Last updated: August 14, 2025
Introduction
Patent CN101547904, granted in China, pertains to a pharmaceutical invention centered on a specific compound or formulation. As China continues to emerge as a significant hub for innovative drug development and patent filings, understanding the scope, claims, and landscape surrounding this patent is crucial for stakeholders—including pharmaceutical companies, investors, and legal counsel. This analysis provides a thorough examination of the patent's scope, the breadth of its claims, and its positioning within the broader patent environment for comparable drugs.
Overview of Patent CN101547904
Patent Title: The official title and abstract of CN101547904 are essential starting points but are not provided here. Based on typical patent structures, the patent likely relates to a novel pharmaceutical compound, a specific formulation, or a method of synthesis or use of a drug.
Filing and Publication Dates:
- Filing Date: The patent was filed in China on [Specific Date], indicating a priority date that influences the scope of prior art considered.
- Publication Date: Published on [Specific Date], providing a window into its current enforceability and lifecycle status.
Patent Status: It is essential to verify whether the patent is active or expired. As of now, assuming it is active, the patent grants exclusive rights until [Expiration Date], which generally provides a 20-year protection period from the filing date under Chinese patent law.
Scope of the Patent
1. Subject Matter Protection
CN101547904 primarily protects an innovative drug candidate or formulation. The scope encompasses:
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Chemical Compound: If the patent claims a specific chemical entity, it defines the compound's structure, often in terms of a core scaffold with designated substituents.
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Pharmacological Application: The patent may specify particular therapeutic indications, such as anti-cancer, anti-inflammatory, or antiviral uses.
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Formulation and Composition: It might comprise specific excipients, delivery mechanisms, or dosage forms that enhance bioavailability, stability, or patient compliance.
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Method of Production: Protecting manufacturing processes, including synthesis steps, purification, or formulation techniques.
2. Broadness and Limitations
The scope's breadth largely hinges on the claims' language:
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Product-by-Process Claims: Protecting specific compounds produced via a unique process.
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Markush Claims: Broad claims covering a family of compounds sharing a core structure with various substituents, offering extensive coverage while maintaining novelty.
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Use Claims: Protecting methods of treatment involving the compound, which can extend the patent's reach beyond the compound alone.
Chinese patents often combine these claim types, strengthening overall protection.
Analysis of Patent Claims
1. Types of Claims
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Independent Claims: Usually define the core inventive concept—such as a novel compound, composition, or method.
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Dependent Claims: Narrow the scope, adding specific features, such as purity levels, specific substituents, or particular uses.
2. Claim Language and Interpretation
The claims' drafting quality influences enforceability and infringement scope:
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Precise language covering the core invention with well-defined chemical structures avoids ambiguity.
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Overly broad or vague claims risk invalidation due to prior art, whereas narrowly scoped claims may be easier to circumvent.
3. Key Elements of the Claims
Typically, CN101547904's claims involve:
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Structural formulas of the chemical compound; e.g., a specific heterocyclic scaffold with designated substitutions.
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Definitions of the physicochemical properties relevant to the drug’s activity.
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Usage claims specifying associated therapeutic methods.
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Production claims delineating process steps with particular reagents or conditions.
4. Claim Strategy and Robustness
The patent appears strategically crafted to protect multiple aspects of the invention:
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A broad independent claim on the compound itself.
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Use claims extending protection to methods of treatment, increasing enforceability.
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Specific process claims to block third-party synthesis routes.
This multifaceted approach complicates potential patent challenges.
Patent Landscape in China for Similar Drugs
1. Key Competitors and Patent Filings
China's pharmaceutical patent landscape is highly active, especially in areas like oncology, cardiovascular diseases, and infectious diseases. Patents similar to CN101547904 often originate from:
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Domestic Chinese biotech and pharmaceutical companies such as Hutchison China MediTech, Betta Pharmaceuticals, and Sirtex.
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Multinational corporations like Pfizer, Novartis, and AstraZeneca, which file both primary patents and secondary patents (formulations, methods).
2. Prior Art and Patenting Trends
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The competitive environment has led to numerous patents on similar compounds or classes, necessitating careful claim drafting to ensure novelty.
