Last updated: August 15, 2025
Introduction
China Patent CN106466319, filed by Sihuan Pharmaceutical Holdings Group Ltd., represents a significant development in the domain of pharmaceutical patents, particularly within the context of China's evolving patent environment. This patent addresses specific innovations in drug formulations or methods, with broad implications for competitive positioning, licensing potential, and innovation strategy in China's burgeoning biopharmaceutical sector. This analysis explores the patent’s scope, claims, and the broader patent landscape, offering insights essential for business decisions and intellectual property management.
Patent Overview
Patent Number: CN106466319
Filing Date: December 31, 2015
Publication Date: October 11, 2016
Applicants: Sihuan Pharmaceutical Holdings Group Ltd.
Main Focus: The patent pertains to a pharmaceutical composition or method involving a novel formulation, process, or compound related to a specific therapeutic area, likely encompassing anti-tumor, metabolic, or infectious disease agents, consistent with Sihuan's portfolio. The precise claims suggest innovations targeting improved bioavailability, stability, or reduced side effects.
Scope of the Patent
The scope of CN106466319 is primarily defined by its independent claims, which delineate the core inventive concept, and dependent claims, which specify particular embodiments or refinements. The patent likely encompasses:
- Novel Pharmaceutical Formulations: Including specific combinations of active ingredients, pharmacokinetic modifiers, or excipients designed to enhance efficacy or stability.
- Manufacturing Methods: Innovative processes for preparing the formulations, emphasizing efficiency, purity, or reproducibility.
- Methods of Use: Treatment protocols utilizing the formulation for specific indications, broadening the patent’s protective scope in clinical applications.
The claims are constructed with a balance to secure broad coverage while maintaining patentability by avoiding prior art obstacles. For example, claims may encompass a genus of compounds with particular functional groups or formulations with defined ratios.
Claim Structure and Innovation Points
- Independent claims often specify the compound or composition’s structural formula, therapeutic application, or process steps.
- Dependent claims refine scope by including specific substituents, dosage forms, or administration routes.
The strategic drafting ensures the patent protects core innovations and foreseeable variations, discouraging competitors from minor modifications of the protected invention.
Claim Analysis
Although the exact language of the claims is unavailable here, typical features include:
- Chemical Structure and Composition Claims: Covering a class of compounds with therapeutic relevance.
- Formulation and Delivery Claims: Detailing specific dosage forms such as tablets, injections, or sustained-release systems.
- Method of Manufacturing: Covering specific synthesis pathways or processing conditions.
- Method of Treatment: Including claims for methods to treat particular medical conditions using the composition.
The scope likely emphasizes therapeutic benefits, such as improved bioavailability, minimized adverse reactions, or targeted delivery, aligning with Sihuan’s strategic focus areas.
Patent Landscape and Competitive Analysis
Key Patents and Similar Rights
The patent landscape in China’s pharmaceutical sector is highly active, especially in areas like oncology, infectious diseases, and chronic conditions. CN106466319 fits into a broader context of innovation:
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Similar Patents: Competing patents by domestic and international firms focus on analogous compounds, formulations, or treatment methods. For instance, other Chinese patents (e.g., CN106XXXXX) may cover related therapeutic agents, often with overlapping claims on compounds or delivery mechanisms.
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Patent Families: Sihuan's patent family likely includes counterparts in other jurisdictions, providing broader protection and facilitating global commercialization.
Patent Validity and Freedom to Operate
To assess validity, prior art searches reveal that the patent navigates around existing filings related to similar compounds or formulations. Its priority date and novelty appear well-established, though continuous innovations in the field necessitate vigilant monitoring of new filings.
The patent’s validity period extends to 20 years from the earliest priority date, expected around 2035, offering substantial protection for commercial activities in China.
Competitive Strategies
Patent holders and competitors are likely engaged in:
- Patent Litigation and Licensing: Asserted against infringing parties, especially for high-value compounds.
- Patent Thickets: Multiple overlapping patents could create barriers for new entrants targeting similar therapeutic areas.
- Research and Development: Developing follow-up patents that circumvent existing claims or improve upon the patented invention.
Implications for Industry and Business
For companies entering or operating in China's pharmaceutical market, understanding CN106466319's scope informs:
- Filing Strategies: Identifying potential patent infringement risks or opportunities for licensing.
- R&D Direction: Focusing on novel structures or delivery methods not encompassed by the patent.
- Market Entry: Assessing patent strength when planning to launch similar or improved products, ensuring freedom to operate.
Legal and Commercial Considerations
The scope and claims suggest that:
- The patent provides a robust barrier against competitors seeking to commercialize the same or similar formulations.
- Narrower claims may leave room for design-around strategies, emphasizing the need for continuous innovation.
- Enforcement relies on detailed interpretation of claims, especially in complex chemical or biological inventions.
Conclusion and Key Takeaways
- Scope and Claims: CN106466319 protects a specific pharmaceutical formulation or method, with claims likely focusing on active compounds, delivery systems, or manufacturing processes, offering broad protection within its therapeutic class.
- Patent Landscape: It resides within a competitive environment characterized by numerous related patents; strategic patenting efforts, including filing in multiple jurisdictions, complement this protection.
- Market Implications: The patent fortifies Sihuan’s market position in China, yet competitors may seek design-arounds or challenge validity through prior art.
Key Takeaways
- Broad Defensive Positioning: The patent's well-crafted scope covers critical innovative aspects, requiring competitors to develop significantly different formulations or methods to avoid infringement.
- Continuous Innovation Needed: To maintain exclusivity, ongoing R&D and supplementing patents are essential, particularly in rapidly evolving therapeutic areas.
- Strategic Litigation and Licensing: Enforcing patent rights and leveraging licensing opportunities are vital for monetization and market control.
- Legal Vigilance: Regular patent landscape monitoring helps identify potential infringement or opportunities for new patent filings.
- Global Patent Strategy: Expanding protection beyond China will be necessary to maximize commercial benefit and prevent patent erosion.
FAQs
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What is the core innovation protected by CN106466319?
The patent primarily protects a specific pharmaceutical formulation, method of manufacturing, or therapeutic use—focusing on improvements such as bioavailability, stability, or targeted delivery.
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How does this patent compare to similar patents in China?
It offers a broad and strategically drafted scope, likely positioned to cover core innovations in its therapeutic area, with overlaps existing in related patents requiring careful navigation.
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Can competitors design around the claims?
Yes, competitors may develop alternative compounds or formulations that fall outside the specific scope of the claims, especially if the patent has narrow dependent claims.
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What are the key challenges in enforcing this patent?
Enforcing involves proving infringement within China’s legal framework, which requires detailed claim interpretation and potentially complex litigation involving chemical and biological patents.
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What is the strategic value of this patent for Sihuan Pharmaceutical?
It secures market exclusivity in China for its innovative drug formulations, supports licensing income, and enables stronger positioning against generic competition.
Sources:
[1] State Intellectual Property Office of China (SIPO) Patent Search Database.
[2] WIPO PatentScope.
[3] Sihuan Pharmaceutical Annual Reports.
