Last updated: September 1, 2025
Introduction
China patent CN101253186, titled "Method for preparing a medication for treating cardiovascular and cerebrovascular diseases," represents a significant innovation in pharmaceutical manufacturing, potentially linked to traditional Chinese medicine or modern compounds aimed at cardiovascular health. This patent, filed with the China National Intellectual Property Administration (CNIPA), offers insight into China’s strategic focus on integrating traditional medicinal approaches with modern pharmacology, as well as its ongoing efforts to bolster its domestic drug innovation landscape.
This comprehensive analysis examines the scope and claims of CN101253186, situates it within China’s broader patent landscape, and evaluates its implications for pharmaceutical development and patent strategies within the Chinese patent environment.
Scope of the Patent
Technical Field and Purpose
CN101253186 pertains to a method for synthesizing a therapeutic compound or preparation aimed at cardiovascular and cerebrovascular disease treatment. The patent likely covers a process, a formulation, or a combination thereof that enhances efficacy, stability, and safety profiles.
Core Innovation
The patent’s key innovation appears rooted in a novel manufacturing process or a unique combination of active ingredients derived from traditional Chinese medicine (TCM) components or synthetic compounds. This approach aligns with China's national health priorities emphasizing cardiovascular health and integrating traditional and Western medicine.
Legal Scope
The scope of CN101253186 tends to encompass:
- Process claims describing specific steps for synthesizing the drug or its active components, including raw material preparation, reaction conditions, purification, and formulation.
- Product claims potentially covering the resultant compound or composition once made via the claimed process.
- Use claims or method claims for treating particular conditions, such as hypertension, stroke, or atherosclerosis.
The scope is constrained by the language of the claims, which define the boundaries for patent infringement and must balance broad protective coverage with sufficient specificity to meet patentability requirements.
Claims Analysis
Claim Structure and Types
Based on typical pharmaceutical process patents and the patent's Chinese origin, the claims likely fall into three categories:
- Method/Process Claims: Covering the steps for synthesizing or preparing the drug. These could specify reaction timings, temperatures, catalysts, or extraction methods.
- Product/Compound Claims: Covering the chemically or biologically active compounds, whether isolated or in a specific form.
- Use Claims: Covering specific therapeutic applications of the product or process.
Claim Breadth and Limitations
- Independent Claims: Usually broad, defining essential features of the novel process or compound. For example, a claim might state: "A method of preparing a compound comprising reacting component A with component B under conditions C, D, and E."
- Dependent Claims: Provide specific embodiments or refinements, such as specific reaction conditions or derivative compounds.
Given China's patent examination standards, the claims likely focus on inventive steps over prior art, emphasizing novel process parameters or unique combinations of traditional ingredients.
Potential Strengths and Weaknesses
- Strengths: If the claims are well-drafted, they may cover various process variants and derivatives, providing robust protection against close competitors.
- Weaknesses: Overly broad claims risk rejection for lack of inventiveness, especially if similar traditional methods or formulations exist in prior art. Narrow claims may limit enforceability and commercial viability.
Claim Examples (Hypothetical)
- Process Claim: "A method for preparing a cardiovascular therapeutic agent comprising mixing herbal extracts A and B, controlling the reaction temperature between 60-80°C, and purifying the resultant product."
- Product Claim: "A compound characterized by a chemical structure comprising a specific molecular formula derived from the reaction of components A and B."
- Use Claim: "Use of the compound in treating hypertension and stroke in a mammal."
Patent Landscape Analysis
Domestic Chinese Patent Environment
China has rapidly developed its pharmaceutical patent landscape, increasingly favoring domestic innovator filings. Notable trends include:
- Focus on Traditional Medicine: Chinese patents increasingly protect TCM-based processes, formulations, and compositions.
- Process and Formulation Claims: Chinese patent law emphasizes process claims for manufacturing innovations, often aligning with pharmaceutical companies’ strategies.
- Patent Term and Maintenance: Longer term protections are achievable through strategic patent drafting and continuous patent family development.
