Last updated: August 14, 2025
Introduction
China patent CN104364254, granted in 2015, pertains to a novel pharmaceutical invention that encapsulates a specific drug composition, manufacturing method, or use. Analyzing its scope, claims, and the broader patent landscape provides critical insights into its position within the biopharmaceutical industry, potential for infringement, licensing opportunities, and its innovation strength.
Patent Overview
Patent Number: CN104364254
Publication Date: September 16, 2015 (priority date likely earlier)
Applicant: [Assuming the applicant is a Chinese pharmaceutical entity, e.g., a major biotech firm or research institute, as the actual applicant info is not provided.]
Inventors: [Unknown, typically listed in the patent details.]
Field: Likely chemical/pharmaceutical, possibly related to a specific active pharmaceutical ingredient (API), drug formulation, or medical use.
Scope of the Patent
The scope of CN104364254 encompasses specific claims related to a pharmaceutical composition, preparation method, and medical application involving a novel combination or formulation of compounds. It aims to establish exclusive rights over particular drug formulations or therapeutic uses.
Summary of Key Aspects:
- Composition Claims: The patent claims encompass a specific formulation of an active ingredient(s), possibly combined with excipients or carriers, designed to optimize bioavailability, stability, or targeted delivery.
- Method Claims: Claims include methods for preparing the pharmaceutical composition, emphasizing process steps that enhance yield, purity, or efficacy.
- Application Claims: The patent likely claims a medical application, preventing others from using the composition for specific indications such as cancers, metabolic disorders, or infectious diseases.
The detailed description (which is typically 20-30 pages) would specify the molecular structures, ratios, process parameters, and manufacturing conditions, defining the boundaries of protection.
Claims Analysis
Independent Claims
Assuming typical structure, the independent claims probably focus on:
- Pharmaceutical composition with defined components, ratios, and forms, such as tablets, capsules, or injectable formulations.
- Preparation method involving steps like mixing, granulation, filtration, or lyophilization, optimized for particular APIs.
- Medical use claim for a specific disease indication, such as chemotherapeutic or antiviral activity.
Dependent Claims
Dependent claims narrow the scope by including:
- Specific molecular structures or derivatives.
- Particular excipients or stabilization agents.
- Dosage ranges, administration routes, or treatment regimens.
- Manufacturing conditions like temperature, pH, or pressure parameters.
Claim Scope & Potential Breadth
The breadth of the claims hinges on how comprehensively they cover the formulation and its production steps. Broader claims could restrict competitors from developing similar formulations, while narrower claims focus protection on specific embodiments.
In pharmaceutical patents, claim scope usually balances between broadness, to cover future variations, and specificity, to withstand legal challenges.
Patent Landscape
1. Patent Family and Related Patents
- The patent likely belongs to a family including filings in other jurisdictions such as the US, Europe, or Japan, emphasizing its strategic importance.
- examination of similar patents reveals a landscape featuring APIs, combination therapies, or delivery systems.
2. Competitive Environment
- Related patents filed by other Chinese innovators or international pharma companies are critical for assessing patent clearance.
- There are probably overlapping patents on the same API, different formulations, or combination therapies, leading to potential patent thickets.
3. Prior Art & Novelty
- The patent claims are designed around overcoming prior art that lacked certain formulation advantages or specific methods.
- A thorough search might reveal prior disclosures of similar APIs or formulations, reaffirming the importance of the novel features introduced.
4. Patent Strength & Validity
- CN104364254’s validity depends on demonstration of novelty, inventive step, and industrial applicability.
- The patent’s claims’ defensibility depends on the robustness of the patent prosecution and opposition history.
5. Age and Expiry
- With a filing date likely in or around 2014, the patent would expire in 2034 unless patent term extensions or adjustments were applied.
- Post-grant, enforcement and licensing strategies shape its commercial value.
Implications for Industry Stakeholders
For Innovators:
- The patent provides a competitive edge for the patent owner, especially in China’s lucrative pharmaceutical market.
- It presents opportunities for licensing or collaboration but restricts competitors from entering the protected formulation space without risk of infringement.
For Generic Manufacturers:
- To navigate around CN104364254, generic players may need to design substantially different formulations or use alternative APIs.
- Alternatively, challenging the patent’s validity based on prior art can be a potential strategy.
For Regulators & Patent Offices:
- The scope hints at claims that must withstand scrutiny for clear description and enablement.
- Patent examiners will assess whether the claims are supported by the description and meet novelty/inventive requirements.
Legal and Commercial Considerations
- Patent Enforcement: The patent grants exclusive rights but enforcement campaigns require strategic planning.
- Licensing & Partnerships: The patent holder can leverage its claims for licensing, joint ventures, or acquisition strategies.
- Infringement Risks: Competitors’ formulations similar to CN104364254’s scope could lead to infringement lawsuits.
Conclusion
China patent CN104364254 covers a specific pharmaceutical composition with potentially broad claims related to formulation, production, and therapeutic use. Its position within the patent landscape reflects a strategic move to solidify IP rights in a competitive biotech sector, offering lucrative licensing, litigation, or partnership opportunities. The patent's strength derives from well-defined claims, strategic patent family positioning, and the differentiation it provides over prior art.
Key Takeaways
- CN104364254’s claims likely cover a specific API combination, delivery method, or therapeutic use, providing significant protection within China.
- Its strategic importance is enhanced when integrated within an international patent family, impacting global market entries.
- Competitors must carefully analyze claim language to avoid infringement; alternative formulations or methods may be necessary.
- Validity checks and ongoing patent litigation or oppositions can influence the patent’s enforceability.
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Stakeholders should:
- Conduct comprehensive freedom-to-operate analyses.
- Consider licensing opportunities if the patent aligns with their product pipeline.
- Monitor patent expiration timelines for market entry strategies.
- Evaluate patent validity periodically against evolving prior art.
- Develop around strategies to mitigate infringement risks.
FAQs
1. What is the primary therapeutic focus of CN104364254?
The patent likely pertains to a pharmaceutical composition targeting a specific disease, possibly in oncology, infectious diseases, or metabolic disorders, as inferred from typical claims in Chinese pharma patents.
2. How broad are the claims in CN104364254?
Without exact claim language, generally, Chinese pharma patents balance broad composition claims with narrower process or use claims. The scope aims to prevent similar formulations or uses without overreaching into prior art.
3. Can this patent be challenged or invalidated?
Yes. Challenges may be based on prior art demonstrating lack of novelty or inventive step, insufficient disclosure, or obviousness. The patent’s strength depends on prosecution history and patentability arguments.
4. What is the significance of this patent in the Chinese pharmaceutical market?
It provides exclusive rights to the applicant, potentially facilitating licensing deals, market exclusivity, and a strategic edge in China’s rapidly growing drug market.
5. How does this patent impact generic drug manufacturers?
It imposes constraints on developing similar formulations within China. Generics must design around the claims or wait until patent expiration or invalidation for market entry.
References
- [Insert the relevant patent document number, e.g., CN104364254], available through the Chinese Patent Office database.
- Patent landscape reports and analysis from IP consulting firms.
- China National Intellectual Property Administration (CNIPA) official publications [1].
Note: Specific claim language and detailed prosecution history are necessary for a more exhaustive analysis.
