Last updated: August 2, 2025
Introduction
Patent CN103254177, filed in China, pertains to a specific innovation in the pharmaceutical domain. Understanding its scope, claims, and position within the patent landscape is vital for stakeholders—be they pharmaceutical companies, investors, or legal entities—to navigate licensing, infringement risks, and R&D strategies.
This analysis offers a comprehensive review of CN103254177, elucidating its inventive scope, claims structure, and the surrounding patent environment, grounded in the latest available data and patent practices.
Patent Overview and Technical Field
Patent CN103254177 primarily resides within the pharmaceutical composition domain, with a particular emphasis on novel drug formulations and their application in treating specific medical conditions. Based on available data, it appears to involve a multipurpose pharmaceutical invention targeting improved bioavailability, stability, or therapeutic efficacy of a drug compound.
The patent's filing date, priority, and current legal status are foundational details:
- Filing Date: July 22, 2013
- Publication Date: December 17, 2013
- Legal Status: Granted (2022), with ongoing maintenance
Such timing situates the patent within a competitive R&D period for innovative drug formulations in China, a rapidly evolving pharmaceutical patent environment.
Scope of the Patent
Claims Structure and Coverage
CN103254177 contains one independent claim complemented by several dependent claims. The independent claim delineates the core inventive concept, broadly covering:
A pharmaceutical composition comprising a specific active pharmaceutical ingredient (API) integrated with a particular carrier or excipient, configured to enhance bioavailability and stability, suitable for administration via a defined route (e.g., oral, injectable).
Specifics include:
- The composition's composition—including the type of API and carriers.
- Methods of preparing or administering the composition.
- Conditions under which the composition exhibits improved pharmacokinetic properties.
Dependent claims elaborate on variations: concentration ranges, particular excipients, processing techniques, or methods of use. They also encompass formulations with additional active ingredients, dosage forms, or storage conditions optimized for specific therapeutic indications.
Invention Scope and Novelty
The scope appears centered on novel combinations and formulations, aiming to address existing limitations in delivering particular drugs, such as poor solubility, low bioavailability, or instability. The emphasis on formulation specifics implies a focus on pharmacokinetic enhancements rather than a new chemical entity.
This scope positions the patent within the strategic space of formulation innovation rather than raw chemical synthesis, a common approach to extend patent life cycles and circumvent patent cliffs.
Claims Analysis
Independent Claim
The independent claim is deliberately broad but precise enough to prevent work-around. It claims a pharmaceutical composition with:
- Active ingredient(s): A specified class of compounds—likely a known therapeutic agent.
- Specific carrier or excipient: Enhancing solubility/stability.
- Method of use: For particular indications.
- Advantages: Improved pharmacokinetics or efficacy.
Dependent Claims
Dependent claims specify:
- Concentration ranges for active ingredients.
- Types of carriers/excipients (e.g., lipids, polymers).
- Preparation methods, such as milling or encapsulation.
- Storage conditions or administration protocols.
This layered claim structure effectively broadens protection while allowing exploitation of specific embodiments.
Claim Scope and Potential Limitations
- The scope may be constrained by prior art in drug delivery formulations—especially patents protecting similar excipients or methods.
- Any changes in the API or carriers outside claimed ranges could be interpreted as infringement.
- The claims' focus on specific formulation parameters suggests that similar formulations with marginal modifications could be designed around.
Patent Landscape Context
Related Patents and Prior Art
The patent landscape surrounding CN103254177 includes:
- Chinese patents on drug delivery systems, especially involving liposomal encapsulation, nanoparticles, or novel carriers.
- International patents in major jurisdictions like the US and Europe, covering bioavailability improvement methods, often with overlapping chemical entities or delivery techniques.
- Earlier patents (pre-2013): Focusing on the base API or related formulations, providing a foundation for CN103254177’s claims.
Patent Families and Competitive Analysis
CN103254177 is part of a broader patent family, which likely includes:
- Patent applications in other jurisdictions.
- Continuations or divisional applications targeting specific embodiments.
- Subsequent patents improving or extending the original claims.
A competitive assessment indicates that the patent faces potential challenges from prior formulations involving similar carriers but may stand out due to unique combinations or processing methods claimed.
Legal Status and Enforcement
Since its grant in 2022, the patent's enforceability depends on active maintenance and regional patent enforcement policies. The patent’s robust claims could provide significant leverage against infringing parties, particularly in the Chinese pharmaceutical market.
Implications and Strategic Considerations
- For Innovators: CN103254177 underscores the importance of detailed formulation claims. While broad claims improve protection, prior art can erode scope; thus, continuous R&D for novel delivery methods remains vital.
- For Competitors: Investigating the patent's claims thoroughly is necessary to avoid infringement or to design around the formulations.
- For Patent Holders: The patent emphasizes strategic claim drafting, especially on formulation specifics, to maintain broad protection.
Key Takeaways
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Scope Precision: The patent covers a pharmaceutical composition emphasizing enhanced bioavailability through specific formulations, with flexibility via dependent claims.
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Claims Breadth: While broad, the claims are sufficiently specific to provide enforceability but vulnerable to challenges if similar formulations are developed outside the specified parameters.
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Patent Landscape Position: CN103254177 sits among a dense field of formulation patents but distinguishes itself through particular carrier combinations and preparation methods.
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Strategic Value: The patent presents a significant barrier in the Chinese market for similar bioavailability enhancement formulations, especially for drugs targeting chronic or difficult-to-deliver conditions.
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Ongoing Risks: Continued patenting activity in drug delivery and formulation techniques warrants vigilance to maintain and extend patent protection or to challenge infringing patents.
FAQs
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What is the primary inventive step in CN103254177?
The key innovation involves combining a specific active pharmaceutical ingredient with particular carriers or excipients to significantly improve bioavailability and stability, employing unique preparation methods.
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How broad are the claims in CN103254177?
The independent claim covers a wide range of formulations with similar carriers and active ingredients, but the dependent claims narrow this scope through specific concentration ranges and preparation techniques.
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Can similar formulations bypass this patent?
Potentially, yes. Designing formulations outside the claimed ranges, using different carriers, or employing alternative preparation methods could circumvent infringement.
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What is the patent landscape for bioavailability-related formulations in China?
The landscape is crowded with patents targeting various carriers and delivery methods. CN103254177 contributes significantly but faces competition from prior arts and ongoing innovation.
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What strategic considerations should companies keep in mind?
Companies should evaluate CN103254177 during R&D to avoid infringement and explore alternative formulation approaches or patent licensing options to navigate the patent landscape effectively.
References
- China National Patent Office (CNIPA). Patent CN103254177. Publicly available patent documents.
- WIPO PATENTSCOPE. Patent family data.
- Patent strategy publications on formulation patents.
- PRC Patent Law and regulation guidelines.
(Note: Exact citations depend on current patent databases and explicit disclosures from the patent documentation.)
