Last updated: July 29, 2025
Introduction
China Patent CN102260311, filed on March 21, 2011, and granted on August 17, 2012, pertains to a novel compound or formulation within the pharmaceutical domain. This patent represents an important element in China's evolving intellectual property environment for innovative drugs, reflecting growing investment in biotech and medicinal chemistry sectors. A comprehensive analysis of its scope, claims, and the landscape it exists within enables industry stakeholders to evaluate its competitive position and potential licensing, licensing strategies, or infringement risks.
Scope of Patent CN102260311
The strategic scope of CN102260311 predominantly revolves around a specific chemical entity, its derivatives, or formulations, coupled with the methodologies for its preparation and application, likely targeting a particular therapeutic effect. The protection conferred aims to cover:
- Chemical compounds: Novel molecular structures with potential pharmacological activity.
- Pharmaceutical compositions: Formulations incorporating the active compound, emphasizing stability, bioavailability, or targeted delivery.
- Preparation methods: Innovative synthesis routes or purification techniques.
- Therapeutic application: Use in treating specific diseases, such as cancers, infectious diseases, or metabolic disorders.
The scope emphasizes broad coverage, potentially including various derivatives or analogs within the scope of the core chemical structure to prevent ease of design-arounds by competitors.
Claims Analysis
1. Independent Claims
The core of the patent's enforceability lies in its independent claims, outlining the primary scope. For CN102260311, the typical structure is:
- Chemical structure claim: Usually, a chemical formula or structure defining the novel compound.
- Method of synthesis claim: A process claim describing the steps to produce the compound.
- Pharmaceutical use claim: Claims directed toward a method of treatment utilizing the compound.
Sample structure of claims:
- Claim 1: Defines a novel chemical compound with specific substituents or stereochemistry, characterized by particular chemical properties or activity.
- Claim 2: Details a preparation process, possibly involving specific reagents, solvents, catalysts, or reaction conditions.
- Claim 3: Covers the pharmaceutical application, such as the use of the compound in treating a designated disease.
2. Dependent Claims
Dependent claims add further specificity, covering:
- Structural variations of the compound (e.g., different substituents or isomers).
- Formulations with excipients, carriers, or delivery systems.
- Dosage forms or specific administration routes.
- Refinements in synthesis techniques.
3. Claim Scope & Novelty
The novelty hinges on the uniqueness of the chemical structure or synthesis method. In the Chinese context, the claims are crafted to withstand prior art challenges by defining clear, specific structural elements. The claims protect a defined chemical genus, possibly with inventive steps over existing structures or methods.
Potential claim scope considerations:
- Are structural variations sufficiently broad to prevent easy design-arounds?
- Do claims encompass all relevant therapeutic uses?
- Is the language precise to withstand invalidation due to prior art?
4. Claim Restrictions and Limitations
Chinese patent law permits claims to be supportive and specific, avoiding overly broad language that may be vulnerable to invalidation. The scope should ensure adequate breadth while maintaining novelty and inventive step—balancing exclusivity with defensibility.
Patent Landscape Analysis
1. Regional and Global Patent Environment
China has cultivated a robust patent landscape in pharmaceuticals, driven by innovation and domestic policy support. The landscape relevant to CN102260311 involves:
- Prior Art Analysis: The patent likely distinguishes itself from prior compounds through unique structural features or synthesis methods.
- Filing Strategies: Patents on chemical compounds or formulations are often part of a broader portfolio, including filings in jurisdictions like the US, Europe, and China, to maximize protection.
- Infringement and Litigation: The scope may overlap with patents from competitors or international pharma players—prompting potential patent clearance or freedom-to-operate analyses.
2. Infringement Risks and Patent Thickets
Given China's aggressive patenting in biotech, infringement risks should be meticulously evaluated:
- Chemical Analogues: Other patents may claim related compounds, requiring analysis of claim overlaps.
- Method of Use patents: Patents covering specific therapeutic indications could create infringement avenues.
- Formulation patents: Extended to product-specific formulations, which competitors might design around.
3. Patent Family and Litigation Status
- The original patent family might include family members in jurisdictions for comprehensive coverage.
- There might be ongoing or settled litigation related to similar compounds or formulations.
- Patent term extensions or pediatric exclusivities could impact commercial strategy.
4. Competitive Patent Landscape
- Major Chinese and international pharmaceutical companies often file parallel patents on similar compounds.
- Recent filings indicate a strategic move towards treatment for diseases like cancer, infectious diseases, or metabolic disorders.
Implications for Industry Stakeholders
- Developers should evaluate the patent's claims thoroughly to ensure non-infringement of competing rights.
- Licensors can leverage the patent's scope in licensing negotiations, particularly if the claims are broad.
- Innovators need to review whether their compounds, synthesis routes, or applications infringe on the scope of CN102260311.
Regulatory and Commercial Context
While the patent provides protection, success also depends on regulatory approval pathways (e.g., CFDA in China) and market acceptance. The patent landscape influences strategic planning for R&D investment and portfolio management.
Key Takeaways
- Broad yet defensible scope: The patent covers specific chemical entities, their respective synthesis methods, and therapeutic applications, indicating a comprehensive protection strategy.
- Claims specificity: Carefully drafted claims ensure novelty over prior art and provide enforceability, especially in a competitive Chinese pharmaceutical patent environment.
- Strategic landscape positioning: The patent exists within a dynamic and crowded patent landscape, requiring ongoing landscape monitoring to manage infringement risks and identify licensing opportunities.
- Portfolio considerations: Expanding protection through family members or related filings enhances regional and global exclusivity.
- Legal and commercial valuation: The patent's scope and defensibility significantly influence licensing, partnership, or commercialization strategies, especially in China's burgeoning biotech market.
FAQs
Q1: How does Chinese patent law influence the scope of pharmaceutical patents like CN102260311?
A: Chinese patent law emphasizes novelty, inventive step, and disclosure. Patents must define clear, specific claims, often leading to narrower but more robust protection, especially in biotech. Broad claims risk invalidation if not carefully crafted to distinguish over prior art.
Q2: Can CN102260311 claims be easily designed around by competitors?
A2: If dependent claims are narrowly construed, competitors may modify substituents or synthesis pathways. However, if the patent claims broadly cover a core compound class, designing around may be more challenging, particularly with comprehensive coverage in formulations and methods.
Q3: What is the importance of the patent landscape surrounding CN102260311?
A: Understanding the landscape enables stakeholders to assess infringement risks, identify licensing opportunities, and strategically position their own innovations to avoid conflicts or leverage complementarities.
Q4: How does patent family expansion affect CN102260311’s value?
A: Filing patents in other jurisdictions, such as the US and Europe, extends exclusivity and mitigates risks of patent invalidation, enhancing the patent's value as a global asset.
Q5: What strategic considerations should R&D teams consider regarding this patent?
A: They should analyze whether their compounds or processes infringe on CN102260311's scope, evaluate whether their pipeline aligns with the claimed therapeutic applications, and consider licensing or designing around the patent to ensure legal safety.
References
- [1] China National Intellectual Property Administration (CNIPA). Patent CN102260311.
- [2] World Intellectual Property Organization (WIPO). Patent Landscape Report, Chinese Pharmaceutical Patents.
- [3] Gao, H., et al. (2018). "Analysis of the Chinese Patent System and Its Impact on Pharmaceutical Innovation." J. Chinese IP Law.
