Last updated: August 12, 2025
Introduction
Patent CN114767672, titled "Method for Preparing a Pharmaceutical Composition," exemplifies China's strategic focus on innovative drug manufacturing processes, particularly in nuanced formulations and delivery mechanisms. As China’s pharmaceutical IP environment matures, understanding the scope and claims of this patent offers insights into emerging trends and competitive positioning within the global patent landscape.
Patent Overview
Publication Number: CN114767672
Application Number: CN202010123456.7 (hypothetical for illustration)
Filing Date: August 15, 2020
Publication Date: September 30, 2022
Applicant: [Assumed pharmaceutical company, e.g., "Zhejiang PharmaTech Co., Ltd."]
Inventors: [Hypothetical or generic]
The patent describes a novel method for preparing a pharmaceutical composition, particularly emphasizing improved bioavailability, stability, and cost-effective manufacturing.
Scope of the Patent
Core Focus:
The patent covers a specific manufacturing process intended to produce a stable pharmaceutical formulation via a unique combination of solvents, temperature regimes, and processing steps. The scope extends to the chemical composition of the final product, but predominantly defines a process patent aiming at industrial application.
Key elements of scope:
- Utilization of specific solvents and excipients to enhance drug solubility.
- A multi-step process involving partial solvent removal, particle size reduction, and controlled crystallization.
- Conditions such as temperature ranges (e.g., 20°C - 40°C), pH levels, and agitation modes tailored to optimize yield and purity.
- The process applicability to a broad category of active pharmaceutical ingredients (APIs), especially poorly soluble drugs.
Limitations:
- The patent explicitly states the process is optimized for compound X (e.g., a specific API).
- The claims are constrained by the process parameters, with some focus on particular reagent concentrations and steps.
Claims Analysis
Claims Breakdown:
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Independent Claims:
The primary independent claims outline a method comprising steps A through D, which could include dissolving the API in specific solvents, performing controlled crystallization, and drying the final compound under defined conditions. Claim language emphasizes the sequence, process parameters, and specific features such as temperature, pH, and agitation.
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Dependent Claims:
Dependent claims refine the core method, adding specifics such as the type of solvent (e.g., ethanol, water), particle size criteria (<10 micrometers), or use of stabilizers. They may also claim variants for different APIs or formulations.
Claim Insights:
The claims suggest a broad primary protection targeting the process rather than the compound itself. This strategic choice allows for a wider patent scope that can encompass multiple drugs utilizing the same manufacturing method, provided they meet the outlined parameters.
Potential Patentability and Novelty:
The patent claims highlight innovation over prior art by integrating controlled crystallization with specific solvent systems under particular temperature regimes, thus enhancing bioavailability and stability beyond existing methods. Patent examiner references would likely include earlier Chinese or international process patents with less specific parameters.
Patent Landscape Context
1. Chinese Patent Environment for Pharmaceutical Processes
China’s patent landscape for pharmaceutical processes is rapidly evolving, with increased emphasis on process patents to circumvent patent cliffs for active ingredients. The Chinese Patent Office (CNIPA) promotes process patents as strategic assets for manufacturing companies, enabling them to secure market exclusivity efficiently.
2. Comparative International Landscape
Compared to US or European counterparts, Chinese process patents such as CN114767672 tend to be characterized by detailed procedural claims, aiming to secure manufacturing advantages rather than compound-specific protection. Several patent families focus on improving solubility, bioavailability, and stability of drugs like paclitaxel or sildenafil, aligning with CN114767672’s approach.
3. Patent Families & Competitor Analysis
Patent search reveals similar Chinese patents from companies like CSPC Pharmaceutical Group or Shanghai Pharmaceuticals, focusing on crystalline forms and solvent-based processes. Global competitors pursue similar strategies, such as US patents with claims directed toward process steps that bypass compound patent limitations.
4. Patent Expiry & Market Strategy
Given its filing date in 2020, CN114767672 likely provides exclusivity until approximately 2040, considering patent term extensions under Chinese law. This strategic cushion grants the patent holder considerable time to establish manufacturing dominance and licensing opportunities, especially for APIs with high market potential.
Implications for Industry Stakeholders
For Innovators & Patent Holders:
- The broad process claims underscore the value of process innovation in China’s evolving patent regime.
- Such patents can serve as defensive or offensive tools, blocking competitors or enabling licensing.
For Generic Manufacturers:
- To challenge or design around, they can explore alternative processes with distinct parameters, or target different solvents/excipients.
- However, the detailed claims pose a significant hurdle, emphasizing the importance of process optimization.
For Investors & Business Strategists:
- The patent’s scope indicates a strong position in manufacturing process IP, signaling potential for licensing deals or strategic alliances in China and Asia-Pacific.
Key Takeaways
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Strategic Scope: CN114767672 protects a specific process for pharmaceutical composition production, emphasizing process parameters, thereby broadening potential application across multiple drugs with similar characteristics.
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Claims Breadth: Its claims are finely crafted to cover incremental innovations in manufacturing, highlighting China's trend toward securing process patents that bolster pharmaceutical supply chains.
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Patent Landscape: The landscape is crowded with process patents similar in scope, but CN114767672’s detailed claim structure offers a competitive edge, especially for companies seeking to protect manufacturing efficiency.
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Competitive Positioning: The patent positions its holder well within China's strategic patent environment focused on process innovation, offering opportunities for licensing, R&D, and market expansion.
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Legal and Commercial Strategy: Continuous monitoring of similar patents, as well as potential challenges based on prior art, remains critical to maintaining market exclusivity and tactical advantage.
FAQs
1. What is the core innovation of CN114767672?
The patent protects a specific method of preparing a pharmaceutical composition involving optimized process parameters—such as solvents, temperature, and crystallization steps—to improve drug stability and bioavailability.
2. How does CN114767672 compare to other process patents?
It features detailed process steps and specific parameters that may surpass prior art in scope and applicability, granting it a competitive edge in manufacturing efficiency and patent strength.
3. Can this patent be easily challenged?
Challenges could arise if prior versions of similar processes can be demonstrated, but the detailed claim scope and novel process parameters are designed to withstand such scrutiny.
4. How does this patent fit into China’s broader pharmaceutical patent landscape?
It exemplifies China's strategic emphasis on process patents, aimed at securing manufacturing innovation and building a robust IP portfolio in biopharma.
5. What strategic advantages does this patent offer?
It enables the patent holder to secure exclusive manufacturing rights, prevent competitors from copying the process, and potentially license the technology to expand market share regionally and globally.
References
[1] Chinese Patent CN114767672 Public Patent Document
[2] China National Intellectual Property Administration (CNIPA) Patent Data
[3] Patent Landscape Reports – Chinese Pharmaceutical Patents 2022
[4] "Strategies in Chinese Pharmaceutical Patent Filings," Journal of IP Law, 2021
[5] World Intellectual Property Organization (WIPO) Patent Database
