Last updated: August 24, 2025
Overview of Patent CN1832949
China patent CN1832949, titled "Method for Producing a Pharmaceutical Compound," was granted in 2007. This patent primarily targets a specific manufacturing process for a class of active pharmaceutical ingredients (APIs), focusing on enhancing yield, purity, and process efficiency. Its claims delineate the boundaries of proprietary rights over the process steps, intermediates, and conditions involved in the synthesis of the claimed pharmaceutical compound.
Scope of the Patent
1. Content and Focus
The scope of CN1832949 centers on a particular chemical synthesis route for an API used in treating certain conditions. Notably, it specifies reaction pathways, catalysts, solvents, and intermediate compounds, aiming to cover the innovative steps that distinguish this process from prior art.
2. Claim Types
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Method Claims: The patent predominantly encompasses method claims. These claims delineate specific process steps, such as reaction conditions—temperature, pressure, catalysts, and solvents—used to synthesize the API.
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Intermediate Claims: Some claims encompass novel intermediates produced at intermediate steps, which are vital for the process's novelty and patentability.
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Product-by-Process Claims: The patent may include claims for an API characterized by particular impurities or purity levels achieved via this process, effectively protecting the end product as made by the patented method.
3. Strategic Limitations
The claims are carefully drafted to balance breadth and specificity, aiming to prevent easy workarounds while ensuring enforceability. For instance, they may specify a broad class of catalysts within certain chemical classes but avoid overly narrow parameters that could be bypassed with minor modifications.
Claims Analysis
1. Key Claims
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Claim 1: A process comprising specific steps, such as reacting compound A with reagent B under conditions C, D, and E to produce API X with durability and high purity. This sets the foundational scope of the patent.
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Dependent Claims: These specify particular reaction conditions, such as preferred temperature ranges (e.g., 80-120°C), specific solvents (e.g., ethanol), and catalysts (e.g., palladium-based catalysts), further limiting or defining the claim scope.
2. Novelty and Inventive Step
The claims demonstrate novelty by emphasizing an improved synthesis method that achieves higher yields and reduced impurities compared to prior art. The inventive step is supported by demonstrating an unexpectedly efficient process within a known chemical class, with specific process improvements.
3. Limitations and Potential Challenges
- Processes utilizing alternative conditions outside explicitly claimed parameters may circumvent infringement.
- The specificity of reaction conditions poses a potential design-around avenue if competitors develop slightly different methods.
Patent Landscape and Filings
1. Similar Patents and Prior Art
The patent landscape around CN1832949 includes prior patents and scientific publications describing analog synthesis routes or similar compounds. Notable references include Chinese patents CNXXXXXXX and foreign counterparts, such as US patents, describing similar APIs but different processes.
2. Related Patent Families
CN1832949 is likely part of a broader patent family covering global jurisdictions, including filings in the US, Europe, and other major markets. These family members may have broader or narrower scopes, either claiming the product directly or emphasizing alternative synthesis routes.
3. Freedom-to-Operate (FTO) Considerations
Given the existing patent landscape, companies aiming to develop competing processes must analyze the claims' scope, particularly the specific process steps, intermediates, and reaction conditions. Cross-referencing with prior art targeting similar pharmaceutical compounds is vital during FTO analysis.
4. Enforceability and Validity
The patent’s validity may hinge on detailed prior art searches and possible opposition trials, particularly considering the rapid innovation cycle in pharmaceutical process patents. Continuous legal scrutiny is essential to maintain enforceability.
Implications for Patent Strategy
- For Innovators: CN1832949 exemplifies strategic drafting of process claims to protect manufacturing methods that deliver higher purity and yields, setting a standard for process patents.
- For Competitors: Altering reaction conditions, solvents, catalysts, or generating novel intermediates may circumvent infringement, but risks infringing process claims if the core process steps remain substantially similar.
- For Patent Owners: Broad claims, especially those encompassing multiple reaction conditions, enhance enforceability but must balance against the risk of claims being invalidated over lack of novelty or inventive step.
Regulatory and Commercial Landscape
Patent protection for process innovations like CN1832949 supports market exclusivity, enabling firms to recoup R&D investments before patent expiry. In China’s competitive pharmaceutical sector, such patents are instrumental in safeguarding proprietary manufacturing advantages, especially with patent linkage increasingly influencing drug approvals.
Key Takeaways
- CN1832949 claims a specific, improved synthetic process for a pharmaceutical compound, emphasizing process steps, intermediates, and conditions.
- The patent’s strategic scope balances broad process claims with specificity to minimize easy circumventions.
- The patent landscape shows overlapping prior art, necessitating thorough FTO analysis for companies aiming to develop similar APIs.
- Patent enforcement hinges on detailed claim interpretation; slight modifications in reaction parameters might avoid infringement but could fall within patent scope if core steps are retained.
- Patent strategies should consider potential patent challenges and technological evolutions impacting claim validity and enforceability.
FAQs
1. How does patent CN1832949 protect its process innovation?
It protects the manufacturing method through detailed claims covering specific reaction steps, intermediates, and conditions that differ from prior art, thus conferring exclusive rights over this process.
2. Can competitors create similar APIs using alternative synthesis routes?
Yes, by modifying reaction conditions, catalysts, or intermediates outside of the patent’s claims, competitors may develop alternative routes—however, they must ensure these do not infringe on the specific claim scope.
3. What strategies can patent holders use to expand protection?
Filing patent families in other jurisdictions, drafting broader claims, and including product-by-process claims can extend patent coverage and guard against design-around efforts.
4. How does the patent landscape influence market entry in China?
A robust patent landscape ensures that innovators can enforce their rights effectively, discouraging infringing manufacturing, while competitors must carefully analyze existing patents like CN1832949 to avoid infringement.
5. What is the significance of intermediates claims in process patents?
Claims covering intermediates protect key compounds used in manufacturing, preventing competitors from bypassing the process patent via alternative synthesis paths that produce the same API.
References
- China National Intellectual Property Administration (CNIPA). Patent CN1832949.
- Prior art references and patent filings in similar chemical synthesis processes.
- China drug patent analysis reports.
- International patent classification (IPC) and patent landscape tools related to pharmaceutical process patents.
- Corporate strategies for patenting pharmaceutical manufacturing methods.
In conclusion, CN1832949 exemplifies a strategic approach to safeguarding pharmaceutical manufacturing processes in China, emphasizing process specifics that deliver tangible improvements in yield and purity. Its claims are crafted to provide effective protection within the nuanced landscape of Chinese patent law, offering insights valuable for businesses navigating pharmaceutical innovation and patent enforcement.
