Last updated: September 26, 2025
Introduction
Patent CN102186465, titled "Preparation method and application of a compound for preventing and treating cardiovascular diseases," represents a significant development within China's pharmaceutical intellectual property landscape. This patent exemplifies China's expanding pharmaceutical innovation, particularly in cardiovascular therapy, an area of intense research and commercial interest. This analysis explores the scope, claims, and broader patent landscape surrounding CN102186465, offering insights relevant for patent strategists, biotech firms, and pharmaceutical companies operating within or entering the Chinese market.
Patent Overview
Filing Details and Legal Status
CN102186465 was filed on August 21, 2010, with a grant date of October 15, 2012. It is held by Sichuan Kelun Pharmaceutical Co., Ltd., a prominent Chinese pharmaceutical entity known for its R&D in cardiovascular and traditional Chinese medicine (TCM) formulations [1].
Abstract Summary
The patent discloses a novel compound, its preparation method, and intended application, specifically targeting cardiovascular diseases. The invention emphasizes enhancing therapeutic efficacy, reducing adverse effects, and offering a cost-effective process suitable for large-scale production.
Scope and Claims Analysis
1. Core Technical Disclosure
The patent primarily claims a specific chemical structure, a compound featuring a unique fusion of traditional medicinal ingredients with modern pharmacologically active moieties. The compound purportedly exhibits significant efficacy in preventing or treating conditions such as hypertension, myocardial ischemia, and atherosclerosis.
2. Claims Hierarchy
The patent's claims can be categorized into three tiers:
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Independent Claims:
These define the scope of the invention in broad terms, including the chemical structure, preparation process, and principal therapeutic application. For instance, Claim 1 covers the chemical entity with specific substituents, while Claim 9 addresses a method of preparing the compound. These independent claims establish the primary boundaries of patent protection.
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Dependent Claims:
Subordinate claims specify particular embodiments, such as specific dosages, formulations, or process parameters, thereby narrowing the scope but enhancing enforceability against infringing parties employing similar but not identical variants.
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Use Claims:
Claims extend protection to the application of the compound in specific therapeutic contexts, notably for cardiovascular diseases, thus capturing the method of treatment aspect.
3. Chemical Structure and Novelty
The compound's structure combines traditional medicinal elements—possibly derived from plant extracts—with synthetic modifications intended to enhance bioavailability and reduce toxicity. The novelty lies in the specific configuration and synthesis pathway, which, according to the patent, differentiates it from prior art, such as existing cardiovascular drugs, including those covered by prior Chinese and international patents.
4. Claim Limitations and Breadth
The broad independent claims cover a range of similar compounds by varying substituents within defined parameters (e.g., chemical groups at specific positions). This claim drafting strategy balances broad protection with sufficient specificity to withstand validity challenges.
Patent Landscape Context
1. Prior Art and Overlapping Patents
The landscape includes numerous Chinese patents on cardiovascular pharmaceuticals, especially those involving traditional Chinese medicine components and synthetic derivatives. Prior art references include:
- Patents on similar chemical scaffolds used in hypertension or myocardial protection.
- Existing compounds derived from plant extracts with known therapeutic effects.
- Method-of-use patents for cardiovascular treatments involving natural or synthetic compounds.
These prior arts necessitate that CN102186465 demonstrate non-obviousness and clear inventive step, which its novel chemical structure and synthesis route appear to do.
2. Competitive Patent Environment in China
Chinese patent filings in cardiovascular medicines have surged over the past decade, with a focus on integrating TCM with modern pharmacology [2]. Major players include domestic firms like Kelun, Tianjin Tasly, and others, each filing their own patent portfolios aimed at protecting innovative compounds and formulations.
The protection scope of CN102186465 potentially overlaps with other patents covering similar chemical classes or therapeutic indications; thus, patent landscape analysis of related patents is crucial for freedom-to-operate assessments.
3. Patent Expiry and Lifecycle
Given its filing date in 2010 and grant in 2012, the patent is pending expiry around 2030, assuming standard 20-year patent terms in China. This timeline influences market entry strategies, licensing opportunities, and potential for generic development.
Implications for Strategic Stakeholders
1. For Innovators and R&D Entities
The detailed claims covering both chemical entities and manufacturing processes suggest a robust patent position. Innovators must consider designing around claims or seeking licensing if similar compounds are developed.
2. For Generic Manufacturers
The patent's scope indicates opportunities post-expiry; however, any process or compound falling within the claims constitutes infringement during the patent's active term. Thorough patent mapping is recommended before biosimilar or generic development.
3. For Patent Examiners and Legal Professionals
The patent exemplifies judicious claim drafting focused on broad composition claims complemented by narrower process and use claims, serving as a model for patent strategy in China’s pharmaceutical space.
Conclusion
Patent CN102186465 exemplifies a strategic Chinese pharmaceutical patent blending traditional medicinal knowledge with modern chemical innovation to advance cardiovascular therapeutics. Its scope encompasses specific chemical structures, preparation methods, and therapeutic uses. The patent landscape surrounding this patent is dynamic, with numerous similar patents within China and internationally, emphasizing the importance of continuous landscape monitoring and strategic patent management.
The patent’s longevity, coupled with its broad claims, makes it a notable asset in China’s burgeoning cardiovascular drug market. Stakeholders should leverage this analysis for patent filing, licensing, or market entry strategies within China.
Key Takeaways
- Broad Coverage: CN102186465's independent claims protect a specific chemical structure, their manufacturing process, and intended therapeutic use, limiting competitors' options in China.
- Landscape Context: The patent operates within a competitive field rife with similar innovations, underscoring the importance of detailed freedom-to-operate and landscape analyses.
- Innovation Strategy: The combination of traditional medicine and chemical synthesis aligns with China’s national innovation policies promoting TCM modernization.
- Legal and Commercial Significance: The patent’s expiry date is crucial for planning generic strategies, licensing negotiations, and R&D development cycles.
- Ongoing Monitoring: Given the rapid pace of pharmaceutical patent filings in China, continuous surveillance of related patents is mandatory to maintain competitive advantage.
FAQs
Q1: How does CN102186465 compare to international patents in cardiovascular drugs?
A1: While many international patents focus on synthetic pharmaceuticals or biologics, CN102186465 uniquely combines traditional Chinese medicinal elements with synthetic modifications, reflecting China's integration of TCM into modern pharmacology.
Q2: Are the claims of CN102186465 enforceable against generic manufacturers?
A2: Yes, during the patent’s active term, any compounds that fall within the scope of the claims infringe on the patent rights, subject to legal challenges or validity defenses.
Q3: What are the risks of patent infringement when developing similar compounds?
A3: Risks include potential litigation and damages if the compound infringes upon the patent's scope. Conducting a freedom-to-operate analysis helps mitigate these risks.
Q4: How can companies leverage this patent landscape for strategic advantage?
A4: Companies can explore licensing agreements, design around the claims, or focus on developing novel compounds outside the patent scope, while monitoring patent expirations and related filings.
Q5: What is the significance of China’s patent policies on pharmaceutical innovation?
A5: China’s patent policies incentivize innovation through stronger patent protections, especially for tradittional medicine-based innovations, fostering a fertile environment for pharmaceutical R&D.
References
[1] State Intellectual Property Office of China. Patent CN102186465 Patent Document.
[2] World Intellectual Property Organization. China’s Patent Landscape for Pharmaceuticals, 2022.
