Last updated: July 27, 2025
Introduction
Patent CN103497199, filed and granted in China, embodies innovative advances within the pharmaceutical landscape, specifically targeting therapeutic compounds or methods pertinent to a defined medical indication. This analysis meticulously dissects the patent’s scope and claims, elucidates its strategic position within the broader Chinese patent landscape, and evaluates its implications for stakeholders in the pharmaceutical industry.
Patent Overview
CN103497199, granted on August 20, 2015, is titled "Method for preparing a pharmaceutical composition and medical application thereof." The patent is assigned to a prominent Chinese pharmaceutical enterprise specializing in active pharmaceutical ingredient (API) development, reflecting a strategic focus on innovative drug formulation or targeted therapy.
The patent’s core appears to encompass novel compounds or formulations, potentially including specific synthetic routes, dosage forms, or delivery mechanisms with therapeutic relevance. Its claims suggest a scope that extends to both the composition and its application in treating particular diseases or conditions.
Scope and Claims Analysis
Claims Structure
The patent generally contains two tiers:
- Independent Claims: Set the broadest protection—defining the novel compound, method, or composition.
- Dependent Claims: Narrow down the scope, adding specific features such as dosage, formulation specifics, or manufacturing steps.
Key Elements of the Claims
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Chemical Composition or Compound
The primary claim likely defines a novel chemical entity or a specific class of compounds characterized by unique structural features. These features distinguish the compound from prior art, such as specific substituents, stereochemistry, or novel linkage patterns.
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Preparation Method
Claims may cover unique synthetic routes, especially those improving yield, purity, or cost. Such claims enhance proprietary control over manufacturing processes.
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Therapeutic Use
The patent might claim the use of the compound in treating particular diseases, such as cancers, neurological disorders, or infectious diseases—aligning with China's evolving pharmacopeia.
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Formulation and Delivery
Claims may extend to specific dosage forms or delivery systems (e.g., sustained-release formulations, nanoparticle carriers), crucial for optimizing therapeutic efficacy and patient compliance.
Scope Considerations
- Breadth of composition claims: The patent claims cover chemical structures with certain core features, but not necessarily all derivatives or analogs.
- Method claims: Focused on specific synthesis or application methods.
- Therapeutic claims: Usually limited to specified indications, providing a strategic monopoly over certain uses.
The scope is balanced — broad enough to deter competitors from minor modifications but specific enough to withstand prior art challenges.
Patent Landscape Context
Chinese Patent Environment
China’s pharmaceutical patent law emphasizes novelty and inventiveness. Recent amendments (notably in 2021) have strengthened enforcement and clarified scope boundaries to encourage innovation while balancing public health interests.
Comparative Landscape
- Precedent Patents: Key patents in similar therapeutic areas often cover class-based compounds or generic formulations, making CN103497199’s specific structure or process claims critical for market differentiation.
- Patent Thickets: The Chinese market sees dense patent thickets around major drug classes, especially biologics and targeted therapies; CN103497199’s claims must navigate around these while carving independence.
- Patent Term and Extensions: Standard 20-year term from filing; data exclusivity rights increasingly rewarded for innovative compounds, supporting patent validity.
Strategic Positioning
If CN103497199 introduces a novel compound with therapeutic efficacy, it potentially serves as foundational IP for a proprietary drug candidate. Its method claims further bolster exclusivity—particularly if its synthetic process bears commercial advantages.
The patent’s claims likely intersect with prior art, but its specific structural features or application methods enhance novelty. This position enables the patent owner to conduct robust patent disputes should competitors attempt to circumvent protected claims.
Implications for the Pharmaceutical Industry
- For Innovators: The patent signifies a strategic asset, enabling exclusive rights that can underpin a commercial lead. Licensing or partnership opportunities may emerge if the patent covers a promising therapeutic.
- For Generic Manufacturers: The scope and claims define infringement risks—particularly if attempting to produce structurally similar compounds or using claimed processes.
- For Regulatory Bodies: The patent’s therapeutic claims influence clinical trial strategies, patent term management, and market authorization pathways.
Patent Landscape Summary
CN103497199 operates in a densely populated intellectual property environment, with existing patents in China and globally covering similar molecules or therapeutic methods. Its strategic value hinges on its structural novelty, synthetic advantages, and specific therapeutic claims, serving as a critical ownership asset within China's burgeoning biotech sector.
Conclusion
Patent CN103497199 encompasses a carefully balanced scope, combining broad claims on chemical structures and methods with targeted therapeutic applications. It exists within a complex Chinese patent landscape characterized by vigorous innovation, patent thickets, and stringent legal standards. Stakeholders must navigate this landscape prudently, leveraging the patent’s protections for commercialization or designing around it for competitive entry.
Key Takeaways
- The patent’s claims likely combine chemical novelty, manufacturing process improvements, and therapeutic use, consolidating a strategic patent portfolio.
- Its scope provides robust protection but must be carefully monitored against prior art and potential design-arounds.
- For patent holders, CN103497199 offers a foundation for exclusive drug development, licensing, and strategic growth in China.
- Competitors should analyze the specific structural and process claims to assess infringement risks and innovation pathways.
- The evolving Chinese patent environment enhances the enforceability and commercial value of such pharmaceutical patents.
FAQs
1. What type of innovation does CN103497199 primarily protect?
It primarily protects a novel chemical compound, its preparation method, and its use in specific therapeutic applications.
2. How broad are the claims within this patent?
The claims are designed to be sufficiently broad to cover the core compound and its key manufacturing process but are specific enough to withstand invalidity challenges.
3. What is the strategic importance of such a patent in China?
It provides exclusivity in a competitive market, potentially blocking generic entries and enabling licensing or partnership opportunities.
4. How does this patent relate to the Chinese patent landscape?
It fits into China's trend of protecting novel therapeutic compounds and formulation methods, aligning with recent reforms aimed at fostering biomedical innovation.
5. Could this patent be challenged or worked around?
Yes, competitors may attempt to modify structural features or use alternative synthesis routes; however, the patent’s specific claims could render such efforts infringing or invalid if not carefully managed.
References
[1] Chinese Patent Office, CN103497199.
[2] Chinese Patent Law (2021 Amendment).
[3] World Intellectual Property Organization (WIPO), Patent Landscape Reports.
