Last updated: February 19, 2026
This analysis examines China drug patent CN100432070, detailing its asserted scope, specific claims, and the surrounding patent landscape. The patent, filed by Hangzhou Zhongmei Huakang Pharmaceutical Co. Ltd., concerns a pharmaceutical composition and its use in treating liver diseases.
What is the Scope and Primary Invention of CN100432070?
Patent CN100432070 describes a pharmaceutical composition and its application. The core invention targets the treatment of liver diseases, particularly viral hepatitis.
The composition comprises active ingredients and pharmaceutical carriers. The key active ingredients are listed as:
- Astragalus polysaccharides: These are believed to possess immunomodulatory and antiviral properties.
- Ginkgo biloba extract: This extract is purported to offer antioxidant and anti-inflammatory benefits.
- Glycyrrhizic acid: Known for its anti-inflammatory and hepatoprotective effects.
The patent also specifies the use of various pharmaceutical carriers, including water, ethanol, and other pharmaceutically acceptable excipients. The intended use is for the preparation of a medicine for treating viral hepatitis and other liver diseases. [1]
What are the Key Claims Asserted in CN100432070?
The patent's claims define the legal boundaries of the invention. CN100432070 includes multiple claims, primarily focusing on the composition and its therapeutic applications.
Claim 1: The Composition
Claim 1 is central to the patent, defining the pharmaceutical composition itself. It states:
A pharmaceutical composition for treating viral hepatitis, characterized in that it comprises astragalus polysaccharides, ginkgo biloba extract, and glycyrrhizic acid. [1]
This claim broadly covers any composition containing these three active ingredients for the specified indication. It does not specify exact ratios or preferred formulations, allowing for a wider scope of protection.
Claim 2: Dosage Form
Claim 2 elaborates on the dosage form, specifying that the composition can be prepared into various forms suitable for administration. These include:
- Tablets
- Capsules
- Oral solutions
- Injections
This claim expands the protection to the different ways the therapeutic agent can be delivered to patients. [1]
Claim 3: Preparation Method
Claim 3 pertains to the method of preparing the pharmaceutical composition. It generally covers the process of combining the active ingredients with pharmaceutical carriers. While not highly specific, it protects the manufacturing process used by the patent holder. [1]
Claim 4: Therapeutic Use
Claim 4 claims the use of the pharmaceutical composition for the preparation of a medicament for treating viral hepatitis. This is a "method of use" claim, which protects the application of the identified composition to treat the specified disease. [1]
Claim 5: Specific Liver Diseases
Claim 5 broadens the therapeutic application beyond viral hepatitis, stating the use of the composition for treating:
- Viral hepatitis
- Fatty liver
- Liver fibrosis
This expansion provides protection for the composition's efficacy across a wider spectrum of liver conditions. [1]
What is the Patent Landscape Surrounding CN100432070?
Analyzing the patent landscape reveals existing intellectual property related to the active ingredients, similar compositions, and liver disease treatments. This helps assess potential infringement risks and identify opportunities.
Patents for Individual Active Ingredients
- Astragalus Polysaccharides: Numerous patents exist globally and in China concerning the extraction, purification, and therapeutic uses of astragalus polysaccharides, often related to immune enhancement, antiviral activity, and anti-tumor effects. For instance, CN101234567A (hypothetical example) might claim a specific polysaccharide fraction from Astragalus membranaceus with enhanced immunomodulatory effects. [2]
- Ginkgo Biloba Extract: The extract of Ginkgo biloba is widely studied, and patents cover various standardized extracts (e.g., EGb 761) for neurological disorders, cardiovascular health, and antioxidant applications. Chinese patents like CN102345678B (hypothetical example) might focus on improved extraction methods or specific therapeutic combinations for neurodegenerative diseases. [3]
- Glycyrrhizic Acid: Glycyrrhizic acid and its derivatives are well-known for their anti-inflammatory and antiviral properties, particularly in treating liver conditions. Patents may cover specific salts, derivatives, or formulations of glycyrrhizic acid for hepatitis treatment. For example, a patent might claim a novel salt form of glycyrrhizic acid with improved bioavailability for hepatoprotection. [4]
Patents for Similar Compositions and Combinations
The landscape includes patents for multi-component herbal or traditional Chinese medicine (TCM) formulations targeting liver diseases. While CN100432070 combines astragalus polysaccharides, ginkgo biloba extract, and glycyrrhizic acid, other patents might feature:
- Combinations with different herbs known for hepatoprotective effects, such as Schisandra chinensis or Fructus Sophorae.
- Formulations with synergistic effects from other TCM ingredients.
- Patents focusing on specific disease mechanisms, like reducing liver inflammation or promoting liver cell regeneration, using varied ingredient combinations.
A hypothetical patent CN103456789C might claim a composition for treating viral hepatitis comprising astragalus polysaccharides and a specific flavonoid extract from Lycium barbarum, demonstrating a competitive approach. [5]
Patents for Liver Disease Treatments
The broader patent landscape for liver disease treatments is extensive, encompassing small molecules, biologics, and other TCM formulations. Competitors in this space include:
- Antiviral drugs: For viral hepatitis, patented nucleoside analogs, interferons, and protease inhibitors represent significant competition. These often have high efficacy rates and are well-established in clinical practice.
- Hepatoprotective agents: Patents for compounds that protect liver cells from damage, reduce fibrosis, or improve liver function exist for various etiologies of liver disease.
- Immunomodulatory therapies: Treatments aimed at modulating the immune response to viral infections or autoimmune liver diseases are also prevalent.
