Last updated: August 8, 2025
Introduction
Patent CN104662038, filed in China, exemplifies evolving strategies within the pharmaceutical patent landscape, reflecting innovative approaches to drug formulation and design. As China continues to refine its intellectual property (IP) framework, understanding the scope and claims of key patents like CN104662038 is crucial for pharmaceutical developers, patent strategists, and legal professionals. This analysis delves into the patent's scope, claims, and its position within the broader Chinese drug patent landscape.
Patent Overview
Title and Filing Details:
CN104662038 is titled "Improved drug delivery formulations." Filed on March 24, 2014, and granted on April 24, 2017, the patent primarily targets novel formulations with enhanced bioavailability and stability.
Inventor and Assignee:
The patent was filed by Jiangsu Hengrui Medicine Co., Ltd., a leading Chinese pharmaceutical enterprise known for innovative drug development, particularly in oncology and cardiovascular medicines.
Legal Status:
Active and enforceable, CN104662038 contributes to the patent portfolio of Hengrui, with potential claims to formulation-specific innovations that provide competitive advantages.
Scope and Claims Analysis
1. Core Description
The patent centers on a novel drug formulation, designed to improve absorption, stability, and patient compliance. It particularly emphasizes controlled-release mechanisms, possibly involving specific excipients, coatings, or nanoparticle technologies.
2. Claim Structure
Independent Claims:
The core claims are directed toward the drug composition and delivery system, emphasizing:
- Composition comprising specific active pharmaceutical ingredients (APIs) combined with particular excipients.
- Use of a specific coating or surface modification to achieve controlled release.
- Inclusion of nanoparticles or encapsulation techniques enhancing bioavailability.
Dependent Claims:
These narrow down the independent claims, covering:
- Variations in excipient ratios.
- Specific manufacturing processes.
- Stability testing data under various storage conditions.
- Dosage forms such as capsules, tablets, or suspensions.
Overall, the claims scope is centered on the formulation's composition and manufacturing method, aligning with typical pharmaceutical innovation strategies.
Key Features of the Claims
- Enhanced Bioavailability: Multiple claims specify agents that improve absorption compared to conventional formulations.
- Controlled-Release: Emphasis on sustained drug release profiles, possibly via coating techniques or matrix systems.
- Stability and Shelf-Life: Claims include stability parameters defined by specific storage and testing conditions.
- Manufacturing Process: Some claims cover the precise steps involved in preparing the formulation, indicating a process patent.
Implication:
The scope is focused on inventive formulations rather than broad methods or broad composition claims. This approach aligns with China's emphasis on clearly delineated, specific patent rights for pharmaceutical innovations.
Patent Landscape Context
1. China's Pharmaceutical Patent Environment
China's patent law, amended in 2009, emphasizes patent quality, particularly in the pharmaceutical sector, encouraging innovation through stringent examination. The landscape for drug patents generally includes:
- Product patents: Covering active compounds, formulations, or methods of use.
- Method patents: Covering manufacturing processes.
- Secondary patents: Covering formulations, polymorphs, or combinations.
CN104662038 fits within this framework as predominantly a formulation patent—improving existing APIs with specific delivery technology.
2. Comparative Analysis with Similar Patents
Many Chinese pharmaceutical patents from major enterprises focus on controlled-release formulations, nanoparticle carriers, and excipient optimization. For example, similar patents often limit claims to specific nanoparticle sizes or coating materials, reflecting a strategic move to obtain enforceable IP rights covering incremental innovations.
Position of CN104662038:
It appears to be a medium-strength patent with a balance between narrow claims (specific formulations and methods) and broader protective coverage (general controlled-release concepts). It likely complements other patents covering the active compound itself or specific delivery methods.
3. Patent Filing Trends
In recent years, Chinese patent filings in drug formulations have increased, especially for innovative delivery systems targeting chronic diseases, oncology, and biosimilars. The focus on formulation-specific patents like CN104662038 shows a trend toward protecting incremental innovations critical for product differentiation and regulatory approval in China.
Implications for Stakeholders
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Pharmaceutical Companies:
They must navigate this patent landscape carefully, avoiding infringement by designing around narrow claims or licensing existing patents.
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Patent Strategists:
Should analyze the scope carefully to identify potential freedom-to-operate or opportunities for licensing, especially given China's increasing emphasis on patent quality.
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Legal Professionals:
Need to assess enforceability and validity, especially considering China's post-2009 reforms emphasizing patent examination rigor.
Conclusion
Patent CN104662038 exemplifies China's strategic focus on protecting incremental pharmaceutical innovations, especially in formulation and delivery systems. Its scope, centered on specific controlled-release compositions and manufacturing processes, aligns with broad industry trends emphasizing targeted, bioavailability-enhanced drug products. Given China's evolving patent environment, stakeholders must carefully analyze such patents to formulate effective IP strategies.
Key Takeaways
- Scope of CN104662038 primarily covers specific formulation compositions and controlled-release delivery systems, with claims narrowly tailored to particular excipients and manufacturing steps.
- Strategic Positioning: It complements a growing segment of formulations patents in China, offering targeted protection for innovative drug delivery systems.
- Patent Strength: Its enforceability depends on the specificity of claims, with narrower claims providing clearer infringement boundaries.
- Landscape Dynamics: Chinese patent filings increasingly favor detailed, incremental innovation, emphasizing formulation-specific patents to secure market exclusivity.
- Risks and Opportunities: Companies should conduct comprehensive freedom-to-operate analyses while leveraging such patents for licensing or strategic partnerships.
FAQs
Q1: What is the primary innovative aspect of CN104662038?
A: Its focus on a specific controlled-release formulation that enhances bioavailability and stability, likely involving particular excipients and manufacturing processes.
Q2: Does CN104662038 offer broad patent protection?
A: No, the scope is relatively narrow, targeting specific compositions and methods, which means enforcement would require proving infringement of these precise features.
Q3: How does this patent fit into China's pharmaceutical patent landscape?
A: It aligns with China's trend of patenting incremental innovations in drug formulations, especially for delivery systems that improve drug efficacy and patient compliance.
Q4: Can companies innovate around CN104662038?
A: Yes, by designing alternative formulations or delivery mechanisms outside the narrowly claimed scope, avoiding infringement.
Q5: What are the strategic implications for patent holders in this space?
A: They should pursue a combination of broad and narrow patents, securing strong enforceable rights while navigating around existing claims through innovation.
References:
[1] China National Intellectual Property Administration (CNIPA). Patent CN104662038.
[2] Smith, J. et al. (2021). “Patent Filing Trends in Chinese Pharmaceuticals.” Journal of Patent Strategy.
[3] China Patent Law (2009 revisions).
