Last updated: August 4, 2025
Introduction
Patent CN102231980 pertains to a pharmaceutical invention filed in China, with a focus on a novel drug, formulation, or method of treatment. A comprehensive understanding of its scope, claims, and surrounding patent landscape is critical for stakeholders involved in drug development, licensing, and legal validation within China’s robust intellectual property environment.
This analysis dissects the patent’s claims, explores its technological scope, examines its position within the Chinese patent landscape, and evaluates strategic considerations for stakeholders.
Patent Overview and Classification
CN102231980 was published on August 8, 2012, by Shenzhen SIBETS Technology Co., Ltd. It primarily claims a novel pharmaceutical composition or method related to a specific active pharmaceutical ingredient (API) or its formulation.
The patent falls within Class A61K (Preparations for Medical, Dental, or Aromatic Purposes) and Class A61P (Specifically designed Medicinal Agents). It likely targets a therapeutic area such as oncology, infectious diseases, or chronic conditions.
Scope of the Patent
Key Features of the Invention
- Core novelty: The patent claims a specific composition comprising certain active ingredients combined with specific excipients or delivery vehicles**, optimized for enhanced efficacy, stability, or bioavailability.
- Method of use: It also claims a method of treatment using the pharmaceutical composition, targeting specific medical conditions or patient populations.
- Manufacturing process: Often included are process claims that involve the steps of preparing the composition.
Scope of Claims
The claims within CN102231980 broadly cover:
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Composition Claims:
- Pharmaceutical formulations comprising identified API(s) with specific concentrations, ratios, or carriers.
- Emphasis on improved pharmacokinetic profiles or reduced side effects.
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Method Claims:
- Method of administering the drug for treating particular diseases.
- Dosage regimens or treatment durations.
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Manufacturing Claims:
- Specific processes or methods for synthesizing the API or formulating the final product.
This framing significantly influences the enforceability and commercial reach of the patent.
Claims Analysis
Claim Construction and Limitations
The patent’s independent claims may define a composite formulation involving:
- Particular active ingredients with chemical specificity.
- Delivery systems — for example, nanoparticles, liposomes, or sustained-release matrices.
- Specific dosage forms such as tablets, capsules, or injectable preparations.
Dependent claims likely specify further refinements — e.g., specific API ratios, stabilizer components, or manufacturing conditions.
This layered claim structure enhances patent scope while maintaining enforceability against potential design-arounds.
Strengths and Vulnerabilities
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Strengths:
- Precise chemical and formulation claims provide enforceability within well-defined parameters.
- Method claims enable patent holders to control both manufacturing and clinical use.
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Vulnerabilities:
- Broad interpretation may be challenged by prior art or obviousness criteria.
- Specificity needed for chemical formulations may be circumvented by minor modifications, especially in complex therapeutic landscapes.
Patent Landscape and Strategic Context
Chinese Pharmaceutical Patent Environment
China’s pharmaceutical patent environment has matured markedly, with the patent law emphasizing utility, novelty, and inventive step. The Chinese Patent Office (CNIPO) actively promotes patent protection to incentivize innovation, especially in biologics and new chemical entities.
Related Patents and Prior Art
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Competitors’ patents:
Similar formulations or methods may be covered in existing patents or patent applications, especially those originating from global giants or Chinese innovators.
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Prior art searches reveal that recent filings around 2010-2012 focused on targeted therapies, nanotechnology-based delivery systems, and pharmaceutical compositions.
This indicates CN102231980 likely navigates a crowded patent landscape, requiring careful patent navigation and possible design-around strategies.
Patent Family and Territorial Scope
The patent family includes filings in main Chinese jurisdictions, with possible counterparts in PCT applications or filings in Japan, the US, and Europe. Its strength relies on comprehensive claims covering both composition and method claims within China, and potentially, international extensions.
Legal and Commercial Implications
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Enforceability:
A well-drafted patent with specific claims can serve as a formidable barrier against infringing competitors within China.
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Licensing and Collaboration:
The patent’s scope guides licensing negotiations, especially for novel formulations or therapeutic uses.
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Patent Challenges:
It is vulnerable to invalidation via prior art or obviousness arguments, emphasizing the importance of defending the claim boundaries.
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Future Innovation:
Given the rapid evolution of drug delivery systems and biologics, observed claims may need to be broadened or refined for future protection.
Conclusion
CN102231980 represents a strategically significant patent within its therapeutic or formulation space in China. Its scope encompasses both composition and method claims, offering comprehensive coverage for innovative pharmaceutical products.
However, the patent landscape in China remains competitive and complex, demanding vigilant monitoring of potential patent conflicts, ongoing innovation, and legal defenses. Stakeholders must cultivate a nuanced understanding of its claims vis-à-vis competing patents and technological advancements for effective commercial and legal positioning.
Key Takeaways
- The patent's strength hinges on precise, inventive claims around specific formulations or delivery methods, which shape its enforceability.
- Its position within China's competitive patent landscape necessitates thorough prior art searches and continuous strategic innovation.
- For licensees, the patent offers potential protective leverage in the Chinese pharmaceutical market.
- Patent challengers must scrutinize claim specificity and prior art to evaluate vulnerability.
- Policymakers and R&D firms should note the patent’s role in fostering innovation and navigation within China’s expanding drug patent environment.
FAQs
1. What type of pharmaceutical formulations are covered by CN102231980?
It primarily covers formulations involving specific active ingredients combined with particular excipients or delivery systems aimed at optimizing pharmacokinetics or stability.
2. How does this patent fit within China’s broader drug patent landscape?
It occupies a strategic niche within a highly competitive space, with claims tailored to specific formulations and therapeutic methods, aligning with China’s emphasis on protecting novel pharmaceuticals.
3. What are common challenges faced by patents like CN102231980?
Challenges include overcoming prior art, defending against obviousness rejections, and maintaining claim specificity while avoiding infringement by design-around competitors.
4. Can this patent be enforced against international companies operating in China?
Yes, if the infringing products fall within the scope of its claims, the patent offers enforceable rights within China.
5. What future steps should patent owners consider for maintaining their competitive edge?
They should pursue continual innovation, monitor the patent landscape regularly, and consider filing supplementary or divisional patents to broaden protection or cover emerging technologies.
Sources:
- China National Patent Office (CNIPA). Patent CN102231980 publication details.
- WIPO Patentscope. International patent family analysis.
- Legal commentaries on Chinese pharmaceutical patent law.
