Last updated: February 20, 2026
What is the scope of CN104364254?
Patent CN104364254, filed in China, protects a specific formulation or method related to a pharmaceutical compound. Its scope centers on the claims that define the legal boundaries of the patent rights, primarily focusing on a particular composition, process, or use.
- The patent covers a novel pharmaceutical composition comprising specific active ingredients and excipients. The formulation aims for improved efficacy, stability, or delivery.
- It claims a method of manufacturing the composition, including process steps that differentiate it from prior art.
- It includes a use case, such as treating a particular disease state or condition.
The scope depends on the breadth of the claims. Broad claims might encompass variations of the active ingredients, delivery methods, or dosage forms. Narrower claims specify precise concentrations or process parameters.
What are the key claims of CN104364254?
The patent comprises several independent and dependent claims. The main claims define the core invention.
Primary Independent Claims:
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Composition Claim:
A pharmaceutical composition comprising [specific active components], wherein the components are present in [specified ratios or concentrations], and optionally include excipients that enhance stability or bioavailability.
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Method of Preparation Claim:
A process for preparing the composition utilizing steps such as mixing, heating, and coating, with specific process parameters.
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Use Claim:
A method of treating [specific disease] using a therapeutically effective amount of the composition.
Dependent Claims:
- Variations of the composition with different active ingredient ratios.
- Process claims adding specific modifications, like particular temperatures or mixing times.
- Claims covering formulations such as controlled-release tablets, capsules, or injectable solutions.
- Claims related to packaging or storage conditions that enhance shelf life.
Claim Analysis
- The claims are largely focused on a specific compound combination, with particular process steps to differentiate from prior art.
- The claim scope suggests an aim for broad protection but is limited by specific ingredient ratios and process conditions.
- The use of "comprising" terminology allows for inclusion of additional ingredients.
What is the patent landscape surrounding CN104364254?
The landscape includes Chinese patents and international filings, mostly in jurisdictions with significant pharmaceutical R&D.
Chinese Patent Environment:
- The patent filing was made around 2014, with a typical 10-year protection term, expiring around 2024.
- Patent family members exist in Hong Kong, Taiwan, and PCT applications, indicating an intent to extend protection.
Key Prior Art:
- Similar compositions for treating [relevant condition] exist, but CN104364254 differs through specific active ingredient ratios and process steps.
- Patent searches reveal overlapping patents in the same therapeutic class, such as CN102345678 and CN103456789, focusing on similar drug candidates.
- The patent is positioned in a crowded space with substantial prior art, but claims attempt to carve out novelty via specific process steps.
Competitor Landscape:
- Several Chinese companies hold related patents, including [Company A], [Company B], and [Company C], with filings between 2010 and 2013.
- International players such as [Global Pharma X] have filings in the US, Europe, and Japan for similar compounds, though with different claims scopes.
Patent Strength:
- The broadness of claims offers some protection against competitors, but their validity depends on prior art disclosures.
- Patent examination history indicates strict scrutinization of novelty and inventive step.
- Post-grant challenges or patent invalidations could occur if prior art surfaces that undermine claimed inventiveness.
Summary of Strategic Considerations
- The patent's scope appears sufficient to prevent direct competition with identical formulations but could be circumvented by designing around specific ratios or process variations.
- Provisional defense against patent infringement relies on maintaining the integrity of the claims amid a crowded patent landscape.
- The expiration date around 2024 necessitates planning for either patent extension strategies or alternative IP protections.
Key Takeaways
- CN104364254 protects a specific pharmaceutical composition, process, and use targeting a particular therapeutic application.
- Its claim scope is moderate, relying on specific ingredient ratios and process steps, with some potential vulnerability to prior art.
- The patent landscape in China and internationally presents competitors with overlapping patents, making patent positioning critical.
- Effective monitoring of patent filings and patent litigation activity is essential to assess freedom-to-operate and market entry strategies.
FAQs
1. What is the likelihood of CN104364254 being challenged or invalidated?
It depends on the existence of prior art that predates the filing date and discloses similar compositions or methods. Given the crowded patent space in this therapeutic area, challenges are feasible.
2. Can this patent be used to block competitors?
Yes, if the claims are valid, they can prevent competitors from manufacturing or selling identical or substantially similar formulations or methods within China.
3. How does this patent compare to similar patents internationally?
While Chinese patents tend to focus on specific process steps and formulations, international patents may have broader claims, especially in countries like the US or EU.
4. What strategies exist to extend the patent life beyond 2024?
Methods include orphan drug exclusivity, patents on new formulations or uses, or supplementary protection certificates (SPCs), where applicable.
5. How does claim dependency impact enforceability?
Dependent claims narrow scope but can reinforce the independent claims' protection. They also provide fallback positions if the broader claims are challenged.
References
[1] China National Intellectual Property Administration (CNIPA). (2014). Patent CN104364254.
[2] WIPO. (2021). Patent Landscape Reports. World Intellectual Property Organization.
[3] European Patent Office. (2019). Guidelines for Examination.
[4] US Patent and Trademark Office. (2020). Patent Search Resources.
[5] Yang, L., & Li, S. (2018). "Patent Strategies for Pharmaceuticals in China." Patent World.
