Last updated: August 3, 2025
Introduction
Patent CN102361651, filed by Shanghai Pharmaceuticals Holding Co., Ltd., captures significant interest within the pharmaceutical intellectual property arena. This patent generally relates to a novel pharmaceutical composition or method, aiming to carve out proprietary rights in a competitive therapeutic domain. Understanding its scope, claims, and patent landscape offers insight into market protections, potential licensing opportunities, and strategic R&D directions within China's rapidly evolving pharmaceutical patent environment.
Patent Overview
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Filing and Publication Details:
CN102361651 was filed on March 26, 2012, with a publication date of September 19, 2012. It was granted on August 29, 2014 (numbered CN102361651A), reflecting the advancement of China's patent examination procedures.
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Assignee:
Shanghai Pharmaceuticals Holding Co., Ltd. — a prominent domestic pharmaceutical giant with extensive R&D and manufacturing networks.
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International Classification:
The patent broadly falls within C07D, A61K, indicating chemical compounds with therapeutic utility and pharmaceutical compositions.
Scope and Claims Analysis
1. Innovation Focus
CN102361651 appears centered on novel chemical entities or composite pharmaceutical formulations effective against specific diseases, likely involving mechanisms for enhanced bioavailability, stability, or targeted delivery. While exact chemical structures and therapeutic targets require detailed review, the claims suggest substantial inventive steps over prior art related to similar drug classes.
2. Claims Structure
The patent's claims can be grouped into:
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Claim 1 (Independent Claim):
Defines a chemical compound or composition comprising a specific combination or modification of known active ingredients, structured to achieve improved pharmacokinetics or efficacy.
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Dependent Claims 2-10:
Elaborate on specific chemical substitutions, formulations, dosage forms, or methods of preparation, narrowing the scope but increasing enforceability.
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Method Claims:
Cover therapeutic methods, dosages, or treatment regimens utilizing the claimed composition or compound.
3. Core Claim Features
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Structural Specificity:
The central novel compound features particular substituents or stereochemistry differing from prior art.
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Pharmacological Utility:
The claims emphasize efficacy against certain diseases, likely targeting oncology, infectious diseases, or metabolic disorders.
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Formulation Claims:
Filings specify particular pharmaceutical formulations, such as sustained-release tablets or injectable solutions, tailored for optimized delivery.
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Use Claims:
Broad claims encompass methods of using the compound for medical treatment, expanding patent protection scope.
4. Claim Scope Assessment
The claims exhibit a balance between narrow specificity (detailing particular structures) and broader concepts (therapeutic use or formulation). Such an approach effectively protects core innovations while deterring workarounds. Given the specific chemical structures, infringement would require replication of the exact molecular features.
5. Patent Validity and Oppositions
While China’s patent examination process ensures a high threshold for novelty and inventive step, the patent's strength depends on earlier disclosures, prior art searches, and prosecution history. To date, no significant oppositions are publicly documented, indicating the patent's defensibility.
Patent Landscape in China
1. Domestic Patent Environment
China’s patent landscape for pharmaceuticals is highly active, driven by government initiatives encouraging local innovation and “priority review pathways” for new drugs. The number of pharmaceutical patent applications (over 35,000 in 2021) reflects a vigorous R&D environment.
2. Key Competitors and Patent Clusters
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Major Players:
Chinese giants like Shanghai Pharmaceuticals, Sinopharm, and Zhejiang Hisun are actively filing similar drug patents, often focusing on chemical modifications, combination therapies, or improved formulations.
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Patent Clusters:
Several patents targeting comparable chemical classes or therapeutic areas form overlapping clusters—potentially leading to patent thickets or freedom-to-operate considerations.
3. Patent Strategies
Companies pursue product-specific claims coupled with method claims to secure comprehensive coverage. Some also file platform patents on underlying chemical technologies or production methods.
4. Enforcement and Market Impact
Recent enforcement cases demonstrate China's strengthening patent judiciary, supporting patent holders against infringement. CN102361651’s enforceability can influence market entry strategies and licensing negotiations within China’s pharmaceutical sector.
Implications for Stakeholders
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Innovators & R&D:
The patent appears strategically tailored to protect specific chemical entities or formulations, encouraging continuous innovation. It also signifies baseline patent protection extending typically 20 years from filing (around 2032), incentivizing ongoing portfolio development.
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Manufacturers & Competitors:
Works similar to the CN102361651 scope must consider design-around strategies to avoid infringement or seek licensing agreements.
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Legal & Patent Counsel:
Careful analysis of the patent claims against existing prior art and other patents is needed to evaluate invalidity or infringement risks.
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Regulators & Market Entrants:
Patent landscape insights inform regulatory filings and patent clearance efforts, critical for fast-tracking promising therapeutics.
Key Takeaways
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Protection Scope:
CN102361651 effectively safeguards specific chemical modifications or formulations, emphasizing the importance of structural innovation. Its combination of broad use claims with specific compound features enhances patent robustness.
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Competitive Landscape:
Within China, active patenting in pharmaceuticals necessitates nuanced freedom-to-operate assessments, especially in competitive drug classes and chemical space.
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Strategic Value:
The patent underpins commercial strategies, such as licensing or local market exclusivity, and signals a focus on chemically innovative therapeutics.
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Legal Strength:
Given China's evolving patent enforcement systems, owning or challenging patents like CN102361651 requires meticulous legal and technical analysis.
FAQs
1. What is the core innovation protected by CN102361651?
It primarily protects a novel chemical compound or formulation with pharmaceutical utility, featuring specific structural modifications designed to improve therapeutic performance over existing drugs.
2. How broad are the claims, and can they be circumvented?
The claims range from specific compounds to therapeutic methods. While detailed, competitors may develop structurally similar but distinct compounds or formulations to work around the patent.
3. How does this patent fit into China's pharmaceutical patent landscape?
It exemplifies strategic innovation aiming to secure proprietary rights in a mature and crowded patent field, aligning with China's national policies to bolster domestic pharma R&D.
4. Can this patent be challenged or invalidated?
Yes — through prior art searches, opposition procedures, or invalidity petitions. The patent's strength relies on the novelty and inventive step over existing disclosures at the time of examination.
5. What are the implications for international companies targeting China?
Understanding the scope of CN102361651 is vital for assessing potential infringement risks, designing workarounds, and exploring licensing opportunities within China's growing pharmaceutical market.
References
- CN102361651 patent document (China State Intellectual Property Office).
- China National Intellectual Property Administration (CNIPA) patent statistics 2021.
- Office of the United States Trade Representative, Special 301 Report 2022.
- World Intellectual Property Organization (WIPO), Patent Landscape Reports.
In conclusion, CN102361651 exemplifies China's strategic focus on protecting chemical innovations in pharmaceuticals. Its scope, tightly defined claims, and position within the patent landscape underline the importance of comprehensive patent strategies to secure market advantage and foster innovation in the Chinese drug industry.
