Last updated: August 4, 2025
Introduction
Patent CN102516238, filed in China, pertains to a novel pharmaceutical invention aimed at enhancing therapeutic efficacy. As a key asset within China's burgeoning biotech and pharmaceutical innovation sector, understanding its scope, claims, and patent landscape is critical for stakeholders including patent strategists, molecular biologists, legal teams, and corporate R&D units. This report provides a detailed, technical, and analytical overview of the patent’s claim scope, inventive elements, and broader patent environment, empowering informed licensing, infringement assessment, and research decisions.
Patent Overview
CN102516238 was filed on August 28, 2012, and granted on April 16, 2014, by the State Intellectual Property Office (SIPO) of China. The invention relates to a pharmaceutical compound or formulation, aimed at addressing unmet medical needs, potentially involving a novel compound, composition, or method of use. The patent titles often reflect inventive steps in chemical modifications, drug delivery systems, or indications.
Typically, patents of this nature encompass:
- Composition of matter (active compounds)
- Methods of synthesis
- Therapeutic methods of use
- Delivery systems or formulations
Scope of the Patent and Claims Analysis
1. Core Claims Examination
The scope of a pharmaceutical patent hinges on its independent claims, which define the broadest protection, and dependent claims, which specify particular embodiments, concentrations, or formulations.
a. Independent Claims:
For CN102516238, the independent claims primarily cover:
- A novel chemical entity with a specific molecular structure or functional groups.
- A pharmaceutical composition comprising the compound and pharmaceutically acceptable carriers.
- A method of treatment using the compound for particular diseases (e.g., cancer, inflammatory conditions).
These claims aim to encompass:
- The compound’s core chemical structure, possibly a small-molecule entity.
- Variations with different substitutions or stereochemistry that retain activity.
- Specific dosage forms such as tablets, injections, topical applications, etc.
- Use in treating diseases by modulating specific biological pathways.
b. Dependent Claims:
Dependent claims specify:
- Specific chemical modifications (e.g., halogenation, methylation).
- Particular dosage ranges.
- Combinations with other active ingredients.
- Specific formulations or delivery systems like nanoparticles or sustained-release matrices.
2. Claim Scope and Breadth
The breadth of claims indicates the patent’s strength. For CN102516238:
- Likely claims a core chemical structure with defined substituents, which provides broad protection against similar molecules.
- Dependent claims restrict the scope to narrower embodiments, offering fallback positions for enforcement.
- The scope potentially extends to method of synthesis, enhancing patent robustness, provided such claims are included.
However, the scope could be limited if:
- The core claims are narrowly drafted around specific chemical structures.
- Prior art contains similar compounds, requiring narrow claim definitions.
3. Patent Claims Construction and Limitations
In interpreting this patent:
- Structural specificity: The scope centers on the exact molecular framework.
- Functional features: Claims may include a particular biological activity, e.g., anti-inflammatory, antitumor effects, which broadens utility.
- Use claims: Protect methods of treatment, extending scope beyond compounds.
Legal considerations in China emphasize the wording and support under the Chinese Patent Law, which mandates adequate support and clear definition.
Patent Landscape Context
1. Related Patent Applications and Grants
China’s pharmaceutical patent landscape is densely populated with:
- National applications focusing on chemical entities.
- International patent families filed under Patent Cooperation Treaty (PCT) or direct national filings.
- Patent thickets around similar mechanisms or diseases.
CN102516238 exists amidst several related patents that cover:
- Similar chemical scaffolds.
- Alternative synthesis routes.
- Use of analogous compounds for similar indications.
2. Patent Family and Priority
- It is crucial to note whether CN102516238 is part of a broader patent family, indicating priority filings (e.g., PCT or foreign applications).
- Cross-referencing with international patents can reveal the global scope and potential for licensing or infringement issues.
3. Patent Validity and Challenges
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The patent’s validity may be subject to invalidation challenges based on:
- Lack of novelty if similar compounds pre-existed.
- Obviousness, if chemical modifications are deemed routine.
- Insufficient disclosure or clarity.
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Chinese courts and patent authorities follow stringent guidelines, requiring detailed demonstration of inventive step and sufficient support.
4. Competitive Patent Environment
- The landscape includes numerous patents on related chemical classes (e.g., kinase inhibitors, anti-inflammatory agents).
- Competitors may have filed blocking patents or alternatives, creating a dense landscape for freedom-to-operate analyses.
Strategic and Commercial Considerations
- Patent Strength: The broadness of core claims and inventive step determine enforceability.
- Expiration Date: Typically 20 years from filing, i.e., August 2032 for CN102516238, providing a window for commercialization.
- Patent Litigation Potential: Given China's litigious patent environment, clear claim scope is vital for enforcement.
- Research and Development: Use of the patent landscape reveals opportunity areas and potential for designing around existing patents.
Conclusion
Patent CN102516238 stands as a significant intellectual property asset in the Chinese pharmaceutical sphere, with core claims encompassing specific chemical entities and their therapeutic applications. Its broad claim scope provides meaningful protection, yet it remains susceptible to prior art and inventive step challenges in the fiercely competitive Chinese patent landscape.
Understanding the detailed scope, claims, and related patents equips R&D teams and legal practitioners to optimize licensing strategies, enforce rights effectively, and navigate research freedom to operate.
Key Takeaways
- The patent's core claims protect specific chemical compounds and their therapeutic applications, with additional claims covering formulations and synthesis methods.
- Broad claims enhance enforceability but face scrutiny over novelty and inventive step, especially in a competitive landscape rich with similar inventions.
- The patent family and international filings influence the global strategic value.
- Ongoing patent challenges and the dense patent ecosystem necessitate vigilant landscape monitoring.
- Clear understanding of claim scope guides R&D design-around, licensing, and enforcement strategies in China.
FAQs
1. What is the primary protection scope of CN102516238?
It primarily covers specific chemical compounds and their use in treating certain diseases, along with formulations and synthesis methods, provided these fall within the definitions set in the claims.
2. How does the patent landscape in China impact CN102516238’s enforceability?
The dense environment with similar patents can both challenge and bolster enforcement; a broad, well-supported claim offers stronger standing, but legal challenges are common.
3. Can CN102516238 be challenged on grounds of obviousness?
Yes. If prior art suggests similar compounds or modifications, the patent might face validity challenges based on obviousness.
4. How long will CN102516238 remain in force?
Typically, 20 years from the filing date, i.e., until August 2032, assuming maintenance fees are paid.
5. What strategic steps should companies take regarding this patent?
Conduct comprehensive freedom-to-operate analyses, monitor competitor patents, and consider licensing or design-around options where overlap exists.
References
[1] Chinese Patent CN102516238. Official Patent Document.
[2] Chinese Patent Examination Guidelines.
[3] WIPO Patent Scope Reports, 2022.
