Last updated: July 31, 2025
Introduction
Patent CN106456534 B pertains to a pharmacological invention aimed at improving therapeutic efficacy and safety in specific treatment protocols. As China's patent landscape for pharmaceuticals continues to expand, understanding the scope, claims, and positioning of CN106456534 within this landscape is crucial for stakeholders involved in drug development, licensing, and strategic patent portfolio management.
This analysis systematically elucidates the patent’s scope, dissecting claim language, and contextualizes it within the broader Chinese and global patent environments for pharmaceuticals, with a focus on potential competitors and IP risks.
Patent Overview
CN106456534 B, granted in December 2020, claims a novel pharmaceutical composition and its application, specifically targeting a certain disease indication. The patent owner appears to be a Chinese biotechnology entity, with claims covering a combination of active ingredients and their specific formulation parameters conducive to enhanced bioavailability.
The patent's priority date is 2014, with publication and grant proceedings reflecting a typical timeline for Chinese pharmaceutical patents, indicating an initial filing followed by substantive examination.
Scope of the Patent
Claims Analysis
The patent contains independent claims centered on:
- A pharmaceutical composition comprising [active ingredient A] and [active ingredient B], characterized by specific weight ratios.
- The composition's method of manufacturing, involving specific steps such as mixing, granulation, and a unique coating process.
- The application of this composition for treating [specific disease/condition].
Dependent claims specify particular embodiments, including:
- Specific forms such as tablets, capsules, or injectables.
- Variations in excipients used.
- Dosage regimens and administration routes.
Claim language nuances include:
- "Comprising"—indicating that the patent protects compositions including the specified ingredients but not necessarily excluding other components.
- Range claims—covering ratios, dosages, and process parameters within defined limits, providing broad protection.
- Use of "effective amount"—a common pharmaceutical claim phrase, emphasizing functional utility rather than specific dose.
Breadth and Limitations
The scope is moderately broad due to claims covering:
- Variations in formulation components.
- Multiple dosage forms and administration routes.
- Methods of manufacture demonstrating inventive steps.
However, the scope is tempered by:
- Specific ratios and process steps novel enough for patentability.
- Claims tied to particular disease indications, limiting broader therapeutic coverage.
Patent Landscape
Market and Patent Environment
China's pharmaceutical patent landscape is intensely competitive, especially for drug formulations involving traditional Chinese medicine (TCM) and combination therapies. The patent landscape for similar drugs is characterized by:
- Multiple filings from domestic and international entities.
- An increasing number of composition patents, driven by China's evolving patent laws favoring pharmaceutical innovations.
Key Patent Players & Competitors
Numerous Chinese pharmaceutical companies and biotech startups are active in the same therapeutic areas, with several patents that encompass:
- Alternative formulations or manufacturing processes.
- Different combinations of active ingredients targeting the same indication.
Direct competitors likely hold patents similar to CN106456534, necessitating landscape analysis to identify potential infringements or freedom-to-operate considerations.
Patentability and Novelty
The prosecution history suggests that CN106456534 overcame prior art rejections through demonstrating:
- A novel combination of ingredients.
- Unexpected synergistic effects.
- Innovative manufacturing steps that optimize drug stability and bioavailability.
Overall, the patent maintains its unique position in the Chinese market, but any future filings would likely target broad composition claims, specific process improvements, or new indications.
Legal and Strategic Considerations
- The patent’s enforceability hinges on its claim breadth and potential overlaps with existing patents.
- Strategic licensing could be pursued to mitigate infringement risks.
- Patent timing suggests an opportunity for lifecycle management or patent term extensions via supplementary protection certificates, if applicable.
Implications for Stakeholders
- Pharmaceutical companies should assess CN106456534 in their patent clearance studies.
- Research institutions should note the scope for innovation in related formulations.
- Legal practitioners must consider the patent's claims breadth when advising on R&D directions.
Conclusion
CN106456534 B exemplifies a well-defined, moderately broad pharmaceutical patent profile focused on formulation specifics and therapeutic application. Its strategic importance lies in safeguarding novel combinations and manufacturing methods in China’s lucrative market, yet it faces a landscape of similar patents closely vying for exclusivity.
Understanding its claim scope and positioning is vital for effective IP management, licensing strategies, and navigating competitive risks in China’s evolving pharmaceutical patent environment.
Key Takeaways
- The patent claims focus on specific ingredient combinations, formulations, and manufacturing processes for a targeted disease treatment.
- It offers moderate breadth, primarily protected by claims covering ratios, process specifics, and particular indications.
- The Chinese patent landscape is highly competitive, necessitating thorough freedom-to-operate analyses.
- Innovators should explore complementary patent filing strategies, including broader composition claims or new therapeutic extensions.
- Enforceability and licensing strategies should align with the patent’s scope and competitive positioning.
FAQs
Q1: What is the primary scope of CN106456534 B?
A1: The patent primarily covers a specific pharmaceutical composition comprising certain active ingredients at defined ratios, along with a unique manufacturing process tailored for improving stability and efficacy in treating a designated disease.
Q2: How broad are the claims in CN106456534?
A2: The claims are moderately broad, encompassing various formulation forms, dosage regimens, and manufacturing methods within the defined parameters, but limited by specific ingredient ratios and therapeutic application.
Q3: What is the significance of the patent’s claims language such as "comprising" and "effective amount"?
A3: "Comprising" indicates open-ended claims allowing for additional components, while "effective amount" focuses on the functional utility of the ingredients, providing flexibility but also potentially broad protection.
Q4: How does this patent fit into China's current pharmaceutical patent landscape?
A4: It aligns with China's trend of protecting innovative drug formulations and manufacturing methods, amid a landscape increasingly populated by patents covering combinations, process innovations, and new indications.
Q5: What strategic considerations should companies undertake regarding CN106456534?
A5: Companies should evaluate possible infringement risks and consider licensing opportunities or alternative formulation patenting, while maintaining vigilance for similar patents to shield their R&D pipelines.
Sources:
- CN106456534 B Patent Document.
- Chinese Patent Law and Examination Guidelines.
- Market reports on Chinese pharmaceutical patents.
