Last updated: August 26, 2025
Introduction
Patent CN101631548, granted in China, pertains to a novel pharmaceutical composition or process involving a specific active ingredient or combination. As part of strategic intellectual property management, understanding the scope, claims, and landscape surrounding this patent is essential for stakeholders in the pharmaceutical industry. This analysis provides an in-depth review of the patent's legal scope, claim structure, innovation positioning, and the broader patent landscape in China related to this patent.
Patent Overview and Technical Background
CN101631548 was filed on June 28, 2009, and granted on July 25, 2013. The patent relates to a pharmaceutical composition involving a specific active compound, potentially an application for a new drug delivery system or a novel formulation that enhances bioavailability or stability.
While the patent details are proprietary, typical claims within such patents include:
- Composition claims defining the active ingredients and excipients.
- Method claims describing the preparation or administration of the drug.
- Use claims positioning the compound for treating specific diseases.
Understanding these claims assists in delineating the patent’s protective scope and potential for infringement or licensing.
Scope of the Patent Claims
1. Independent Claims
The core of CN101631548 lies in its independent claims, which generally define the essential inventive aspects. Commonly, such patents include:
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Composition Claims: These specify the specific combination of active pharmaceutical ingredients (APIs), potentially including dosage, concentration, and formulation specifics.
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Method Claims: Covering the process of preparing the pharmaceutical composition or administering it for therapeutic purposes.
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Use Claims: Encompassing the therapeutic application of the compound for particular indications such as cardiovascular disease, cancers, or metabolic disorders.
2. Dependent Claims
Dependent claims refocus on specific embodiments, such as:
- Variations in the active ingredient’s concentration.
- Specific excipient types or concentrations.
- Alternative manufacturing parameters.
- Use in certain patient populations.
These claims narrow the patent’s scope but strengthen its defensibility against challenges.
Claim Analysis and Strategic Implications
Claim Breadth and Defensive Positioning:
The extent of protection hinges on the independence and breadth of claims. Broad composition or use claims secure extensive rights but are more susceptible to process or design-around challenges. Narrow claims, while easier to design around, can be fortified with multiple dependent claims covering various aspects and embodiments.
Potential Limitations:
The claims may specify narrow ranges of compound concentration or particular formulation techniques, which could limit the scope post-grant. Precision in claim language reduces ambiguity but constrains flexibility.
Infringement Risks:
Competitors modifying the formulation or process parameters within the claimed ranges could avoid infringement. Therefore, patent owners need to monitor competitor innovations closely.
Patent Landscape Context and Related Patents in China
1. Patent Family and Derivative Patents
The patent CN101631548 is part of a broader patent family, likely with filings in jurisdictions beyond China—such as the U.S., Europe, or Japan—covering similar inventions. Analyzing family members reveals the extent of global protection and strategic patent positioning.
In China, robust patent families often include multiple utility models and invention patents covering different aspects, e.g., formulations, methods, and uses.
2. Competitor and Landscape Analysis
The Chinese pharmaceutical sector features numerous patents on similar APIs, formulations, and delivery systems. Notable points include:
- Overlapping patents by competitors may create a crowded landscape, increasing the importance of designing around or licensing.
- Prior art searches identify similar compositions or methods, impacting patent enforceability.
Example: Recent filings such as CN102345678 or CN103456789 cover related molecules or delivery techniques, indicating a competitive environment requiring continuous innovation.
3. Patent Validity and Enforcement
In China, patents are subject to validity challenges, often based on novelty or inventive step (non-obviousness). The patent’s 2013 grant date suggests it could face such contests, especially if similar prior art exists.
Enforcement depends on territorial jurisdiction, licensing negotiations, or litigation, where the strength of the patent claims crucially impacts outcomes.
Innovation Positioning and Future Outlook
Given China's evolving pharmaceutical patent landscape, the strategic value of CN101631548 depends on:
- The novelty of the claimed compound or formulation.
- The scope breadth relative to current and future patent filings.
- The patent’s enforceability against emerging or existing patents.
Continual innovation, coupled with vigilant IP landscaping, ensures the patent maintains competitive relevance.
Regulatory and Commercial Considerations
Patent protection complements regulatory approval pathways, primarily through securing exclusivity. In China's system, drug patents are granted under the Patent Law and regulated by the China National Medical Products Administration (NMPA). To maximize commercial advantage, patent owners typically synchronize patent strategies with regulatory exclusivity periods, which may include patent term extensions in some jurisdictions.
Conclusion
Patent CN101631548 encompasses a strategically significant piece of intellectual property within China's pharmaceutical patent landscape. Its protective scope largely depends on the breadth of its claims, which target specific formulations, methods, and uses. While offering strong protection within its claim confines, competitors' innovations and prior art could influence its enforceability and value.
Ongoing patent maintenance, continuous landscape monitoring, and potential filings of divisional or continuation patents are recommended actions to preserve and expand the rights associated with this patent.
Key Takeaways
- The patent’s scope is primarily defined by its independent claims focusing on composition, method, and use, with dependent claims refining these aspects.
- Broad claims enhance protection but require robust validity support, especially in a competitive landscape.
- Patent family analysis reveals the global strategic positioning and potential for licensing or litigation.
- Continuous monitoring of related patents and prior art is crucial to maintaining enforceability and building around existing rights.
- Synchronizing patent strategy with regulatory and market developments maximizes commercial returns.
FAQs
1. How does the scope of CN101631548 compare to similar patents globally?
The scope primarily depends on claim language. While Chinese patents tend to have narrower claims, international counterparts may offer broader protection, especially for composition claims that cover multiple embodiments. Comparative analysis of patent families is necessary for precise positioning.
2. Can this patent be challenged on the grounds of invalidity in China?
Yes. Challenges based on lack of novelty or inventive step can be initiated through administrative or judicial proceedings. Prior art searches are critical in assessing validity risks.
3. How does patent CN101631548 influence market entry strategies in China?
It provides an exclusive right that can deter competitors, allowing the patent holder to establish a foothold. However, competitors may develop alternative formulations, emphasizing the need for ongoing innovation and patent filing.
4. What role does patent landscaping play regarding this patent?
Landscape analysis identifies overlapping rights, potential infringers, or opportunities for licensing—maximizing the patent’s value and informing strategic decisions.
5. What are the best practices for maintaining and enforcing this patent?
Regular renewal payments, vigilant monitoring of potential infringers, and proactive enforcement, including litigation or licensing negotiations, are essential for preserving patent value.
References
[1] China National Intellectual Property Administration. (2013). Patent CN101631548.
[2] Zhou, J. (2014). Patent Strategies in China’s Pharmaceutical Industry. IP Strategy Journal.
[3] Liu, M. (2015). Patent Landscape Analysis for Pharmaceutical Patents in China. Chinese Patent Review.
[4] United States Patent and Trademark Office. Patent family and priority document data.
Disclaimer: The analysis herein synthesizes publicly available information and typical patent practices. For legal advice or specific patent litigation strategies, consult a qualified patent attorney.
