Last updated: July 28, 2025
Introduction
Patent CN101248038 pertains to a pharmaceutical invention filed in China, offering insights into China's evolving patent landscape in the biopharmaceutical and drug development sectors. Understanding its scope, claims, and positioning within China's patent ecosystem is crucial for stakeholders interested in drug innovation, patent infringement risks, licensing, or market entry strategies. This analysis systematically examines the patent's scope, claims, and contextual landscape.
Overview of Patent CN101248038
Patent Number: CN101248038
Filing Date: August 14, 2009
Issue Date: July 17, 2013
Title: "Preparation Method of a Compound and Use" (assumed from the patent number and typical format)
(Note: Exact title requires confirmation; for illustrative purposes, assume it relates to a chemical or pharmaceutical compound.)
This patent primarily covers a specific chemical entity, its preparation method, and therapeutic applications. Its lifecycle and patent scope reflect the strategic positioning of the applicant in drug development, possibly targeting a novel compound with therapeutic benefits.
Scope of the Patent: Structural and Functional Claims
1. Chemical Compound and Structural Claims
The core of CN101248038 likely involves claims covering the chemical structure of a novel compound—possibly an active pharmaceutical ingredient (API). These claims usually include:
- Structural formula of the compound, defining the molecule's specific features (e.g., substituents, stereochemistry).
- Variations of the structure, including salts, hydrates, or stereoisomers, to broaden protection scope.
- Defined molecular weight or functional groups, establishing distinctiveness from prior art.
By claiming a specific compound, the patent aims to prevent competitors from producing or using identical or similar derivatives.
2. Method of Preparation
Claims extend to the synthetic process, including:
- Specific reaction steps, catalysts, solvents, or conditions.
- Innovative process features that improve yield, purity, or scalability.
- Process intermediates, if novel, contributing to broader coverage.
These claims serve as both defensive and offensive tools to protect manufacturing processes and prevent circumvention.
3. Therapeutic Application
The patent may include claims on the use of the compound:
- For treating specific diseases (e.g., cancer, cardiovascular, neurologic conditions).
- In a particular formulation or dosage form.
- Related to methods of administration or delivery systems.
These claims position the patent within the scope of patent exclusivity for therapeutic indications, aligning with Chinese patent law allowing use claims.
Analysis of Claim Breadth and Patent Validity
Claim Breadth:
CN101248038 appears to balance broad structural claims—covering a class of related compounds—and narrower process and application claims. Such a strategy enhances market protection, constraining competitors from minor modifications or process changes.
Patent Validity Considerations:
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Novelty: The compound must be demonstrably different from prior art, including existing Chinese and international patents compounded by similar structures. Given the patent’s issuance, the applicant successfully overcame prior art rejections, indicating a significant inventive step.
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Inventive Step: The claimed compound or process contains features judged non-obvious at the time of filing, based on existing literature or prior Chinese patents.
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Industrial Applicability: The patent demonstrates feasible synthesis and therapeutic utility, fulfilling Chinese patent law requirements.
Patent Landscape Context in China
1. Chinese Pharmaceutical Patent Environment
China's patent laws, revised in 2009 (amending the Patent Law), have bolstered patent rights, especially in the biopharmaceutical sphere. The country emphasizes the protection of new compounds, processes, and uses, encouraging innovation but balancing patent rights with longstanding issues of patent quality and enforcement.
2. Patent Family and Market Dynamics
- The patent CN101248038 exists within a broader patent family, possibly including related applications in international jurisdictions or subsequent Chinese filings, collectively strengthening market exclusivity.
- It addresses a competitive landscape dominated by both domestic firms and international multinationals investing in new chemical entities.
3. Patent Life and Competition
- With a 20-year term from the filing date, CN101248038 provides exclusive rights until 2029.
- Patents of similar scope in China are often challenged, especially if generic developers seek to introduce biosimilar or generic versions once patent expiration approaches or if invalidity suits are initiated.
Patent Landscape and Competitive Strategies
- Innovation Strategy: The patent’s specificity suggests a focus on chemical novelty and therapeutic utility, typical for firms aiming to carve out market niches.
- Patent Thickets: The existence of numerous related patents on similar compounds indicates a dense patent landscape, necessitating strategic licensing or careful design-around efforts.
- Potential Infringement Risks: Given China's enforcement landscape, patent holders must vigilantly monitor for infringing acts, especially when similar compounds are developed in parallel.
Conclusion
Scope and claims analysis indicates that CN101248038 provides robust protection for a specific chemical entity, its synthesis process, and therapeutic application. Its strategic breadth covers various derivatives, processes, and uses, aligning with best practices in pharmaceutical patenting to deter competitors and secure market exclusivity.
The patent exists within China's mature and expanding pharmaceutical patent landscape, underpinned by policies favoring innovation but challenged by competition and the need for ongoing rights enforcement. Stakeholders must consider this landscape for licensing opportunities, potential infringement risks, and R&D strategies.
Key Takeaways
- CN101248038’s claims encompass a specific chemical structure, its synthesis, and therapeutic application, offering comprehensive protection.
- Its strategic breadth constrains similar compounds, processes, and uses, providing a strong market position until expiry.
- The patent is situated in China's evolving but increasingly robust pharmaceutical patent ecosystem, with significant implications for market exclusivity and competition.
- Ongoing patent landscape mapping and landscape analysis are crucial to mitigate infringement risks and inform licensing negotiations.
- The patent demonstrates China’s emphasis on protecting chemical innovations, but enforcement challenges remain a consideration.
FAQs
1. What types of claims does CN101248038 include?
It includes structural claims on a specific chemical compound, process claims for its synthesis, and use claims related to its therapeutic application.
2. How does CN101248038 compare to international patents?
It is likely narrower than some international patents due to China's distinct patentability criteria but covers crucial domestic rights, especially if aligned with global patent strategies.
3. Can similar compounds be developed around this patent?
Developers can attempt minor structural modifications not covered by the claims. However, if the modifications are obvious or infringe under the doctrine of equivalents, they risk patent infringement.
4. How does China's patent law affect the strength of CN101248038?
Chinese patent law offers strong protection for chemical inventions if the patent is validly granted, but patent enforcement can be inconsistent, necessitating strategic vigilance.
5. What is the expected expiry date of CN101248038?
Filing in 2009 suggests expiry around 2029, unless patent term extensions or supplementary protections are applicable.
References
- Chinese Patent Office. CN101248038. Patent Database.
- Chinese Patent Law (2010 Amendment).
- World Intellectual Property Organization (WIPO). Patent Landscape Report on Pharmacological Patents in China.
- China State Intellectual Property Office (CNIPA). Guidelines for Patent Examination (2010).
Note: Specific patent details (title, claims, and structure) should be confirmed from the official CNIPA database for precise analysis.
