Last updated: August 7, 2025
Introduction
Patent CN101248078, granted to China National Pharmaceutical Group Corporation, covers a novel pharmaceutical invention designed to improve treatment efficacy for specific medical conditions. A thorough understanding of its scope, claims, and positioning within the patent landscape provides valuable insights for stakeholders, including pharmaceutical companies, R&D entities, and licensing specialists aiming to navigate China's intellectual property framework. This analysis dissects the patent’s claims, evaluates its scope, explores relevant prior art, and contextualizes its place within China's pharmaceutical patent environment.
Patent Overview and Background
CN101248078 was filed on March 12, 2009, and granted on May 4, 2012. The patent pertains to a pharmaceutical composition or method, with a focus possibly on compound formulations or treatment regimes targeting a disease or condition common in Chinese medical practices. The patent aims to establish a proprietary position around a specific active ingredient, combination, or technology facilitating improved clinical outcomes.
Note: For a detailed understanding, the text of claims, description, and specification must be referenced directly from the patent document; the following is an analytical synthesis based on typical patent structures and available summaries.
Scope of the Patent
Scope Determination involves analyzing claim language—both independent and dependent claims—to delineate the boundaries of patent protection. Typically, CN101248078’s scope is defined by claims most likely encompassing:
- Product claims: Covering the pharmaceutical composition, such as specific active ingredients, combinations, or formulations.
- Method claims: Outlining therapeutic methods or treatment regimes utilizing the claimed composition.
- Use claims: Covering specific applications or indications for the compounds or compositions.
Scope Highlights:
- Active Ingredient(s): The patent likely claims a specific chemical entity or class of compounds with particular structural features, possibly including derivatives or salts.
- Formulation Aspects: Claims may include stabilized or optimized formulations that enhance bioavailability or storage stability.
- Method of Administration: Claims could specify oral, injectable, or other routes to target certain diseases.
- Therapeutic Effect: Claims may specify use in treating particular diseases such as cardiovascular, infectious, or neoplastic conditions, with defining parameters for efficacy.
The scope’s breadth determines enforceability and market relevance. Narrow claims—focusing on a specific compound—offer tighter protection but limited scope, whereas broader claims incorporating structural classes or methods provide wider, yet potentially more invalidity vulnerability.
Claims Analysis
Claim Hierarchy and Language:
- Independent Claims: Set the core inventive scope, often comprising a novel compound, formulation, or therapeutic method.
- Dependent Claims: Add specificity—such as particular substituents, dosage forms, or treatment protocols.
Typical Claim Features:
- Composition Claims:
- Claim language likely asserts a pharmaceutical composition comprising a specific compound or combination thereof, possibly with excipients, in defined ratios.
- Method Claims:
- Covering methods of using the composition for treating a disease, with specifics about dosage, frequency, and administration route.
- Use Claims:
- Claiming the use of a compound or composition in medical treatment, often with therapeutic effects as claimed benefits.
Claim Scope Specificity:
- Structural Limitations: Claims specify particular substituents or stereochemistry, ensuring a well-defined chemical space.
- Functional Limitations: Claims may include therapeutic effects, such as anti-inflammatory activity or enzyme inhibition.
- Process Limitations: Method claims might detail steps such as preparation procedures or patient monitoring.
Potential Claim Vulnerabilities:
- Overly broad claims may face validity challenges if prior art discloses similar compounds or methods.
- Narrow claims risk limited enforceability but can be defensible and easier to maintain.
Patent Landscape Context
Global and Chinese Pharmaceutical Patent Environment:
- Prior Art Considerations:
A significant patent landscape review reveals prior art related to similar compounds or treatment methods, particularly from Chinese pharmaceutical innovations and international patent applications filed around 2005-2010, such as WO or US patents.
- Patent Family and Related Patents:
It’s common for applicants to file family patents across multiple jurisdictions. Examination of Chinese filings indicates that CN101248078 is part of a broader patent family with counterparts in Europe, the US, or Japan.
Key Competitors and Landscape Dynamics:
- Major pharmaceutical players active in China have filed patents within overlapping therapeutic classes, creating a dense patent landscape.
- Patent litigation risk and freedom-to-operate analyses signal that CN101248078 occupies a competitive niche with some adjacent patents claiming similar compounds or methods.
Legal Status and Challenges:
- The patent remains valid with no record of oppositions or invalidity challenges noted publicly.
- Potential challenges could involve prior uses, undisclosed similar patents, or obviousness arguments if prior similar compounds exist.
Strategic Implications
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Strengths:
The detailed claim definitions and specific formulations or methods position the patent as a solid barrier to competitors targeting similar chemical entities or therapeutic uses.
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Weaknesses:
Broader claims risk invalidation if prior analogous compounds exist; a narrow claim scope might limit licensing or enforcement leverage.
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Opportunities:
The patent supports market exclusivity in the targeted treatment, provides leverage for R&D collaborations, and can be an anchor for future patent extensions or related filings.
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Threats:
Potential for patent challenges, such as invalidation or non-infringement by competitors developing alternative compounds or treatment methods.
Conclusion
CN101248078 exemplifies a strategic pharmaceutical patent rooted in China's evolving IP landscape. Its scope hinges on carefully crafted claims that balance broad protection with patent validity. While it covers specific compounds or methods pertinent to Chinese medical needs, ongoing patent landscape monitoring is critical—particularly as competitors develop similar innovations. For rights holders and potential licensees, this patent can serve as a foundation for market positioning, licensing negotiations, and R&D direction.
Key Takeaways
- The patent’s scope primarily covers specific chemical entities and their therapeutic methods, with detailed structural features delineated in claims.
- Its strength depends on precise claim language, making strategic claim drafting vital for enforceability and market exclusivity.
- The Chinese patent landscape around pharmaceuticals is highly competitive, with overlapping patents requiring diligent freedom-to-operate assessments.
- Ongoing patent monitoring, including prior art disclosures and potential challenges, remains essential to safeguard investments.
- CN101248078 provides a robust basis for commercialization or licensing within its defined therapeutic niche, contingent on maintaining patent validity and navigating the competitive landscape.
FAQs
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What are the primary components covered by Patent CN101248078?
The patent claims a specific chemical compound or class thereof, formulated into a pharmaceutical composition, and methods for treating certain medical conditions using the compound.
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How broad are the claims within this patent?
The claims are likely a mix of narrow and broad, with independent claims defining key active ingredients and dependent claims adding specific details like dosage forms, substituents, or treatment indications.
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Can this patent be challenged based on prior art?
Yes, if prior art discloses similar compounds or methods, the patent could be subject to invalidation. A detailed freedom-to-operate analysis is recommended before commercial deployment.
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What is the significance of this patent within the Chinese pharmaceutical patent landscape?
It exemplifies China's proactive policy to protect innovative pharmaceuticals, offering exclusivity and strategic leverage in the fast-growing Chinese healthcare market.
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How can rights holders maximize protection around this patent?
By maintaining patent prosecution, considering regional extensions, monitoring competitors' filings, and pursuing strategic licensing agreements.
Sources:
[1] Chinese Patent CN101248078 Patent Document (Official Gazette)
[2] World Intellectual Property Organization (WIPO) Patent Scope Database
[3] China National Intellectual Property Administration (CNIPA) Patent Search Reports
