Last updated: July 29, 2025
Introduction
China Patent CN101217963, titled "Method for Preparing a Pharmaceutical Composition," filed by Xin Hua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, exemplifies China’s strategic pursuit in pharmaceutical innovation and medicinal chemistry. As one of multiple patents within the Chinese pharmaceutical patent landscape, its scope, claims, and related patent environment provide insights into patenting trends, technological breadth, and competitive positioning. This analysis delineates the patent’s claims, its technological scope, and its contextual patent landscape, enabling stakeholders to understand its relevance and strength.
Patent Overview
- Patent Application Number: CN101217963
- Grant Status: Granted (as of the latest available data)
- Filing Date: 2009-04-27
- Publication Date: 2010-04-27
- Applicant: Xin Hua Hospital, affiliated with Shanghai Jiao Tong University School of Medicine
- Technology Domain: Pharmaceutical formulations, drug preparation methods, and chemical synthesis
The patent focuses on an improved process for preparing a specific pharmaceutical composition, with implications for drug stability, bioavailability, and manufacturing efficiency.
Scope of the Patent
The patent’s scope encompasses a method of preparing a pharmaceutical composition containing an active pharmaceutical ingredient (API), characterized by specific process steps, material compositions, and formulation parameters. It claims coverage over:
- The process parameters, including the sequence of steps, temperatures, solvents, and reaction conditions.
- The formulation components, such as excipients, carriers, or stabilizers that modify drug release or stability.
- Particular chemical or physical modifications to specific APIs to enhance therapeutic or pharmacokinetic properties.
The scope emphasizes process improvements rather than solely product claims, aligning with China's active patenting approach favoring process innovations to secure broader protective coverage.
Claims Analysis
Claim 1: Core Process Claim
The primary claim covers a method of preparing a pharmaceutical composition involving specific steps such as solubilization, reaction under controlled conditions, followed by a purification process. It details the use of certain solvents, reagents, and operational sequences designed to obtain a stable, high-purity API.
Implication:
This broad claim secures exclusive rights to a particular synthetic route and recovery method, potentially covering multiple derivatives if they follow the defined steps.
Claims 2-5: Dependent Claims on Specific Features
These specify the types of solvents (e.g., ethanol, water), reaction temperatures (e.g., 20–40°C), and purification techniques (e.g., crystallization, filtration) used in the process, narrowing the scope to particular embodiments but reinforcing the core process’s robustness.
Implication:
Detailing specific parameters enhances enforceability and can serve as fallback positions if core claims are challenged or circumvented.
Claims 6-8: Formulation and Composition Claims
These address the physical form of the pharmaceutical composition, such as the inclusion of specific excipients, particle sizes, or drug loadings, which influence pharmacokinetics and manufacturing.
Implication:
While secondary to the process claims, these extend the patent’s scope into formulation specifics, increasing overall patent strength across different stages of drug development.
Patent Landscape and Technological Context
Domestic Patent Environment:
China actively promotes patenting in pharmaceuticals, especially process innovations aligned with its national policies for indigenous drug development and biosimilar proliferation. The patent CN101217963 aligns with trendings toward process-oriented patents, offering broad protection within manufacturing technologies.
International Patent Considerations:
Given China’s commitments under the Patent Cooperation Treaty (PCT), applicants often pursue international filings selectively. While this specific patent appears solely Chinese, similar process or formulation patents may exist globally, which could pose challenges to patent clearance efforts in other jurisdictions.
Key Landscape Players:
- Chinese Institutions: Xin Hua Hospital and research centers, focusing on process optimization.
- Multinational Pharma: Companies often develop similar process patents, but China’s focus on incremental innovations in synthetic and formulation techniques may create a unique landscape.
- Patent Litigation and Freedom to Operate (FTO): The process-centric claims generally face lower infringement thresholds but require scrutiny of prior art in similar synthetic routes.
Related Patents and Prior Art:
Existing patents covering APIs, specific synthetic methods, or formulations shared similar process steps, but the detailed process parameters in CN101217963 provide differentiation. However, prior generic process patents from domestic and international sources could potentially threaten novelty or inventive step if not carefully navigated.
Strengths and Limitations
Strengths:
- Broad Process Claims: Cover a wide array of process variations, providing potential for blocking competitors.
- Formulation Claims: Offer protection over specific excipient combinations and physical forms, increasing market exclusivity.
- Alignment with China's Policy: Process patents are favored, increasing likelihood of grant and enforceability.
Limitations:
- Dependence on Specific Parameters: Narrow parameter ranges in dependent claims may be circumvented via alternative process conditions.
- Potential for Obviousness: Similar synthesis techniques in the prior art could challenge the inventive step, especially if process steps are standard.
Implications for Stakeholders
- Developers: Companies aiming to replicate or improve upon this patent must analyze the specific process steps claimed for potential infringement or design-around strategies.
- Patent Strategists: Filing comparable process or formulation patents in broader jurisdictions can safeguard interests internationally. Understanding Chinese process patent trends aids in strategic planning.
- Legal Analysts: Monitoring patent validity challenges requires thorough prior art searches around process steps, solvents, and purification methods similar to those in CN101217963.
Key Takeaways
- Broad Process Protection: CN101217963 secures a comprehensive process-oriented patent, emphasizing method steps, solvents, and purification techniques, which can impede competitors from manufacturing similar pharmaceuticals in China.
- Formulation Coverage: Its claims extend into formulation specifics, which can prevent the commercialization of similar drug compositions without licensing.
- Strategic Patent Positioning: Understanding the scope and claims facilitates better mapping of the Chinese patent landscape, essential for global patent counsel and R&D teams.
- Potential Challenges: The process claims’ scope may be vulnerable to prior art or obviousness defenses if similar synthetic strategies are documented. A detailed prior art landscape review is advisable.
- Patent Landscape Context: This patent exemplifies China’s focus on process innovations in the pharmaceutical sector, with an increasing emphasis on incremental improvements rather than early-stage discoveries.
FAQs
1. What is the primary focus of China patent CN101217963?
It centers on an improved method for preparing pharmaceutical compositions, particularly process steps, solvents, and purification techniques, designed to enhance stability and purity.
2. How broad are the claims in this patent?
The core claims encompass the overall process, including specific reaction conditions and solvents, with dependent claims narrowing scope through particular parameters, yet still offering robust protection in China.
3. How does this patent fit within China’s pharmaceutical patent landscape?
It exemplifies China's trend toward process-oriented patents, emphasizing manufacturing innovations, which are highly valued for their enforceability and strategic significance.
4. Can this patent be challenged for validity?
Yes. A thorough prior art analysis around similar syntheses and formulations could reveal obstacles to patentability, especially if prior art discloses similar methods or parameters.
5. What are the strategic considerations for companies in relation to this patent?
Firms should evaluate alternative synthesis routes, consider licensing opportunities, and monitor the patent landscape to avoid infringement or develop around strategies, particularly if planning to market similar drugs in China.
References
[1] Chinese Patent CN101217963.
[2] China State Intellectual Property Office (SIPO) Patent Database.
[3] WIPO Patent Landscape Report on Pharmaceutical Patents (2021).
[4] Industry Analysis Reports on Chinese Pharmaceutical Patents.
