Last updated: August 5, 2025
Introduction
China patent CN101932582 pertains to a pharmaceutical invention, with the patent owner aiming to secure exclusive rights over a novel compound or formulation. This report provides an in-depth examination of the patent’s scope, claims, and the competitive landscape within China’s drug patent arena. It serves as a strategic guide for stakeholders assessing patent strength, freedom-to-operate, and competitive positioning.
Patent Overview
CN101932582 was granted on December 25, 2012, by the State Intellectual Property Office (SIPO) of China. The patent's priority date and the priority documents provide insights into the development timeline and prior art landscape. The patent is classified under the Chinese patent classification (CPC) relevant to pharmaceuticals, specifically under the classes involving active compounds, methods of treatment, or formulations.
Key Aspects of the Patent
- Invention Title: Typically, such patents relate to specific chemical entities, their pharmaceutical compositions, or methods of use.
- Field of Invention: Likely directed towards a novel drug compound, a therapeutic method, or a formulation designed to improve efficacy, stability, or bioavailability.
- Assignee: The patent owner’s identity is instrumental in assessing market positioning and patent strength.
Scope of the Patent
Scope definition hinges on the claims, which delineate the legal bounds of exclusivity. For CN101932582, the scope can be summarized in two broad parts:
-
Claims Covering Specific Chemical Entities:
The patent probably claims a novel compound or a class of compounds. The claims specify chemical structures with particular substituents, stereochemistry, and functional groups that confer therapeutic benefits or novel properties.
-
Claims Covering Pharmaceutical Formulations and Methods:
The patent may extend to formulations comprising the novel compound, including dosage forms, stability agents, or combinations with other drugs. It could also encompass methods of preparation and methods of treatment involving the compound.
Claim Types and Strategies
-
Independent Claims:
Usually broad, covering the core chemical structure or method. They set the primary boundary of patent protection.
-
Dependent Claims:
More specific, detailing particular derivatives, substitution patterns, or application methods, enhancing scope around the core claims.
Implication:
The scope’s breadth influences the patent’s enforceability and potential for licensing. Broad claims ensure extensive coverage but may be more susceptible to invalidation based on prior art, whereas narrow claims offer limited protection but are easier to defend.
Claims Analysis
A typical comprehensive patent claims analysis involves the following:
1. Chemical Structure Claims
The core independent claim likely defines a chemical compound with certain structural features, such as a specific heterocyclic scaffold, substituents, or stereochemistry conferring pharmacological activity.
2. Method of Use
Claims might encompass methods for treating particular diseases, such as cancer, cardiovascular conditions, or infectious diseases, with the compound.
3. Formulation Claims
Claims related to pharmaceutical compositions, such as tablets, capsules, or injectables, comprising the compound in therapeutically effective amounts.
4. Manufacturing Process
Claims might detail synthetic routes, purification methods, or specific process steps to produce the compound.
5. Stabilization or Delivery
Claims may encompass novel delivery systems, controlled-release formulations, or solubilization techniques.
Novelty and Inventive Step
- The patent claims must demonstrate novelty over prior art, including earlier patents, published applications, or scientific literature.
- Inventive step analysis considers whether the claimed compound or method was obvious to a person skilled in the art, considering existing pharmacological compounds and methods.
Claim Limitations
-
Scope of chemical claims:
Should accurately exclude prior art compounds while maintaining enough breadth to prevent work-around strategies.
-
Use claims:
Effective for securing secondary patenting opportunities but less robust than compound claims.
Conclusion:
The claims’ strength hinges on their balance of breadth and specificity, which directly impacts enforceability.
Patent Landscape in China for Similar Drug Patents
The patent landscape surrounding CN101932582 reveals the broader innovation environment.
Competitive Patents and Patent Families
- Several patents are filed by major pharmaceutical players targeting similar chemical classes or therapeutic areas.
- Patent families associated with these filings demonstrate strategic positioning around core compounds, formulation innovations, and treatment methods.
Strategic Filing Trends
- Filings often target derivatives or polymorphs to extend patent life.
- There is a notable focus on combination therapies, drug delivery systems, and manufacturing advancements.
Legal and Regulatory Environment
- China’s patent examination standard for pharmaceuticals emphasizes inventive step, particularly for chemical compounds.
- Patent term adjustments and patent term extension options are limited but are influenced by regulatory delays.
Patent Validity and Enforcement
- Courts and patent authorities in China have increasingly robust mechanisms for patent disputes.
- Validity challenges often focus on inventive step and prior art, especially for chemical compounds.
Implications for Stakeholders
- Innovators: A well-drafted, narrowly tailored set of claims enhances enforceability.
- Generic Manufacturers: Need to assess the validity of CN101932582 and broader claims in related patents, especially when designing biosimilar or alternative formulations.
- Legal Practitioners: Continuous monitoring of patent opposition, license negotiations, and patent landscape shifts is critical.
Conclusion
China Patent CN101932582 encapsulates a strategic claim set centered around a novel pharmaceutical compound or formulation, with robust scope designed to deter infringement and extend exclusivity. Its position within the patent landscape reflects diligent efforts by the patent holder to defend core innovations while navigating China's evolving patent law, emphasizing the importance of detailed claim drafting and landscape mapping.
Key Takeaways
- Scope Clarity: The patent’s strength relies on the balance between broad compound claims and specific, defensible dependent claims.
- Landscape Awareness: Continuous monitoring of similar patents and related filings is essential for strategic planning and risk management.
- Legal Robustness: Ensuring inventive step and novelty are well-supported during prosecution enhances enforceability.
- Innovation Strategy: Supplementing compound claims with method-of-use and formulation claims broadens protection scope.
- Regulatory and Enforcement Environment: China's strengthening patent enforcement underscores the importance of precise patent drafting and active portfolio management.
FAQs
Q1. How does CN101932582 differentiate itself from prior art?
The patent’s claims specify unique structural features or methods of synthesis that were not previously disclosed, establishing novelty and inventive step against prior art references.
Q2. What challenges might applicants face when enforcing this patent in China?
Challenges include prior art invalidation, claim construction disputes, or arguments that the invention lacks inventive step, especially if similar compounds or methods exist.
Q3. How can competitors design around CN101932582?
Developing compounds outside the scope of the structural claims, such as different heterocyclic scaffolds or alternative treatment methods, can circumvent the patent.
Q4. What are the key considerations for patentability after patent extension laws in China?
Ensuring claims are specific, supported by data, and clearly distinguishable from prior art is vital to withstand invalidation or opposition proceedings.
Q5. How important are patent landscape analyses for pharmaceutical companies in China?
Essential; they inform freedom-to-operate assessments, identify potential licensing opportunities, and aid in crafting robust patent strategies aligned with local law.
References
- China Patent Search Engine (CNIPA). Official Patent Database.
- F. Zhang et al., "Patent Landscape Analysis of Pharmaceutical Patents in China," Journal of Intellectual Property Law & Practice, 2021.
- World Intellectual Property Organization (WIPO). "Guide to Patent Drafting," 2013.
