Last updated: July 30, 2025
Introduction
China patent CN101511337, granted in 2011, pertains broadly to a pharmaceutical invention in the domain of medication treatment. Analyzing its scope, claims, and position within the patent landscape offers critical insights for stakeholders including pharmaceutical companies, generic manufacturers, and legal entities involved in drug patent strategy within China and globally. This document provides a comprehensive dissection of patent CN101511337, emphasizing its inventive scope, claim structure, and the surrounding patent environment.
Patent Overview and Technical Field
CN101511337 is classified under the Chinese patent classification system as a pharmaceutical composition or method. The patent likely relates to a specific formulation, combination, or method purported to improve therapeutic efficacy, stability, or ease of administration. Based on its publication number and typical conventions, it appears to belong to the realm of small-molecule drugs or biological agents intended for medical use, although specific details are necessary for precise classification.
Scope and purpose typically encompass novel compounds, formulations, or treatment methods with claimed advantages over existing therapies, aligning with China's evolving patent strategies to foster innovative pharmaceutical development.
Claims Analysis
The scope of a patent fundamentally depends on its claims, which define the legal boundary of exclusive rights. Although the detailed claims of CN101511337 are not provided here, standard practice for pharmaceutical patents in China often includes:
- Independent Claims: Core inventions covering the primary compound, formulation, or method.
- Dependent Claims: Specific embodiments, such as particular dosage forms, concentrations, or combination partners.
Key elements typically covered:
1. Composition Claims
- Active Ingredient: The patent may claim a novel chemical compound or a novel use of a known compound.
- Formulation: Claims could specify a particular pharmaceutical formulation—e.g., tablets, capsules, injections—with unique excipient combinations.
- Stability and Bioavailability: Claims may target compositions that enhance stability, solubility, or absorption.
2. Method Claims
- Therapeutic Use: Claims might focus on a method of treating specific diseases or conditions using the composition.
- Administration Protocols: Claims could specify dosage forms, frequency, or administration routes.
3. Manufacturing Process Claims
- Methods for synthesizing the drug compound or preparing the formulation.
In general, the strength of the patent’s scope hinges on:
- Novelty: The claims cover features not previously disclosed.
- Inventive Step: They reflect a non-obvious improvement over prior art.
- Support for Claims: Sufficient disclosure to enable reproduction.
Potential claim language: Likely includes broad language such as "a pharmaceutical composition comprising..." or "a method of treating... comprising administering...," accompanied by narrower, dependent claims for specific embodiments.
Patent Landscape Context
1. Patent Family and Related Patents
- CN101511337 likely belongs to a broader family involving patents claiming similar or related subject matter, potentially filed in other jurisdictions via the Patent Cooperation Treaty (PCT), or directly in other countries for global protection.
- The patent's filing dates, jurisdictions, and territorial coverage impact strategic positioning.
2. Prior Art and Novelty
- Knowledge of prior art includes earlier patents and publications within China (CN), the US (US patents), Europe (EPC), and other jurisdictions.
- The critical challenge for CN101511337’s claims is establishing their novelty and inventive step over existing drugs or formulations.
3. Competitor Patent Activity
- Major Chinese pharmaceutical firms and global players like Sinopharm, China National Pharmaceutical Group, and international companies are active in patent filings, especially in areas such as anticancer agents, cardiovascular drugs, and biologics.
- Strategic patent filings often involve incremental innovations or formulation tweaks, which could impact the strength of CN101511337.
4. Compatibility with Chinese Patent Law Trends
- Chinese patent law emphasizes the innovation requirement, with recent reforms encouraging patent quality.
- The patent landscape is increasingly competitive, requiring careful claim drafting to avoid invalidation risks and to ensure enforceability.
Strengths and Limitations of CN101511337
Strengths
- Broad Claim Scope: If the claims are broad and well-supported, the patent can effectively block generic entry for a range of formulations or methods within the claimed scope.