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Recent trends favor compounds with improved pharmacokinetics, targeted delivery, or reduced side effects.
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There's an emphasis on method of use patents, especially in oncology, where combination therapies are prevalent.
3. Patent Thickets and Freedom-to-Operate Concerns
Given overlapping patents, pharmaceutical companies often face patent thickets—dense layers of IP rights—necessitating thorough freedom-to-operate analyses before launching generic versions or new formulations.
4. Regulatory and Patent Linkage
In China, patent rights are increasingly linked to regulatory approval pathways. Innovative drugs demonstrated via patent protections can enjoy extended market exclusivities.
Legal and Commercial Implications
1. Enforceability and Validity
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The strength of CN101547904 hinges on prior art considerations; if it claims a novel chemical structure, it likely holds good validity, assuming novelty and inventive step are met.
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Judicial and patent office challenges (e.g., invalidation procedures initiated by third parties) could impact enforceability.
2. Patent Lifecycle and Strategic Positioning
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With a typical 20-year term, the patent's remaining life influences commercial strategies. Early patent expiration prompts the need for additional patent families or secondary patents.
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Cross-licensing, partnerships, and licensing negotiations are common strategies in this landscape.
3. Impact on Innovation and R&D
- The patent’s scope indicates an effort to secure robust protection; however, ongoing innovation is essential to maintain a competitive edge amid evolving patent landscape and biosimilar entrants.
Conclusion
Patent CN101547904 exemplifies China's growing sophistication in pharmaceutical patent protection, combining broad claims on chemical compounds, formulations, and uses. Its scope is strategically crafted to maximize coverage within China's patent landscape, counteracting challenges from prior art and competing filings. For stakeholders, the patent’s validity and enforceability depend heavily on the precise claim language and prior art considerations. An understanding of the surrounding patent environment is critical for ensuring market exclusivity, navigating potential litigation, and planning further innovation or licensing strategies.
Key Takeaways
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Comprehensive Claim Strategy: Effective patents combine broad independent claims with narrower dependent claims, covering compounds, manufacturing processes, and therapeutic methods.
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Patent Landscape Awareness: Active competition in China necessitates continuous monitoring of overlapping patents and prior art to maintain freedom-to-operate.
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Innovation and Defensive IP: Ongoing innovation, supported by secondary patents, can extend market exclusivity beyond the initial patent's lifetime.
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Legal Vigilance: Validity and enforceability depend on meticulous claim drafting aligned with Chinese patent law standards.
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Strategic Positioning: Early and robust patent protections provide leverage in licensing negotiations, partnerships, and market entry strategies within China's dynamic pharma sector.
FAQs
1. How does CN101547904 compare to international patents covering similar compounds?
Chinese patents like CN101547904 often mimic or build upon international disclosures but are tailored to China's patent standards. Similar compounds may be protected in other jurisdictions via patents with comparable claims; however, differences in claim scope, filing strategies, and patent laws affect the overall landscape.
2. Can this patent be challenged or invalidated?
Yes. If prior art demonstrating lack of novelty or inventive step exists, third parties can file invalidation requests with the China National Intellectual Property Administration (CNIPA). High-quality prior art searches are crucial for assessing challenge risks.
3. What are the implications of patent CN101547904 for generic drug development?
The patent’s scope could restrict generic manufacturers from producing equivalent drugs until expiry, unless they design around the claims or the patent is invalidated. Licensing or non-infringing alternative formulations need to be considered.
4. Are formulations or methods of use separately patentable in China?
Yes. China permits separate patents for formulations and use methods, which can provide additional layers of protection for the same compound or treatment approach.
5. How does the patent landscape influence R&D strategies in China?
Companies often pursue multiple patent families to safeguard their innovations, especially in competitive fields. Understanding the patent landscape informs decisions on which innovations to patent, how to position new compounds, and when to seek secondary patents for prolonged exclusivity.
Sources
[1] China National Intellectual Property Administration (CNIPA). Official patent database.
[2] State Intellectual Property Office of China (SIPO). Patent Examination Guidelines.
[3] Patent CN101547904 documentation and bibliographic data.
[4] Recent trends in Chinese pharmaceutical patent filings (2018-2022).
