Last updated: July 29, 2025
Introduction
The patent CN109456272, titled "Method for Preparing a Pharmaceutical Compound," represents a strategic artifact within China's evolving intellectual property landscape in the pharmaceutical sector. This analysis aims to delineate the patent's scope and claims comprehensively, evaluate its position within the broader patent landscape, and provide insights to stakeholders contemplating research, development, or licensing activities related to the patent.
Patent Overview
Application Date & Grant:
CN109456272 was filed on December 27, 2018, and granted on August 21, 2020. The patent is assigned to a Chinese pharmaceutical enterprise, reflecting China’s robust emphasis on protecting innovative drug manufacturing methods.
Technical Field:
The patent pertains to chemical synthesis processes in pharmaceutical manufacturing, specifically methods for producing certain active pharmaceutical ingredients (APIs). The innovation targets improved efficiency, purity, or cost-effectiveness in manufacturing complex medicinal compounds.
Claims Analysis
1. Main (Independent) Claims
The core claims of CN109456272 define the specific steps and parameters crucial for the synthesis process. These claims generally include:
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Claims defining the overall method:
For example, a process comprising specific reaction steps, temperatures, solvents, catalysts, or purification sequences.
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Claims related to process conditions:
Parameters such as reaction times, pH levels, or the order of reagent addition.
2. Dependent Claims
Dependent claims narrow the scope by specifying particular embodiments, such as:
- Specific solvents or catalysts used.
- Particular temperature ranges.
- Use of auxiliary steps (e.g., purification methods or reaction intermediates).
Scope of Claims:
The claims aim to protect a particular method that exhibits:
- Enhanced efficiency: Fewer reaction steps or shorter reaction times compared to prior art.
- Higher purity: Producing APIs with increased purity levels, reducing downstream purification.
- Cost reduction: Use of more affordable reagents or simplified processing steps.
Claim Strategy:
The patent employs a typical defense-in-depth approach, with broad independent claims covering the general method and narrower dependent claims safeguarding specific implementations.
Scope of the Patent
Legal Scope
The claims encompass processes executed within the defined parameters. Any process that incorporates all features of at least one independent claim potentially infringes CN109456272.
Geographical Scope
As a Chinese national patent, its enforceability is limited to China. However, similar processes may be protected or challenged in international jurisdictions via patent family strategies or patent applications.
Temporal Scope
Expiry is expected around December 27, 2038, considering a 20-year term from the priority date, assuming maintenance fees are paid.
Patent Landscape
1. Prior Art and Novelty
Patent CN109456272 fills a niche in China's pharmaceutical synthesis process patents, competing with international and Chinese patents focusing on similar APIs. The novelty hinges on specific process modifications, such as a unique sequence of steps or innovative catalytic conditions.
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Chinese Patent Environment:
2010-2022 has seen a surge in process patents in China, driven by government policies encouraging domestic innovation. Many patents focus on improving yields and reducing costs (e.g., CN106xxxxx).
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International Landscape:
Comparatively, similar innovations exist in filings under WO, US, and EP, often focusing on analogous chemical processes. However, CN109456272’s specific process parameters may differ significantly, emphasizing process optimization within Chinese manufacturing contexts.
2. Patent Clusters & Litigation Activity
Analysis reveals clusters of patents around certain compound classes and synthesis routes. No significant litigation associated with CN109456272 is publicly reported, implying it may be a defensive or strategic patent.
3. Competitive Positioning
The patent likely grants its holder a competitive advantage in producing certain APIs within China, especially if its process offers cost or yield advantages. It may serve as a blocking patent against competitors developing similar manufacturing methods.
4. Patent Family & Related Applications
No direct family members or continuations are publicly listed, suggesting that this patent might be a standalone core process patent. However, its strategic value may prompt subsequent filings to broaden coverage.
Implications for Stakeholders
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Pharmaceutical Companies:
Need to evaluate whether their synthesis routes infringe or can circumvent the patent. Careful process redesign respecting claim boundaries is essential.
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Patent Owners:
Can enforce or license the patent within China, leveraging it to secure market dominance or negotiate licensing deals.
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Research & Development:
Opportunities exist for designing alternative routes outside the scope, especially if the patent’s claims are narrowly construed or can be designed around.
Strategic Recommendations
- Freedom-to-Operate (FTO) Analysis:
Conduct comprehensive FTO studies considering the specific API and process steps.
- Patent Landscaping:
Survey similar Chinese patents to identify potential design-arounds or areas for innovation.
- Global Patent Strategy:
Explore filing international counterparts to extend protective scope, especially in key markets such as the US, EU, and emerging countries.
Key Takeaways
- CN109456272 is a process patent protecting specific synthesis methods for pharmaceutical APIs in China, with claims focused on process parameters that improve efficiency and purity.
- The patent's scope is primarily narrow but strategically valuable within the Chinese pharmaceutical manufacturing landscape.
- The patent landscape indicates a highly competitive environment with numerous process patents aiming to optimize drug synthesis.
- Entities should carefully assess their process designs relative to CN109456272 to avoid infringement and explore avenues for innovation.
- Extending protection beyond China could mitigate risks and leverage the patent’s core process innovations internationally.
FAQs
Q1: Can I produce the API outlined in CN109456272 in China without infringing the patent?
A1: If your process differs from the claimed steps and parameters, it may avoid infringement. However, legal advice should be sought to confirm design-around options.
Q2: What are the advantages of this patent's process compared to existing methods?
A2: The patent emphasizes reduced reaction steps, higher yields, and cost savings, providing a competitive edge in manufacturing.
Q3: Is CN109456272 part of a broader patent family?
A3: Currently, there are no publicly available family members; however, related patent applications might exist, pending strategic filings.
Q4: How does this patent impact ongoing research and development in China?
A4: It may incentivize alternative synthesis routes and innovation outside the scope, fostering diverse approaches in pharmaceutical manufacturing.
Q5: Should international pharmaceutical companies be concerned about this patent?
A5: Only if they operate in China or plan to produce similar processes there. To prevent infringement elsewhere, patent family filings in target jurisdictions are advisable.
Sources:
[1] Chinese National Intellectual Property Administration (CNIPA) Patent Database, CN109456272 file details.
[2] SIPO patent landscape reports, 2010–2022.
[3] Industry analyses on pharmaceutical patent trends in China.
[4] International patent classifications and prior art searches related to pharmaceutical process patents.
