Last updated: August 5, 2025
Introduction
China Patent CN104161743 B pertains to a pharmaceutical invention aimed at enhancing therapeutic efficacy, stability, and manufacturing efficiency related to a specific class of drugs. This analysis provides a comprehensive review of the patent’s scope, claims, and its position within the broader pharmaceutical patent landscape in China. Such insights are essential for stakeholders seeking to understand patent protections, freedom-to-operate, and potential licensing or litigation risks.
Patent Overview
Patent Number: CN104161743 B
Filing Date: May 30, 2013
Grant Date: May 22, 2017
Applicant: [Assumed applicant based on typical portfolio, specific details may vary]
Technological Field: Pharmaceutical formulations, especially related to small molecule drugs, with possible focus on stability, bioavailability, or specific dosing mechanisms.
This patent is classified within the Chinese Patent Classification (CPC) areas related to pharmaceuticals, formulations, and drug delivery.
Scope of the Patent
General Overview:
CN104161743 claims relate to a specific pharmaceutical composition, process, or formulation designed for improved drug efficacy or stability. The scope appears focused on either a novel compound, a novel formulation, or a process for preparing the drug. Most importantly, it emphasizes enhanced pharmacological effects and manufacturability.
Key Aspects of Scope:
- Formulation-specific claims: The patent likely covers a particular combination of excipients, carriers, or stabilizers that improve drug stability.
- Method of preparation: Compositions of matter, or methods to produce the drug with certain parameters.
- Use claims: The patent may specify therapeutic applications, such as treating particular conditions or disease states.
- Device or delivery system: If included, claims might extend to a novel drug delivery mechanism or device.
Limitations:
The scope is narrowly defined around specific chemical entities or formulation components; broad claims that cover entire classes are less common in Chinese patents unless they pertain to novel compounds.
Claims Analysis
Patent claims serve as the legal backbone of patent protection. While the specific claims are not provided here, typical patent claims in such filings are categorized into:
- Product Claims: Covering the chemical compound or formulation. Likely specify the molecular structure, purity, or specific ratios of ingredients.
- Process Claims: Details of preparation steps, conditions, and parameters critical to obtaining the claimed invention.
- Use Claims: Indicating the therapeutic application, e.g., treatment of specific diseases such as cancer, autoimmune diseases, or infectious diseases.
- Device/Delivery Claims: If present, these specify new delivery systems like sustained-release formulations, patches, or formulations suitable for specific routes of administration.
Typical Claim Features:
- Narrower than broad, more focused on particular embodiments.
- May include dependent claims that specify preferred embodiments or specific modifications.
- Likely to contain chemical structure illustrations if the invention pertains to novel compounds.
Claim Strengths & Vulnerabilities:
- If the claims are narrowly tailored, competitors may design around; broader claims risk invalidation during examination.
- Claims focused on specific, novel compounds or formulations generally offer stronger protection.
- Using multiple dependent claims enhances scope and fallback positions.
Patent Landscape and Comparative Analysis
Position within the Chinese Patent Environment:
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Innovation level:
CN104161743 aligns with China's strategic emphasis on pharmaceuticals, especially in innovative drug delivery systems or formulations. It likely fits into the broader trend of protecting novel formulations to extend patent life and market exclusivity.
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Competing patents:
In China, numerous patents cover similar therapeutic classes or formulation techniques. A search of similar patents shows highly fragmented patent rights, especially among domestic companies and foreign multinational pharma players.
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Prior Art and Novelty:
An extensive prior art landscape includes prior formulations, manufacturing methods, or administration techniques. The patent’s novelty hinges on specific features such as unique excipient combinations or process conditions not previously disclosed.
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Patent Families & Extensions:
Given the filing date in 2013, the patent term extends until about 2033, considering possible extensions or supplementary protection certificates (SPCs) in China.
Comparison with International Patents:
- Similar patents elsewhere, such as in US or Europe, might have broader or narrower claims. These differences can influence licensing or enforcement strategies for Chinese counterparts.
Legal & Commercial Implications
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Scope enforcement:
Given the claim scope, patent infringement analysis must focus on the specific formulation or process steps. Generic manufacturers attempting to produce similar formulations would need to scrutinize each claim element for potential infringement.
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Freedom to operate:
The patent’s narrow or broad scope determines whether other formulations or methods within the same pharmaceutical class are protected. Companies developing alternatives must conduct freedom-to-operate analyses considering this patent and related rights.
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Potential for licensing:
The patent’s strategic importance may position it as a licensing asset for innovator companies seeking to expand formulations or delivery methods within the Chinese market.
Innovation & Future Trends
Given China's emphasis on pharmaceutical innovation, CN104161743 likely serves as part of a broader portfolio focused on improving existing drugs’ formulations. Future developments may include:
- Next-generation formulations leveraging nanotechnology or targeted delivery.
- Combination patents integrating this formulation with other active pharmaceutical ingredients (APIs).
Key Takeaways
- Narrow but targeted scope: The patent likely offers protection over specific formulations or processes, requiring detailed infringement analysis.
- Strategic positioning: It strengthens the patent holder’s portfolio in the Chinese pharmaceutical landscape, supporting exclusivity, licensing, or settlement negotiations.
- Potential for around-around strategies: Competitors may innovate around the specific claims by modifying formulations or manufacturing steps.
- Importance of monitoring: Ongoing patent filings related to similar drugs or formulations could impact the patent’s strength or provide infringing opportunities.
- Legal enforcement: Given China's recent judicial strengthening of patent rights, the patent may serve as a robust basis for litigations or injunctions.
FAQs
1. What is the primary technological innovation of CN104161743?
It primarily covers a specific pharmaceutical formulation or method that enhances stability or bioavailability, though precise chemical or process features are necessary for detailed assessment.
2. How does CN104161743 compare with similar patents internationally?
While similar patents globally protect formulations or processes, CN104161743’s scope may be narrower or broader depending on local patent strategy and prior art landscape, impacting global freedom-to-operate considerations.
3. Can this patent be challenged for invalidity?
Yes; challenges could focus on prior art disclosures, lack of novelty, or obviousness, especially given the extensive patent landscape in pharmaceutical formulations.
4. How should pharmaceutical companies strategize around this patent?
Companies should evaluate their formulations for potential infringement, consider licensing opportunities, or design around specific claims through modification of formulation components or process steps.
5. What is the significance of this patent for drug commercialization in China?
It provides a legal barrier against generic equivalents, supporting market exclusivity, especially if the formulation addresses critical efficacy or stability issues, thereby enhancing commercial competitiveness.
References
- China State Intellectual Property Office (SIPO). CN104161743 B patent details.
- WIPO PatentScope. Analysis of Chinese pharmaceutical patents.
- China Patent Law and Examination Guidelines.
- Industry reports on pharmaceutical patent filing trends in China.
Overall, CN104161743 exemplifies focused protection of innovative pharmaceutical formulations within China’s rapidly developing IP landscape — a vital asset for drug developers and patent practitioners.
