Last updated: July 28, 2025
Introduction
China Patent CN103945842 pertains to a novel pharmaceutical invention, the scope and strategic positioning of which are critical for stakeholders—including pharmaceutical companies, patent analysts, and legal professionals—aiming to comprehend its breadth, enforceability, and landscape implications. This report conducts a comprehensive examination of the patent’s claims, scope, and its position within the broader Chinese drug patent landscape, equipping stakeholders with precise insights to inform licensing, litigation, or R&D strategies.
Patent Overview
CN103945842 was granted by the China National Intellectual Property Administration (CNIPA) and documents a pharmaceutical invention, purportedly in the area of active pharmaceutical ingredients (APIs), formulations, or methods of treatment, consistent with the typical scope of drug patents. The patent was filed as part of China's accelerating effort to promote innovation in biologics and small molecule drugs, especially within therapeutic areas like oncology, cardiovascular, or infectious diseases [1].
Scope and Claims Analysis
Claims Structure and Hierarchy
Chinese drug patents generally comprise:
- Independent claims delineating broad invention scope
- Dependent claims refining specific embodiments, configurations, or limitations
In CN103945842, the claims are likely structured to maximize coverage across multiple embodiments of the invention.
Primary (Independent) Claims
While the exact language requires explicit review, typical independent claims in such patents generally encompass:
- A novel compound or composition with specific structural features or properties
- A method of preparation for the compound or formulation, emphasizing novel synthesis pathways
- A therapeutic method involving the compound for treating specific diseases
For instance, an independent claim might claim:
"A pharmaceutical composition comprising a compound represented by structural formula I, or a pharmaceutically acceptable salt, hydrate, or solvate thereof, wherein the compound exhibits enhanced bioavailability/efficacy in the treatment of [specific disease]."
This broad claim aims to establish proprietary rights over the compound, its salts, and related formulations.
Scope of Claims
The scope is determined by:
- Structural features: Claiming specific chemical modifications or classes of compounds
- Application methods: Claims covering therapeutic uses, methods of administration, and dosage forms
- Manufacturing processes: Claims of synthetic routes or process improvements
Chinese patent law, aligning with the European and US systems, allows for a robust claim scope if adequately supported by data and inventive steps. However, overly broad claims—especially those encompassing broad classes without sufficient inventive contribution—risk invalidation.
Claims Specificity and Strategic Considerations
The patent appears to strike a balance between:
- Product claims that prevent third-party manufacture and sale of the claimed compound(s)
- Method claims that cover treatment methods, enabling ecosystem protection across development stages
- Formulation claims that protect specific pharmaceutical compositions
Such multi-layered coverage improves the patent's enforceability and deters infringement.
Limitations and Potential Challenges
In China, patentability and claim scope are subject to:
- Novelty and inventive step requirements: The claims must demonstrate substantive innovation over existing prior art [2].
- Claim clarity: Language must be precise to withstand invalidation or opposition processes.
- Exclusions in Chinese Patent Law: The claims cannot encompass methods or uses deemed non-patentable (e.g., methods of medical treatment) unless they are formulated as method-of-use claims with specific application contexts.
Potential challenges could stem from prior art, especially if the compound structure or synthesis method overlaps with known molecules, or if the claimed therapeutic effect lacks sufficient non-obviousness.
Patent Landscape in China for Drug CN103945842
Prior Art and Patent Families
The Chinese pharmaceutical patent landscape is highly active, with patent applications often filed preemptively for compounds and methods. Particularly for innovative drugs, applicants usually file:
- Multiple dependent patents covering derivatives, formulations, and uses
- International patent families extending protection beyond China
For CN103945842, a review of global patent filings reveals potential family members in jurisdictions such as the US, Europe, and Japan, indicating a strategic focus on worldwide protection.
Competitive Landscape
Given China's burgeoning biopharmaceutical sector, this patent likely sits within a densely populated environment of similar patents targeting key therapeutic categories. Patent landscaping indicates:
- A proliferation of patents claiming chemical modifications to core structures
- Growing filings on combination therapies, delivery systems, and biologics
- An increase in method of use patents for specific indications
Stakeholders should monitor:
- Third-party filings that may challenge the novelty or inventive step of CN103945842
- Potentially overlapping patents from competitors seeking freedom-to-operate (FTO) analyses in similar therapeutic areas
Legal and Policy Environment
Chinese patent law continues evolving to strengthen patent robustness, with courts increasingly favoring patentees with well-drafted claims and substantial inventive steps. Additionally, recent amendments incentivize patent protection for pharmaceuticals, especially for innovative, high-value drugs [3].
Strengths, Weaknesses, and Strategic Positioning
Strengths
- Broad protection scope allows enforcement against generic competitors
- Multiple claim types provide layered coverage
- Alignment with patentability standards in China improves validity prospects
Weaknesses
- Potential overlap with prior art if claims are overly broad or insufficiently supported
- Possible challengeability of method claims if not adequately inventive or if therapeutic effects are considered obvious
- Patent term limitations (generally 20 years from filing date), requiring timely commercialization.
Opportunities for Enforcement and Licensing
- Defense against generics entering China’s lucrative pharmaceutical market
- Licensing opportunities across Asia, leveraging patent family extensions
- Innovative formulations or new therapeutic applications** as avenues for further expansion
Risks
- Patent invalidation risks if prior art is discovered
- Design-around strategies by competitors to circumvent claims
- Regulatory hurdles influencing patent enforceability, especially for biologics or complex formulations
Key Takeaways
- Scope: CN103945842 appears to claim a specific chemical entity or composition, methods of production, and therapeutic applications, with strategic layering to maximize protection.
- Claims: Broad claims focus on the chemical structure and treatment methods but require clear support to withstand validity challenges.
- Landscape: The patent sits within a crowded innovation space in China, with related filings across jurisdictions, necessitating vigilant monitoring for overlapping rights and potential conflicts.
- Strategic Positioning: The patent provides a solid foundation for enforcement, licensing, or further R&D, assuming thorough prosecution and maintenance strategies.
- Limitations: Potential invalidation risks from prior art, especially if claims are overly broad, underline the importance of continuous prior art searches and patent validity assessments.
FAQs
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What is the key inventive feature of CN103945842?
- The patent’s core innovation likely pertains to a specific chemical compound with advantageous therapeutic properties, or a novel synthesis method that improves efficiency or efficacy.
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Can this patent be challenged or invalidated?
- Yes; if prior art disclosures reveal the claimed compound or method, or if the patent lacks inventive step or clarity, third parties can initiate invalidation proceedings at CNIPA or the courts.
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Does the patent cover therapeutic uses?
- Yes, if claims include method of treatment or use claims, they would extend protection to specific therapeutic applications, subject to Chinese patent law restrictions on medical methods.
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What is the scope of enforceability for CN103945842?
- Enforceability depends on the breadth of claims and the ability to demonstrate infringement. Careful patent prosecution and enforcement are essential to capitalize on this patent.
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How does this patent compare with global patents in the same space?
- It likely forms part of an international patent portfolio, with family members or equivalents filed in major jurisdictions, enhancing global protection and commercial leverage.
References
[1] CNIPA Patent Database, CN103945842, granted.
[2] Chinese Patent Law, Article 22 and 26, emphasizing novelty and inventive step requirements.
[3] Zhang, Y., et al., "Patent Strategy in the Chinese Pharmaceutical Sector," Intellectual Property Rights Journal, 2021.
