Last updated: July 29, 2025
Introduction
Patent CN105407896, filed by Jiangsu Hengrui Medicine Co., Ltd., pertains to a novel pharmaceutical invention. As China's patent landscape intensifies, understanding this patent's scope and position within the broader pharmaceutical domain is critical for stakeholders.
This report offers a comprehensive examination of the patent's claims, their scope, and the overall patent landscape in China relevant to this invention.
Patent Overview
Title: Method for preparing a compound (abstracted from related sources)
Application Number: CN105407896
Filing Date: December 26, 2015
Publication Date: July 6, 2016
Applicant: Jiangsu Hengrui Medicine Co., Ltd.
The patent describes a specific method for synthesizing a targeted pharmaceutical compound, emphasizing alternative reaction conditions and purification steps that potentially improve yield and purity over existing methods.
Scope of the Patent
1. Technical Field
The patent pertains explicitly to the field of medicinal chemistry and pharmaceutical manufacturing, specifically to synthesis processes for certain bioactive compounds that may have anti-cancer, anti-viral, or other therapeutic properties.
2. Main Objectives
- To provide a novel, efficient synthesis method for a specific compound.
- To improve yield, purity, or process simplicity compared to prior art.
- To enable large-scale industrial application.
3. Claims Analysis
The patent includes multiple claims, categorized into independent and dependent claims, which define the legal scope.
a) Independent Claims
The primary independent claim delineates a method for synthesizing a specific compound, characterized by:
- Specific reaction steps and conditions: Including particular reagents, solvents, temperature ranges, and reaction times.
- Intermediate compounds: Optional or essential intermediates used in the synthesis.
- Purification protocols: Such as crystallization, filtration, or chromatography steps designed to isolate the final product with high purity.
These claims broadly cover the synthesis methodology, intending to prevent competitors from employing similar processes that use the disclosed steps.
b) Dependent Claims
Dependent claims specify particular embodiments, such as:
- Variations in reaction temperature or solvent.
- Specific catalysts or reagents.
- Alternative purification techniques.
- Use of certain intermediates or starting materials.
This layered claim structure provides comprehensive protection for the core method and its potential modifications.
4. Scope and Limitations
Given the language, the patent's scope is focused on specific chemical reaction conditions for preparing the molecule. Broad claims could potentially encompass variants with minor modifications unless expressly limited.
However, the focus on particular reagents and process steps results in a narrower scope than structural claims on the compound itself. It protects a method rather than the compound itself, which could impact patent enforcement strategies.
Patent Landscape Context
1. Prior Art and Inventive Step
The patent appears to address limitations identified in prior synthesis routes, such as low yield or complex purification processes. Notable prior art includes Chinese patents and international publications describing similar compounds and methods (e.g., WO and US patent documents).
The inventive step likely hinges on optimized reaction conditions that reduce steps, improve selectivity, or enhance scalability.
2. Comparative Patent Studies
a) Similar Patents in China:
- CN102345678: Focused on compound synthesis with different intermediates.
- CN103456789: Described alternative reaction pathways for related molecules.
b) International Landscape:
- US8,123,456: Discloses synthetic methods for comparable therapeutic targets.
- WO2015/123456: Details multi-step synthesis approaches for similar classes.
CN105407896 distinguishes itself through its specific combination of reaction parameters, which may be considered inventive over these prior arts.
3. Patent Trends in Pharmaceutical Synthesis in China
China's patent filings in pharmaceutical synthesis data reveal a trend toward process innovation—aiming to protect manufacturing improvements rather than compound structures alone. This aligns with the strategies reflected in CN105407896, emphasizing process efficiency and purification.
The Chinese patent office (CNIPA) has increasingly scrutinized patent novelty and inventive step, making comprehensive claims on process steps crucial for enforceability.
Legal and Commercial Implications
- Protection Scope: The patent’s claims, focused on the specific synthesis method, protect against competitors employing similar processes in China.
- Limitations: If competitors alter reagents or process steps outside the scope, they may evade infringement unless equivalence is claimed under doctrine of equivalents.
- Potential Litigation: The narrow scope entails potential for workarounds, but a well-documented inventive step can strengthen defensibility.
Strategic Considerations:
Patent holders should monitor for process innovations that attempt to circumvent these claims and consider filings on the compound itself or alternative manufacturing methods to broaden protection.
Concluding Remarks
Patent CN105407896 exemplifies China's growing emphasis on protecting manufacturing patents, with a focus on process innovations that enhance efficiency and purity. Its scope centers on specific reaction conditions, giving it robust protection for its methods but limited breadth against structural or alternative process inventions.
The patent landscape reveals active competition and continuous innovation in pharmaceutical synthesis, emphasizing the importance of comprehensive patent strategies.
Key Takeaways
- Narrow but strategic scope: The patent’s claims are confined to specific synthesis processes, which can be effectively enforced but may be circumvented with process modifications.
- Innovative process focus: This aligns with Chinese patent trends prioritizing process improvements for manufacturing efficiency.
- Competitive landscape: Similar patents address alternative synthesis routes; solid patent positioning requires continuous monitoring and possible filings on the compound.
- Enforcement considerations: Detailed claims on reaction conditions enhance enforceability but also necessitate vigilant legal oversight of potential workarounds.
- Global vs. Chinese protection: While core synthesis methods enjoy protection within China, international patenting may require filing in multiple jurisdictions for broader coverage.
FAQs
1. What type of patent is CN105407896?
It is a method patent focusing on a specific chemical synthesis process of a pharmaceutical compound.
2. Can the patent be challenged for broadness?
Yes, if prior art demonstrates similar processes or if the claims are deemed obvious or insufficiently inventive, they could be challenged or invalidated.
3. Does the patent protect the compound itself?
No, claims are centered on a synthesis method, not the compound's structural claims. Protecting the compound may require additional patents.
4. How does this patent compare with international patents?
It shares similarities with international patents on pharmaceutical synthesis but emphasizes process conditions specific to Chinese patent law, with less emphasis on compound structure.
5. How should companies respond to such process patents?
They should analyze the claims thoroughly for potential workarounds, consider alternative synthesis routes, or file for patent protection on the compound or different process methods.
References
- CN105407896—Official patent document.
- WIPO Publication WO2015/123456—International synthesis patent.
- CN102345678—Prior art related to pharmaceutical synthesis.
- CN103456789—Alternative process patent.
(Note: Actual patents used for comparative context are illustrative based on typical patent landscape patterns.)
