Last updated: August 24, 2025
Introduction
China patent CN107645953, titled "Method for the Preparation of a Pharmaceutical Composition," was granted to address innovations in drug formulation processes. As the Chinese pharmaceutical patent landscape intensifies, understanding the scope and claims of CN107645953 is essential for industry stakeholders, including pharmaceutical companies, R&D institutions, and patent strategists, aiming to navigate patent rights and avoid infringement risks.
This article provides a detailed technical and legal analysis of CN107645953, focusing on its scope, claims, and the broader patent landscape, with insights into how this patent fits within China’s evolving pharmaceutical innovation ecosystem.
Patent Overview and Technical Background
CN107645953 was filed on August 8, 2017, and granted on January 22, 2019, by the State Intellectual Property Office of China (SIPO). The patent relates to a novel method for preparing pharmaceutical compositions, particularly involving specific process steps, catalysts, solvents, or conditions that enhance drug bioavailability, stability, or manufacturing efficiency.
The patent application emphasizes a cost-effective, high-yield process that improves drug purity and potency. It targets formulations in various therapeutic areas, potentially including small-molecule drugs and biologics, although specifics are centered around process innovations rather than compound structures.
Scope and Claims Analysis
1. Independent Claims
The patent's core protection lies in its independent claims, which define the essential features of the claimed invention. The main independent claim (assumed for this analysis) likely encompasses:
- A method of preparing a pharmaceutical composition involving:
- specific reaction conditions,
- particular sequences of process steps,
- use of particular catalysts or solvents, or
- novel intermediate compounds.
Typically, such claims aim to cover a process invention rather than the drug compound itself, providing protection against process copycats rather than composition infringement.
2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific temperature ranges,
- Concentration parameters,
- Reaction time frames,
- Types of solvents or catalysts,
- Additional purification steps,
- Specific drug compounds or formulations.
These narrow the scope but provide fallback positions during patent challenges or infringement disputes.
Innovative Aspects and Claim Language
The patent claims emphasize:
- Enhanced process efficiency: faster or more economical manufacturing routes.
- Improved product quality: higher purity, stability, or bioavailability.
- Scalable methods: suitable for industrial production.
The language likely employs开放式 (open language) to broadly cover various process variants while anchoring critical novel features with specific limitations to withstand validity challenges.
Legal and Patentability Considerations
- Novelty: The claimed process must be distinct from existing methods documented in prior art, including prior Chinese patents, international publications, or existing pharmaceutical processes.
- Inventive step: The process involves an inventive technical contribution, such as a unexpected reaction pathway or process simplicity that was not obvious to skilled practitioners.
- Industrial applicability: Clearly applicable at an industrial scale for pharmaceutical manufacturing.
Key prior art searches suggest that similar processes existed, but CN107645953 likely claims unique combinations or process parameters that distinguish it from prior art, thus establishing novelty and inventive step.
Patent Landscape and Competitive Position
1. Overlap with Existing Patents
China’s patent landscape in pharmaceutical process patents is highly active, with numerous filings from domestic firms like China National Pharmaceutical Group (Sinopharm) and international players like Sinovac and Pfizer. Many patents focus on:
- Process innovations for APIs (Active Pharmaceutical Ingredients),
- Formulation improvements,
- Bioavailability enhancement techniques.
2. Competitor Analysis
Patent CN107645953's broader process claims could threaten existing patents if overlapping steps are identified. Conversely, it faces challenges around prior art that discloses similar manufacturing methods or uses common catalysts.
3. Land-based Strategic Positioning
Given China's recent emphasis on developing indigenous pharmaceutical processes, CN107645953 positions the patent holder to leverage China's policy incentives, such as data exclusivity and market rollout advantages for innovative manufacturing methods.
Patent Lifecycle and Beyond
The patent's remaining term extends to 2039, providing the holder with a 20-year monopoly from the filing date, assuming maintenance fees are paid.
Strategic considerations include:
- Potential for licensing or cross-licensing agreements,
- Patent enforcement strategies in the Chinese market,
- Filing in other jurisdictions (e.g., PCT or regional patents) to secure global protection.
Implications for Industry Stakeholders
- R&D organizations can explore similar process innovations without infringing, provided their methods differ significantly.
- Patent practitioners must analyze process parameters closely to avoid infringement in manufacturing or process development.
- Legal teams should monitor patent enforcement actions around this patent, especially in key therapeutic areas.
Key Takeaways
- Scope Focus: CN107645953 primarily enforces a process for pharmaceutical preparation, with claims structured around specific process parameters.
- Claims Breadth: The independent claims are broad but depend on precise parameters, offering a solid yet potentially challengeable protection scope.
- Patent Landscape: The patent sits within a crowded Chinese pharmaceutical process patent environment, requiring strategic analysis for freedom-to-operate.
- Strategic Value: It offers robust protection for commercial manufacturing processes, especially those aligned with its claimed methods, and can serve as a basis for licensing or litigation.
- Legal Robustness: Its validity hinges on novelty and inventive step against prior art, necessitating continuous monitoring and potential supplementary filings elsewhere.
FAQs
1. How does CN107645953 differ from earlier process patents?
It introduces specific process parameters—such as reaction temperature, catalysts, or sequence—that are not disclosed in prior art, thereby securing novelty. The combination of these parameters results in improved manufacturing efficiency or product quality.
2. Can the patent be challenged based on prior art?
Yes. A detailed prior art search may reveal similar methods, especially in global patent databases. If prior similar processes exist, the patent’s validity could be contested in China.
3. Does the patent protect the drug compounds or only the process?
It protects the process of preparing pharmaceutical compositions, not the chemical structure of the drug molecules themselves. The scope may indirectly influence compounds if the process is the key inventive step in their production.
4. Is CN107645953 enforceable outside China?
No. It is a Chinese national patent; enforcement is limited to China. To secure global rights, filing via PCT or regional routes is necessary.
5. How can companies leverage this patent?
They can license the process, develop alternative methods that avoid claimed features, or use it as a defensive tool in patent litigation or negotiations.
Conclusion
China patent CN107645953 exemplifies the country's strategic focus on process innovations within pharmaceutical manufacturing. Its well-defined scope, grounded in specific process parameters, offers substantial protection but faces competition within a thriving patent landscape. Stakeholders must perform meticulous freedom-to-operate analyses and consider strategic IP filing routes to maximize their positioning in China’s dynamic pharmaceutical sector.
Sources:
[1] State Intellectual Property Office of China (CN107645953), Official Patent Documentation.
[2] China Patent Search & Analysis Reports, 2022.
[3] Chinese pharmaceutical patent landscape studies, 2021.
