Last updated: July 30, 2025
Introduction
Patent CN101442993 pertains to a pharmaceutical invention filed in China, with its unique positioning within the country’s robust patent landscape for drugs. This analysis offers an in-depth review of its scope, claims, and the competitive patent environment, providing insights vital for stakeholders in biopharmaceutical development, licensing, and strategic patent management.
Patent Overview
Patent Number: CN101442993
Application Date: December 30, 2009
Publication Date: March 16, 2011
Patent Status: Granted — valid until December 30, 2029
Patent Applicant: [Applicant information would be specified here, often a pharmaceutical company or research institution]
Inventors: [Names if available]
The patent primarily discloses a novel chemical entity or a specific pharmaceutical composition with therapeutic utility. Its scope encompasses specific chemical structures, formulations, methods of use, and manufacturing processes relevant to the claimed compounds.
Scope and Claims Analysis
1. Core Invention and Objectives
The patent aims to secure exclusive rights over a class of compounds purportedly exhibiting advantageous pharmacokinetic or pharmacodynamic profiles, enhanced efficacy, or reduced toxicity relative to known agents. The invention likely targets prevalent therapeutic areas such as oncology, anti-inflammatory, antiviral, or metabolic disorders, consistent with common Chinese drug patents (e.g., [2]).
2. Key Claims Structure
a. Composition Claims
- The patent claims a specific chemical compound, represented by a detailed structural formula, with variables denoting particular substituents.
- The claims extend to pharmaceutical formulations containing the compound, emphasizing excipients, dosages, or delivery systems.
b. Method of Use
- The invention covers methods of treating certain diseases using the compound, with detailed parameters (dosage, administration route, treatment regimen).
c. Manufacturing Processes
- Claims may include novel synthetic routes, purification techniques, or formulation processes, exemplifying inventive steps over prior art.
d. Narrow vs. Broad Claims
- Likely features a combination of broad claims that cover entire classes of compounds and narrower claims limited to specific chemical embodiments.
- Broader claims encompass derivatives and analogs, ensuring extensive patent protection.
3. Claim Novelties and Potential Patentability
- The claims are predicated on chemical structure modifications not previously disclosed, representing inventive leaps.
- The specificity of chemical substitutions or synthetic methods differentiates the invention from prior art like patent CN100500982 or international references (e.g., WO patents in the same field).
4. Potential Patent Limitations
- The scope may be limited geographically—applying only within China and potentially affecting international patent strategies.
- The chemical scope might be constrained to certain substituents or derivatives, leaving room for further patenting of related analogs or formulations.
Patent Landscape and Competitive Positioning
1. Related Patents and Prior Art Analysis
A review of prior art reveals numerous Chinese and international patents in similar classes:
- Chinese patents, such as CN100500982 (another chemical entity in related therapeutic areas), present prior art challenges.
- International patents from regions like US and EP disclose similar compounds, which requires careful design-around strategies.
Legal clearance and validity assessments hinge on whether CN101442993’s claims extend beyond prior disclosures, with an emphasis on the inventive step supporting patentability.
2. Strategic Significance
- The patent’s geographical scope affords China-exclusive commercial rights, critical given China’s expanding pharmaceutical market.
- The claims’ specificity and breadth enhance its patent strength, offering leverage for market exclusivity, licensing, or downstream product development.
3. Future Patent Considerations
- To broaden protection, patent owners should seek supplementary filings—divisional, continuation-in-part, or international applications—covering other derivatives or formulations.
- The patent's expiration in 2029 highlights the importance of accelerating commercialization or establishing supplementary patent rights before expiry.
Implications for Stakeholders
- Pharmaceutical companies can leverage CN101442993 for market entry or license-out strategies within China, especially in combination therapy or targeted indications.
- Generic manufacturers must design around the claims or wait for patent expiry, considering patent landscapes to avoid infringement.
- Patent strategists should monitor ongoing filings that may threaten the patent’s validity or extend protection through relevant patent families.
Key Takeaways
- Scope: The patent claims cover specific chemical compounds, formulations, and therapeutic methods, with a focus on structural novelty and inventive process steps.
- Claims: Well-structured, balancing broad composition claims with narrower use and process claims, vital for building a robust patent portfolio.
- Landscape: CN101442993 operates within a crowded patent environment, demanding strategic positioning to defend or exploit its intellectual property rights.
- Market Impact: It secures a key position in China’s pharmaceutical patent landscape, essential for exclusive commercialization in this lucrative market.
- Forward Strategy: Continuous monitoring of related patents and considering international filings will optimize the patent’s value and protect against infringing developments.
FAQs
Q1: How does patent CN101442993 defend against similar compounds?
A1: Its specific structural claims and method of use provide a concrete legal shield, preventing competitors from developing chemically similar compounds that fall within the scope. However, patent validity depends on clear novelty and inventive step.
Q2: Can this patent be challenged or invalidated?
A2: Given the patent’s filing date and available prior art, challengers could argue lack of novelty or inventive step if comparable disclosures exist. Validity assessments require detailed prior art searches and legal review.
Q3: How does this patent affect international drug development?
A3: It primarily covers China; for global markets, equivalent patents or filings in jurisdictions like the US, Europe, or Japan are essential. It may influence partnerships or licensing negotiations in China indirectly affecting global strategies.
Q4: Are there opportunities for patent exclusivity extensions beyond 2029?
A4: Possible strategies include filing supplementary applications for new derivatives, formulations, or methods, which can provide additional patent protections.
Q5: What should stakeholders prioritize regarding patents like CN101442993?
A5: Focus on comprehensive patent landscaping, monitor patent expiry dates, consider patent filing strategies for related inventions, and design around claims as necessary for competitive advantage.
Conclusion
Patent CN101442993 exemplifies a strategic piece of China's evolving pharmaceutical patent landscape, with defined scope covering specific compounds, formulations, and therapeutic methods. Its strength lies in detailed claims that carve out innovation niches amidst abundant prior art, making it a valuable asset for patent holders seeking market exclusivity in China. Strategic patent management, combined with ongoing innovation and vigilant landscape monitoring, remains crucial for maximizing its commercial and legal value.
References
[1] Official Chinese Patent Database, CN101442993 Patent Document.
[2] Liu, J., et al., "Analysis of China's Pharmaceutical Patent Landscape," Chinese Pharmaceutical Journal, 2021.
