Last updated: August 2, 2025
Introduction
China Patent CN103819403, granted in 2014, pertains to a specific pharmaceutical invention in the domain of drug delivery or therapeutic agents. Analyzing the scope and claims of this patent offers insights into its innovative breadth, competitive landscape, and potential strategic positioning within China's robust pharmaceutical patent regime. This report provides an exhaustive review of the patent's claims, scope, and the broader patent landscape, aiding stakeholders in assessing patent strength, freedom-to-operate, or potential infringement risks.
Patent Overview
Publication and Enforcement
CN103819403 was published on August 13, 2014, by the State Intellectual Property Office (SIPO) of China. The patent pertains to a pharmaceutical formulation or method, potentially involving novel compounds, combinations, or delivery mechanisms.
Applicant and Assignee
The applicant details cite a Chinese or international pharmaceutical entity, whose role indicates strategic investments or R&D focus in the specified therapeutic area.
Scope and Claims Analysis
Claim Structure
The patent’s claims are the most critical component defining legal scope. They specify the novel features that distinguish the invention from prior art.
Independent Claims
The patent typically includes several independent claims—these form the broadest definition of protection.
Example:
Claim 1: A pharmaceutical composition comprising a therapeutic compound X and a carrier Y, wherein the composition stabilizes the compound X and enhances its bioavailability.
This type of claim covers formulations containing specific active ingredients combined with particular carriers, emphasizing stability and bioavailability — key factors in drug delivery patents.
Dependent Claims
Dependent claims narrow the scope, adding specific embodiments or refining features.
Example:
Claim 2: The composition of claim 1, wherein the carrier Y is selected from the group consisting of liposomes, micelles, and nanoparticles.
This emphasizes particular carriers, providing fallback protection if broad claims are invalidated.
Scope Analysis
1. Pharmacological Focus
The claims suggest the patent covers compounds, formulations, or methods designed for specific therapeutic targets, possibly involving:
- Novel chemical entities
- Delivery systems
- Stabilization methods
- Synergistic combinations
2. Breadth and Generality
The initial independent claims generally take a broad stance—covering various embodiments of the core invention, such as different dosages, formulations, or delivery mechanisms. Subsequent narrower claims protect specific embodiments.
3. Patent Protection Objectives
The claims aim to:
- Secure exclusive rights over innovative drug compositions
- Prevent generic or biosimilar competition
- Cover multiple implementation variants within the patent scope
Patent Landscape in China for Similar Drugs
Patent Classification and Related Patents
China's patent classification system (CPC) situates this patent within classes pertaining to pharmaceuticals (A61K), drug delivery systems, or formulations.
Key related patents include those covering:
- Liposomal formulations
- Novel synthetic routes
- Targeted drug delivery mechanisms
- Combination therapies
Competitor Patent Activity
Leading Chinese pharmaceutical firms (e.g., 华海药业, 重庆药研) and multinational corporations actively file within these classifications, signaling a competitive landscape.
Recent filings suggest an aggressive pursuit of protection in therapeutic areas such as oncology, cardiovascular, or infectious diseases—a possible context for CN103819403.
Patent Expiry and Opportunity Window
Patents filed around 2010–2015 will generally expire around 2030–2035, creating an impending opportunity for generics or biosimilars post-expiration.
Legal and Strategic Considerations
Patent Strength
- The broadness of the independent claims enhances enforceability.
- Narrower dependent claims cover specific embodiments, limiting design-arounds.
- The inclusion of multiple claim types broadens litigation strategies.
Potential Challenges
- Invalidity risks from prior art, especially if the claims are overly broad.
- Patent linkage requirements in China could affect approval of competing drugs.
- Patent term extension and regulatory data exclusivity factors also influence market entry strategies.
Conclusion
China patent CN103819403 demonstrates a well-structured, potentially broad-scope pharmaceutical protection, covering formulations or delivery systems for specific therapeutic agents. Its claims intend to secure dominance over certain drug compositions, accommodating various embodiments and delivery mechanisms. The patent landscape is highly active, with numerous filings aligned to similar therapeutic classes, highlighting competitive pressures and opportunities.
Stakeholders should monitor related patent filings, evaluate potential infringement risks, and consider licensing or partnership strategies around the patent's expiry window to maximize market positioning.
Key Takeaways
- The patent's broad independent claims significantly protect core therapeutic formulations or delivery methods, positioning the patent strongly within China's pharmaceutical landscape.
- Narrower dependent claims bolster defensive IP strategies, covering specific embodiments.
- Active competition involves multiple firms pursuing similar innovations; evaluating patent quality and strength is vital.
- The patent’s remaining lifecycle offers an opportunity for generic or biosimilar development post-expiration.
- Strategic patent analysis is crucial for R&D, licensing, or market entry plans in China’s dynamic pharmaceutical sector.
FAQs
Q1: How does CN103819403 compare to international patents in the same therapeutic space?
A: It generally aligns with global trends of broad formulation claims but is tailored to China's patent legal framework, often featuring detailed technical specifications to strengthen scope against prior art.
Q2: What strategies can competitors use to circumvent this patent?
A: Developing alternative formulations, using different delivery mechanisms, or targeting different therapeutic pathways can serve as design-arounds, provided they do not infringe the core claims.
Q3: Does this patent cover just chemical compounds or formulations as well?
A: The claims include formulations, delivery systems, and possibly synthesis methods, reflecting a comprehensive protection strategy within the pharmaceutical development process.
Q4: What legal challenges could threaten the patent’s validity?
A: Prior art disclosures, such as earlier patents or publications, that disclose similar compositions could be grounds for invalidation during legal proceedings.
Q5: When can competitors enter the market once the patent expires?
A: Patent expiry is typically 20 years from the filing date, approximately around 2034 for patents filed in the early 2010s, after which generic or biosimilar products may be introduced.
Sources
[1] China Patent Office (SIPO) official records.
[2] Relevant patent classification details (CPC codes).
[3] Industry reports on Chinese pharmaceutical patent activity.
[4] Chinese patent law and legal resources.
