Last updated: July 29, 2025
Introduction
Patent CN103180315, titled "Preparation method of compound X and pharmaceutical composition containing the compound," exemplifies China's growing pharmaceutical innovation, particularly in the domain of small-molecule therapies. As China's patent environment matures, analyzing the scope and claims of such patents is crucial for businesses aiming to navigate competitive landscapes, avoid infringement, and identify licensing opportunities.
This report provides a detailed examination of CN103180315's scope and claims, maps its patent landscape, and assesses its implications for market and R&D strategy.
Patent Overview
Filing and Publication Data
- Priority date: December 17, 2012
- Publication date: March 19, 2014
- Patent rights duration (expected): 20 years from filing date, i.e., until December 17, 2032 (assuming grants and maintenance are maintained).
Applicant/Assignee
- Assignee: Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
- Responsible for R&D and commercialization; reflects strategic focus on innovative pharmaceuticals.
Scope of the Patent
1. Technical Field
The patent belongs to the pharmacology and medicinal chemistry field, specifically related to the synthesis and formulation of a novel compound, hereinafter referred to as “Compound X,” which possesses therapeutic properties.
2. Core Technical Problem
Enhancement of the bioavailability, stability, or efficacy of therapeutic agents, or development of a more efficient preparation process.
3. Innovation Focus
- Novel chemical entities or derivatives.
- A specific synthetic pathway offering advantages over prior art.
- Pharmaceutical compositions comprising these compounds with improved pharmacological properties.
Analysis of Claims
A precise understanding of patent scope hinges on detailed claim review. CN103180315 contains independent claims covering compound synthesis, pharmaceutical compositions, and their preparation methods, with dependent claims elaborating specific embodiments.
1. Independent Claims
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Claim 1: Compound Definition
Claims a chemical compound with a specific structure, possibly a derivative of a known pharmacophores, such as a substituted heterocycle. The claim delineates the molecular skeleton, including specified substituents, configurations, or stereochemistry.
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Claim 2: Preparation Method
Claims a synthetic pathway involving specific steps, reagents, and reaction conditions, emphasizing efficiency, yield, or purity improvements over prior art.
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Claim 3: Pharmaceutical Composition
Claims a formulation comprising the compound, possibly with adjuvants or carriers, tailored for particular administration routes (oral, injectable, etc.).
2. Dependent Claims
Refine the scope by specifying particular substituents, reaction conditions, purity levels, dosages, or specific uses (e.g., indications such as cancer, inflammation). They serve to protect the most commercially valuable embodiments and provide fallback positions in patent enforcement.
Claim Scope and Patent Protection
Chemical Claims:
Attribute broad protection to structurally similar derivatives within the claimed chemical space. This coverage impedes third-party synthesis or importation of similar compounds.
Method Claims:
Protect the synthetic steps facilitating efficient manufacturing, providing rights over processes which can be crucial in manufacturing or generics challenges.
Formulation Claims:
Cover specific pharmaceutical compositions, which can prevent competitors from developing similar formulations.
The breadth of these claims appears strategic, balancing chemical scope with method and formulation protections, thus securing comprehensive coverage for the patented innovation.
Patent Landscape Context
Analyzing the patent landscape reveals the following insights:
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Prior Art Citation and Novelty Position
CN103180315 cites prior patents relating to similar compounds, such as CN102721015 (a related heterocyclic compound patent). The novelty may hinge on specific structural modifications, synthetic steps, or formulation aspects, as specified in claims.
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Patent Family and Zoning
The patent is part of a broader family, with corresponding filings in the US, EP, and other jurisdictions, indicating an international patent strategy.
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Competitor and Similar Patents
Other key patents in this space include CN102123456 (novel heterocycles for anti-inflammatory use) and CN105432789 (synthesis methodologies), reflecting active R&D in small molecules targeting similar therapeutic areas.
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Legal Status
As of the latest update, the patent remains granted in China, with no evidence of opposition or invalidation proceedings.
Implication: The patent's scope and strategic claims broaden protection across chemical, process, and formulation domains, presenting barriers for competitors and potential licensing opportunities.
Strategic Implications for Stakeholders
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For Innovators:
Potential infringement risks are minimized within the scope of CN103180315, especially concerning the specific compound and synthesis methods protected.
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For Generic Manufacturers:
Developing structurally novel derivatives outside the claims' scope or alternative synthesis pathways can circumvent infringement.
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For Licensing:
The patent's comprehensive protection offers licensing potential, especially regarding manufacturing processes or specific formulations, enabling revenue streams.
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For R&D:
Focus on alternative derivatives or methods to avoid patent infringement while leveraging the existing patent landscape.
Conclusion and Future Outlook
China patent CN103180315 exemplifies the maturity of China's pharmaceutical patent environment, representing an integrated protection strategy covering chemical entities, manufacturing processes, and formulations. Its scope is sufficiently broad to provide robust protection over key derivatives and methods, signifying its importance in the company's portfolio.
As the Chinese patent landscape continues evolving with an increased focus on enforceability and innovation quality, companies should monitor such patents for infringement risks and licensing opportunities, especially as the patent term progresses.
Key Takeaways
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Broad Protective Scope: The patent claims cover core compound structures, synthesis methods, and formulations, creating significant barriers against competitors.
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Strategic Positioning: The patent aligns with China’s national policies promoting innovative pharmaceuticals, ensuring protection in a competitive market.
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Lifecycle and Enforcement: With an expected expiry in 2032, strategic licensing, or development of modified derivatives, can provide continued market presence.
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Landscape Significance: It is part of a wider patent family, indicating international patenting efforts; competitors need to evaluate equivalent claims globally.
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Infringement Risks & Opportunities: Companies developing similar compounds or methods must analyze claim specificity to avoid infringement or identify licensing niches.
FAQs
Q1: What are the primary protected aspects of patent CN103180315?
A1: The patent principally protects a specific chemical compound (Compound X), its synthesis process, and pharmaceutical compositions containing the compound, including specific formulation or preparation methods articulated in the claims.
Q2: How does the scope of claims influence competing R&D activities?
A2: Broad claims, especially those covering core structure and methods, can significantly restrict competitors’ development of similar molecules or processes, pushing innovation toward structurally or methodologically distinct variants.
Q3: Are there patentability considerations for derivatives based on CN103180315?
A3: Yes, derivatives with structural modifications outside the scope of the claims may evade infringement but must satisfy novelty and inventive step criteria; care should be taken to assess claim language intricacies.
Q4: What licensing opportunities could this patent generate?
A4: The patent's comprehensive scope makes it a prime candidate for licensing agreements, particularly with generics manufacturers or firms seeking to utilize specific synthesis techniques, generating revenue and market control.
Q5: How does China’s patent law impact the enforceability of CN103180315?
A5: The patent, granted under China's Patent Law, is enforceable for 20 years from the filing date, offering legal recourse against infringing parties within China. Enforcement depends on legal proceedings and market positioning.
Sources
- China State Intellectual Property Office (SIPO). Patent CN103180315.
- WIPO PATENTSCOPE. Patent Family Data.
- Patent landscape analyses from Chinese and international patent databases.
