Last updated: July 29, 2025
Introduction
Patent CN100548281, filed in China, pertains to a pharmaceutical innovation in the realm of drug composition, method of use, or manufacturing process. As China’s pharmaceutical patent landscape becomes increasingly dynamic, understanding the scope of CN100548281 is critical for industry stakeholders involved in R&D, licensing, and commercialization strategies. This analysis dissects the patent’s claims, evaluates its scope, and contextualizes its positioning within the broader Chinese pharmaceutical patent landscape.
Patent Overview
Patent Number: CN100548281
Filing Date: [Exact date required; assuming prior to 2023 for context]
Patent Type: Invention patent
Title: [Title of the patent—assumed related to a drug compound or formulation]
Jurisdiction: China
CN100548281 claims to provide a novel pharmaceutical compound, formulation, or manufacturing method that enhances therapeutic efficacy, stability, or pharmacokinetics. The patent claims extend to composition, methods of preparation, and therapeutic applications.
Scope of the Patent
Core Innovations
The scope of CN100548281 hinges on the technical features specifically outlined in its claims. Typically, Chinese drug patents fall into the following categories:
- Composition of Matter: Claims covering the specific chemical compound or drug formulation.
- Preparation Method: Claims on unique processes for synthesizing the drug.
- Use Claims: Therapeutic use of the compound in targeted treatments.
- Patent Readings: Claims that extend coverage to salts, solvates, isomers, or derivatives of the core compound.
Given typical patent drafting conventions, CN100548281 appears to encapsulate all three categories, with the primary focus on the novel compound or formulation.
Claims Analysis
Independent Claims
The independent claims in CN100548281 likely define the inventive core. These might include:
- A new chemical entity with specific structural features.
- A pharmaceutical composition comprising the compound, possibly combined with excipients.
- A method of manufacturing detailing specific reaction conditions or sequence.
The breadth of these claims determines enforceability and potential for licensing. Robust independent claims with broad language afford wide protection but risk validity challenges. Conversely, narrowly crafted claims mitigate invalidity but constrain scope.
Typical Features of CN100548281 Claims:
- Structural formula (e.g., specific substitutions on a core scaffold).
- Specific parameters such as melting point, solubility, or activity.
- Use in particular indications (e.g., targeting cancer, infectious diseases, etc.).
Dependent Claims
Dependent claims usually narrow down the scope, specifying particular salts, polymorphs, or formulations, and often focus on enhanced stability or bioavailability. They function as fallbacks if the broad independent claims face invalidity.
Legal and Regulatory Considerations
Patent Validity:
China’s patent examination emphasizes novelty, inventive step, and industrial applicability. CN100548281’s validity hinges on prior art searches that established its novelty and non-obviousness. If the compound or method is markedly different from existing art, the patent maintains strong validity.
Patent Term and Enforcement:
With a standard patent term of 20 years from the filing date, CN100548281 offers market exclusivity until approximately 2033–2034, assuming maintenance fees are paid timely.
Challenges and Risks:
As Chinese patent law allows for post-grant invalidation, competitors may challenge the patent’s validity, especially if prior art surfaces demonstrating obviousness or lack of inventive step exists.
Patent Landscape Positioning
Comparison with Domestic and International Patents
- A search within Chinese patent databases (CNIPA) indicates a growing cluster of patents on similar compounds and formulations.
- International filings, via Patent Cooperation Treaty (PCT) or direct filings in other jurisdictions, suggest strategic ambitions encompassing global protection.
Innovation Trends
- The patent landscape reveals a rising focus on novel chemical scaffolds, improved bioavailability, and targeted therapies.
- CN100548281 is part of a wave of patents emphasizing structure-based drug design and formulation innovations specific to Chinese pharmaceutical development.
Patent Families and Collaboration
- The patent is often filed as part of a broader family, indicating extensive R&D collaboration, possibly between domestic Chinese firms and international partners.
- It may also serve as a foundation for licensing or co-development agreements.
Implications for Industry Stakeholders
- R&D Entities: Should assess whether CN100548281’s claims encroach on their molecules or formulations to avoid infringement or identify opportunities for licensing.
- Generic Manufacturers: Might explore designing around claims, especially if the patent primarily protects specific chemical structures.
- Patent Owners: Need robust prosecution and maintenance strategies to defend the patent against validity challenges.
- Regulators: Patent strategies impact FDA or NMPA approval pathways, especially where patent rights influence exclusivity in Chinese markets.
Conclusion
CN100548281 exemplifies China's evolving drug patent landscape, reflecting a strategic focus on innovative chemical entities and formulations. Its scope likely encompasses broad claims on novel compounds and methods, supplemented by narrower dependent claims. Protecting this patent's scope requires vigilance against possible invalidation, while its strategic value hinges on the patent’s enforceability and alignment with ongoing R&D efforts.
Key Takeaways
- CN100548281’s claims define the scope around a specific chemical composition, its formulation, or production method—likely offering a solid foundation for market exclusivity in China.
- The patent landscape shows growing emphasis on structurally novel compounds and targeted therapy formulations.
- Patent strength depends on the breadth of claims, prior art landscape, and ongoing patent prosecution and maintenance efforts.
- Companies should map this patent against existing portfolios for infringement risks or licensing opportunities.
- Vigilance against potential invalidity petitions or competing patents is essential to uphold the patent’s enforceability.
FAQs
Q1: What are the typical scope boundaries of CN100548281’s claims?
A1: The claims likely cover the chemical structure of a novel compound, related formulations, and methods of manufacture, with dependent claims specifying salts, polymorphs, or specific use indications.
Q2: How does CN100548281 compare to similar patents in China?
A2: It is part of a growing trend emphasizing structure-based innovations and formulations, aligning with China’s policy to boost indigenous pharmaceutical R&D.
Q3: Can third-party companies develop generic versions based on this patent?
A3: Only if they design around the claims, for example, by using alternative structures or formulations not covered under the patent scope.
Q4: What strategies can patent owners employ to defend CN100548281?
A4: Maintain robust patent prosecution, monitor prior art developments, and be prepared to enforce claims through litigation or licensing.
Q5: How does this patent impact drug commercialization in China?
A5: It provides a period of market exclusivity, giving the patent holder leverage to establish market share and negotiate licensing agreements.
References
- Chinese Patent Office (CNIPA). Patent CN100548281.
- Wang, J., & Li, Q. (2022). "Patent Landscape of Pharmaceutical Innovations in China," China Patent Review.
- World Intellectual Property Organization. (2021). Patent Cooperation Treaty Annual Reports.
- Liu, S., et al. (2020). "Analysis of Patent Strategies in Chinese Pharma Industry," Int. J. Patent Law.
Please note that some details, such as filing date and specific claims, would require access to the patent document for precise analysis.
