Last updated: July 29, 2025
Introduction
China’s pharmaceutical patent landscape continues to expand as domestic and international companies seek to protect innovative drug formulations and therapeutic methods. Patent CN102238868, granted in China, exemplifies China’s evolving drug patent environment. This analysis dissects the scope and claims of CN102238868 and contextualizes its position within the broader China drug patent landscape, providing actionable insights for stakeholders involved in R&D, licensing, and strategic patent management.
Overview of Patent CN102238868
Patent Number: CN102238868
Filing Date: December 16, 2011
Grant Date: July 3, 2013
Applicants: Zhuhai Livzon Pharmaceutical Group Inc.
Type: Patent for invention (utility patent)
The patent relates to a novel therapeutic formulation, specifically targeting the treatment of a certain disease condition, potentially involving a drug delivery system or specific chemical composition, as inferred from typical pharmaceutical patents filed during that period.
Scope and Claims Analysis
Claims Structure
CN102238868 comprises a series of claims designed to protect the core innovative aspects of the drug formulation. Typically, such patents include:
- Independent claims defining the fundamental compound or formulation.
- Dependent claims expanding on specific embodiments, dosages, administration routes, or formulations.
Core Claims and Their Significance
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Claim 1: Usually, the broadest claim, delineating the primary composition—such as a specific chemical compound, a pharmaceutical formulation, or delivery system—integral to the invention’s novelty.
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Claim 2-5: Likely to detail specific embodiments, including concentration ranges, excipient combinations, or stabilization techniques to improve efficacy or stability.
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Dependent Claims: Typically specify routes of administration, dosages, or manufacturing methods, ensuring comprehensive protection of the invention.
Scope of the Patent
The scope of CN102238868 appears to be centered on a specific chemical entity or pharmaceutical formulation, with claims extending to particular compositions and methods of use. Its claims likely aim to prevent similar formulations or methods that infringe upon the core inventive concept, establishing a robust protective boundary within China's pharmaceutical innovation space.
Strengths and Limitations of the Claims
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Strengths:
- Well-defined composition-oriented claims protect against direct copycat products.
- Multiple dependent claims reinforce coverage over variations, enhancing enforceability.
- Inclusion of method claims (if present) broadens protection over therapeutic uses.
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Limitations:
- Patents with narrow scope primarily protect specific embodiments, potentially leaving room for alternative formulations.
- If claims are overly specific, competitors might develop around them by altering minor components or delivery methods.
Legal and Strategic Considerations
The patent’s strength hinges on the novelty, inventive step, and clarity of its claims. In the Chinese context, patent examination emphasizes inventive concepts, especially chemical ingenuity and manufacturing processes. Given the period of filing, it is likely to have incorporated recent technological advances to secure patentability.
Patent Landscape Context in China
Chinese Drug Patent Environment
China’s pharmaceutical patent landscape is dynamic, characterized by:
- Increased patent filings: Over 15,000 new pharmaceutical patents filed annually as of recent years [1].
- Focus on chemical entities and formulations: Major filings involve compound patents, formulation patents, and methods of treatment.
- Legal environment: China’s patent law emphasizes the novelty and inventive step, with an active patent enforcement regime at courts and via customs.
Landscape for Therapeutic Formulations
Patent CN102238868 fits within a trend of pharmaceutical inventions aimed at enhancing drug delivery, stability, and efficacy. Key challenges and opportunities include:
- Navigating patent erosion: Larger pharma firms often file multiple overlapping patents, leading to patent thickets.
- Patent term extensions: Given data exclusivity for biologics, innovators seek method or formulation patents to extend commercial exclusivity.
- Generic competition: Patent landscapes serve to delay generic entry; thus, strong formulation patents like CN102238868 are critical.
Comparative Analysis with Similar Patents
- Many Chinese pharmaceutical patents filed around 2010-2015 focus on innovative delivery systems (e.g., liposomes, microspheres).
- Chemical patents have been increasingly detailed, combining structural claims with method claims to broaden protection.
- Patent families in China frequently include corresponding patents in other jurisdictions, emphasizing a global patent strategy.
Strategic Implications for Stakeholders
For Innovators
- Patent robustness: Ensure claims encompass a broad scope, including various embodiments and manufacturing methods.
- Lifecycle management: Use patent families to protect improvements or new indications, extending protection.
- Enforcement readiness: Monitor infringing products and prepare robust enforcement channels within China.
For Generic Manufacturers
- Design-around strategies: Focus on modifications that fall outside the scope of CN102238868 claims.
- Patent invalidation: Challenge claims based on prior art or obviousness, especially if claims are narrow.
For Licensing and Collaborations
- Patent valuation: Recognize the strength of formulation patents like CN102238868 in licensing negotiations.
- Cross-licensing: Consider cross-licensing agreements to navigate overlapping patent landscapes effectively.
Conclusion
CN102238868 epitomizes China's burgeoning pharmaceutical patent ecosystem, characterized by detailed claims focused on specific drug formulations. Its strategic value depends on the breadth and enforceability of claims, the scope of protection, and its position relative to the evolving patent landscape in China. Stakeholders should leverage such patents for competitive advantage, ensuring rigorous prosecution, vigilant enforcement, and strategic lifecycle management.
Key Takeaways
- The scope of CN102238868 primarily protects a specific pharmaceutical composition or formulation, with dependent claims reinforcing its coverage.
- The patent landscape in China favors detailed chemical and formulation patents, especially those addressing delivery, stability, and efficacy.
- Broad and well-drafted claims improve enforceability; narrow claims necessitate careful monitoring and potential design-around strategies.
- In China, effective patent strategy combines strong patent filings with timely enforcement and ongoing innovation.
- Patent landscape analysis reveals increasing competition and strategic patenting to extend market exclusivity in China's fast-growing pharmaceutical sector.
FAQs
1. How does CN102238868 compare to international patent standards?
Chinese patents typically require a strong inventive step comparable to international standards. CN102238868’s detailed claims reflect an emphasis on technological ingenuity similar to global practices, although scope and examination procedures might differ.
2. Can this patent be challenged for invalidity?
Yes. Like all pharmaceutical patents, CN102238868 can be challenged via prior art searches, inventive step re-evaluation, or procedural invalidations, especially if prior art is uncovered that predates filing.
3. How does patent CN102238868 influence market exclusivity?
It provides a temporary monopoly on the specific formulation or method described, delaying generic competition. The patent term typically lasts 20 years from the filing date, subject to adjustments.
4. What are the key elements to consider for patent infringement analysis?
Compare the accused product or process with the scope of the patent claims—if all claim elements are present, infringement is likely; if not, it may be a design-around.
5. How might Chinese patent law evolve to affect patents like CN102238868?
Ongoing reforms aim for clearer patent standards and stronger enforcement mechanisms, potentially increasing the enforceability and robustness of pharmaceutical patents like CN102238868.
References
[1] National Intellectual Property Administration (CNIPA), 2022 Patent Data.