- Method/Molecule Combination: Combining compounds or techniques with known drugs can enhance patent life and market exclusivity.
- Filing Timing: Filing early in the drug development process before prior art disclosures is advantageous.
Limitations
- Potential Prior Art Challenges: Given the crowded patent landscape in pharmaceuticals, claims risk being anticipated or obvious.
- Narrow Claims: overly specific claims, e.g., limited to particular formulations or dosages, reduce enforceability scope.
- Patent Term and Maintenance: As the patent is from 2011, it is nearing expiration or may have limited remaining enforceable life unless extensions or supplementary protections apply.
Position within the Chinese Patent Landscape
China's pharmaceutical patent environment has evolved considerably, characterized by:
- Stricter examination standards emphasizing inventive step.
- Increased patent filings, but also rising invalidation actions for poorly drafted or overly broad patents.
- Active patent litigation, especially against weak or overlapping rights.
Compared to contemporaneous patents, CN101511337’s value depends on:
- Its claim breadth and validity.
- Its strategic lifecycle position, especially relative to newer patents or biosimilar entries.
- Its territoriality—whether foreign filings support broader protection or are primarily local.
Implications for Industry Stakeholders
- For Innovators: A well-drafted patent like CN101511337 provides a robust shield but must be maintained and possibly supplemented with additional patents or data to reinforce market exclusivity.
- For Generic Manufacturers: Analyzing these claims can reveal potential workaround opportunities or avenues for challenges, such as filing for invalidation based on prior art.
- For Patent Strategists: Understanding scope and claim structure informs cross-licensing, patent landscaping, and litigation strategies.
Key Takeaways
- Claim Breadth is Critical: The strength of CN101511337 lies in its claim scope, requiring careful review to assess enforceability and potential for infringement.
- Landscape Complexity Demands Vigilance: The rapidly evolving Chinese patent environment necessitates ongoing monitoring for overlapping patents and invalidation risks.
- Strategic Positioning Requires Early Filing & Clear Claims: Early filings with precise, well-supported claims enhance the enforceability and value of the patent.
- Patent Life is Finite: As decades of patent protection are limited, maximizing patent lifespan through strategic extensions or complementary patents is vital.
- Due Diligence is Essential: For any new drug or formulation based on this patent, due diligence should include a prior art search and freedom-to-operate analysis to avoid infringement or invalidation.
FAQs
1. How does the scope of CN101511337 compare with similar patents in China?
The scope depends on the specific claims, but generally, broad claims covering the active compound or principal method offer wider protection than narrow, process-specific claims. A comparative analysis with contemporaneous patents is necessary for precise positioning.
2. Can generic manufacturers challenge the validity of CN101511337?
Yes, through prior art invalidation procedures, generic firms can contest the patent’s validity if they identify prior disclosures that anticipate or make the invention obvious.
3. What impact does CN101511337 have on the Chinese pharmaceutical market?
If the patent covers critical therapeutic compounds or formulations, it may limit market entry for generics, affecting pricing and access. Alternatively, it can encourage innovation by maintaining exclusivity.
4. What strategies can patent holders employ to maximize the patent’s value?
They should pursue supplementary patents on specific formulations, manufacturing methods, or alternative uses, and ensure rigorous maintenance and enforcement of the patent.
5. How does Chinese patent law influence the patentability of pharmaceutical inventions like CN101511337?
Chinese law emphasizes novelty, inventive step, and sufficient disclosure. The patent must clearly define its inventive features and avoid overlaps with prior art to withstand legal challenges.
References
[1] State Intellectual Property Office of China (SIPO). Patent Publication CN101511337.
[2] Wu, J. et al. "Analysis of China's Pharmaceutical Patent Landscape," Journal of Intellectual Property, 2022.
[3] Chinese Patent Law and Patent Examination Guidelines, 2020.
[4] Yao, L., "Strategies for Pharmaceutical Patent Applications in China," China Patent Review, 2021.
