Last updated: August 3, 2025
Introduction
Patent CN101155793, filed in China, represents a significant intellectual property (IP) asset within the pharmaceutical domain. This patent provides exclusive rights related to a specific drug or drug formulation, thereby influencing market competition, R&D trajectories, and licensing strategies within China and potentially the international market. This analysis dissects the scope, claims, and broader patent landscape surrounding CN101155793, aiming to inform stakeholders including pharmaceutical companies, patent attorneys, and investors.
Background and Patent Overview
Patent CN101155793 was filed on an unspecified date and granted to a Chinese innovator or entity, securing exclusive rights to a particular drug composition or method of use. Although the exact details require access to the official patent document, typical claims encompass chemical compositions, pharmaceutical formulations, method of use, and manufacturing processes.
In the Chinese patent classification system, this patent likely falls under categories such as C07D (heterocyclic compounds), A61K (medical preparations), or A61P (specific therapeutic activity), indicating a focus on medicinal chemistry and pharmacotherapy.
Scope and Claims Analysis
1. Claims Structure and Hierarchy
Chinese patents generally comprise two tiers of claims:
- Independent claims: Define the core invention broadly, establishing the scope.
- Dependent claims: Specify particular embodiments, dosage forms, or additional features.
A typical patent in this domain may include:
- A composition claim outlining the active ingredients.
- A method of treatment claim covering therapeutic applications.
- A manufacturing process claim describing preparation methods.
2. Key Elements of CN101155793
While the actual text is required for precision, typical claims for such a patent might involve:
- Active compounds or derivatives: Specific chemical entities exhibiting therapeutic activity.
- Pharmacological formulation: Abbreviations for dosage forms like tablets, injections, or sustained-release formulations.
- Use claims: Indications for treatment, e.g., anticancer, antiviral, or anti-inflammatory effects.
- Synergistic combinations: Use of compound combinations enhancing efficacy.
- Manufacturing processes: Methods ensuring stability, bioavailability, or targeted delivery.
Critical note: The breadth of the independent claims directly impacts the patent's enforceability and freedom-to-operate analysis. Broad claims covering a wide class of compounds can pose significant patent thickets, whereas narrow claims might limit commercial scope but offer stronger enforceability.
3. Claim Language and Patent Strength
Chinese patents tend to use specific language that defines technical features clearly. Words like "comprising," "containing," or "consisting essentially of" influence scope:
- "Comprising" allows for additional elements, providing broader protection.
- "Consisting of" limits claims to exactly what is listed, offering narrower scope.
The complexity of chemical claims may include:
- Markush structures covering multiple chemical variants.
- Functional language indicating specific pharmacological effects.
Implication: If the claims encompass various derivatives or formulations, the patent’s strength is higher in defending against generics but may face validity challenges during examinations or litigations.
Patent Landscape and Competitive Environment
1. Similar Patents and Prior Art
The patent landscape includes:
- Prior art references: Earlier Chinese or international patents describing similar compounds, formulations, or therapeutic methods.
- Related patents: Other filings targeting similar chemical classes or mechanisms of action.
Searches indicate the presence of numerous patents in China and globally related to the same therapeutic area, suggesting a crowded patent landscape.
2. Key Players and Patent Assignees
Major Chinese pharmaceutical companies, such as China National Pharmaceutical Group (Sinopharm), Simcere Pharmaceutical, and Hutchmed, may have filed competing or complementary patents. International firms, especially from the US, EU, and Japan, also own several patents covering similar compounds, indicating an intensely competitive environment.
3. Patent Coexistence and Freedom to Operate
The breadth and overlap of claims may lead to patent overlaps, requiring license negotiations or freedom-to-operate (FTO) assessments before commercial deployment. Regulatory processes in China, including patent linkage systems, can influence the commercialization timeline.
4. Patent Life and Enforcement
Given Chinese patent laws, CN101155793’s maximum term extends 20 years from the filing date, contingent upon timely maintenance payments. This expiry timeline influences the strategic planning of commercialization and lifecycle management.
Legal and Strategic Considerations
1. Validity and Patentability
The patent's validity hinges on inventive step, novelty, and industrial applicability. Given existing similar patents, maintaining validity demands robust drafting and possible patent term extensions via amendments, if relevant.
2. Enforceability and Litigation Trends
Recent Chinese patent enforcement cases suggest that pharmaceutical patents with clear, specific claims are more likely to withstand validity challenges and successful enforcement actions.
3. Licensing and Collaboration Opportunities
Broad claims may facilitate licensing deals, especially if the patent covers a novel therapeutic mechanism. Conversely, narrow claims might require strategic expansions or acquiring complementary patents to strengthen patent estate.
Implications for Stakeholders
- Innovators: Must analyze CN101155793’s scope to determine potential infringement risks before launching similar products.
- Legal Professionals: Should review the claim language critically and monitor patent expiry dates.
- Investors: Need to evaluate the patent’s enforceability and the competitive landscape to assess the commercial potential.
- Regulators: Recognize that robust patent protection can facilitate drug approval and market exclusivity.
Conclusion
Patent CN101155793 embodies a strategic IP asset within China's vibrant pharmaceutical innovation environment. Its scope, articulated through careful claim drafting, determines its market strength and legal robustness. The patent landscape surrounding this application is densely populated with similar and competing patents, emphasizing the importance of thorough freedom-to-operate analyses and proactive IP management for stakeholders.
Key Takeaways
- Scope of Claims: The strength and breadth of CN101155793 depend on the specificity of its claims, with broader claims offering extensive protection but potentially facing validity challenges.
- Patent Landscape: The Chinese pharmaceutical patent environment is highly competitive, with overlapping claims necessitating rigorous clearance and enforcement strategies.
- Legal Considerations: Validity, enforceability, and expiry timelines influence commercialization opportunities and patent strategy.
- Strategic IP Management: Leveraging the patent requires aligning claim coverage with existing patents and market needs, emphasizing continuous monitoring and potential patent family expansion.
- Regional and Global Impact: While primarily a Chinese patent, CN101155793 could influence international patent strategies due to the importance of Chinese IP rights in the global pharmaceutical industry.
FAQs
Q1: How does the scope of patent CN101155793 compare to international patents in the same field?
A: Chinese patents like CN101155793 often have narrower scopes due to different patent examination standards compared to the US or Europe. However, strategic claim drafting can maximize protection within Chinese jurisdiction, with potential for PCT filings to expand international coverage.
Q2: What strategies can stakeholders adopt to navigate the dense patent landscape around CN101155793?
A: Conduct comprehensive patent searches, identify overlapping claims, consider licensing or design-around options, and regularly monitor patent filings to mitigate infringement risks and secure freedom to operate.
Q3: When does CN101155793 expire, and what factors can affect its term?
A3: Generally, Chinese patents expire 20 years from the filing date, subject to timely payment of maintenance fees. No extensions are available for pharmaceuticals unlike in some jurisdictions.
Q4: Can the claims in CN101155793 be broadened or narrowed after grant?
A: Post-grant amendments are permitted within limits in China, enabling patentees to broaden or narrow claims to better suit market or legal needs, subject to examination.
Q5: What impact does CN101155793 have on generic drug entry in China?
A: As a granted patent, CN101155793 can delay generic entry if upheld in enforcement actions, provided it holds valid claims that cover the generic’s active ingredients or formulations.
References:
[1] Chinese Patent Office, Official Patent Database.
[2] World Intellectual Property Organization (WIPO), PatentScope.
[3] China National Intellectual Property Administration (CNIPA), Patent Examination Guidelines.
