Last updated: August 2, 2025
Introduction
China Patent CN104311472 pertains to a proprietary pharmaceutical invention, whose scope and claims significantly influence the landscape of corresponding therapeutic modalities. As a strategic asset, a detailed analysis of this patent offers insights into the innovation boundaries, potential competitive barriers, and alignment with global patent trends within the pharmaceutical sector.
Patent Overview
CN104311472 was granted by the China National Intellectual Property Administration (CNIPA) and typically associated with pharmaceutical compounds, formulations, or methods of use. While the specific chemical entity or therapeutic application needs to be verified directly from the official publication, the patent's claims suggest an innovative approach to a particular drug candidate, combination, or delivery system.
Scope of the Patent
1. Territorial and Temporal Scope
The patent provides exclusive rights within China, valid generally for 20 years from the filing date, which, assuming a standard application date around 2014, expires around 2034. Its territorial scope is localized unless licensed or extended internationally through patent cooperation treaties (PCT), patent family, or equivalent filings.
2. Technical Scope
The patent's scope encompasses:
- Chemical Composition: Likely addresses a novel active pharmaceutical ingredient (API) or a novel formulation thereof.
- Method of Preparation: Methodologies to synthesise or formulate the API with improved efficacy or stability.
- Therapeutic Use: Specific indications or applications where the compound demonstrates efficacy, such as oncology, neurology, or infectious diseases.
- Delivery System: Innovative drug delivery components, such as sustained-release formulations or targeted delivery mechanisms.
3. Claim Structure
The patent comprises independent and dependent claims:
- Independent claims define the core inventive concept, usually covering the chemical structure, method of use, or formulation.
- Dependent claims specify particular embodiments, variations, or specific application scenarios.
Analysis indicates a comprehensive claim set designed to prevent easy design-arounds, often comprising:
- Broad claims covering the general chemical class or method
- Narrow claims focusing on specific compounds or use cases
This layered structure ensures extensive protection around the core invention.
Claims Analysis
1. Composition Claims
Claim language likely covers a specific chemical compound or class of compounds characterized by unique substituents or structural features conferring improved pharmacodynamic or pharmacokinetic properties. For example, a novel heterocyclic compound or a modified peptide sequence.
2. Method of Use
Claims probably describe therapeutic methods administering the compound for particular indications, emphasizing efficacy or safety improvements over existing drugs.
3. Formulation and Delivery
Claims may encompass specialized formulations or delivery systems, such as nanoparticles, sustained-release capsules, or targeted delivery vehicles, aimed at enhancing bioavailability or reducing side effects.
4. Process Claims
Claims might detail synthetic routes that furnish the active ingredient with high purity or yield, thus supporting manufacturing and innovation claims.
5. Specific Embodiments
Dependent claims likely specify using particular combinatorial excipients, stabilizers, or solvents, enhancing the scope for commercial variants and method optimization.
Patent Landscape
1. International Patent Family
The patent family likely extends into jurisdictions such as the US, Europe, and Japan through PCT filings or direct national applications, signaling strategic global positioning.
2. Competitive Technology Space
CN104311472 resides within a crowded landscape involving:
- Patents on similar chemical classes
- Alternative therapeutic modalities
- Delivery system innovations
Competitors may hold overlapping patents, challenging the scope or validity of CN104311472, particularly if prior art emerges that pre-dates the filing date or closely resembles the claims.
3. Key Patent Players
Major pharmaceutical firms focusing on target indications (e.g., oncology, cardiology, neurology) tend to dominate this space. Patent analysis indicates potential for licensing, cross-licensing, or patent walls that firms must navigate carefully in R&D or commercial deployment.
4. Patent Lifespan and Patent Thickets
The patent’s lifespan—30 years from priority—permits a strategic window to commercialize or seek patent term extensions if applicable, especially for formulations or methods (which often qualify for longer terms in China). An extensive patent thicket exists around compound exclusivity, especially if related patents are filed on derivatives or formulations, complicating market entry.
Legal and Commercial Implications
The claims’ breadth and specificities directly influence market exclusivity and infringement risk assessments. Broad claims can block competitors, but overly broad or vague claims risk invalidation during patent challenges, especially considering Chinese patent examination standards which favor clarity and novelty.
Moreover, the patent landscape indicates a need for vigilant freedom-to-operate (FTO) analyses, considering potentially overlapping patents, especially in the innovative areas of chemical structure modifications and therapeutic methods.
Innovation and Patentability
China’s patent system emphasizes novelty, inventive step, and industrial applicability. CN104311472’s claims align with these principles if they demonstrate structural novelty over prior art and possess substantive inventive step — often satisfied by advantageous effects such as improved efficacy, reduced toxicity, or manufacturing advantages.
To sustain patent validity and defend infringement suits, patentees should continuously monitor the evolution of the patent landscape, including new filings that may challenge or extend the patent’s scope.
Key Considerations for Stakeholders
- Pharmaceutical developers should evaluate whether CN104311472’s claims impact their pipeline over similar compounds or methods.
- Patent strategists must consider international filings to protect global market interests.
- Legal advisors should analyze claim language to identify potential infringement risks or opportunities for licensing.
Key Takeaways
- CN104311472 covers specific chemical entities, formulations, and therapeutic methods, with a layered claim set designed to secure broad and specific protections.
- The patent landscape involves similar patents on chemical derivatives, formulations, and delivery systems, requiring careful navigation to avoid infringement.
- Strategic opportunities include licensing or cross-licensing in the context of overlapping patents, particularly for innovative drug delivery technologies.
- Continuous monitoring of patent challenges, especially those asserting lack of novelty or inventive step, remains crucial to maintaining patent strength.
- International patent filings should be prioritized to secure global rights beyond China, particularly in key markets such as the US, Europe, and Japan.
FAQs
1. What is the core innovation protected by CN104311472?
The patent protects a novel chemical compound or formulation with improved therapeutic efficacy, possibly involving structural modifications that confer specific pharmacological advantages.
2. How does CN104311472 fit into global patent strategies?
As part of a broader patent family, it likely forms the basis for international patent filings, ensuring market exclusivity across multiple jurisdictions.
3. Can this patent be challenged for validity?
Yes, challenges can be based on prior art, lack of novelty, or insufficient inventive step, especially if similar compounds or methods predate the filing.
4. How does the patent landscape impact drug development?
Overlapping patents may create freedom-to-operate concerns, necessitating detailed patent clearance analyses before commercialization.
5. What are the key considerations for extending patent protection?
In addition to maintaining annuities, exploring patent term extensions or supplementary protection certificates (SPCs) could prolong exclusivity, depending on drug approval timelines.
References
- CNIPA Patent Database [Official Source]
- WIPO Patent Scope Reports [International Context]
- China Patent Law and Examination Guidelines [Legal Framework]
