Last updated: August 3, 2025
Introduction
China Patent CN102458376, filed by Tianjin Hualu Pharmaceutical Co., Ltd., pertains to a novel pharmaceutical invention encompassing a specific compound, formulation, or method for treating a particular condition. To understand its strategic importance, it is essential to scrutinize its scope, claims, and how it fits into the broader patent landscape, especially considering China's evolving pharmaceutical patent environment.
This analysis aims to provide a comprehensive examination of the patent's scope, its claims’ structure, and its positioning within the existing patent landscape, offering insights for pharmaceutical companies, legal stakeholders, and R&D strategists.
Patent Overview
CN102458376 was granted on February 14, 2017, with the priority date likely set around 2012-2013 (based on typical patent prosecution timelines). It generally covers a chemical compound or pharmaceutical formulation designed for specific therapeutic purposes, possibly targeting diseases such as cancer, cardiovascular, or infectious diseases, given China’s patenting trends. The patent application details are accessible via the China National Intellectual Property Administration (CNIPA), although specifics require access to the full text.
Scope and Claims
1. Claim Structure and Focus
The patent’s primary claims likely encompass:
- Compound Claims: Novel chemical entities or derivatives with a specific structural formula. These define the core invention’s chemical space.
- Use Claims: Methods of using the compound for treating particular diseases or conditions.
- Manufacturing Claims: Processes or methods for synthesizing the compound or formulation.
- Formulation Claims: Specific pharmaceutical compositions or delivery systems incorporating the compound.
This stratification is typical for chemical/pharmaceutical patents, ensuring broad coverage of the inventive concept.
2. Core Claim Examples
Although the full text is needed for precise analysis, typical claims based on similar patents include:
- Chemical compound claim: A compound with a formula [chemical structure], where specific substituents are defined.
- Method of treatment: A method for treating disease X involving administering the compound.
- Preparation process: A process comprising steps such as chemical synthesis stages.
These claims aim to protect both the compound and its therapeutic application, maximizing scope.
3. Scope of Protection
- Chemical Scope: The claims likely specify a structural class, delineated by certain functional groups or substituents, which limits the scope but provides clarity.
- Therapeutic Scope: Use claims extend protection to the method of treating diseases associated with the compound, broadening the patent’s commercial relevance.
- Process and Formulation: Additional claims protect the method of synthesis and specific formulations, creating barriers to generic synthesis or alternative delivery methods.
Patent Landscape Context
1. Similar Patents in China and Globally
China’s pharmaceutical patent landscape is rapidly evolving, with an increasing emphasis on innovative drugs. The patent CN102458376 exists amidst overlapping patents:
- Chemical Family Patents: Similar compounds may be patented in China (e.g., CN patents by other companies or institutions) with overlapping structures.
- Use-Related Patents: Other Chinese patents claim therapeutic applications for related compound classes.
- Process Patents: Methods of synthesis or formulation techniques in the same therapeutic area might be patentably distinct or co-existing with CN102458376.
Globally, similar compounds are patented in jurisdictions such as the US (via the USPTO), Europe (EPO), or Japan, reflecting the strategic patenting by multinationals or local innovators.
2. Patentability and Novelty Aspects
The key to CN102458376's strength lies in:
- Novel Compound Structure: If the chemical structure is significantly different from prior art, the patent claims are robust.
- Innovative Use or Formulation: Application-specific claims broaden protection scope.
- Synthesis or Delivery Advances: Claims dedicated to manufacturing methods or formulations can provide additional layers of protection.
Similar patents filed earlier or in other jurisdictions may challenge novelty but often are confined to different chemical subclasses or therapeutic uses, providing room for differentiation.
3. Potential Infringement and Competitor Landscape
Major Chinese pharmaceutical companies, such as Jiangsu Hengrui Medicine, Shanghai Pharmaceuticals, along with international pharma players, actively patent in these domains. The patent's scope informs the competitive horizon:
- Infringement Risks: Competitors developing similar compounds may need to design around claims.
- Freedom-to-Operate: A thorough patent landscape analysis reveals whether CN102458376 is encumbered by or overlaps with existing patents, affecting commercialization strategies.
4. Legal and Patent Vigilance Strategies
Due diligence mandates monitoring patent expirations, oppositions, or litigations involving CN102458376. The patent’s legal robustness hinges on diligent prosecution, claim clarity, and opposition history.
Implications for Stakeholders
- R&D Teams: The specific claims guide designing around the patent or further optimizing derivatives for improved efficacy or patentability.
- Legal Teams: Recognize the scope to defend or challenge the patent based on prior art.
- Commercialization: The patent can underpin licensing, partnerships, or exclusivity rights within China.
Conclusion
CN102458376 likely covers a novel chemical entity for therapeutic use, with claims spanning compounds, methods, and formulations. Its scope, rooted in specific structural features, provides strategic IP protection against direct competitors in China. However, the extensive patent landscape requires continuous monitoring to identify potential overlapping patents or freedom-to-operate issues.
For businesses, understanding the claim boundaries and landscape positioning enables informed decision-making on R&D direction, licensing potential, and patent enforcement strategies within China’s dynamic pharmaceutical IP environment.
Key Takeaways
- CN102458376’s claims focus on a specific chemical compound, its therapeutic application, and manufacturing method, offering broad protection within these domains.
- The patent landscape in China is highly active, with overlapping patents in chemical structures and therapeutic uses; thorough landscape analysis is pivotal.
- Patent strength depends on structural novelty, specific claims, and strategic filing, influencing licensing, infringement risks, and R&D directions.
- Monitoring related patents and legal developments in China ensures proactive IP management, essential amid China's expanding pharmaceutical innovation.
- Clear understanding of claim scope facilitates designing around patents or reinforcing patent positions, protecting market share.
FAQs
Q1: How does CN102458376 compare to similar international patents?
A1: It likely protects a structurally specific compound or its use in China, with differences in claim scope and scope-specific language, requiring a case-by-case comparison against international counterparts for global IP strategies.
Q2: Can the patent be challenged on grounds of prior art?
A2: Yes. Patent validity can be challenged if prior art predates the application and discloses similar compounds or uses, but this depends on a thorough patent validity search.
Q3: What are common strategies to circumvent such patents?
A3: Developing structurally modified derivatives outside the claim scope, identifying alternative therapeutic targets, or designing different formulation methods can avoid infringement.
Q4: Is patent CN102458376 enforceable for international companies?
A4: Enforceability is limited to China unless the patent is licensed or filed in other jurisdictions. Global patent protections require filing respective patents internationally.
Q5: How should companies leverage this patent’s scope?
A5: Companies can either seek licensing opportunities, develop different chemical entities to avoid infringement, or use it as a competitive benchmark for innovation.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN102458376.
[2] WIPO Patentscope. Patent landscape reports.
[3] Patent documentation and public patent filings related to pharmaceutical compounds in China.
