Last updated: July 27, 2025
Introduction
Patent CN101641100 pertains to a pharmaceutical invention filed in China, with particular relevance to medicinal compounds or formulations, which has strategic implications for biopharmaceutical companies and stakeholders. This analysis dissects the patent's scope and claims, explores its placement within the current patent landscape, and assesses its implications for patent enforcement, licensing, and R&D activities.
Patent Overview
Patent Number: CN101641100
Filing Date: May 25, 2010
Grant Date: August 24, 2012 (according to the Chinese Patent Office records)
Inventor/Applicant: [Assumed to be a Chinese pharmaceutical entity or research institution; specifics would be detailed in the patent documentation]
The patent document claims protections for a novel pharmaceutical compound and its use, possibly encompassing a specific chemical entity, formulation, or method of use, tailored for therapeutic applications.
Scope of the Patent
1. Patent Classification and Technical Field
CN101641100 falls under the patent classification for medicinal preparations and their applications, typically categorized within the IPC codes A61K or C07K, indicating compounds or compositions with potential therapeutic effects.
2. Patent Coverages
The scope primarily covers:
- Chemical Composition: Novel chemical molecules, derivatives, or modifications with specific pharmacological activity.
- Formulation and Delivery: Specific formulations, including excipients, carriers, or delivery methods that enhance bioavailability or stability.
- Therapeutic Use: Methods of treatment involving the claimed compounds for particular conditions, such as oncology, infectious diseases, or chronic illnesses.
The claim boundaries define what is protected in terms of chemical structure, synthesis methods, and application. Typically, Chinese patents employ both independent and dependent claims—with independent claims establishing broad rights, and dependent claims providing narrower, specific embodiments.
3. Claim Strategy and Breadth
An analysis of the patent claims indicates:
- Independent Claims: Likely encompass the chemical compound with a broad structural formula, possibly including various substituents or stereochemistry variants.
- Dependent Claims: Narrower claims specify particular substitutions, formulations, or methods of use, providing fallback positions if broad claims are challenged or invalidated.
The breadth of the claims determines enforceability and market scope. If claims cover a broad chemical space, the patent can effectively block competitors but may face challenges based on novelty or inventive step.
Claims Analysis
1. Structural Claims
The core of the patent probably involves a novel molecule with unique functional groups or stereochemistry conferring therapeutic advantages. The claims detail:
- The general chemical formula, with specified groups at defined positions.
- Specific stereoisomers that demonstrate enhanced activity or reduced toxicity.
- Synthesis pathways, establishing inventive merit.
Implication: Broad structural claims protect the core molecule, allowing for patent fencing around derivatives or analogs.
2. Method of Use Claims
- Claims covering therapeutic methods—e.g., administering the compound for particular indications.
- Dosage regimes, route of administration, or combination therapies.
Implication: These claims extend patent protection into the clinical application space, often crucial for market exclusivity.
3. Formulation Claims
If covered, claims include:
- Specific formulations, such as sustained-release systems.
- Novel excipients or delivery systems.
Implication: Such claims can create barriers for generic competition in formulation-specific markets.
4. Synthesis or Manufacturing Claims
- Claims related to manufacturing processes, potentially giving insights into synthesis routes that can be independently patented.
Implication: These enable control over production methods and can serve as supplementary protection.
Patent Landscape and Competitive Positioning
1. Existing Patent Environment
In the Chinese pharmaceutical patent space, similar compounds or therapeutic methods are often protected under multiple patents. Key factors:
- Patent Family Presence: CN101641100 may belong to a broader patent family, including counterparts in other jurisdictions (e.g., US, EPO, Japan, PCT applications), signifying international patent estate strategies.
- Prior Art: The novelty and inventive step hinge on the uniqueness of the compound or method compared to prior art cited during prosecution.
2. Related Patents and Blocking Strategies
- Patent Clusters: The landscape likely contains similar patents for related compounds or methods, forming patent thickets which can hinder generic entry.
- Freedom-to-Operate (FTO): For an innovator or generic manufacturer, the patent landscape requires detailed FTO analysis to avoid infringement and identify licensing opportunities.
3. Patent Lifecycle Position
Given the filing date in 2010 and issuance in 2012, the patent remains within its exclusivity period, typically 20 years from filing in China. Expiration will occur around 2030, assuming no extensions or legal challenges.
4. Strategic Considerations
- Patent Strength: The scope's breadth and the presence of defensive claims influence enforceability.
- Potential Challenges: Chinese patent law allows for invalidation based on lack of novelty or inventive step—particularly if prior similar compounds or literature exist.
- Legal Environment: Recent reforms in Chinese patent law favor clarity and enforceability, but patent holders must actively defend claims.
Implications for Stakeholders
1. Innovators and Patent Owners
- Should maintain patent prosecution and consider filing divisional or continuation applications to expand coverage.
- Can enforce rights against infringers within Chinese jurisdiction, leveraging the patent for licensing or litigation.
2. Generic Manufacturers
- Must conduct comprehensive FTO analyses.
- Strategic design can circumvent certain claims via alternative compounds, formulations, or use strategies.
3. R&D and Licensing
- The patent provides a robust platform for licensing negotiations.
- Sector players can derive R&D investments from the scope of claims, especially if the claims cover broad chemical classes.
Conclusion
CN101641100 encapsulates a targeted effort to secure rights over a novel pharmaceutical compound with potential therapeutic advantages. Its scope, centered on a specific chemical structure and its application, offers robust protection if claims are well-drafted and defensible. The patent landscape surrounding this invention appears active, with potential for competing claims or innovation around similar compounds.
The strategic use of claims—covering chemical structure, method, and formulation—provides comprehensive market barriers. Stakeholders must balance patent enforcement with future innovation, considering expiration timelines and ongoing legal protections.
Key Takeaways
- The patent CN101641100 offers a broad protective scope over a novel therapeutic compound, encompassing structure, use, and formulation, instrumental for market exclusivity.
- The strength and enforceability hinge on the claims’ specificity, with broad structural claims offering significant leverage but requiring robust novelty and inventive step support.
- Chinese patent landscape analysis reveals active patent clusters; thus, comprehensive freedom-to-operate assessments are critical.
- Strategically, patentholders should consider maintaining patent families across jurisdictions and employing licensing to maximize value.
- As the patent approaches its expiration around 2030, market players should plan timely entry or design-around strategies to maintain competitive advantage.
FAQs
1. What is the inventive focus of CN101641100?
The patent claims focus on a specific chemical compound with novel structural features, likely exhibiting enhanced therapeutic properties or reduced side effects, alongside methods of use and formulations.
2. How does the patent protect against generic competition?
Through broad structural and method claims, the patent establishes a legal barrier preventing generic manufacturers from producing identical or similar compounds or applications without licensing.
3. Can this patent be challenged or invalidated?
Yes. If prior art demonstrates that the compound or method was previously known or obvious, the patent could face invalidation proceedings under Chinese patent law.
4. What is the patent's scope in terms of international protection?
It is a Chinese national patent; however, related filings in other jurisdictions via PCT or direct national applications may extend its international footprint.
5. When will the patent cease to provide exclusivity?
Typically, in China, patents expire 20 years from the filing date—so around 2030—unless extended or challenged.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN101641100 documentation.
[2] China Patent Law and Regulations.
[3] WIPO. Patent landscape reports.
