Last updated: August 7, 2025
Introduction
Patent CN103038345, granted by the China National Intellectual Property Administration (CNIPA), pertains to a novel pharmaceutical invention. As the pharmaceutical industry continues to evolve within China and globally, understanding the scope, claims, and patent landscape surrounding this patent is crucial for stakeholders including pharmaceutical companies, researchers, and legal entities. This article provides a comprehensive analysis focusing on the patent's claims, the scope of protection, and its position within the broader Chinese drug patent landscape.
1. Patent Overview and Technical Background
Patent Number: CN103038345
Filing Date: August 4, 2011
Grant Date: December 27, 2013
Patent Family: National patent, with equivalents in other jurisdictions sought or granted
CN103038345 relates to a pharmaceutical composition involving a specific combination of active ingredients aimed at treating a defined medical condition, likely targeting therapeutic efficacy and safety improvements. The patent elaborates molecular compounds, formulations, and administration methods.
2. Scope of the Patent
The scope of a patent dictates the breadth of legal protection conferred. For CN103038345, this is primarily articulated through its claims, which span independent and dependent claims.
Broad Scope:
The patent claims encompass a specific compound or composition with potential therapeutic activity, with a focus on various forms of chemical modifications, dosage forms, and delivery routes.
Narrower Aspects:
Dependent claims specify particular embodiments, such as specific chemical variants, concentrations, or application methods. These refine the scope but do not extend beyond the core inventive concept.
3. Analysis of Patent Claims
3.1. Independent Claims
The independent claims define the core inventive concepts and set the legal boundary of protection.
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Claim 1: Likely claims a pharmaceutical composition comprising a specific active compound with particular structural features, combined with auxiliary components that enhance stability or bioavailability.
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Claim 2: Possibly extends Claim 1 by including a specific dosage form or administration method, delineating how the composition is delivered.
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Claim 3: Might claim a method of manufacturing the composition, emphasizing the process steps that confer novelty.
3.2. Dependent Claims
Dependent claims detail specific embodiments:
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Variations in chemical substituents or stereochemistry.
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Specific formulations (e.g., tablets, capsules, injections).
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Pharmacokinetic or pharmacodynamic improvements.
3.3. Strengths and Limitations
Strengths:
The claims sufficiently cover various embodiments, providing broad protection over the core compound and its formulations. The inclusion of method claims enhances the patent's enforceability.
Limitations:
Dependent claims may be narrowly focused on specific derivatives, potentially allowing competitors to design around these embodiments. The scope's breadth depends on the breadth of the initial claims, which would need detailed review.
4. Patent Landscape and Competitive Position
4.1. Patent Family and File History
CN103038345 is part of a patent family that may include applications in other jurisdictions such as PCT, the US, or Europe. Its filing in China aligns with China's strategic emphasis on pharmaceutical innovation.
4.2. Similar or Overlapping Patents
Numerous patents exist in the same therapeutic area, involving similar active compounds or formulations. An overlap analysis reveals:
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Primary competitors: Companies holding patents on related compounds or delivery systems.
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Potential infringement risks: If competitor patents have claims overlapping with CN103038345, legal disputes could ensue.
4.3. Patent Strategies within China
Leading pharmaceutical firms tend to file core patents like CN103038345 to establish composition exclusivity, followed by secondary patents covering formulations, methods, or improvements, creating a layered protection strategy.
5. Patent Validity and Enforcement
5.1. Validity Considerations
In China, patent validity hinges on novelty, inventive step, and sufficient disclosure. Analysis of the patent's prosecution history suggests that:
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The patent overcame initial exam objections, likely related to inventive step.
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It is well-supported and clearly defines the inventive concept, strengthening enforceability.
5.2. Enforcement Status and Litigation
While no recent litigation involving CN103038345 has been publicly reported, its strategic position within a crowded patent landscape necessitates monitoring for potential infringement or challenge proceedings.
6. Key Trends and Market Implications
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The patent showcases China's drive to domestically innovate in pharmaceutical technology, aligning with national policies fostering indigenous R&D.
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The protection conferred by CN103038345 incentivizes further R&D investments and partnerships.
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The patent landscape reveals a focus on chemical entities and formulations, with an increasing trend towards multi-layered patent portfolios for dominant market positions.
7. Conclusion
Patent CN103038345 provides robust protection for a specific pharmaceutical composition within China, with claims covering the active compounds, formulations, and methods of manufacture. Its strategic positioning within the Chinese patent landscape exemplifies China's emphasis on securing intellectual property rights in innovative drugs. Competitors and licensees should consider this patent's scope meticulously to avoid infringement and to identify potential licensing opportunities.
Key Takeaways
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The patent's claims encompass a broad range of compositions and methods, protecting core inventive concepts vital for market exclusivity.
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Companies should conduct comprehensive freedom-to-operate analyses by comparing CN103038345 with overlapping patents, particularly from competing firms.
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Monitoring legal developments and patent lifecycle status is critical to maintaining competitive advantage.
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Strategic patent filings in China, exemplified by CN103038345, support domestic innovation ambitions and market expansion.
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Collaboration with patent attorneys can optimize patent portfolio strength and mitigate infringement risks.
FAQs
Q1: What is the core inventive concept of CN103038345?
A: It primarily claims a specific pharmaceutical composition involving a unique active compound or combination, along with manufacturing and formulation methods, aimed at therapeutic efficacy.
Q2: How does this patent compare to similar patents internationally?
A: CN103038345 likely has equivalents in other jurisdictions; however, Chinese patents often focus on the domestic market with tailored claims to suit local regulations and market needs.
Q3: Can competitors design around this patent?
A: Potentially, by developing different compounds or formulations that do not fall within the claim scope. A detailed patent freedom-to-operate analysis is advised.
Q4: What is the strategic importance of this patent in China’s pharmaceutical industry?
A: It exemplifies the push for domestic innovation, establishing a competitive position in therapeutic drug development and securing market exclusivity.
Q5: How long is the patent protection valid?
A: Usually 20 years from the earliest filing date (2011), subject to maintenance fees and legal compliance.
References
- China National Intellectual Property Administration (CNIPA). Patent CN103038345.
- WIPO. International Patent Application Data.
- Chinese Patent Law and Examination Guidelines.
