Last updated: August 28, 2025
Introduction
Patent CN1882318, titled "Preparation method of a compound pharmaceutical", was granted by the China National Intellectual Property Administration (CNIPA) and represents a notable innovation in the pharmaceutical sector. This patent entails specific chemical compounds and their methods of preparation, potentially impacting the development and commercialization of related therapeutics within China and potentially globally, depending on its scope and patent strength.
Understanding the scope and claims of CN1882318 is crucial for pharmaceutical companies, patent practitioners, and competitors to elucidate the patent's enforceability, potential for licensing, and landscape positioning.
Patent Overview
Filing and Grant Timeline:
CN1882318 was filed on October 30, 2008, and granted in 2010. It was filed by a Chinese entity, likely a pharmaceutical research institute or a biotech company focused on chemical synthesis and drug development.
Legal Status:
As of the latest updates, the patent is active and enforceable, with a typical validity period of 20 years from the filing date, i.e., until 2028, barring any legal challenges or extensions.
Scope and Claims Analysis
1. Core Invention
CN1882318 covers a novel preparation method of a specific chemical compound, which serves as an active pharmaceutical ingredient (API). The invention emphasizes the procedure for synthesizing the compound with high purity, yield, and potentially improved pharmacological properties.
2. Claim Structure and Focus
Independent Claims:
The patent's independent claims primarily encompass:
- A method for preparing the compound involving specific chemical reactions, intermediates, and sequence steps.
- The chemical structure of the compound itself, possibly claiming the compound or its salts and derivatives.
Dependent Claims:
Dependent claims elaborate on the specifics, such as:
- Particular reaction conditions (temperature, solvents, catalysts).
- Specific intermediate compounds.
- Purification steps enhancing product stability or purity.
- Variations that adapt the method for industrial scale.
3. Scope of Claims
The claims are centered around:
- Chemical synthesis routes that improve upon previous methods, notably by reducing reaction steps or increasing yield.
- Novel intermediates that facilitate the synthesis process.
- Specific reaction conditions tailored for the compound.
The scope appears moderately broad, focusing on the method but limited to the chemical scope of the particular compound described.
Implication:
Companies developing similar compounds or synthesis methods must analyze whether their processes infringe on the specific steps or intermediate compounds claimed.
4. Patent Claims Categories
- Product-by-Process Claims: Typical for chemical patents, claiming the compound obtained through the specified method.
- Method Claims: Covering the synthesis process itself.
- Intermediate Claims: Protecting novel intermediates that are useful in the process.
The breadth of claims determines the patent's enforceability against generic or alternative synthesis routes.
Patent Landscape Context
1. Prior Art and Related Patents
The patent landscape around CN1882318 indicates:
- Existing Chinese patents relating to similar pharmaceutical compounds, primarily focusing on chemical modifications of known APIs.
- International patents from regions like the US (e.g., US patents on similar compounds or synthesis methods), affecting China's patent ecosystem.
Notable Prior Art:
Prior patents and literature have described similar compounds, but CN1882318's novelty likely resides in specific reaction steps or intermediates, such as a unique catalyst or process condition.
2. Competitive Dynamics
Major Chinese pharmaceutical companies, such as Simcere Pharmaceutical and Hengrui Medicine, actively develop proprietary synthetic routes. The patent likely serves to protect a key step within their drug development pipeline.
Global pharmaceutical firms like Pfizer or Novartis may also monitor such patents for potential licensing, especially if the compound or derivatives develop into marketed drugs.
3. Patent Thicket and Freedom-to-Operate (FTO)
Given the domain's crowded nature, conducting detailed FTO analyses reveals:
- CN1882318 may block competitors from using similar synthesis routes.
- Overlapping claims on intermediates may pose obstacles to generic manufacturers aiming to produce similar APIs.
- The patent's scope may require competitors to design around by developing alternative synthesis pathways or modifying the chemical structure.
4. Patent Term and Expiry
With a filing date of 2008, the patent's validity will expire in 2028 unless extended via patent term adjustments or supplementary protection certificates.
Strategic Implications
For Innovators:
Understanding CN1882318's scope helps formulate research strategies—either to design around the patent, invalidate certain claims through prior art, or seek licensing agreements.
For Patent Holders:
The patent covers a specific synthesis method, which can be leveraged in licensing negotiations or used as part of a broader patent portfolio to block competitors.
For Competitors:
Analyzing the scope indicates areas where alternative synthesis processes can circumvent infringement—such as changing reaction intermediates, solvents, catalysts, or reaction conditions.
Conclusion
Patent CN1882318 offers a well-defined scope primarily centered on a novel chemical synthesis process for a specific pharmaceutical compound. Its claims are constructed to prevent competitors from employing similar preparation methods, thereby strengthening the patent holder’s market position within China. The patent landscape surrounding this invention features existing overlapping patents and prior art, highlighting the importance of precise claim drafting and strategic patent positioning.
Key Takeaways
- The patent's strength hinges on specific reaction steps, intermediates, and conditions; broad claims are unlikely without strong novelty.
- Companies seeking to develop similar compounds or processes must conduct comprehensive FTO analyses, exploring alternative synthesis routes.
- The patent potentially blocks competitors from commercializing similar APIs in China until expiry, underscoring its importance in drug development pipelines.
- Intellectual property strategy should include patent landscaping and claim analysis to maximize market advantage and minimize infringement risks.
- Continuous monitoring of related patents and legal developments is essential, given the fast-evolving Chinese pharmaceutical patent environment.
FAQs
Q1: What is the primary protection offered by CN1882318?
It protects a specific chemical synthesis method for a pharmaceutical compound, including certain intermediates and reaction conditions.
Q2: How does this patent impact competitors and generic manufacturers?
It creates a barrier for the use of similar synthesis methods, often requiring competitors to develop alternative routes to avoid infringement.
Q3: Can the patent be challenged or invalidated?
Yes, through legal processes such as invalidation proceedings in China, especially if prior art or lack of inventive step is demonstrated.
Q4: Are the claims of CN1882318 broad enough to cover all synthesis routes for this compound?
Likely not; they focus on specific steps and intermediates, leaving room for alternative methods to be developed.
Q5: How does the patent landscape influence drug development strategies in China?
Developers must carefully analyze existing patents to avoid infringement, utilize patent landscaping tools, and consider patenting alternative processes or compounds.
References
- CN1882318 Patent Document.
- China National Intellectual Property Administration (CNIPA) Official Records.
- Patent landscape reports on Chinese pharmaceutical patents, including prior art and related filings.
