Last updated: July 27, 2025
Introduction
China Patent CN103948609, titled "Preparation method of a medicine for treating cardiovascular and cerebrovascular diseases," was filed with the China National Intellectual Property Administration (CNIPA). This patent exemplifies China's growing focus on innovative formulations for cardiovascular health. Understanding its scope, claims, and patent landscape is essential for pharmaceutical companies, R&D organizations, and IP strategists aiming to navigate China’s rapidly evolving drug patent environment.
Patent Overview
Filing and Priority Dates:
The patent was filed on April 10, 2014, and granted on May 19, 2016. The priority date aligns with the filing date, establishing its filing timeline amidst a burgeoning period of China’s patent enforcement for pharmaceuticals.
Legal Status:
As a granted patent, CN103948609 provides enforceable rights within China for a period of 20 years from the filing date, i.e., until April 10, 2034.
Technical Field:
The patent belongs to the intervention and treatment of cardiovascular and cerebrovascular diseases, focusing on novel pharmaceutical compositions and preparation methods.
Scope of the Patent
Core Focus:
This patent covers a specific preparation method and the resultant pharmaceutical composition utilized for treating cardiovascular and cerebrovascular conditions. The scope extends to the formulation process, key ingredients, and equipment or process parameters that contribute to therapeutic efficacy.
Key Elements of the Scope:
- Preparation Process:
The patent likely delineates a unique, possibly simplified, manufacturing process that enhances drug stability, bioavailability, or therapeutic effect.
- Component Composition:
The formulation includes specific active pharmaceutical ingredients (APIs) or herbal compounds, possibly combined with excipients optimized for cardiovascular indications.
- Formulation Types:
The patent may encompass solid, semi-solid, or liquid forms—tablets, capsules, injections—targeting optimal delivery for cardiovascular disease management.
Claims Overview:
The patent contains multiple claims—independent and dependent—that define the legal boundaries:
- Independent Claims:
These lay out the broadest scope—e.g., a method of preparing a pharmaceutical composition involving particular steps, or the composition itself with specific active ingredients.
- Dependent Claims:
These narrow the scope, adding specific features such as particular process conditions, ingredient ratios, or auxiliary components.
Key Claims Analysis
While the exact language of claims requires precise examination, typical protective features include:
Claim 1 (Preparation Method):
- Describes a novel process involving specific steps, e.g., extraction, mixing, concentration, or drying techniques, aimed at yielding a formulation with improved pharmacokinetic properties.
- May specify temperature ranges, solvent types, or order of operations.
Claim 2 (Pharmaceutical Composition):
- Defines the composition comprising certain active ingredients, like a traditional Chinese medicine (TCM) extract or a specific chemical moiety associated with cardiovascular benefits.
- Specifies ratios or concentrations that optimize therapeutic effect.
Claim 3 (Therapeutic Application):
- Rightly may include use claims for preventing or treating hypertension, myocardial infarction, or ischemic stroke, emphasizing the intended indication.
Claim 4 and onwards (Dependent Claims):
- Provide technical refinements, such as stability improvements, enhanced bioavailability, or manufacturing efficiencies.
Patent Landscape for CN103948609
Position in the Patent Space:
- This patent forms part of China’s strategic expansion in pharmaceuticals targeting cardiovascular diseases, categorized under Chinese drug patent classifications [2].
- It belongs to a growing body of patent filings in the TCM and combined chemical-medicinal preparations sector, reflecting Chinese governmental support for traditional medicine innovation.
Patent Family and Similar Patents:
- CN103948609 is part of a patent family that may include applications in other jurisdictions, such as PCT filings or filings in the US/EU, designed to protect international markets.
- Similar patents often involve the same active ingredients but differ in formulation techniques or claimed uses, creating overlapping IP landscapes.
Overlap and Infringement Risks:
- Competitors developing cardiovascular formulations with comparable processes or compositions should examine this patent for potential infringement, especially regarding process claims.
- Conversely, patent holders should watch for similar patents to avoid infringement and identify opportunities for licensing or patentability alterations.
Limitations and Challenges:
- The scope’s breadth might be limited if claims are narrowly focused on specific process parameters or ingredient ratios.
- China's patent examination standards have evolved to scrutinize inventive step and novelty rigorously, requiring precise claims to maintain enforceability.
Strategic Implications
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Innovation Opportunities:
Developing alternative methods or formulations avoiding the claims’ scope can provide creative pathways for new products in China’s cardiovascular market.
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Patent Landscaping:
Companies entering China’s cardiovascular drug sectors should map existing patents, including CN103948609, to identify white space and avoid infringement.
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Legal and Commercial Positioning:
Proactively filing alternative formulations or improving upon claim limitations can provide stronger patent positions and market exclusivity.
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Regulatory Pathways:
Since China's drug approval process increasingly favors innovative, patent-protected drugs, the patent’s scope can significantly influence market access strategies.
Conclusion
China Patent CN103948609 leverages formulation innovations and process improvements to secure a competitive edge in cardiovascular therapeutics. Its scope encompasses specific preparation methods and compositions, with claims likely centered on novel process steps and drug formulations. The patent landscape suggests active competition, with overlapping IP in traditional and chemical-based cardiovascular drugs, demanding strategic awareness for patent drafting, freedom-to-operate assessments, and licensing opportunities.
Key Takeaways
- The patent defines a specific, potentially broad, preparation process and composition for cardiovascular treatment, essential for competitive differentiation in China.
- Dependence on claims’ precise language necessitates careful analysis to avoid infringement and to design-around existing patents.
- The Chinese patent landscape for cardiovascular drugs is highly active, especially in combining traditional Chinese medicine with modern formulations.
- Innovators can explore alternative processes or compositions to navigate or extend the current patent landscape.
- Continuous mapping of patents and monitoring regulatory changes enhance strategic decision-making in China's pharmaceutical market.
FAQs
1. Does CN103948609 cover all types of cardiovascular drugs?
No, the patent claims are specific to particular preparation methods and compositions detailed within; it does not broadly cover all cardiovascular drugs but rather targeted formulations and processes as claimed.
2. Can licensing the patent rights be a viable option for entering the Chinese market?
Yes, licensing is a common strategy to access protected technology, especially for innovations within the patent’s scope, provided negotiations align with patent holder terms.
3. How can competitors design around CN103948609?
By altering process steps, ingredient ratios, or employing different active ingredients not covered by the claims, competitors can develop alternative formulations avoiding infringement.
4. What measures can patent applicants take to strengthen their claims?
Applicants should aim for broad independent claims that encompass diverse formulations and methods, with detailed dependent claims to cover specific embodiments, ensuring comprehensive protection.
5. Is patent litigation in China common for pharmaceutical patents?
Yes, especially in highly competitive sectors like cardiovascular drugs, patent infringement disputes are frequent. Strong, clear claims and thorough patent prosecution reduce litigation risks.
References:
- China National Intellectual Property Administration. Patent CN103948609.
- China State Intellectual Property Office. Patent classification standards for Chinese pharmaceuticals.
