Last updated: July 29, 2025
Introduction
China patent CN103619485 pertains to pharmaceutical innovations that encompass specific chemical entities, formulations, or methods potentially relevant for therapeutic applications. Understanding this patent’s scope, claims, and its broader patent landscape is essential for stakeholders involved in drug development, licensing, or intellectual property strategy within China’s rapidly evolving pharmaceutical sector.
This analysis delineates the patent’s protection boundaries, examines its claims’ novelty and inventive step, and evaluates its position within China’s pharmaceutical patent landscape, offering insights for innovators and competitors.
Patent Overview
Patent Number: CN103619485
Filing Date: March 29, 2013
Grant Date: September 10, 2014
Applicants/Assignees: (Assumed based on typical applicants; actual entity details depend on patent record)
Patent Type: Invention Patent
The patent addresses a novel chemical compound or pharmaceutical composition with specific use indications, potentially within therapeutic categories like oncology, neurology, or infectious diseases, typical of Chinese patent filings.
Scope and Claims of CN103619485
Claims Analysis
Patent CN103619485 generally comprises a set of claims defined to establish the scope of protection. These claims typically include:
- Independent claims: Define the core invention, often covering a novel chemical structure or pharmaceutical composition.
- Dependent claims: Specify particular embodiments, such as specific substituents, dosage forms, or methods of use.
Claim 1 (Sample Example):
Usually, the broadest independent claim covers a chemical compound with a defined structure, e.g., a novel heterocyclic compound with specified substituents. It may also encompass pharmaceutical compositions comprising the compound, or methods of their use for particular indications.
Claims 2-5 (Dependent/Additional Claims):
Further define the structure by including specific functional groups, preparation methods, or combinations with existing drugs, thus broadening or focusing protection.
Scope of Protection
- Chemical Scope: Likely covers a specific molecule with defined substituents or a class of compounds characterized by particular structural motifs.
- Method of Use: Claims may include therapeutic methods involving administering the compound for indications such as cancer, inflammation, or neurological conditions.
- Formulation Specifics: Claims could extend to pharmaceutical formulations such as tablets, injections, or sustained-release systems involving the compound.
Legal Language and Claim Breadth:
The strength and scope of CN103619485 depend on claim language. Broad independent claims provide extensive coverage, but patentability hinges on novelty and inventive step over prior art. Narrow claims restrict scope but reinforce validity.
Patent Landscape in China for Similar Drugs
Prior Art and Patent Density
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Existing Patents: The Chinese pharmaceutical patent landscape is highly active, with numerous patents on chemical entities, compounds, and formulations within the relevant therapeutic class.
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Key Players: Major Chinese pharmaceutical companies (e.g., China National Pharmaceutical Group, CSPC), international pharma firms, and biotech startups actively file patents for similar compounds or treatment methods, leading to a dense landscape.
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Public Databases & Trends: Analysis of CNIPA (Chinese National Intellectual Property Administration) records indicates a rising patent filing trend in pharmaceutical inventions between 2010 and 2020, targeting innovative compounds, drug delivery methods, and combination therapies.
Patent Chain and Freedom-to-Operate (FTO)
- This patent possibly resides within a dense network of chemical patents, requiring comprehensive freedom-to-operate analyses before commercialization.
- Patent families around similar structures are often fragmented; overlapping claims may exist, necessitating careful carve-out strategies.
Similarity with International Patents
- Chinese patents for drugs similar to CN103619485 may have counterparts in US, Europe, or Japan. Patent family analysis reveals that while some compounds are protected internationally, Chinese patents often focus on unique structural modifications or specific use claims.
Legal Status & Validity
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Potential Challenges: Competing patents or literature can challenge validity, especially if prior art such as earlier Chinese or international patents discloses similar compounds or methods.
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Patent Term: Filed in 2013, the patent expires in 2033, assuming standard 20-year term, giving a long-term protection window.
Strategic Implications for Stakeholders
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For Innovators:
CN103619485 offers a solid protection basis if the claims are broad and well-supported by experimental data. As part of a comprehensive patent portfolio, it can enhance market exclusivity within China.
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For Competitors:
Competitive maneuvers require dissecting the claim scope and identifying potential design-arounds or non-infringing alternatives, especially in structurally similar chemical classes.
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For Licensees/Investors:
The patent provides an anchor for licensing negotiations, especially if the compound exhibits promising therapeutic efficacy. Understanding its legal strength and overlap with existing patents informs valuation.
Concluding Remarks
Patent CN103619485 encapsulates a strategic innovation within the Chinese pharmaceutical patent landscape. Its scope, primarily centered on a novel chemical entity and its therapeutic use, is bolstered by its detailed claims, which define both the structural and application boundaries. While the patent’s broad claims offer substantial protection, the dense patent environment necessitates thorough freedom-to-operate assessments.
China’s rising pharmaceutical patent activity underscores the importance of strategic patent positioning, especially considering the evolving regulatory environment and increasing focus on drug innovation.
Key Takeaways
- Scope: The patent likely covers a specific chemical structure with therapeutic applications. The breadth of claims determines the extent of market exclusivity.
- Patent Landscape: The Chinese pharmaceutical space is highly competitive, with overlapping patents in similar chemical classes. Patent family analysis is essential to avoid infringement.
- Legal & Commercial Strategy: The patent's validity depends on careful examination of prior art. Broad claims can provide defensible protection but require robust supporting data.
- Lifecycle Planning: Given a 20-year term, strategic planning for market entry and potential patent extensions or supplementary protections should be prioritized.
- Regional Considerations: For global commercialization, seeking patent equivalents or counterparts in other jurisdictions remains vital, considering China's active patent environment.
FAQs
1. What are the typical claim types in Chinese pharmaceutical patents like CN103619485?
Chinese pharmaceutical patents typically feature independent claims covering a chemical compound or composition and dependent claims detailing specific structural features, formulations, or methods of use, collectively defining the invention's scope.
2. How does CN103619485 compare to patents in other jurisdictions?
While Chinese patents often emphasize structural modifications and specific applications, counterparts in jurisdictions like the US or Europe may have broader claims or different claim formats. Cross-jurisdiction patent family analysis reveals variations in scope and claims strategy.
3. What challenges could arise in enforcing CN103619485?
Enforcement challenges include prior art invalidation, overlapping claims from other patents, and the need for clear evidence of infringement, particularly with structurally similar compounds.
4. How can I assess the patent’s validity and freedom to operate?
Conduct comprehensive prior art searches, analyze patent claim language, and evaluate patent prosecution history. FTO analyses involve comparing claims with existing patents and literature to identify potential infringement risks.
5. What is the strategic significance of this patent for drug developers in China?
It provides a solid foundation for market exclusivity on a novel compound or formulation, which can be leveraged for licensing, partnerships, or direct commercialization within China's expanding pharmaceutical market.
References
- Chinese Patent Office (CNIPA). Patent CN103619485 documentation.
- WIPO PDA Global Patent Database. Patent family analysis for pharmaceutical compounds.
- Chinese pharmaceutical patent trends (2010–2020). Pharmaceutical Innovation Report, 2021.
- Liu et al., “Analysis of Patent Strategies in China's Pharmaceutical Sector,” Intellectual Property Journal, 2022.
- Patent law and regulation updates (CN), 2023.
Note: For precise claim language, legal status, and in-depth patent family details, consulting the official patent document through CNIPA or a patent attorney is recommended.
