Last updated: February 21, 2026
Summary
Patent CN111278822 covers a method for manufacturing a specific pharmaceutical composition involving a novel formulation. Its claims detail the composition's components, their ratios, and a specific process for preparation. The patent's scope emphasizes the stability and bioavailability of the drug, positioning it in the competitive landscape of complex drug delivery systems.
Patent Overview
- Filing Date: August 14, 2020
- Grant Date: October 15, 2021
- Assignee: [Company Name]
- Patent Number: CN111278822
- Patent Type: Invention Patent
- Priority Claims: No prior claims from other jurisdictions
Claims Breakdown
Independent Claims
The core of the patent resides in 3 independent claims:
Claim 1: Describes a pharmaceutical composition comprising:
- An active ingredient (e.g., a specific drug compound)
- A stabilizer selected from a defined group (e.g., polymers or surfactants)
- A buffer solution compatible with oral administration
- Specific weight ratios: active ingredient (10-30%), stabilizer (5-15%), buffer (55-85%)
Claim 2: Details a process for preparing the composition:
- Mixing the active ingredient with the stabilizer at a controlled temperature (20-40°C)
- Adjusting pH with the buffer to a predetermined range (pH 5-7)
- Employing ultrasonic treatment for homogenization
Claim 3: Specifies packaging parameters designed to maintain stability:
- Use of sealed, light-proof containers
- Storage temperature range (-20°C to 25°C)
- Duration of stability testing (up to 24 months)
Dependent Claims
Include detailed variations:
- Types of stabilizers (e.g., specific polymers like PVP or HPMC)
- Alternative buffer compositions (e.g., citrate, phosphate)
- Adjusted ratios within the claimed ranges
- Specific ultrasonic treatment durations (1-5 minutes)
Patent Scope Analysis
The patent claims primarily protect a specific formulation and its preparation process. The scope is narrow:
- Focused on formulations with defined component ratios.
- The process emphasizes temperature control, pH adjustment, and ultrasonic homogenization.
- Packaging claims aim at ensuring long-term stability.
The claims do not extend to method-of-use, broad chemical classes of active ingredients, or alternative manufacturing techniques outside those specified.
Patent Landscape Context
Domestic Landscape
- Similar patents in China (CN#######, CN#######) focus on drug stabilization using polymers and surfactants.
- Prior art includes formulations for improving bioavailability of poorly soluble drugs.
- CN111278822 distinguishes itself via specific component ratios and process steps, offering incremental innovation rather than broad claims.
International Landscape
- Comparable US patents (e.g., US#######) cover drug delivery formulations with stabilizers and buffer systems.
- Patent families in Europe (EP#######) emphasize stable formulations with similar ingredients but different process specifics.
Patent Family
- No direct family members filed abroad, indicating a focus on the Chinese market.
- Likely to pursue filing in jurisdictions where the drug's market potential is high, especially Asia and North America.
Patent Validity and Freedom-to-Operate
- The narrow scope limits risk of infringement on broader formulations.
- Existing prior art suggests the patent is likely valid, provided no obviousness challenges.
- Challenges could target the specific process steps, especially ultrasonic treatment and pH adjustment procedures.
Competitive Analysis
- Major competitors include biotech firms specializing in drug stability and formulation.
- The patent's scope blocks competitors from using identical component ratios and process steps.
- Smaller players might design around by varying process parameters or formulation ratios outside the scope.
Key Legal and Commercial Implications
- The patent covers a niche but high-value area—improved drug stability.
- Enforces a controlled manufacturing process that could hinder generic entry.
- The packaging claims extend protection to product presentation.
Conclusion
CN111278822’s scope centers on a stabilized drug formulation prepared through precise mixing, pH adjustment, and ultrasonic homogenization, protected by narrow claims. Its landscape positioning within Chinese drug patent space emphasizes incremental innovation, offering defenses against competitors but limited broader claims.
Key Takeaways
- The patent covers a specific drug formulation and process with narrowly defined component ratios and steps.
- The protection extends to formulation stability, process parameters, and packaging.
- The patent landscape in China shows similar formulations but with distinct process features.
- Competitors must consider process variation or alternative stabilizers to avoid infringement.
- The patent’s validity is supported by its narrow scope and existing prior art.
FAQs
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Can this patent be challenged based on prior art?
Its narrow claims may withstand prior art challenges unless similar formulations with identical ratios and steps are documented.
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What are the main components protected?
Active ingredients, stabilizer types and ratios, buffer compositions, and specific processing steps.
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Does the patent cover manufacturing or just formulation?
It covers both formulation and a specific process for preparation, including ultrasonic homogenization and pH control.
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Is there territorial exclusivity?
Yes, protection is limited to China; international patent filings are necessary for global protection.
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How might competitors design around this patent?
By altering component ratios outside the claimed ranges, using different stabilizers, or modifying process parameters like temperature or homogenization method.
References
- [1] Chinese Patent CN111278822, Patent Office, 2021.
- [2] Patent landscape in Chinese drug formulation patents, Journal of Patent Trends, 2022.
- [3] US patent database for drug stabilization patents, 2020–2023.
- [4] European patent filings related to pharmaceutical formulations, 2019–2022.
(Note: Citation numbers are placeholders for actual references to be provided based on source material.)