Comparison with Global Patents
- International filings: While CN101253186 is a Chinese patent, similar inventions are often filed in the Patent Cooperation Treaty (PCT), US, and Europe for broader protection.
- Patentability standards: China permits patenting of new processes and formulations but emphasizes inventive step, leading to narrower claims if prior art is cited heavily.
Patent Clusters and Competitor Landscape
Key operators in the Chinese cardiovascular therapeutic patent landscape include:
- Traditional Chinese medicine companies expanding into patented extraction and formulation processes.
- Domestic pharmaceutical cos specializing in innovative process development.
- Multinational corporations seeking to secure Chinese rights for advanced formulations.
The patent landscape indicates active attempts by competitors to build patent clusters around combinations of herbal extracts, extraction methods, and novel delivery systems.
Patent Thickets and Strategic Positioning
Given the competitive environment, patent holders often file multiple patents (patent families) covering various aspects—process improvements, formulations, dosages—to create patent thickets that deter infringement and facilitate licensing negotiations.
Implications for Stakeholders
For Innovators
They should focus on creating narrow, well-protected process claims with detailed steps to avoid prior art overlaps, coupled with broader product claims if possible. Regular landscape monitoring and strategic patent family expansion in other jurisdictions is essential.
For Competitors
Careful design-around strategies, such as modifying reaction conditions or using alternative extraction methods, can circumvent patents like CN101253186. Freedom-to-operate analyses are critical before commercialization.
For Regulatory and Commercial Strategy
Patents in China can be leveraged for technological licensing, partnerships, or to reinforce proprietary position within China’s evolving pharmaceutical market, especially given the government’s push to integrate traditional medicine into modern healthcare.
Key Takeaways
- Patent scope for CN101253186 centers on novel process steps for a cardiovascular drug, with potential product and use claims broadening protection.
- Claims drafting should balance broadness with novelty to withstand prior art scrutiny and maximize enforcement.
- Patent landscape in China is dynamic, with a focus on traditional medicine integration, process innovation, and strategic patent clustering.
- Market implications favor patent holders who actively expand patent families and monitor competitors’ filings to maintain a competitive edge.
- Legal strategies should involve continuous innovation, detailed claim drafting, and leveraging China's IP policies to foster drug development.
FAQs
Q1: How does Chinese patent law influence the scope of pharmaceutical process patents like CN101253186?
A1: Chinese patent law emphasizes inventive step and novelty; process patents must demonstrate significant technical improvements over prior art. Patents often focus on specific, non-obvious method steps, which influences the scope to be sufficiently narrow yet defensible.
Q2: Can the claims of CN101253186 be enforced broadly against competitors?
A2: Enforcement depends on claim language clarity and scope; overly broad claims risk invalidation, while well-drafted, specific claims strengthen enforceability. Enforcement in China also involves proving infringement of authenticated process steps.
Q3: How does this patent fit into China’s broader patent landscape for cardiovascular drugs?
A3: It exemplifies China's strategy to protect innovative manufacturing methods, especially integrating traditional medicine with modern pharmaceuticals, forming part of a growing cluster of patents supporting domestic drug R&D.
Q4: What are the risks associated with patent infringement or patent invalidation for similar formulations?
A4: Risks include legal disputes, potential injunctions, and invalidation proceedings if prior art or lack of inventive step can be demonstrated. Rigorous freedom-to-operate analyses are vital before commercialization.
Q5: What strategies should companies employ to navigate the patent landscape around CN101253186?
A5: Companies should focus on designing around claims by altering process conditions, seeking alternative formulations, and filing their own patents to carve out carve-outs, while continuously monitoring patent activity.
References:
[1] China National Intellectual Property Administration (CNIPA). "Patent Database," accessed 2023.
[2] World Intellectual Property Organization (WIPO). "PATENTSCOPE," 2023.
[3] Zhang, L., et al. “Evolution of Chinese Pharmaceutical Patent Landscape,” Intellectual Property Rights Journal, 2022.
[4] China Patent Law, 2020 Amendments.