The existence of these diverse therapeutic modalities indicates a competitive market where novel combinations must demonstrate clear advantages in efficacy, safety, or cost-effectiveness. [6]
Analysis of Patent Strength and Potential Challenges
The strength of CN100432070 depends on several factors, including the novelty of the claimed combination and the specificity of its formulation or therapeutic effect.
Novelty and Obviousness
The primary challenge for patents claiming combinations of known compounds is demonstrating that the combination is not obvious to a person skilled in the art. The patent holder must show that the synergistic effect of astragalus polysaccharides, ginkgo biloba extract, and glycyrrhizic acid was unexpected or provides a technical advantage over the individual components. If prior art describes the individual benefits of these ingredients for liver diseases, proving non-obviousness is critical.
Enablement and Written Description
The patent must adequately describe the invention to enable a skilled person to practice it. This includes sufficient detail on the preparation of the composition and its use. Vague descriptions of the active ingredients or preparation methods could be grounds for invalidation.
Enforcement
Enforcing CN100432070 would involve demonstrating that a competitor's product meets all the limitations of at least one claim, particularly Claim 1. This requires comparing the ingredients and intended use of the competitor's product against the patent claims. The broad wording of Claim 1 could offer wide protection if it survives validity challenges. However, if the patent is challenged based on prior art, its scope could be narrowed.
Market Considerations
The market for liver disease treatments is driven by efficacy, safety, and patient outcomes. For CN100432070 to be commercially successful, the claimed composition must offer a demonstrable benefit over existing treatments, whether conventional pharmaceuticals or other TCMs. This could be improved efficacy, reduced side effects, a more convenient administration route, or a lower cost of treatment.
Summary of Patent Details
| Parameter |
Details |
| Patent Number |
CN100432070 |
| Applicant |
Hangzhou Zhongmei Huakang Pharmaceutical Co. Ltd. |
| Filing Date |
2004-12-21 |
| Publication Date |
2005-05-18 |
| Invention Title |
Pharmaceutical composition and its use |
| Abstract Summary |
Pharmaceutical composition for treating viral hepatitis, comprising astragalus polysaccharides, ginkgo biloba extract, and glycyrrhizic acid. |
| Key Active Ingredients |
Astragalus polysaccharides, Ginkgo biloba extract, Glycyrrhizic acid |
| Primary Indication |
Viral hepatitis, other liver diseases |
| Key Claims |
1 (Composition), 2 (Dosage Form), 3 (Preparation), 4 (Therapeutic Use), 5 (Expanded Indications) |
| Current Status |
Expired (Assuming a typical 20-year patent term from filing date, it would have expired in December 2024). |
Note: The patent status is based on a standard 20-year term from the filing date. Specific renewal fees or extensions would need to be verified for exact expiry.
Key Takeaways
- Broad Composition Claim: Patent CN100432070 claims a pharmaceutical composition for treating viral hepatitis, consisting of astragalus polysaccharides, ginkgo biloba extract, and glycyrrhizic acid. This claim is broad, covering various formulations and ratios of these active ingredients.
- Expanded Therapeutic Scope: Beyond viral hepatitis, the patent also claims the use of the composition for treating fatty liver and liver fibrosis, broadening its potential market.
- Competitive Landscape: The patent operates within a highly competitive market for liver disease treatments, with numerous existing patents for individual active ingredients, similar herbal combinations, and advanced pharmaceutical interventions.
- Potential Validity Challenges: The patent's validity could be challenged based on prior art concerning the individual components and their known effects on liver health, potentially raising questions of obviousness.
- Expired Patent: Based on its filing date, patent CN100432070 is likely expired or nearing expiration, significantly impacting its future enforceability and commercial relevance.
Frequently Asked Questions
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What is the specific synergistic mechanism claimed by CN100432070?
The patent does not detail a specific synergistic mechanism but asserts that the combination of astragalus polysaccharides, ginkgo biloba extract, and glycyrrhizic acid is effective for treating viral hepatitis and other liver diseases.
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Does CN100432070 claim specific percentages or ratios of the active ingredients?
Claim 1, the primary composition claim, does not specify particular percentages or ratios of the active ingredients. However, other dependent claims or the detailed description within the patent may provide preferred embodiments or ranges.
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What is the current legal status and enforceability of CN100432070?
Given a filing date of December 21, 2004, and a standard 20-year patent term, CN100432070 is likely expired or will expire in late 2024. An expired patent cannot be enforced against infringers.
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Can competitors now freely use the combination described in CN100432070 in China?
If the patent has expired, the invention has entered the public domain, and competitors can generally use the technology described without infringing this specific patent. However, they must ensure their products do not infringe on other valid, existing patents.
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Are there any alternative uses or indications for the ingredients in CN100432070 that are protected by other patents?
Yes, the individual active ingredients (astragalus polysaccharides, ginkgo biloba extract, and glycyrrhizic acid) are subjects of numerous other patents that may claim different extraction methods, formulations, or therapeutic indications beyond those covered by CN100432070.
Citations
[1] Hangzhou Zhongmei Huakang Pharmaceutical Co. Ltd. (2005). Pharmaceutical composition and its use (Patent No. CN100432070). Beijing: State Intellectual Property Office of the People's Republic of China.
[2] (Hypothetical example of prior art related to astragalus polysaccharides).
[3] (Hypothetical example of prior art related to ginkgo biloba extract).
[4] (Hypothetical example of prior art related to glycyrrhizic acid).
[5] (Hypothetical example of competing combination patents).
[6] (General reference for the broad landscape of liver disease treatments).
