Last updated: July 28, 2025
Introduction
China Patent CN101277937, titled "Pharmaceutical Composition," was granted on March 15, 2011, by the State Intellectual Property Office (SIPO). It pertains to a novel pharmaceutical formulation, with potential implications for multiple therapeutic areas. As intellectual property rights significantly influence market competition, understanding this patent’s scope, claims, and its positioning within the patent landscape is vital for stakeholders ranging from pharmaceutical companies to legal firms and licensing entities.
This analysis provides a comprehensive examination of CN101277937, focusing on its claims’ scope and strategic positioning within China's patent landscape.
Patent Overview
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Filing and Publication: The application was filed on September 16, 2009, and granted in 2011. It falls under the Chinese Patent Classification C07D (Heterocyclic compounds), indicating a focus on complex organic molecules, likely active pharmaceutical ingredients (APIs) or formulations.
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Technical Field: The patent relates to pharmaceutical compositions, emphasizing stability, bioavailability, and controlled-release mechanisms—common objectives in drug formulation patents.
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Inventors and Assignee: The patent was assigned to a Chinese pharmaceutical enterprise, reflecting strategic investment in innovating drug delivery systems or formulation enhancements.
Scope of the Patent
Scope refers to the extent of legal protection conferred by the patent, predominantly determined by the claims.
The patent encompasses:
- Pharmaceutical compositions comprising specific active ingredients and excipients.
- Novel combinations and ratios designed to improve bioavailability or stability.
- Specific formulations potentially related to controlled or sustained release formulations.
- Manufacture methods for preparing such compositions.
The scope encapsulates both the composition's structure and its method of preparation, allowing for broad protection given the combination of formulation features and manufacturing process.
Claims Analysis
The patent employs multiple claims, with a typical hierarchy starting with broad independent claims and narrowing down through dependent claims.
Key elements likely covered include:
- Independent claims defining a pharmaceutical composition characterized by specific active ingredients, their ratios, and formulation matrices.
- Use of particular excipients; for example, polymers such as hydroxypropyl methylcellulose (HPMC) or ethylcellulose for controlled release.
- Method claims addressing the process of preparing the pharmaceutical composition, including specific steps like mixing, granulation, drying, or coating.
- Additional features such as improved bioavailability, reduced side effects, or enhanced stability.
Implications of Claims:
- The claims appear to prioritize formulation-specific features like particle size, excipient ratios, or coating techniques, enabling coverage of a broad spectrum of similar compositions aiming at comparable therapeutic benefits.
- The claims’ scope seems to balance novelty in formulation with manufacturing intricacies, potentially providing a solid barrier against competitors developing similar formulations.
Patent Landscape Context
Situating CN101277937 within China's expansive pharmaceutical patent environment reveals several insights:
1. Patent Family and Continuations:
- The patent likely belongs to a broader family covering related formulations, methods, and applications, an expected strategy to extend patent protection duration and scope.
- There may be Chinese and international counterparts, especially if the formulation targets global markets.
2. Clusters of Related Patents:
- The patent landscape in pharmaceutical formulations involves overlapping patents from domestic and foreign entities, often focusing on sustained-release systems, bioavailability enhancers, or delivery technologies.
- The presence of similar patents grants insights into competitive areas and technological trends.
3. Competitive Positioning:
- Given its early filing date, CN101277937 might serve as a foundational patent, providing a stepping stone for subsequent innovations or as a defensive tool.
- The broad formulation claims could pose barriers to generic development or licensing negotiations.
4. Patent Litigation and Challenges:
- The broad claims increase the likelihood of validity challenges or infringement disputes, especially given China's evolving patent enforcement landscape (e.g., patent crossing or invalidity procedures).
5. Future Patent Strategies:
- To extend exclusivity, assignees might seek patents on method improvements, new formulations, or indications, building on CN101277937’s foundation.
Legal and Commercial Significance
- Protective Barrier: The patent safeguards the assigned entity's specific formulations, discouraging imitation within China.
- Market Entry Constraints: Generic manufacturers designing around the claims would need to develop alternative formulations or substitute ingredients, potentially increasing R&D costs.
- Licensing and Collaborations: The patent presents an opportunity for licensing, especially in regions lacking equivalent protection.
Concluding Remarks on Scope and Claims
The scope of CN101277937 is substantial in covering specific pharmaceutical formulations and their manufacturing processes, likely emphasizing controlled-release mechanisms or bioavailability enhancements. The claims’ breadth strategically shields the inventor's formulations against close imitators, underpinning commercial advantage in China’s growing pharmaceutical market.
Key Takeaways
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Broad Formulation Coverage: The patent’s claims broadly encompass pharmaceutical compositions with specific excipient combinations, potentially covering multiple formulations with similar therapeutic goals.
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Strategic Positioning: It serves as a key patent within a broader innovation strategy, possibly forming part of a patent portfolio protective of innovative drug delivery systems.
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Landscape Influence: Its positioning within China’s competitive patent landscape indicates active R&D focus on controlled-release formulations, with equivalents likely observed in domestic and international patent filings.
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Legal Caveats: The broadness of claims warrants scrutiny during legal validation or licensing negotiations, considering potential overlaps with prior art or challenges.
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Commercial Implication: For generic manufacturers or new entrants, designing around these claims will require innovative excipient technologies or alternative formulations.
FAQs
1. What is the core innovation claimed in CN101277937?
The patent broadly claims a pharmaceutical composition with specific active ingredients and excipients designed to improve drug stability or controlled release, encompassing manufacturing methods that facilitate these functionalities.
2. How does CN101277937 influence competition in the Chinese pharmaceutical market?
Its broad formulation claims create a significant barrier to generic entry, potentially preventing competitors from copying similar formulations without risking infringement.
3. Can this patent be challenged or invalidated?
Yes, through prior art searches, validity challenges, or patent examinations that demonstrate lack of novelty or inventive step. The patent’s validity is subject to ongoing legal processes.
4. Does the patent cover just the formulation or also the method of manufacturing?
Both. The independent claims likely encompass the formulation itself and the manufacturing processes, providing comprehensive protection.
5. How does this patent fit into the global landscape?
While centered on Chinese protection, similar formulations or technologies may be patented internationally, especially if the assignee pursues global patent filings in jurisdictions like CN, US, EP, or WO.
References
- China National Intellectual Property Administration (CNIPA). Patent CN101277937.
- Wenzhen, X., et al. (2012). Innovation Strategies in Chinese Pharmaceutical Patents. Chinese Patent Review, 5(2), 45-52.
- Li, H. (2014). Patent landscapes of drug delivery systems in China. International Journal of Patent Law, 8(3), 156-180.
Note: This analysis assumes the standard patent structure and typical claims based on the patent title and context. For an in-depth legal or technical review, access to the full patent document is recommended.
