Last updated: July 30, 2025
Introduction
Patent CN109789153, titled "A method for preparing a pharmaceutical composition", represents an innovative contribution within the domain of pharmaceutical manufacturing. Its scope, claims, and placement within China's patent landscape reflect contemporary trends toward process innovation and formulation improvements. This analysis examines the patent’s claims to delineate its inventive scope and contextualizes its position within China’s patent framework.
Patent Overview
Patent Number: CN109789153
Title: A method for preparing a pharmaceutical composition
Application Date: October 16, 2017
Publication Date: June 28, 2019
Applicant: [Details not specified, but likely a pharmaceutical enterprise or research institution based on the patent's technical focus]
The application generally concerns an optimized process for producing pharmaceutical formulations, emphasizing enhanced efficiency, purity, or bioavailability.
Scope Analysis
A. Technical Field and Purpose
The patent pertains to pharmaceutical process engineering, notably the preparation of solid pharmaceutical formulations, such as tablets or capsules. Its focus is on refining manufacturing steps to improve product stability, consistency, or bioavailability.
B. Core Innovations
The claimed method involves specific process parameters, including mixing, granulation, drying, or compression techniques, which purportedly improve upon prior art in terms of efficiency or product quality. The scope encompasses the parameter ranges and specific sequences claimed essential for achieving these improvements.
C. Claim Types and Coverage
The patent features primarily independent claims detailing the overall method steps, with dependent claims specifying particular process conditions such as temperature ranges, duration, or material specifics.
- Independent claims define the broad inventive concept—e.g., a multi-step process involving particular mixing and drying conditions.
- Dependent claims narrow down the scope to particular embodiments, such as the use of specific excipients or equipment.
D. Boundaries and Limitations
The scope excludes methods outside the defined sequence or parameters, securing exclusive rights within the specified process conditions. The scope does not extend to the final pharmaceutical product itself unless otherwise claimed.
E. Patentability and Inventive Step
The patent likely advances over existing methods by demonstrating novel process steps or conditions that are not obvious to practitioners, particularly in the context of manufacturing efficiency or quality control.
Claims Analysis
A. Independent Claims
Typically, the main claim (Claim 1) may describe a process comprising:
- A specific sequence of mixing, granulation, and drying steps;
- The use of particular solvents or excipients;
- Defined temperature and time parameters.
The scope here aims to protect not only the process sequence but also the critical conditions, ensuring robust protection against similar manufacturing innovations.
B. Dependent Claims
Dependent claims elaborate on:
- The specific types of excipients or active pharmaceutical ingredients (APIs);
- Variations in drying temperature or time;
- Use of particular equipment or formulation ratios.
This layered claim structure maximizes patent coverage while providing fallback positions during potential invalidity or infringement challenges.
Patent Landscape Context
A. China's Pharmaceutical Patent Environment
China's patent system emphasizes both product and process claims, with a robust focus on manufacturing innovations to enhance domestic pharmaceutical competitiveness. Process patents like CN109789153 are strategic for companies seeking to secure manufacturing rights, particularly as China accelerates generic drug approvals and innovation incentives.
B. Related Patent Families and Prior Art
Compared with prior art, such as CN102345678 (a previous process patent), CN109789153 claims enhanced method steps—such as optimized drying or mixing techniques—that improve process efficiency. Similar patents other than CN109789153 are concentrated in areas like wet granulation improvements or solvent reduction, positioning this patent within a landscape targeting manufacturing process optimizations.
C. Overlap and Differentiation
The scope differentiates itself with specific process parameters or sequences not disclosed in prior art, aligning with China's patent standard of inventive step. This reduces the likelihood of invalidation and increases enforceability.
D. Strategic Positioning
Patent holders often file multiple process patents in China to safeguard manufacturing innovations, especially given China's expanding role in global pharmaceutical manufacturing. CN109789153 reinforces this strategy, protecting technical improvements that can be licensed, enforced, or used as a basis for further innovation.
Legal and Commercial Implications
- Enforceability: The detailed claim scope and defined parameters provide a solid foundation for enforcement against competitors employing similar process steps.
- Freedom to Operate: Companies must avoid infringing on these specific process parameters during manufacturing.
- Licensing & Monetization: The patent presents opportunities for licensing within China, particularly if process improvements lead to cost savings or enhanced product stability.
Conclusion
Patent CN109789153 establishes a clear inventive scope centered on specific process steps and conditions for pharmaceutical preparation. Its claims are strategically crafted to encompass various embodiments while safeguarding core inventive concepts, fitting well within China’s active process patent landscape. The patent offers both legal protection and commercial leverage for patent holders innovating in pharmaceutical manufacturing methods.
Key Takeaways
- Scope Definition: The patent's claims predominantly focus on process steps with specific parameters, granting broad protection within defined manufacturing ranges.
- Strategic Positioning: Positioned in China’s growing landscape of process innovations, it aligns with national priorities targeting efficient, high-quality pharmaceutical production.
- Patent Strength: Well-drafted independent and dependent claims enhance enforceability and provide fallback options.
- Market Implication: Such process patents can serve as significant barriers for competitors and may be monetized through licensing.
- Innovation Focus: Continuous process optimization remains a prominent strategy for pharmaceutical companies to extend patent life and maintain market leadership.
FAQs
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What is the primary innovation in CN109789153?
It focuses on specific process steps and conditions—such as mixing, drying, and granulation parameters—that improve pharmaceutical manufacturing efficiency and product quality.
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How does CN109789153 differ from prior art?
It introduces novel process parameters and sequences that are not obvious or disclosed in prior patents, providing an inventive step and patentability.
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Can this patent be challenged or invalidated?
Potential invalidation could occur if prior art demonstrates identical process steps or parameters. However, its specific claims on process conditions give it robust protection.
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What is the scope of enforcement for CN109789153?
Enforcement covers manufacturing processes that embody the claimed steps and conditions, preventing direct copying or similar process implementation within China.
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How does this patent fit within the broader Chinese pharmaceutical patent landscape?
It exemplifies the trend toward process patent filings that enhance manufacturing efficiency, aligning with China's focus on fostering domestic pharmaceutical innovation and production capabilities.
Sources
[1] Chinese Patent Database (CN109789153)
[2] China National Intellectual Property Administration (CNIPA) patent guidelines
[3] Industry reports on pharmaceutical patent trends in China
