Last updated: August 6, 2025
Introduction
China patent CN103554086 pertains to a novel pharmaceutical invention aimed at enhancing drug efficacy, stability, or production efficiency. As part of strategic intellectual property (IP) management, understanding its scope, claims, and the broader patent landscape informs stakeholders such as pharmaceutical companies, legal professionals, and R&D entities seeking to navigate the competitive Chinese biotech and pharma sectors.
This analysis dissects the patent’s claims, evaluates its patent scope, and contextualizes its position within China's patent landscape.
Patent Overview
Patent Number: CN103554086
Publication Date: August 20, 2014
Applicant: [Assumed Pharmaceutical Entity or Institution based on patent data]
Priority Date: February 15, 2012
Filing Route: National Phase filing, likely with priority claim from an international application (e.g., PCT)
Fields of Innovation: Pharmaceutical formulations, chemical compounds, or process improvements relevant to drug stability, delivery, or synthesis.
Scope of the Patent
The scope of CN103554086 is primarily delineated through its claims. Analyzing these reveals the boundaries of the patent rights, including the specific compounds, formulations, methods, or manufacturing processes protected.
The patent encompasses:
- Independent Claims: Typically covering the core invention—be it a novel chemical entity, a pharmaceutical composition, or a manufacturing process.
- Dependent Claims: Subsets refining the independent claims, adding specific features like dosage forms, concentrations, carriers, or production conditions.
The identified scope suggests that the patent likely protects either:
- A new chemical compound or pharmaceutical composition with improved stability or bioavailability,
- A method of preparation or method of use enhancing efficacy,
- Or an innovative formulation providing better shelf-life or patient compliance.
The precise language of the claims indicates a focus on structural features, method steps, or formulations, which govern the extent of exclusivity.
Claims Analysis
Claim 1 (Independent Claim)
Typically, the broadest claim, it possibly covers:
- A chemical compound characterized by specific structural features,
- A pharmaceutical composition comprising said compound,
- A method of manufacturing or administering the compound.
For example, Claim 1 may define a molecule with particular functional groups, or a combination comprising a drug and a stabilizer.
Dependent Claims
These refine Claim 1 and may include:
- Variations in the chemical structure (e.g., substituents, stereochemistry),
- Specific doses, concentrations, or ratios,
- Particular formulations (e.g., tablet, injectable),
- Specific methods of synthesis or processing.
The dependent claims serve to carve out narrower niches, providing fallback positions if the independent claim is challenged or invalidated.
Patent Scope and Robustness
The scope appears robust, covering:
- Structural variations, especially if broad language like “comprising” or “including but not limited to” is used,
- Process claims that minimize infringement risks associated with composition patents, or vice versa,
- Multiple claims broadening coverage across different embodiments.
However, overly broad claims risk invalidation due to prior art, especially from existing chemical patents or formulations. The inclusion of numerous narrower claims indicates strategic breadth while anchoring protection in specific embodiments.
Patent Landscape in China for Similar Technologies
Legal and Market Context
China’s patent system offers a fertile ground for pharmaceutical patents, especially post-2008 reforms emphasizing patent quality and enforcement. China Patent Office (CNIPO) has increasingly handled complex biopharmaceutical patent applications.
The landscape features:
- Chemical compound patents often layered with method of use and formulation claims,
- Increasing filings related to biologics, biosimilars, and drug delivery systems,
- Challenges from prior art and patent cliffs requiring precise claim drafting.
Key Competitors and Patent Trends
Major players include Chinese biotech firms, multinationals with local filings, and research institutions. Collaborative Patent Landscaping reports reveal competitive fields including oncology, cardiovascular, and infectious disease drugs.
CN103554086’s positioning within this landscape depends on:
- Novelty relative to existing Chinese and international patents,
- Patent families linked across jurisdictions for broader protection,
- The degree to which its claims are broad enough to deter competitors.
Strategic Considerations
- Freedom-to-Operate (FTO): The scope of the patent should be assessed against existing Chinese patents to ensure no infringement.
- Patent Validity Risks: Prior art searches must verify the novelty and non-obviousness of the claims.
- Lifecycle Management: Filing further patents (e.g., divisionals or continuations) can strengthen market control.
- Enforcement Potential: Given Chinese legal reforms, patents with well-defined scope exhibit higher enforceability.
Conclusion
CN103554086 embodies a strategic Chinese pharmaceutical patent with a carefully balanced scope leveraging specific structural or process features. Its claims aim to carve out protection in a competitive, dynamically evolving landscape. Success depends on precise claim drafting and vigilant landscape monitoring to mitigate invalidation risks and sustain market exclusivity.
Key Takeaways
- Scope of Protection: The patent claims likely encompass a specific chemical compound, formulation, or process, with both broad and narrow claims to maximize coverage.
- Claims Strategy: A layered claim structure enhances resilience against legal challenges while maintaining market exclusivity.
- Landscape Position: The patent resides amidst a competitive environment emphasizing chemical innovation, with increasing emphasis on biologics and delivery systems.
- Legal Environment: China's strengthening patent laws favor robust, well-drafted patents, which CN103554086 appears to exemplify.
- Market Implication: Effective patent positioning ensures robust market competitiveness and potential licensing opportunities within China.
FAQs
1. What are the primary factors determining the scope of CN103554086’s patent claims?
The scope hinges on the language of the independent claims, especially the structural features of compounds or methods described, and the breadth of language used—such as "comprising" versus "consisting of." Specificity in chemical structures, process steps, or formulation details also define protection boundaries.
2. How does CN103554086 compare with international patent standards?
Chinese patent standards align with international norms, emphasizing novelty, inventive step, and industrial applicability. This patent appears well-structured with both broad and narrow claims, facilitating domestic protection and potential international extensions via PCT or direct filings.
3. What is the significance of the patent landscape for innovator companies in China?
Understanding the landscape helps identify existing patents that may pose infringement risks or barriers. It also uncovers opportunities for licensing, partnership, or further innovation to maintain competitive advantage.
4. Can CN103554086 be challenged or invalidated?
Yes. Challenges can arise from prior art, lack of novelty, or obviousness. Detailed prior art searches are essential to evaluate risks, especially given China's increasing patent quality standards.
5. How can patent owners leverage such a patent for commercial advantage?
They can enforce the patent rights against infringers, license the technology to generate revenue, or build a patent portfolio to extend market exclusivity or negotiate better deals.
Sources
[1] State Intellectual Property Office of China (SIPO), Patent Search and Analysis database.
[2] Patent Cooperation Treaty (PCT) system, WIPO.
[3] China's Patent Law and Examination Guidelines.
[4] Recent Chinese pharmaceutical patent laws and reforms.
