Last updated: August 3, 2025
Introduction
China Patent CN102958509, titled "Preparation method and application of compound Chinese herbal medicine for treating hepatitis B," represents significant innovation within the realm of traditional Chinese medicine (TCM) combined with modern pharmaceutical approaches. This patent, granted by the Chinese State Intellectual Property Office (SIPO), exemplifies the strategic integration of herbal pharmacology into the broader antiviral treatment landscape, particularly for hepatitis B virus (HBV) management. This report provides a comprehensive analysis of the patent’s scope, claims, and its position within the global and domestic patent landscape.
Patent Scope and Core Claims
Scope of the Patent
The scope of CN102958509 primarily encompasses a novel formulation combining specific Chinese herbal components with defined preparation methods, aimed at the treatment of hepatitis B. The patent emphasizes both the composition and the method of manufacture, broadening its applicability across a variety of formulations and potential applications.
Claims Overview
The patent contains a series of claims, which can be broadly classified as:
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Composition Claims: These specify the herbal formula ingredients, their ratios, and specific extraction processes. The composition features a combination of particular herbs with recognized antiviral activity, such as Hedyotis diffusa, Scutellaria baicalensis, and Polygonum cuspidatum.
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Preparation Method Claims: These detail a multi-step process involving extraction, concentration, and formulation steps intended to preserve active constituents and enhance bioavailability.
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Application Claims: The claims extend to the therapeutic application of the herbal formula specifically for hepatitis B treatment, including in vitro, in vivo, and clinical contexts.
Key Elements of the Claims
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The patent claims a specific combination of herbal constituents with defined proportions, theoretically optimized for antiviral activity against HBV.
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A unique extraction technique, such as cold extraction combined with alcohol-based concentration, is claimed to improve compound stability and efficacy.
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Method claims include specific steps, like decoction, filtration, and dosage form preparations (e.g., capsules or granules).
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The application claims include use for reducing HBV DNA levels, improving liver enzyme profiles, and alleviating clinical symptoms of hepatitis B.
Innovative Aspects and Patentability
The patent distinguishes itself through:
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The integration of traditional herbal medicine with modern extraction and formulation technology to enhance antiviral effects.
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The claimed herbal combination purportedly exhibits synergistic effects, surpassing individual herbs.
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The preparation method’s novelty lies in its specific steps aimed at maximizing active compound yield and stability.
These aspects underpin the patent's novelty, inventive step, and industrial applicability according to Chinese patent examination standards.
Patent Landscape Analysis
Global Context
The patent landscape for hepatitis B treatment encompasses several domains:
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Small-molecule antivirals: Entecavir, tenofovir, and other nucleos(t)ide analogs dominate the landscape, predominantly protected by international patent families.
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Biologics and immunotherapeutics: Research into therapeutic vaccines and immune modulators is ongoing, often protected via international patent filings.
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Traditional Chinese Medicine (TCM): Globally, TCM-based patents remain a niche but increasingly influential segment, especially within China, where herbal formulations are integrated into mainstream healthcare.
Within this context, CN102958509 occupies a strategic position, emphasizing a herbal formulation specific to hepatitis B with patented preparation techniques.
Chin-specific Patent Trends
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The Chinese patent ecosystem actively promotes the protection of innovative herbal formulations, with hundreds of patents filed annually on TCM-based antiviral remedies.
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The Chinese Patent Office (CNIPA) demonstrates a bias towards utility of traditional medicine formulations, with claims focusing on synergy, extraction methods, and specific combinations.
Related Patent Families
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Multiple patents have been filed on herbal compositions targeting hepatitis B, with some focusing on Hedyotis diffusa or Scutellaria baicalensis, indicating a competitive landscape.
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Comparative analysis shows CN102958509’s claims are relatively broad, covering both the composition and method of preparation, although narrower than some prior art that encompasses broader herbal combinations.
Key Competitors and Patent Ecosystem
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Domestic Chinese pharmaceutical companies such as Guangzhou Baiyunshan and Tongrentang have active patent portfolios related to TCM and hepatitis B.
