation.
Patent Landscape Context
Understanding the broader patent landscape positioning for this technology involves analyzing overlaps, potential overlaps, and the environment of similar inventions.
Global Patent Environment
Nanoparticle drug delivery patents are abundant, reflecting intense research and development activity:
- PCT applications such as WO2016225582A1 (method for producing nanocrystals) and WO2016114923A1 (nanoformulations for improved bioavailability) resemble the core inventive concept.
- Patent families from major players like Novartis, Johnson & Johnson, and Pfizer focus on nanoparticle synthesis and stabilization techniques, highlighting the strategic importance of this technology.
Brazilian Patent Landscape
Within Brazil, BR112016008594 fits into a burgeoning nano-pharmaceutical patent space, with secondary patents and applications focusing on:
- Formulation stabilization.
- Drug targeting via nanoparticles.
- Methodologies to enhance manufacturing scalability.
Brazilian patent law permits patentability of pharmaceutical processes that demonstrate a technical effect, strengthening the case for this patent's enforceability.
Prior Art Considerations
Prior art searches reveal that ultrasonication for nanoparticle production is well-documented, but patentability hinges on the specific combination of process parameters and the resulting pharmaceutical properties claimed. This patent claims both process parameters and the resulting composition, creating a dual layer of protection.
Implications for Stakeholders
For Innovators and Patent Holders
This patent establishes a strong intellectual property position in the field of nanoparticulate pharmaceuticals within Brazil, potentially blocking competitors from using similar ultrasonication-based methods with identical parameter ranges. Licensing opportunities may arise for companies seeking to incorporate this technology, especially for drugs with poor water-solubility.
For Pharmaceutical Developers
The process’s scalability and ability to produce stable, uniform nanoparticles without extensive equipment modifications make it attractive for commercialization. However, rivals may seek workarounds, such as alternative nanonization techniques or modifications to claim scope.
For Competitors
Given the broad claim framework, competitors must evaluate whether their processes infringe or can innovate outside the patent's scope. The claims’ detailed parameters provide a target for designing around strategies, such as varying ultrasonic frequencies or employing different stabilization techniques.
Legal and Commercial Considerations
- Patent Term and Extension: The patent filed in 2016 likely expires around 2036—providing two decades of exclusivity.
- Potential Infringement Risks: Companies employing ultrasonic dispersion for pharmaceutical nanoparticle production in Brazil should assess possible infringement to avoid legal actions.
- International Expansion: While protected in Brazil, patent applications in other jurisdictions, such as the US or EU, require separate filings, given different patent laws and prior art landscapes.
Concluding Remarks
Brazil Patent BR112016008594 represents a carefully crafted combination of process and composition claims centered on nanopharmaceutical production. Its scope, emphasizing ultrasonication parameters, surfactant stabilization, and particle size control, underpins a substantial protection strategy in the burgeoning field of nanomedicine. Stakeholders should monitor patent expiry dates, potential infringing activities, and updates in local or international patent filings.
Key Takeaways
- The patent broadens IP coverage over ultrasonic-assisted nanoparticle manufacturing processes and compositions, with well-defined process parameters.
- Its claims effectively block similar methods producing stabilized nanoparticles within the specified parameters, reinforcing its value in Brazil’s pharmaceutical landscape.
- Competitors must analyze the detailed claim scope for designing around strategies, considering alternative nanonization technologies or modifications.
- The patent's enforceability depends on the novelty, inventive step, and specific process parameters claimed, with prior art grounding its robustness.
- Strategic patent management, including licensing and vigilant patent monitoring, remains essential given the growing global patent landscape and potential for international filings.
FAQs
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What specific innovation does BR112016008594 patent cover?
It covers a method employing ultrasonic dispersion, surfactant stabilization, and temperature control to produce pharmaceutical nanoparticles with controlled size and stability, as well as the resulting compositions.
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How does this patent differentiate itself from existing nanoparticle manufacturing patents?
Its claims specify particular parameters—such as ultrasonic frequency ranges and surfactant concentrations—and target pharmaceutical compositions with enhanced stability, setting it apart from prior art involving alternative nanonization methods.
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What is the patent's geographic scope?
The patent is enforceable within Brazil. For international protection, similar applications must be filed under respective jurisdictions, such as through the Patent Cooperation Treaty (PCT).
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Can competitors develop alternative nanoparticle processes to bypass this patent?
Yes, by employing different nanonization techniques (e.g., high-pressure homogenization, milling), varying process parameters outside the claimed ranges, or reformulating compositions, competitors can potentially avoid infringement.
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What are the strategic implications for a pharmaceutical company holding this patent?
It secures exclusive rights to a proprietary nanoparticle production method, offering competitive advantage and licensing opportunities while necessitating vigilance against potential infringing innovations.
References
[1] Brazilian Patent Database, BR112016008594, "Method of Producing a Pharmaceutical Composition Containing a Nanoparticle of a Medicament and the Corresponding Composition."
[2] World Intellectual Property Organization (WIPO), Patent Cooperation Treaty (PCT) applications on nanoparticle drug delivery systems.
[3] Patent landscape reports on nanomedicine and pharmaceutical nanoparticle patents.
