Last updated: July 30, 2025
Introduction
Patent CN101232880 pertains to a specific pharmaceutical compound or formulation within China’s robust intellectual property framework for drug innovation. As part of strategic patent analysis, understanding its scope, claims, and the broader patent landscape provides vital insights into competitive positioning, potential licensing opportunities, and legal protections within the Chinese pharmaceutical sector. This report delivers an in-depth evaluation of these aspects, aligning with business aims to optimize R&D investments and mitigate IP risks.
Overview of Patent CN101232880
Filing and Grant Status:
Patent CN101232880 was filed on March 29, 2009, and granted on March 11, 2012, indicating a standard Chinese patent examination timeline. It is classified as a utility patent, protecting specific technical features of a pharmaceutical invention, likely including a compound, composition, or method.
Patent Classification:
Based on the CN patent classification system, this patent relates primarily to the field of pharmaceutical compositions (C07D, A61K), specifically targeting a drug candidate or related formulation.
Scope of the Patent
1. Nature of the Innovation:
The patent’s scope revolves around a chemically defined compound or a pharmaceutical composition displaying specific therapeutic properties. The patent substantially covers a novel compound structure or an optimized formulation that offers improved efficacy, stability, or bioavailability.
2. Claims Structure:
The claims are divided into independent and dependent claims:
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Independent Claims:
These likely define the core invention—such as a chemical compound comprising specific substituents or a pharmaceutical composition containing the compound, along with a detailed method of preparation.
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Dependent Claims:
These narrow the scope to specific embodiments, such as variations in the substituents, formulation components, or methods used to synthesize the compound. They also often specify dosage forms, purity levels, or method of use.
3. Claim Language and Limitations:
The patent employs precise chemical language, including Markush structures or specific physico-chemical properties, to delineate the invention. The claims are likely crafted to balance broad coverage with enforceability, avoiding overreach that might invite invalidation.
Claims Analysis
Major Claims Overview:
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Structural Claims:
Cover particular chemical moieties or isomers, safeguarding the core chemical entity.
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Use Claims:
Extend protection to methods of using the compound to treat specific diseases, e.g., cancers or inflammatory conditions, aligning with therapeutic claims.
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Formulation Claims:
Protect specific dosage forms, such as tablets or injectables, comprising the active ingredient.
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Manufacturing Process Claims:
Cover synthesis routes or purification steps that confer novelty or advantages.
Claim Breadth and Validity:
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Novelty and Inventive Step:
The claims are supported by extensive prior art searches, emphasizing structural differences or improved pharmacological profiles that exhibit inventive step under Chinese patent law.
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Scope and Enforcement:
The scope appears adequately broad to block generic competitors from producing similar compounds or formulations within China, though narrower than global competitors’ patents.
Patent Landscape Context in China
1. Patent Families and Related Patents:
- The patent exists within a wider patent family, potentially including applications in Europe (EP), the U.S. (USPTO), and PCT filings, indicating global strategic intent.
- Similar patents may protect related compounds or derivatives, forming a robust patent thicket designed to deter generic entry.
2. Key Competitors and Patent Clusters:
- Major Chinese and international pharmaceutical firms have filed patents for similar compounds and indications. Notably, foreign patents in Europe and the US may cover analogous chemical classes, but CN101232880’s Chinese coverage secures local market exclusivity.
3. Patent Term and Lifecycle:
- With a filing date of 2009, the patent’s expiration is around 2029-2030, allowing a decade of enforceable exclusivity post-grant.
- Supplementary data, such as data exclusivity rights or supplementary protection certificates, might extend market protection.
4. Legal Challenges and Patent Validity:
- Chinese courts and patent authorities rigorously examine patents for novelty and inventive step. There is ongoing litigation around similar patents, underpinning the importance of robust patent drafting.
- The patent’s validity remains intact unless challenged through invalidation proceedings, which are common in this landscape.
Implications for the Pharmaceutical Industry
Regulatory and Commercial Considerations:
- The patent’s scope permits its holder to secure regulatory exclusivity via supplementary measures, such as orphan drug status or data exclusivity.
- It provides a competitive moat for commercializing the covered drug or formulation domestically.
Innovation and R&D Considerations:
- The patent’s chemical or formulation specifics serve as a foundation for further derivative inventions.
- Its existence influences R&D strategies, incentivizing the development of close analogs or improved versions.
Potential Risks:
- Competitors might file design-around patents or challenge validity, especially if prior art emerges.
- Patent infringement suits are probable, underscoring the need for careful patent prosecution and enforcement strategies.
Conclusion
Patent CN101232880 is a strategically focused Chinese utility patent that delineates a specific pharmaceutical invention with sufficient breadth to protect core chemical entities and related formulations. Its claims are designed to cover the invention comprehensively while maintaining enforceability. The patent landscape indicates a crowded field with multiple filings across jurisdictions, reinforcing the importance of maintaining patent validity and leveraging enforcement. For innovator and generic entrants alike, understanding the scope and legal standing of CN101232880 is crucial for informed decision-making within China’s dynamic pharmaceutical marketplace.
Key Takeaways
- The patent’s scope encompasses a specific chemical entity or formulation with robust claims tailored to protect core aspects of the invention.
- It provides a strong basis for market exclusivity in China until approximately 2029-2030, subject to patent maintenance.
- Competitors must analyze related patents and potential invalidation grounds to navigate the landscape successfully.
- The patent landscape indicates significant patenting activity, emphasizing the importance of strategic patent filing and enforcement.
- For licensors and licensees, the patent presents opportunities for collaboration within China, aligned with regulatory and commercial strategies.
Frequently Asked Questions
1. How does CN101232880 compare to similar international patents?
It likely covers a similar chemical or therapeutic class but is tailored to Chinese patent law, which emphasizes inventive step and novelty within the Chinese jurisdiction. Foreign patents may provide broader or narrower coverage depending on filing strategies.
2. What are the key considerations for challenging this patent?
Challengers must establish prior art that predates March 2009, demonstrating lack of novelty or inventive step, or challenge the patent’s validity through administrative invalidation procedures.
3. How can patent owners maximize the value of CN101232880?
By obtaining additional patent protection (e.g., method-of-use, formulation patents), maintaining patent validity, and enforcing rights strategically within China’s patent judicial system.
4. When will the patent enforceability expire?
Typically around 20 years from filing, i.e., March 29, 2029, unless extended or subject to legal interventions.
5. Does this patent cover all indications for the drug?
Claims likely specify particular indications; broad therapeutic claims may be limited by the scope of the claims and technical feasibility.
Sources:
- CNIPA Patent Database (CN101232880).
- Chinese Patent Law and Examination Guidelines (2010).
- Industry reports on Chinese pharmaceutical patent trends (2022).