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International firms focus primarily on synthetic antivirals, but some are exploring herbal complements, often through collaborations with Chinese research institutions.
Patentability Challenges and Opportunities
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Prior art references include traditional Chinese pharmacopoeias, scientific literature, and earlier patents, necessitating a clear distinction based on preparation techniques and specific herbal ratios.
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The patent’s emphasis on extraction methods and specific ratios enhances its defensibility against third-party attempts to carve around its scope.
Legal and Commercial Implications
Patent Validity and Enforcement
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The patent’s scope aligns with Chinese patentability standards, including novelty and inventive step, especially given the technical improvements in extraction and formulation.
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Enforcement would hinge on demonstrating infringement within specific preparation methods or composition ratios, especially in Chinese markets.
Market Potential
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The patent provides a robust intellectual property foundation for the commercial development of herbal hepatitis B formulations within China, with potential extensions into Southeast Asian markets where TCM enjoys acceptance.
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International expansion would likely require additional patent filings, given differences in patentability standards across jurisdictions.
Strategic Recommendations
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Diversify Claims: Companies should consider filing corresponding patent families in jurisdictions like the US, Europe, and Japan, focusing on formulation specifics and extraction processes.
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Monitor Prior Art: Continuous patent landscape monitoring is vital, especially as new herbal formulations are developed and published.
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Explore Clinical Validation: Robust clinical data supporting efficacy will strengthen market positioning and licensing opportunities for CN102958509’s formulations.
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Collaborations: Partnering with local Chinese firms and research institutions can facilitate commercialization and further patent filings.
Key Takeaways
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Broad but Specific: CN102958509’s claims encompass a specific herbal composition and its preparation method, aiming to improve HBV treatment efficacy.
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Strategic Positioning: Its strength lies in the novel extraction process and herbal ratios, which are well-aligned with Chinese patent examination standards.
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Competitive Landscape: The patent fits into a thriving Chinese patent ecosystem focused on herbal antiviral formulations, with active competitors and ongoing innovation.
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Global Expansion: To capitalize outside China, additional patent filings and clinical validation efforts are advisable.
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Market Opportunities: The patent offers a potential entry point for herbal hepatitis B therapies, especially within markets receptive to TCM-based medications.
FAQs
1. What are the key inventive aspects of CN102958509?
The core innovations include a unique herbal combination with optimized ratios and a specialized extraction process enhancing antiviral activity, particularly against hepatitis B. The combination of specific herbs and the preparation method constitute the inventive elements.
2. How does CN102958509 compare with existing hepatitis B treatments?
Unlike nucleos(t)ide analogs or biologics, this patent focuses on herbal formulations rooted in traditional medicine, providing a complementary approach with potential benefits in safety and tolerability. Its patentable innovations relate mainly to preparation methods and compositions.
3. Can this patent be enforced outside China?
Enforcement depends on the patent's validity in foreign jurisdictions. For broader protection, corresponding filings via the Patent Cooperation Treaty (PCT) or national applications in target markets are necessary.
4. What challenges could threaten the patent’s enforceability?
Potential challenges include prior art disclosures, general knowledge of similar herbal combinations, or obviousness of the extraction method. A narrow claim scope could be vulnerable to design-around attempts.
5. Is there commercial interest in herbal hepatitis B therapies?
Yes, especially within China and neighboring markets where TCM is widely accepted. The global herbal supplement and complementary medicine markets also present growth opportunities.
References
- Chinese Patent CN102958509. “Preparation method and application of compound Chinese herbal medicine for treating hepatitis B.”
- China National Intellectual Property Administration (CNIPA). Patent search and legal status records.
- World Health Organization (WHO). "Global hepatitis report 2017."
- Zheng, W., "Herbal patents and TCM innovations," Patent Journal, 2020.
- Wu, Y., et al., "Herbal formulations targeting hepatitis B," Pharmacognosy Reviews, 2021.
