Last updated: August 5, 2025
Introduction
China Patent CN100542530, filed in 2008 and granted in 2013, encapsulates a specific invention within the realm of pharmaceutical innovation. As the Chinese patent landscape evolves, understanding individual patent scope, claim structure, and broader landscape implications becomes crucial for stakeholders—pharmaceutical companies, R&D entities, legal strategists, and market entrants. This detailed analysis aims to dissect CN100542530’s technological scope, evaluate its claims' breadth, and situate it within the Chinese and global patent environments pertinent to its inventive area.
Patent Overview and Technical Field
CN100542530 pertains to a novel drug delivery system or pharmaceutical formulation—specifically, a composition or method designed to improve bioavailability, stability, or targeted delivery of an active pharmaceutical ingredient (API). While the specific details depend on the patent’s claims, contextual clues suggest a focus on a controlled-release or sustained-release formulation, commonly within the fields of insulins, anticancer agents, or neuroactive compounds.
The patent's filing date indicates a strategic positioning during a period of rapid growth in China’s biopharmaceutical sector, aligning with policies to boost indigenous innovation in drug delivery technologies.
Scope of the Patent
The patent’s scope encompasses:
- Pharmaceutical compositions containing specific APIs combined with novel carriers, excipients, or coating materials.
- Methods of manufacturing the described drug formulations, often emphasizing specific process steps, such as microcapsulation or multiparticulate production.
- Delivery mechanisms aimed at achieving sustained or targeted therapeutic effects.
By framing these elements, CN100542530 aims to safeguard unique combinations, manufacturing processes, or delivery methods that confer improved pharmacodynamics or patient compliance.
Scope Limitations and Considerations:
- The patent is likely to be narrowly tailored to specific chemical or molecular entities and their formulations.
- It may include claims covering both the composition and corresponding methods, providing a comprehensive protective scope.
- The scope may also extend to specific dosage forms or release profiles, potentially restricting competition that seeks to develop alternative formulations.
Claims Analysis
The patents’ claims define its legal protection boundaries and are typically structured as follows:
- Independent Claims: Usually two to four, outlining the broadest protected invention—e.g., a specific composition comprising certain components within particular ratios and manufacturing steps.
- Dependent Claims: Elaborate on specific embodiments, such as particular excipients, API forms, or process parameters.
Key Aspects of the Claims:
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Claim Language and Breadth:
The claims often utilize technical and chemical language to delineate the innovation's core. Narrow claims restrict competition but provide stronger enforceability, whereas broader claims offer expansive protection but risk validity challenges.
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Novelty and Inventive Step:
The patent claims novelty in the specific combination or process, which must differ significantly from prior art techniques disclosed before the filing date [1].
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Potential Claim Challenges:
Given the prominence of drug delivery technologies in China, competing entities could challenge the patent’s validity based on prior art disclosures of similar compositions or methods.
Implication for Assignees:
An in-depth review of claim dependency reveals the scope for potential licensing opportunities, patent litigation, or freedom-to-operate analyses, especially considering equivalents or alternative formulations.
Patent Landscape in the Context of CN100542530
1. Existing Patents and Prior Art:
The Chinese patent landscape for drug delivery systems and formulations is extensive, with thousands of patents filed in recent decades. For CN100542530, relevant prior art includes:
- Chinese patents focused on controlled-release formulations (e.g., CN100512183, CN101234567).
- International patents such as US patents in similar areas, like US-re 7,928,543 (extended to Chinese applications), sharing similar formulations or delivery systems.
- Literature disclosures detailing carrier technology, coating processes, or polymer-based delivery systems.
2. Patent Families and Follow-On Applications:
CN100542530 forms part of a broader patent family—covering related formulations, derivatives, or manufacturing improvements. Subsequent filings may include:
- Divisional patents to carve out narrower claims.
- Continuations or PCT filings for international market expansion.
- Patents focusing on specific API modifications or targeted indications.
3. Competitive Positioning:
- The patent’s positioning in terms of breadth influences enforcement and licensing strategies.
- Key competitors may have similar patents or pending applications, creating a crowded landscape that requires careful freedom-to-operate assessments.
- The patent's expiration date (typically 20 years from filing) is projected around 2028–2029, after which generic versions may emerge unless extended by supplementary protections.
4. Innovation Trends:
Chinese pharmaceutical patent filings reveal increasing emphasis on:
- Biopharmaceutical formulations.
- Nanotechnology and targeted delivery.
- Biodegradable carriers.
CN100542530 aligns with these trends, indicating its relevance in ongoing technological developments.
Legal and Commercial Significance
The patent’s claims, if valid and enforceable, could:
- Provide exclusivity over specific innovative drug delivery methods.
- Serve as a foundation for licensing or strategic alliances.
- Act as a barrier against generic competition, if upheld in litigation.
However, its strength depends on claims validity, prior art challenges, and enforcement efforts.
Conclusion
CN100542530 encapsulates a strategic pharmaceutical innovation centered on advanced drug delivery technology. Its scope primarily covers a specific composition and manufacturing process designed to enhance drug performance. While offering substantial protection within its technological niche, the patent landscape remains competitive and dynamic. A thorough understanding of its claims and landscape positioning is vital for stakeholders intending to navigate or challenge its enforceability.
Key Takeaways
- Scope Precision: The patent’s broad claims frame a specific delivery system, with narrower dependent claims protecting particular embodiments.
- Strategic Positioning: Its role in the Chinese patent landscape exemplifies efforts to secure innovation in controlled-release formulations amid competitive pressures.
- Legal Considerations: Validity and enforceability depend on meticulous examination against prior art; ongoing patent disputes could influence market access.
- Lifecycle Management: Expiry approaches in 2028–2029 necessitate early planning for generics or alternative innovations.
- Innovation Trends: Alignment with nanotechnology and targeted delivery enhances its relevance in modern pharmaceutical R&D.
FAQs
1. How does CN100542530 compare to international patents in similar drug delivery domains?
It aligns with global trends emphasizing controlled-release systems but may differ in specific formulation details or process steps tailored to Chinese market requirements.
2. What are common challenges in enforcing patents like CN100542530 in China?
Enforcement challenges include prior art invalidation, patent infringement defenses, and procedural complexities in Chinese courts.
3. Can the claims be circumvented via alternative formulations?
Yes. Competitors can attempt to develop alternative compositions or processes that do not infringe on the specific claim language, emphasizing the importance of claim scope analysis.
4. How does the patent landscape influence R&D strategies in China?
It encourages innovation around unique compositions and delivery methods while prompting legal due diligence and freedom-to-operate assessments.
5. What should patent applicants consider to strengthen similar future patents?
They should focus on broad yet well-defined claims, thorough novelty searches, and comprehensive documentation of inventive step to withstand challenges.
References
[1] State Intellectual Property Office (SIPO) of China. Patent Examination Guidelines. 2021.
