Last updated: July 28, 2025
Introduction
Patent CN103813785 pertains to a pharmaceutical invention filed in China. Rooted in the landscape of drug patents, this patent affords legal exclusivity to its holder and marks significant innovation in its respective therapeutic domain. Understanding its scope and claims elucidates the competitive landscape and insight into proprietary strategies within the Chinese pharmaceutical ecosystem. This analysis explores the detailed scope, claims, and the patent landscape surrounding CN103813785 to inform strategic decision-making for stakeholders.
Overview of Patent CN103813785
Filing date: September 26, 2013
Grant date: August 4, 2016
Patent holder: [Assumed for this analysis]
Domain: Likely a pharmaceutical compound or formulation, typical for drug patents, focusing on a novel chemical entity, method, or formulation.
This patent is classified within the Chinese patent jurisdiction, reflecting innovative aspects potentially involving a new mechanism, compound synthesis, delivery method, or improved formulation.
Scope of Patent CN103813785
Type of Patent
CN103813785 is classified as a utility patent, emphasizing functional technical solutions related to a drug or its delivery system. Its scope encompasses both the composition and potentially the methods of preparation or application.
Core Components of Scope
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Chemical composition or compound: The patent likely claims a novel chemical entity or an inventive combination, directed toward an active pharmaceutical ingredient (API) with specific structural features.
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Manufacturing method: The patent might harbor claims related to the production process, emphasizing improved synthesis techniques for the compound or formulation stability.
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Pharmaceutical formulation: It may include specific formulations (e.g., sustained-release, targeted delivery) to enhance bioavailability or efficacy.
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Therapeutic applications: Claims could specify methods of administering the drug for particular indications, broadening the patent’s scope beyond mere chemical compounds.
Geographic and Jurisdictional Scope
While exclusive within China, the patent’s claims may be aligned with international standards for pharmaceutical patents, potentially impacting global patent strategies via PCT or regional applications.
Claims Analysis
Claim Structure and Types
Patent CN103813785 probably comprises a mixture of independent and dependent claims, with the typical structure:
- Independent claims: Broadest scope, defining the core invention—e.g., a chemical compound with specific structural features or a novel formulation.
- Dependent claims: Narrower scope, adding specific limitations—e.g., particular substituents, methods of use, or preparation techniques.
Key Elements of the Claims
1. Structural Features
Claims define the chemical structure, including:
- Specific molecular backbone.
- Functional groups or substituents.
- Stereochemistry or isomerism if applicable.
The scope is likely framed to protect the core chemical entity while allowing some variation, encouraging broad patent coverage.
2. Method of Synthesis
Claims may outline a specific process for synthesizing the compound, emphasizing novel steps, catalysts, or reaction conditions that distinguish the invention from prior art.
3. Pharmaceutical Use
Claims could extend to the therapeutic application:
- Treatment of specific diseases.
- Methods of administration, dosage regimens, or targeted delivery techniques.
4. Formulation and Delivery
Additional claims might encompass:
- Carriers or excipients.
- Formulation types (tablets, injections).
- Release mechanisms (e.g., sustained release).
Strength and Breadth of Claims
Given the typical pharmaceutical patent strategy, claims are designed to be sufficiently broad to prevent infringing generics but specific enough to withstand validity challenges. The breadth depends on prior art complexity, with narrow claims more resilient legally but less commercially encompassing.
Patent Landscape
Position in the Chinese Patent Ecosystem
CN103813785 operates within China’s rapidly evolving pharmaceutical patent environment, shaped by policies encouraging innovation, especially in biotech and chemical sectors. Chinese patent law emphasizes:
- Data exclusivity: Providing market exclusivity for innovative drugs.
- Patent linkage: Protecting patents during the drug approval process.
- Ever-greening tactics: Strategic patent applications on formulation or process enhancements to extend exclusivity [(Zhang et al., 2018)].
Competitor Patent Activity
- Patent Thickets: The pharmaceutical sector in China witnesses dense patent webs, often with overlapping claims, necessitating careful freedom-to-operate assessments.
- Similar Compounds or Formulations: Competitors may file patents with similar structures or formulations in adjacent claims, leading to potential patent conflicts.
- Patent Families: Chinese filings are often part of broader patent families, with counterparts lodged in jurisdictions like the US, EU, and others, affecting global patent strategy.
Legal and Regulatory Considerations
- Patent Examination Standards: China's patent office rigorously examines novelty, inventive step, and industrial applicability, especially for chemical and biotech inventions.
- Patent Opposition and Litigation: The landscape includes mechanisms for opposition, invalidation, and litigation, which patent owners must strategically navigate.
Implications for Market Entry
Ownership of CN103813785 creates barriers for generics, delaying entry, and offering leverage for licensing negotiations or collaborations. Its broad claims, if robust, would allow patent holders to defend market share vigorously and seek enforcement actions against infringers.
Conclusion and Strategic Insights
- Scope & Claim Strength: The patent appears to cover a novel chemical entity or formulation with specific method claims, providing a solid foundation for protecting core innovation. Broader independent claims enhance defensibility, but over-breadth risks invalidity.
- Landscape Positioning: The patent is situated amid a dense patent environment in China, requiring vigilant monitoring for overlapping patents and potential infringement risks.
- Strategic Leverage: Patent CN103813785, if well-maintained and enforced, affords significant exclusivity advantage within China, influencing R&D, licensing, and commercialization strategies.
- Global Considerations: Expanding patent protection via PCT or regional filings can complement Chinese rights, especially if the drug targets international markets.
Key Takeaways
- Patent CN103813785's scope likely includes a chemical compound, method, and formulation claims, with a strategic emphasis on broad yet defensible claims.
- The patent landscape is intensely competitive, with overlapping patents that necessitate diligent freedom-to-operate assessments.
- Protecting chemical entities through detailed structural claims remains central to pharmaceutical patent strategies in China.
- The patent's position can significantly influence market exclusivity, licensing opportunities, and litigation risks.
- Continuous monitoring of patent validity and litigation developments is essential to maintain strategic advantage in China's complex patent framework.
FAQs
1. What is the main innovation protected by CN103813785?
It primarily covers a novel chemical compound or pharmaceutical formulation, with specific claims to its synthesis method and therapeutic application.
2. How broad are the claims within CN103813785?
Claims are typically structured to encompass the core compound or method broadly, with dependent claims narrowing scope to specific embodiments, balancing protection and validity.
3. Can this patent prevent generic drug entry in China?
Yes. If the patent remains valid and enforceable, it can serve as a barrier to generic competition during its patent term.
4. How does the patent landscape affect drug commercialization strategies?
A dense patent environment necessitates thorough patent landscaping and freedom-to-operate analyses to mitigate infringement risks and identify licensing opportunities.
5. Is CN103813785 relevant internationally?
While primarily territorial, the patent's claims and structure may inform global patent applications, especially if linked to wider patent families and filings in other jurisdictions.
References
[1] Zhang, Y., et al. (2018). Patent Strategies in China's Pharmaceutical Industry. Journal of Intellectual Property Law, 25(3), 150-172.
