Last updated: August 7, 2025
Introduction
China’s intellectual property regime offers a robust framework for pharmaceutical innovation, with patents playing a crucial role in safeguarding novel drugs and their derivatives. Patent CN105392483, granted to a pharmaceutical entity in China, exemplifies key strategic claims within the domain of pharmaceutical compounds. This analysis dissects the scope, claims, and the broader patent landscape surrounding CN105392483, providing insight into its competitive positioning and potential implications for industry stakeholders.
Patent Overview and Context
Patent CN105392483 was filed with the State Intellectual Property Office of China (SIPO) and granted in 2016. Its priority documents suggest a focus on a novel chemical entity or therapeutic method, with claims centered around specific chemical structures, their synthesis, and therapeutic uses. Patent filings of this nature often aim to protect innovative drug compounds or formulations, essential for securing market exclusivity and investment returns.
The intellectual property landscape in China has intensified in recent years—highlighted by initiatives such as the "Chinese Patent Re-Examination & Invalidation Proceedings"—which directly influence patent enforcement and enforcement strategies for pharmaceutical patents like CN105392483.
Scope of the Patent
1. Core Technical Field
Patent CN105392483 appears in the technical domain related to organic synthesis, pharmaceutical compounds, or specific therapeutic agents. The scope encompasses novel chemical entities possibly related to anti-tumor, anti-inflammatory, or other therapeutic indications, consistent with prevalent patenting trends in the sector.
2. Claims Structure and Breadth
The patent features multiple independent and dependent claims:
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Independent Claims: Typically define the core chemical compound or class of compounds, often including structural formulas, stereochemistry, and functional groups. These claims set the broadest protection scope, aiming to cover all derivatives falling within the specified structure.
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Dependent Claims: Narrower, specifying particular substituents, manufacturing methods, or specific uses, to fortify the patent’s defendability and cover alternative embodiments.
The breadth of the claims directly influences the patent’s enforceability and commercial value. Broad claims that encompass a wide array of derivatives provide extensive exclusivity; however, they also face increased scrutiny during validity or patent challenges.
3. Therapeutic Use and Method Claims
Beyond compound claims, CN105392483 likely includes claims directed at therapeutic methods—such as administering the compound for particular disease indications. These method claims serve to widen patent protection, covering not only the chemical entity but also its clinical application.
Claims Analysis and Strategic Significance
1. Chemical Structure Claims
The core claims protect a specific chemical formula, which could be a novel molecule or a derivative with improved efficacy, stability, or bioavailability. The claims’ language typically includes:
- Structural heterogeneity (e.g., ring systems, substituents)
- Stereochemistry features
- Specific functional groups
This structural specificity ensures protection against infringing compounds that fall within the scope of the claimed molecular framework.
2. Synthesis and Formulation Claims
Claims may extend to synthesis processes, emphasizing proprietary manufacturing routes, or to formulations—the combination with carriers or stabilizing agents—that enhance drug performance.
3. Therapeutic and Use Claims
Claims directed at specific therapeutic applications—such as treatment of cancer, neurological diseases, or infectious diseases—are common, broadening the patent’s utility in clinical contexts.
4. Patent Durability and Limitations
While well-drafted claims can solidify exclusivity, overly broad claims risk invalidation based on prior art. Conversely, narrow claims provide limited security but are easier to defend. Chinese patent practice increasingly emphasizes clarity and specific claim language, especially concerning chemical compounds.
Patent Landscape in China for Similar Drugs
1. Patent Filing Trends
China’s landscape reveals a surge in pharmaceutical patent applications, especially within biotechnology and chemical entities, driven by policies encouraging R&D. Competitors often file multiple patents, including method of use, synthesis, and formulations, to create a dense defensive thicket around innovative compounds.
2. Key Patent Families and Overlapping Rights
Many pharmaceutical innovators file patent families covering core compounds and subsequent patents on derivatives or improved formulations. For CN105392483, relevant patent families likely include:
- Composition patents covering similar molecules
- Process patents optimizing synthesis methods
- Use patents for specific therapeutic indications
3. Patent Challenges and Litigation
Chinese courts are increasingly active in patent disputes, especially for high-value pharmaceutical patents. The validity of claims, particularly those covering chemical structures, often faces challenge during litigation or re-examination proceedings.
Notably, prior art searches reveal a competitive environment where similar compounds and synthesis methods are patented, underscoring the importance of claim depth and prosecution strategies in CN105392483’s protection scope.
Innovation and Competitive Positioning
CN105392483’s claims aim to carve out a niche for a novel chemical entity with specific therapeutic advantages. The patent’s strategic value depends on:
- Claim breadth and defensibility: Broad, well-structured claims that withstand validity challenges will provide lasting exclusivity.
- Complementary patent rights: Complementary patents on synthesis and use expand the controlling rights for the applicant.
- Market exclusivity period: China grants patents for 20 years from the filing date, reinforcing the importance of a solid patent estate.
Rapid technological evolution in pharma necessitates continuous patenting of derivatives and methods, making CN105392483 a building block in a broader patent portfolio.
Future Outlook and Patent Strategy Implications
For competitors and licensees, understanding the scope of CN105392483 informs:
- Infringement risk assessment: Determining whether products are covered by the patent claims.
- Freedom-to-operate analyses: Identifying potential patent thickets or conflicting rights.
- Innovation pathways: Developing non-infringing derivatives or alternative compounds.
For patentees, ensuring claim robustness through comprehensive patent prosecution and strategic claims drafting is essential for sustaining competitive advantages.
Key Takeaways
- Patent CN105392483 protects a specific chemical compound or class, with claims covering its structure, synthesis, and therapeutic use in China.
- The scope hinges on claim language; broad claims offer extensive coverage but face validity considerations.
- The Chinese patent landscape is highly competitive, with overlapping patents and active enforcement; patent validity challenges are common.
- Strategic patenting, including claims on synthesis and use, enhances market protection and licensing opportunities.
- Continuous innovation and patent portfolio expansion are critical in maintaining exclusivity in China's dynamic pharmaceutical market.
FAQs
1. What is the primary innovation protected by CN105392483?
It pertains to a novel chemical compound or derivative with specific structural features, alongside potential therapeutic uses, designed to address a particular medical need.
2. How broad are the claims in CN105392483, and what does that mean for competitors?
The claims likely encompass a specific chemical structure with certain variations, providing a protected scope that may cover multiple derivatives, while still being vulnerable to validity challenges if too broad.
3. Can CN105392483 be challenged or invalidated?
Yes. Challenges may arise based on prior art, obviousness, or insufficient disclosure. The Chinese patent examination and invalidation procedures provide mechanisms for such challenges.
4. How does this patent fit within China’s overall pharmaceutical patent landscape?
It forms part of a growing portfolio of innovator patents in China, reflecting increased R&D investment and strategic patenting to secure market exclusivity amid a competitive environment.
5. What strategic considerations should entities evaluate regarding CN105392483?
Entities should analyze the patent’s claims for potential infringement, assess opportunities for licensing or designing around, and consider development of non-infringing derivatives to navigate the landscape effectively.
References
[1] State Intellectual Property Office of China (SIPO), Patent CN105392483 documentation.
[2] Wang, J. et al., "Analysis of Pharmaceutical Patent Trends in China," Journal of Intellectual Property Law (2021).
[3] Chinese Patent Law, 2020 Amendment.
