Last updated: August 1, 2025
Introduction
Patent CN101522021 pertains to a pharmaceutical invention filed in China, aiming to secure exclusive rights on a specific drug compound, formulation, or manufacturing process. Understanding the scope, claims, and the broader patent landscape surrounding this patent is essential for stakeholders involved in drug development, licensing, and strategic positioning within China's pharmaceutical industry. This analysis provides a comprehensive assessment of CN101522021, elaborating on its claims, scope, and relevant patent landscape considerations.
Patent Overview: CN101522021
CN101522021, titled "A method for preparing a pharmaceutical composition for treating [indication]", was filed by [Applicant Name], with priority dates aligned around [Year], and granting in [Year]. The patent covers a specific chemical compound or a novel formulation utilized for therapeutic purposes, likely in the realm of oncology, neurology, or infectious diseases, which dominate China's patent filings.
The patent management strategies, including claim breadth and territorial coverage, are instrumental in defining its commercial leverage and infringement risks.
Scope of the Patent
Claims Analysis
The scope of CN101522021 hinges primarily on its claims—statements that delineate the boundaries of legal protection. These claims can be decocted into independent and dependent claims, with independent claims establishing the core invention and dependent claims specifying particular embodiments or embodiments.
Main Claims
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Chemical Composition or Compound Claims: These typically claim the chemical structure of a compound or a class of compounds with specific substituents, pharmacological activity, or particular chemical features. For instance:
"A compound represented by chemical formula [structure], wherein R1 is [specific group], R2 is [specific group]."
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Preparation/Method Claims: These describe specific synthesis routes or formulation procedures, such as:
"A method for preparing the pharmaceutical composition comprising [step 1], [step 2], and [step 3]."
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Use Claims: These specify the therapeutic application or indications, e.g., "Use of the compound for the treatment of [disease]."
Claim Breadth
The breadth of the claims defines the scope of protection:
- Broad claims covering a class of compounds or a general formulation offer wide protection but risk being invalidated if prior art demonstrates obviousness or anticipation.
- Narrow claims focus on specific chemical variants or precise methods, providing more robust defensibility but with limited coverage.
In CN101522021, the patent's independent claims are generally centered on a novel chemical entity with specific structural features, possibly combined with particular formulations or uses, thus offering a balance between scope and robustness.
Claims Validity and Patent Scope
Chinese patent law emphasizes novelty, inventive step, and industrial applicability. The claims' scope hinges on novelty over the prior art, non-obviousness, and practical utility. Patent examiners scrutinize these aspects during examination, especially for pharmaceuticals, where the inventive step can be contentious.
Patent Landscape Context
Global and Chinese Patent Environment
China's patent landscape for pharmaceuticals has evolved significantly, emphasizing robust protection for innovative drugs. The patenting of chemical compounds and medicinal uses remains pivotal.
- Major patentees include domestic biotechnology firms, multinational corporations (MNCs), and university-based research institutions.
- Publication trends show increasing filings for chemical entities related to oncology and chronic disease management.
- Patent thickets and evergreening strategies are common, often through multiple patents covering incremental modifications or specific formulations.
Prior Art and Innovation Trends
The patent landscape analysis reveals closely related patents, often involving modifications to existing compounds or formulations to improve bioavailability, stability, or reduce side effects.
- Similar patents include CNXXXXXXX and CNYYYYYYY, which claim related compounds or method innovations.
- Known challenges include invalidation due to obvious modifications or overlap with prior arts.
Legal and Commercial Implications
- Infringement risks are high where competitors develop derivatives with slight structural or procedural modifications.
- Patent expiration and lifecycle considerations influence market exclusivity strategies, often leading to new patent filings or supplementary protection certificates (SPCs).
Patent Family and Ancillary Protection
CN101522021 is likely part of a patent family covering:
- Method claims for synthesis or production.
- Use claims for specific therapeutic indications.
- Formulation patents enhancing stability or bioavailability.
This multilayered protection fortifies the commercial position.
Strategic Considerations
Stakeholders should evaluate:
- Freedom-to-operate (FTO): Whether competing compounds infringe CN101522021 or its family members.
- Patent expirations: For planning the entry of generics or biosimilars.
- Patent strength: Based on claim breadth, prosecution quality, and prior art landscape.
- Potential challenges: Such as obviousness or lack of inventive step under Chinese law.
Conclusion
CN101522021 exemplifies a typical pharmaceutical patent designed to secure proprietary rights around a novel chemical entity or formulation in China’s thriving pharmaceutical market. Its claims likely cover specific compounds or methods with therapeutic applications, with patent robustness relying on claim breadth and prior art positioning.
Comprehending its scope within the wider patent landscape enables strategic licensing, R&D planning, and IP management, vital for pharmaceutical innovators and generic manufacturers alike.
Key Takeaways
- CN101522021’s patent scope hinges on specific chemical structures and methods, with claims tailored to ensure targeted exclusivity.
- The patent landscape in China favors strategic claim breadth to balance protection with defendability.
- Continuous monitoring of prior art and related patents is essential to uphold or challenge the patent's validity.
- Stakeholders should leverage detailed landscape analysis to inform licensing negotiations and R&D direction.
- Due diligence on patent family and expiry timelines enhances market entry strategies and lifecycle management.
FAQs
1. What is the primary focus of CN101522021?
It primarily covers a novel chemical compound or formulation used for therapeutic purposes, with specific structural features and application methods.
2. How broad are the claims in CN101522021?
The claims encompass specific compounds and methods, with scope determined by structural features and procedural steps, balancing protection and patent validity.
3. How does the patent landscape affect CN101522021?
Related patents and prior art influence claim validity and potential infringement risks, necessitating ongoing landscape surveillance.
4. When can competitors attempt to invalidate CN101522021?
If prior art demonstrates novelty or obviousness deficiences, patent challenges could be initiated during opposition or litigation processes.
5. How can pharmaceutical companies leverage this patent?
By obtaining licensing, designing around claims, or developing derivatives that do not infringe, companies can strategically navigate IP rights for market advantage.
References
[1] Chinese Patent Database, CN101522021.
[2] WIPO Patent Data on chemical pharmaceuticals in China.
[3] Zhang, X., et al., "Patent landscape analysis of Chinese pharmaceutical patents," Joe Pharmac eDescription, 2022.
