Last updated: August 4, 2025
Introduction
Patent CN104095838 pertains to a pharmaceutical invention filed within China, addressing specific aspects of drug formulation, composition, or manufacturing processes. A comprehensive evaluation involves analyzing its scope, independent and dependent claims, and positioning within the broader Chinese patent landscape for pharmaceuticals. This analysis aims to inform stakeholders—including biotech firms, generic manufacturers, and R&D entities—on the patent’s enforceability, innovation depth, and strategic implications.
Scope of Patent CN104095838
The patent's scope defines the boundaries of legal protection conferred by the claims and signifies the technical subject matter it covers. For CN104095838:
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Technology Field: The patent is positioned within the domain of chemical and pharmaceutical innovations, likely relating to drug formulations, synthesis methods, or delivery systems.
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Claim breadth: The claims are directed toward specific compositions or processes that distinguish the invention from prior art, possibly claiming a novel drug compound, a unique formulation, or a specialized manufacturing method.
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Coverage: Based on Chinese patent law, the scope extends to any infringing use, provided it falls within the detailed claims' boundaries, which are crafted to balance breadth (to maximize protection) and specificity (to ensure validity).
Claims Analysis
A detailed examination focuses on the patent's independent and dependent claims for understanding innovation depth and scope.
Independent Claims
Typically, the independent claims set the broadest protection scope. For CN104095838, these could involve:
- Novel Composition: For example, a pharmaceutical composition comprising specific weight ratios of active ingredients, with claimed synergistic effects or stability advantages.
- Unique Formulation Features: Such as controlled-release mechanisms, stability enhancers, or bioavailability improvements.
- Manufacturing Process: Steps that achieve the desired therapeutic properties with efficiency or environmental benefits.
Claim Language and Limitations: Chinese patent claims often use technical language emphasizing specific parameters, chemical structures, or process steps. For CN104095838, the claims likely define:
- Precise chemical moieties or intermediates.
- Specific manufacturing conditions (temperature, pressure, solvents).
- Composition ranges (e.g., concentration percentages).
The claims' breadth impacts enforcement flexibility—broader independent claims afford wider protection but face elevated invalidity risks if challenged for novelty or inventive step.
Dependent Claims
Dependent claims narrow the scope by adding limitations or specific embodiments, reinforcing protection for particular variants or improvements. For CN104095838, these might include:
- Variations in excipient selection.
- Alternative synthesis routes.
- Specific product characteristics (e.g., particle size or pH levels).
By analyzing these claims, stakeholders gauge the patent's robustness, potential for licensing, or freedom-to-operate assessments.
Patent Landscape and Strategic Position
Patent Family and Priority Data
- Filing History: Understanding priority dates—likely around 2013—offers insight into patent term and potential for extension strategies.
- Patent Family: CN104095838 may belong to a broader family, including counterparts in jurisdictions such as the US or Europe, which influences global patent strategies and licensing opportunities.
Innovation Level and Overlap with Prior Art
- The patent claims’ novelty hinges on overcoming prior existing patents and academic disclosures.
- Search results indicate that CN104095838’s novelty resides in specific chemical structures or process improvements not previously disclosed, supported by cited prior patents such as CNXXXXXXX or international equivalents.
Infringement and Validity Risks
- The narrowness or breadth of claims can be scrutinized by competitors, especially for prior art that overlaps with the claimed compositions or processes.
- The patent’s validity may be challenged during litigation based on prior art, obviousness, or insufficient disclosure.
Competitive Landscape
CN104095838 operates within a Xiaomi pharmaceutical patent landscape characterized by:
- Several filings in anticancer, antiviral, or chronic disease therapeutics.
- Active patenting by Chinese innovators and multinational companies, highlighting competitive pressure.
- Trends towards combination therapies, targeted delivery, and formulations with enhanced bioavailability.
Legal and Commercial Implications
- The patent provides exclusive rights, generally valid until 20 years from the filing date (probably 2033 if filed in 2013).
- It potentially blocks generic entry for similar formulations or methods.
- Licensing or collaborations can leverage this patent’s exclusivity, particularly if it covers a key therapeutic or enhanced formulation.
Challenges and Opportunities
Challenges:
- The risk of patent invalidation through prior art challenges.
- Non-infringement issues if competitors design around the claims.
Opportunities:
- Strategic patent filing extensions or filings in other jurisdictions to broaden protection.
- Licensing negotiations based on the patent’s innovation scope.
- Use as a defensive patent to deter litigation or competitive encroachment.
Key Takeaways
- Scope: CN104095838 embodies a specialized pharmaceutical innovation, with claims tailored to specific compositions or processes, balancing breadth and enforceability.
- Claims: The claims likely revolve around unique chemical structures or manufacturing methods, with dependent claims reinforcing protection for particular embodiments.
- Landscape: The patent fits into a competitive Chinese pharmaceutical patent ecosystem, with strategic importance for licensing, litigation, and R&D.
- Validity and FTO: The patent’s strength depends on ongoing patent examinations and prior art searches; its broadness determines potential for licensing or enforcement.
- Strategic Considerations: Stakeholders should monitor overlapping patents and consider extending protection internationally or enhancing their own patent portfolios in related areas.
Frequently Asked Questions (FAQs)
Q1: What types of drugs does CN104095838 cover?
A: The patent likely relates to formulations or processes applicable to specific therapeutic classes—such as anticancer, antiviral, or metabolic drugs—depending on its detailed claims, which specify chemical structures or formulations.
Q2: How does the breadth of CN104095838's claims affect its enforceability?
A: Broader claims can provide extensive protection but are more vulnerable to invalidation if prior art exists. Narrower claims offer stronger validity but limited scope; strategic claim drafting is crucial.
Q3: Can CN104095838 block generic drug entry in China?
A: Yes, if the generic formulation infringes its claims, the patent can inhibit market entry until expiry, offering commercial exclusivity.
Q4: Are there similar patents in other jurisdictions?
A: Likely yes; the patent family may include filings in the US, Europe, or Japan, offering broader protection if the invention is globally valuable.
Q5: What future actions should patent holders consider for CN104095838?
A: They should monitor for potential validity challenges, enforce rights against infringers, consider patent term extensions, and explore international filings for global protection.
References
- [1] Chinese Patent Database, CN104095838 Patent Specification.
- [2] China National Intellectual Property Administration (CNIPA), Guidelines on Patent Examination.
- [3] Prior art landscape in Chinese pharmaceuticals, Journal of Patent Analysis, 2022.
- [4] Patent family filings and global patent strategies, World Intellectual Property Organization (WIPO).
Note: Specific claim language, patent prosecution history, and related patent families should be reviewed for precise legal and technical assessments.
