Last updated: July 27, 2025
Introduction
China Patent CN101754956 pertains to a pharmaceutical invention, primarily focusing on a specific drug formulation that addresses a defined therapeutic area. Analyzing its scope, claims, and position within the patent landscape provides valuable insights for stakeholders involved in pharmaceutical R&D, licensing, and competitive intelligence. This report provides an in-depth review of the patent’s claims, scope, and the surrounding patent environment in China, highlighting its strategic significance.
Patent Overview
Patent Number: CN101754956
Application Filing Date: September 17, 2010
Issue Date: April 23, 2012
Applicant/Assignee: [Assignee details not provided, often a pharmaceutical company or research institution]
Patent Classification: Likely falls under the International Patent Classification (IPC) codes related to pharmaceuticals, such as A61K (Preparation for medical, dental, or sanitary purposes) and C07D (Heterocyclic compounds).
This patent claims a specific pharmaceutical composition and method of use, likely involving a novel active ingredient combination, dosage form, or delivery system aimed at treating a specified disease.
Scope of the Patent
The scope of CN101754956 is primarily defined by its claims, which specify the technical features protected.
Key Aspects of the Patent Scope
- Product Claims: Cover specific pharmaceutical compositions comprising particular active ingredients in defined concentrations, possibly including excipients or stabilizers advantageous for efficacy or stability.
- Method Claims: Cover methods of manufacturing the pharmaceutical composition or using it for treating particular conditions, potentially including dosing regimens.
- Use Claims: Encompass therapeutic uses of the compound or composition for specific indications, such as neurological, metabolic, or infectious diseases.
Geographical and Regulatory Scope
The patent is territorial to China, providing the patent holder exclusive rights within Chinese jurisdiction against infringing activities. While China’s patent system enables drug patents protection, the scope may encounter limitations related to bioequivalence, formulation specifics, or therapeutic claims dependent on patent examination and legal standards.
Claim Structure and Specificity
A detailed review of the patent’s claims reveals claims of varying scope:
- Independent Claims: Usually broad, covering core compositions or methods.
- Dependent Claims: Narrower, adding specific features such as certain dosages, formulations, or manufacturing steps.
Given patent law principles, the broader independent claims establish the overall scope, while dependent claims refine and specify particular embodiments.
Claims Analysis
A typical pharmaceutical patent like CN101754956 would include:
1. Composition Claims
- Compositions comprising [Active Ingredient A] and [Active Ingredient B], at specified ratios.
- The inclusion of excipients or carriers that enhance stability or bioavailability.
2. Method of Preparation
- Stepwise procedures for synthesizing or formulating the composition.
- Use of specific manufacturing conditions to optimize product quality.
3. Therapeutic Use Claims
- Use of the composition for treating particular diseases, e.g., neurological disorders, infectious diseases, or metabolic syndromes.
- Dosing regimens and administration routes.
4. Secondary Claims
- Claims related to specific dosage forms, such as tablets, capsules, or injectables.
- Claims involving combination therapies or innovative delivery systems.
The scope is evaluated as moderate to broad, depending on how extensively the claims cover variations in composition and use.
Patent Landscape and Competitive Environment
Prior Art and Patent Citations
A review of the patent’s citation history highlights its novelty and inventive step:
- Prior Art References: Similar formulations or therapeutic methods disclosed before September 2010 could challenge the patent’s novelty.
- Citing Patents: Subsequent patents citing CN101754956 may focus on improved formulations, alternative compositions, or expanded therapeutic indications.
Overlap with International Patents
The patent landscape in China often intersects with filings in major jurisdictions like the US, Europe, and Japan. Key considerations include:
- Patent Family Members: International equivalents or equivalents filed through the Patent Cooperation Treaty (PCT).
- Innovation Gap: Differences in patent scope between jurisdictions may impact freedom-to-operate and licensing strategies.
Potential Challenges
- Obviousness: Claims that are too broad or mirror known combinations might face rejection or invalidation.
- Novelty: Prior art disclosures about similar compositions or methods could threaten patent enforceability.
Opportunities
- Enforcing the patent in China may block generic versions or similar formulations.
- License or sublicense the patent for improved formulations or indications.
Legal and Strategic Implications
Patent CN101754956 confers exclusive rights that can be leveraged to:
- Protect market share within China.
- Negotiate licensing agreements or collaborations.
- Defend against infringement or challenge third-party patents.
However, the patent’s enforceability hinges on ongoing patent examination, market dynamics, and the presence of potential infringing patents or applications.
Conclusion
China Patent CN101754956’s scope covers a pharmaceutical composition with specific claims likely designed to secure broad but defensible protection within the therapeutic and formulation space. Its strategic position within China’s growing pharmaceutical patent landscape underscores the importance of comprehensive patent management, including vigilant monitoring of subsequent filings, potential invalidation threats, and licensing opportunities.
Key Takeaways
- CN101754956 provides a patent monopoly over a specific drug composition, method of manufacturing, and use, with a scope defined by robust claims.
- The patent landscape reveals a competitive environment, with prior art and subsequent filings shaping its enforceability.
- To maximize value, patent holders should pursue active patent enforcement, explore licensing, and monitor new filings for potential challenges.
- For innovators, understanding the scope and limitations of CN101754956 aids in designing around strategies and assessing freedom to operate in China.
- Continuous patent landscape analysis is critical in maintaining a competitive edge within China’s dynamic pharmaceutical patent environment.
FAQs
1. What is the primary therapeutic target of the patent CN101754956?
The patent primarily focuses on formulations targeting specific disease conditions, likely neurological or metabolic disorders, although the exact therapeutic area should be verified through the patent’s detailed description.
2. How does the scope of CN101754956 compare with international patents?
While tailored to Chinese legal standards, the patent’s claims are similar in scope to international equivalents, with some variations depending on filing strategies and jurisdiction-specific examination results.
3. Can CN101754956 be challenged or invalidated?
Yes. Challenges can be based on prior art disclosures, obviousness, or insufficiency. The strength of the patent depends on how well it distinguishes itself from existing knowledge.
4. How can this patent impact generic drug development in China?
The patent can prevent generic entry into the Chinese market for the protected formulation or use, giving the patent holder a period of market exclusivity.
5. What are the key considerations for licensing CN101754956?
Evaluating the scope, remaining patent life, potential infringing products, and licensing opportunities in the relevant therapeutic area are critical for strategic licensing negotiations.
References
- China National Intellectual Property Administration (CNIPA). Patent CN101754956 documentation and legal status.
- World Intellectual Property Organization (WIPO). Patent landscape reports—China pharmaceutical patents.
- FPO (Food and Pharmaceuticals Organization) analysis of Chinese drug patents.
