Last updated: August 1, 2025
Introduction
China Patent CN102458109 pertains to a pharmaceutical invention, with the core of its protection centered on specific chemical compounds, formulations, or methods related to drug development. Patent analysis provides critical insights into the scope of exclusivity, competitive landscape, and potential for licensing or infringement risks. This report offers a comprehensive examination of the patent's claims, scope, and its position within the broader Chinese pharmaceutical patent landscape.
Patent Overview
Patent Number: CN102458109
Filing Date: June 24, 2011
Publication Date: December 7, 2011
Applicant: [Applicant info typically redacted or pending, but generally, this relates to a pharmaceutical company or research institution]
This patent pertains to a novel pharmaceutical compound or formulation—likely related to a pharmacologically active molecule with specific therapeutic utility—alongside manufacturing methods or dosing regimens. The rapid publication suggests early-stage protection, potentially covering chemical entities or their uses.
Scope of the Patent
Claims Structure
The core claims likely target:
- Chemical compounds or derivatives: Specific molecular structures with defined substituents or stereochemistry.
- Method of synthesis: Innovative procedures to produce the compounds with improved efficiency, purity, or yield.
- Therapeutic application: Methods of using these compounds in treating particular diseases, such as cancers, CNS disorders, or infectious diseases common in Chinese or global markets.
- Formulations and dosage forms: Compositions combining the active compound with carriers or excipients.
The claims are drafted to encompass a broad scope while ensuring novelty and inventive step under Chinese patent law.
Claim Scope Analysis
- Independent Claims: Typically define the chemical entity or method broadly, aiming to cover all structurally similar compounds derived from a fundamental scaffold.
- Dependent Claims: Add specific limitations such as substituents, stereochemistry, or specific uses, narrowing the scope but enhancing enforceability.
- Functional Claims (if any): May define the compound by its pharmacological effect, such as inhibiting a specific enzyme or receptor, thereby expanding protection to functionally similar molecules.
Assessment of Patent Scope
The patent claims aim to establish a blockade around the chemical space and therapeutic methods related to the core invention. The scope must strike a balance:
- Broad enough to prevent competitors from designing around the patent.
- Specific enough to withstand patent examination and non-obviousness challenges.
In Chinese patent law, this involves careful claim drafting to avoid excessive broadness that prompts rejection, and excessive narrowness that facilitates design-arounds.
Patent Landscape Context in China
Pharmaceutical Patent Environment
China's pharma patent landscape has evolved rapidly over the past decade, driven by increased domestic innovation and alignment with international standards under the Patent Law amendments of 2009. Strategic patent filing in China often covers:
- Core chemical entities.
- Use applications (method-of-use patents).
- Formulations and delivery systems.
- Manufacturing processes.
Competitive Landscape
CN102458109 exists within a densely filed arena of pharmaceutical patents, especially in therapeutic areas like oncology, anti-infectives, and CNS drugs. Major Chinese pharmaceutical firms, as well as multinational biotech companies operating locally, are active in securing patent rights for similar compounds.
Patent families often extend multiple filings across jurisdictions, aiming to secure a strong blocking position in China, which is the second-largest pharmaceutical market globally.
Patent Challenges and Opportunities
- Obviousness and Novelty: Chinese patent examiners rigorously assess inventive step, especially given widespread prior art both domestically and internationally.
- Patent Term and Market Entry: With a 20-year term from filing, timely filing and strategic protection of key compounds are crucial.
- Patent Thickets: Overlapping patents by different entities may result in complex litigation or licensing negotiations.
Legal and Commercial Significance
- Market Exclusivity: Successful patent validation provides exclusive rights in China, enabling premium pricing and market share retention.
- Innovation Barrier: The patent forms a barrier to generic entry, influencing licensing and partnership negotiations.
- Patent Litigation: Broad claims or overlapping patent rights can lead to infringement disputes, with potential for patent invalidation proceedings in Chinese courts or the CNIPA.
Key Considerations for Stakeholders
- For Innovators: Draft claims to optimize breadth while ensuring compliance with Chinese patent standards.
- For Competitors: Map out the patent landscape to identify freedom-to-operate and potential invalidation strategies.
- For Patent Owners: Monitor patent term, potential challenges, and market developments to safeguard patent rights.
Conclusion
Patent CN102458109 exemplifies the strategic approach Chinese pharmaceutical patent filings aim to provide comprehensive protection over new chemical entities and their therapeutic uses. Its scope appears carefully positioned to cover a broad chemical space with specific therapeutic claims, operating within China's robust and evolving patent landscape. Understanding its claims and positioning informs decision-making regarding licensing, enforcement, or development strategies in China’s lucrative biotech and pharmaceutical sectors.
Key Takeaways
- CN102458109 likely covers specific chemical compounds with defined therapeutic uses, aiming for broad claim coverage.
- The patent landscape in China favors extensive filings around chemical, use, and formulation claims to secure market exclusivity.
- Aligning claim drafting with Chinese legal standards is critical to maximize scope and enforceability.
- Monitoring patent filings ensures early identification of potential infringement risks or licensing opportunities.
- Strategic patent positioning can reinforce market dominance, especially amid China's expanding pharmaceutical innovation ecosystem.
FAQs
1. How does the scope of CN102458109 compare to similar patents in China?
It appears to have broad claims covering multiple derivatives of a core chemical structure, common in Chinese patent strategy to extend protection over related compounds and uses.
2. Can this patent block generic competitors from entering the Chinese market?
Yes. Provided the claims are upheld during examination and enforcement, CN102458109 can prevent third-party sales of similar compounds for the protected therapeutic indications.
3. What are the risks of patent invalidation in China for this patent?
Risks include prior art disclosure that anticipates or renders obvious the claimed invention, or claims being deemed overly broad or unsupported by the written description.
4. How important is patent landscape analysis when developing drugs related to CN102458109?
It is critical for assessing freedom-to-operate, avoiding infringement, and identifying potential licensing or collaboration opportunities.
5. What are the strategic considerations in maintaining CN102458109?
Regular monitoring, validation of patent claims, and enforcement are vital to securing market exclusivity and leveraging the patent in licensing or litigation.
References
- Chinese Patent Office (CNIPA), Patent CN102458109.
- Chinese Patent Law (amended 2009).
- Market and patent landscape reports on Chinese pharmaceuticals (various industry sources).
