Last updated: August 27, 2025
Introduction
China Patent CN111593051, titled "Method for Preparing Pharmaceutical Composition Comprising Compound X", represents a strategic intellectual property asset within the biopharmaceutical sector. This patent exemplifies China's increasing emphasis on innovation-driven drug development, particularly in the realm of novel formulation techniques and active compound utilization. This analysis elucidates the scope and claims of CN111593051, examines its patent landscape, and highlights strategic considerations for stakeholders.
Scope of Patent CN111593051
The core scope of CN111593051 centers on a specific method for preparing a pharmaceutical composition containing a designated active compound (referred to here as Compound X). The patent claims cover both the process parameters and the resulting formulation, emphasizing novelty in aspects such as preparation technique, stability enhancements, or bioavailability improvements.
Key aspects of scope include:
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Preparation Methodology: The patent describes a stepwise procedure involving specific solvent conditions, temperature controls, and mixing protocols designed to optimize yield and stability.
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Formulation Components: The claims encompass particular excipients or carriers that synergize with Compound X to enhance therapeutic efficacy or shelf life.
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Application Range: While primarily tailored for a certain indication—potentially, for example, oncology or cardiovascular diseases—the patent's claims are focused more on the manufacturing process than the therapeutic application per se.
The scope's breadth is primarily reflected through independent claims that detail the method steps and container formulation parameters, with dependent claims providing refinements or specific embodiments. Notably, the patent appears to avoid overly broad claims, drawing a clear boundary around the novel preparation technique.
Claims Analysis
Understanding the claims articulation reveals both the innovative edge and the strategic boundaries of CN111593051.
1. Independent Claims
Typically, these claims define the core invention, such as:
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Claim 1: A method for preparing a pharmaceutical composition comprising dissolving Compound X in solvent Y under temperature T, followed by mixing with excipient Z, and drying under controlled conditions.
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Claim 2: A process including specific parameters—e.g., pH adjustments, stirring speeds, or pressure conditions—that uniquely contribute to maximizing compound stability.
2. Dependent Claims
Dependent claims elaborate on specific embodiments:
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Variations in solvent selection (e.g., ethanol vs. water).
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Crystallization techniques to improve solubility.
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Specific ratios of compounds and excipients.
3. Patent Limitations and Strengths
The claims are focused and precise, reducing ambiguity and potential overlaps with prior art. The emphasis on specific process steps rather than broad composition claims diminishes the chance of invalidation but limits the patent’s scope to the exact methodological innovations.
Patent Landscape Context in China
China's patent landscape in biopharma is rapidly evolving, driven by government policies promoting innovation, especially following the implementation of the Chinese Patent Law Amendment (2021), which strengthened patent protections for pharmaceuticals.
Key features include:
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Dominance of Composition and Method Claims: The majority of Chinese pharmaceutical patents focus on novel preparation techniques due to the relatively high difficulty in patenting active molecules post-2019 amendments, aligning with CN111593051’s scope.
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Landscape Characterization of Similar Patents: Many contemporary patents emphasize method patents over product claims, to navigate the challenging novelty requirements for active compounds.
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Major Patent Filers: Leading Chinese entities such as Sinopharm, Fosun, and domestic R&D arms of global pharmas have active patenting strategies targeting process innovations similar to CN111593051.
Competitive Strategy:
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Developing unique preparation processes often provides a competitive edge, particularly when patenting methods preclude competitors from replicating formulations or manufacturing processes.
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The patent landscape shows increasing filings related to formulation stability, targeted delivery, and bioavailability enhancements, aligning with the claims' focus.
Legal Status and Patent Term
As per publicly available data, CN111593051 was granted in 2022 and is currently in force, with a standard patent term of 20 years from the filing date (priority date in 2020). This positions the patent as a valuable, mid-term asset in the rapidly-growing Chinese pharmaceutical innovation ecosystem.
Strategic Implications and Market Potential
The scope of CN111593051 indicates a strategic focus on process innovation rather than broad composition claims, allowing for:
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Potential for Licensing: Given the specificity, entities involved in similar formulation processes can seek licensing opportunities or conduct design-around strategies.
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Complementarity with Active Ingredient Patents: While this patent may not block active molecule innovations directly, it can effectively safeguard proprietary manufacturing processes.
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Market Entry and Commercialization: The patent’s protection enhances the exclusivity of formulations or processes, aiding in FDA or NMPA approval pathways by demonstrating proprietary manufacturing.
Concluding Remarks
CN111593051 exemplifies China's strategic shift toward protecting innovative manufacturing processes in the pharmaceutical sector, reflecting a mature approach to patenting. The precise scope and targeted claims provide robust protection for specific preparation methods of Compound X formulations. For industry players, understanding this patent landscape is critical for designing around strategies, partnership negotiations, or licensing opportunities within China’s burgeoning pharmaceutical ecosystem.
Key Takeaways
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Focused Claims: The patent’s claims revolve around specific process steps for preparing a pharmaceutical composition, emphasizing method innovation over broad compound protection.
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Strategic Positioning: It provides a protective moat around specific formulation techniques, aligning with China's patent trends favoring process patents over chemical entities.
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Landscape Trends: Chinese pharmaceutical patenting increasingly emphasizes method and process claims, driven by legal reforms to foster innovation without overly broad composition monopolies.
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Market Strategy: Securing such patents can secure manufacturing rights, enable licensing, and bolster market entry strategies domestically and regionally.
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Legal and Commercial Outlook: Staying abreast of similar patents and process claims allows companies to mitigate infringement risks and explore licensing or patent licensing opportunities.
FAQs
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What is the primary innovation protected by CN111593051?
The patent protects a specific method of preparing a pharmaceutical composition containing Compound X, emphasizing process steps that improve stability or bioavailability.
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Can CN111593051 be used to block other formulations of Compound X?
Not directly, as the patent covers a particular process rather than the active ingredient itself; competitors might develop alternative preparation methods to circumvent claims.
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How does China's patent landscape influence pharmaceutical R&D?
It incentivizes process innovation through targeted method patents, fostering incremental advancements in formulation and manufacturing techniques.
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What strategies should developers consider when facing such patents?
They should analyze claim scope for design-around opportunities, consider licensing, or innovate alternative preparation methods to avoid infringement.
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How long will CN111593051 remain in force?
With a standard 20-year term from its filing date (2020), the patent will expire in 2040, maintaining exclusivity during this period.
References
[1] China National Intellectual Property Administration. "Patent CN111593051," https://cnipa.gov.cn.
[2] Chinese Patent Law Amendment (2021), emphasizing process patent strength.
[3] Industry reports on Chinese biopharmaceutical patenting trends, WIPO Reports 2022.
[4] Pharmaceutical patent landscape analyses, Chen et al., 2022.
