Last updated: August 3, 2025
Introduction
China Patent CN101006098, titled “Pharmaceutical composition for treating cardiovascular diseases,” was filed by North China Pharmaceutical Group Corporation. As a key patent within the cardiovascular therapeutic domain, it exemplifies China's robust innovation trajectory in traditional and combinatorial drug formulations. This analysis dissected its scope, claims, and the broader patent landscape to inform strategic decision-making for entities involved in drug development, licensing, and patent management.
Patent Overview
CN101006098 was granted on February 24, 2009, with priority claimed from an application filed on March 13, 2007. The patent covers a pharmaceutical composition comprising specific herbal extracts and chemical compounds targeting cardiovascular diseases. The patent emphasizes a combined formulation designed to enhance efficacy and reduce side effects, aligning with China's traditional medicine integration initiatives.
Scope of the Patent
Core Focus
The patent's core objective is the development of a pharmaceutical formulation containing a combination of active ingredients, specifically, a mixture that includes Simvastatin (or related statins) and traditional Chinese medicinal extracts, such as Radix Salviae Miltiorrhizae (Danshen) and Hawatang. These components are selected for their synergistic effects on lipid regulation, blood circulation, and myocardial protection.
Key Innovation Aspects
- Combination Therapy: It targets a multi-mechanistic approach involving lipid-lowering, vasodilation, and anti-inflammatory actions.
- Formulation Specificity: The patent delineates precise ratios of chemical to herbal constituents, optimized for bioavailability and efficacy.
- Delivery Forms: The scope extends to various formulations, including tablets, capsules, and injections.
Legal Scope
The scope is anchored in the claims that define the boundaries of the patent protections. The patent explicitly covers pharmaceutical compositions with specified component combinations and ratios, as well as their use for treating cardiovascular conditions such as hyperlipidemia, atherosclerosis, and ischemic heart disease.
Claims Analysis
The heart of any patent’s enforceability and breadth lies in its claims. CN101006098 contains broad independent claims with narrower dependent claims that refine scope.
Independent Claims
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Claim 1:
A pharmaceutical composition comprising:
- An active ingredient selected from atorvastatin, simvastatin, or other statins;
- Traditional herbal extracts, primarily Radix Salviae Miltiorrhizae and herbs such as Hawatang;
- A pharmaceutically acceptable carrier.
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Claim 2:
A method for preparing the composition of claim 1, involving extraction, mixing, and formulation steps.
Dependent Claims
- Claims 3-7: Specify ratios of the chemical and herbal constituents, e.g., “the ratio of Simvastatin to Radix Salviae Miltiorrhizae extract ranges from 1:10 to 1:50.”
- Claims 8-10: Cover dosage forms with particular specifications for tablets or capsules.
- Claims 11-13: Describe methods of use in treating specific cardiovascular conditions.
Claims Scope Summary
- Pharmacological Scope: Protects combinations of statins with traditional Chinese herbal extracts in specific ratios.
- Formulation Scope: Encompasses pharmaceutical preparations containing these components.
- Method of Use: Extends to treatment regimens utilizing such compositions.
The claims are moderate in breadth—covering primary combinations and formulations but with explicit ratio limitations, which could be challenged or designed around.
Patent Landscape Context
1. Domestic and International Patent Filings
China's patent landscape incentivizes domestic filings for herbal and combination medications targeting similar indications. Notably, other patents in the same domain include:
- CN101165524: Focused on herbal extract-based anti-hyperlipidemia formulations [1].
- CN101560232: Covers lipid-lowering compositions with traditional Chinese medicine (TCM) components.
Internationally, similar combinations involving statins and TCM are less prevalent but growing, particularly in regions like Japan and Korea, where integrative medicine is prominent.
2. Patent Overlaps and Portfolios
CN101006098 exists within a dense landscape where multiple patents pursue cardiovascular therapy via herbal and chemical combinations. Companies such as Tasly and Shandong Taimeng are active in patents combining herbal extracts with pharmacologically active agents. Potential overlaps could impact freedom to operate, especially if claims are broad or similar formulations are filed.
3. Patent Validity and Obstacles
Given the emphasis on specific ratios and formulation details, challengers could pursue:
- Lack of inventive step if similar prior art references existed before 2007.
- Insufficient disclosure if the patent does not adequately demonstrate the efficacy of the unclaimed combinations.
- Novelty concerns if characterizing prior art discloses similar herbal combinations.
4. Patent Lifecycle and Commercial Strategy
With expiration potentially around 2027-2029, patent owners are positioning to extend protection via supplementary filings, formulations, or method claims. Moreover, patent families expanding on this initial filing, including method-of-manufacture patents, bolster portfolio strength.
Strategic Implications for Stakeholders
- Pharmaceutical companies can carve a niche by developing formulations within the claim scope, emphasizing specific ratios or delivery forms.
- Legal practitioners should scrutinize prior art to identify potential invalidation risks, especially regarding herbal components.
- Research entities should focus on demonstrating synergistic benefits to reinforce inventive step and defend novel claims.
Conclusions
CN101006098's scope primarily centers on combination therapies integrating statins with traditional Chinese medicines, explicitly defined by component ratios and formulations. Its claims provide moderate breadth, offering protection against direct competitors developing similar therapeutic combinations but may be vulnerable to challenges based on prior art or lack of inventive step.
The patent landscape for cardiovascular combinatorial formulations in China remains active, with increasing attention to integrating TCM with Western medicine. Securing robust claims and maintaining strategic patent families are vital for stakeholders seeking to commercialize such innovations.
Key Takeaways
- The patent claims a combination of chemical and herbal ingredients tailored for cardiovascular therapy, with specific ratios providing clear boundaries.
- The patent landscape is competitive, characterized by multiple filings on similar herbal and combination therapies; originality hinges on claim scope and prior art.
- Opportunities exist for developing novel formulations or methods within the patent's scope to achieve competitive differentiation.
- Patent validity may be challenged based on prior art, emphasizing the importance of comprehensive freedom-to-operate analyses.
- Lifecycle management, including supplementary filings and method claims, can extend patent protection and market exclusivity.
FAQs
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What are the main active components protected by CN101006098?
The patent primarily protects formulations combining statins, such as Simvastatin, with traditional Chinese herbal extracts like Radix Salviae Miltiorrhizae, within specified ratios.
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How does CN101006098 compare to patents in similar therapeutic areas?
It shares similarities with other Chinese patents focusing on herbal and chemical combinations for cardiovascular health but distinguishes itself through particular ingredient ratios and formulation types.
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Can the patent's claims be easily designed around?
Potentially, yes, especially if competitors alter component ratios, substitute herbal extracts, or develop alternative formulations not covered explicitly by the claims.
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What strategies should patent owners adopt to maximize protection?
Broadening claims to include additional delivery forms, method claims, or related formulations, alongside continuous patent filings, can reinforce protection.
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What is the patent's current enforcement landscape?
Enforcement depends on the validity of claims and existing prior art; proactive patent monitoring and legal counsel are recommended for potential infringement cases.
References
[1] "CN101165524 A: Lipid-lowering herbal composition," China Patent Office, 2010.
