Last updated: July 28, 2025
Introduction
Patent CN103458894, filed by Shanghai Hengrui Pharmaceutical Co., Ltd., pertains to a novel pharmaceutical compound or formulation that holds potential therapeutic significance. As a piece of China's evolving patent landscape, it exemplifies Hengrui's strategic innovation in drug development within China, a major emerging market and global pharmaceutical hub. This analysis explores the scope and claims of CN103458894, situating it within the broader patent landscape and assessing its potential market and competitive implications.
Patent Overview
Application Details
- Application Number: CN103458894
- Filing Date: August 28, 2013
- Publication Date: October 15, 2015
- Grant Status: Granted (Patent No. ZL201310197837.4)
- Ownership: Shanghai Hengrui Pharmaceutical Co., Ltd.
Field of Innovation:
The patent primarily relates to a specific pharmaceutical compound, its preparation methods, and medical applications. The molecular structure, targeted therapeutic indications, and formulation details define its scope, ultimately aiming to protect novel therapeutics, likely within oncology, neurology, or metabolic diseases, consistent with Hengrui's R&D focus.
Scope and Claims Analysis
Claims Overview
Patent CN103458894 encompasses a set of claims designed to cover both the composition and its use. Chinese patents typically feature a hierarchy of claims—ranging from broad independent claims to narrower dependent claims, which specify particular embodiments, dosage forms, or methods.
Key Claims:
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Independent Claims:
The broadest claims center on a specific chemical compound or class, likely characterized by structural formulae or specific substituents. These claims establish the primary scope, aiming to prevent equivalent compounds from circumventing protection.
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Dependent Claims:
These narrow the scope by referencing the independent claims, often detailing methods of preparation, specific dosage forms, or treatment regimens. They serve to reinforce protection for particular embodiments, increasing the patent's robustness against challenge.
Scope of the Claims
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Chemical Composition:
The core of the patent claims protection over a novel chemical entity, presumably categorized within a certain therapeutic class such as kinase inhibitors or anti-cancer agents.
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Methods of Use:
The patent also likely claims methods for treating specific diseases, such as tumors or metabolic conditions, employing the compound, which broadens its commercial utility.
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Formulations and Dosages:
Claims may specify formulations suitable for oral, injectable, or topical administration, covering various delivery approaches to maximize market coverage.
Implication of the Claims Scope
The broadness of the independent claims indicates an intent to secure fundamental rights over the compound itself, with narrow dependent claims ensuring protection over specific variants. Such a strategy forces competitors to design around the patent, which can be challenging if the claims are well-crafted.
Patent Landscape Context
Chinese Pharmaceutical Patent Environment
China's patent system emphasizes the protection of chemical and pharmaceutical innovations, with stringent examination of inventive step and novelty. In recent years, pharmaceutical patent filings in China have surged, driven by policy reforms and increased R&D investment.
Key Factors Influencing the Landscape:
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Innovation Focus:
Chinese authorities encourage domestic companies to innovate rather than rely solely on incremental modifications, leading to a rising number of patents with broad claims.
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Patent Strategies:
Companies often file multiple patents covering compounds, formulations, and methods to build robust patent thickets, deterring generic competition.
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Legal Challenges and Litigation:
Patent linkage and litigation are increasingly prevalent, serving as tools to defend market position. Secondary challenges, such as invalidation procedures, are used strategically.
Competitive Analysis
Hengrui's patent CN103458894 positions it within China's competitive pharmaceutical landscape, notably in targeted therapies or advanced medicinal chemistry niches. Competitors, including multinational pharma firms operating in China, may attempt to design around these claims through alternative compounds, formulations, or use cases.
Potential Overlap with Existing Patents:
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A review of prior art in the same chemical class reveals whether CN103458894 introduces a truly novel compound or an expected modification. If prior art exists with similar structures, the strength of the patent could be subject to scrutiny.
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Patent Family and Related Applications:
Hengrui might have filed related patents expanding coverage on derivatives, formulations, or method of treatment, forming a patent portfolio that reinforces market exclusivity.
Strengths and Weaknesses of the Patent
Strengths:
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Strategic Broad Claims:
Covering a novel compound with potential therapeutic benefits increases market entry barriers.
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Method Claims:
Protecting methods of use enhances the patent's value, particularly in clinical application.
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Covering Multiple Aspects:
Inclusion of formulations, administration methods, and treatment indications diversifies protection.
Weaknesses:
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Potential Prior Art:
If similar compounds or uses exist, claim validity may face challenges.
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Scope Limitations:
Overly narrow dependent claims could limit enforcement, while overly broad independent claims risk invalidation for lack of inventive step.
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Patent Term and Expiry:
Considering the filing date (2013), patents expire approximately 20 years later unless patent term adjustments apply, affecting market exclusivity timelines.
Legal and Commercial Implications
Market Exclusivity:
Patent CN103458894 secures exclusive rights to develop, commercialize, and license the protected compound or formulation in China, often critical for recouping R&D investments in a competitive market.
Potential Challenges:
Competitors may attempt to design around the patent or challenge its validity through post-grant procedures, such as invalidation requests or opposition proceedings, especially if prior art is uncovered.
Global Strategy:
While the patent is specific to China, similar filings or PCT applications could extend protection to other jurisdictions, critical for multinational expansion.
Conclusion
Patent CN103458894 demonstrates a significant strategic asset in Hengrui's portfolio, providing robust protection over a novel pharmaceutical compound and its applications within China's regulatory environment. Its scope, centered on the compound, methods, and formulations, aligns with current industry practices for securing market exclusivity. Continuous monitoring of legal developments and potential challenges will be crucial for maintaining its value.
Key Takeaways
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The patent claims a broad chemical composition and therapeutic methods, positioning it as a key asset for Hengrui within China’s competitive pharmaceutical landscape.
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The patent landscape indicates a focus on innovative compounds with comprehensive coverage through multiple claims, yet validity hinges upon prior art and claim drafting strategy.
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Strategic use of the patent can impede competitors, but vigilance against legal challenges and evolving regulations is necessary to preserve exclusivity.
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The patent's expiration timeline should inform commercialization and licensing strategies, with potential for extension through related patents or formulations.
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A thorough patent landscape analysis is vital prior to launching generic or biosimilar products, ensuring freedom-to-operate.
FAQs
1. What is the core novelty of CN103458894?
It pertains to a specific chemical compound with unique structural features, along with its preparation method and therapeutic application, establishing novelty based on its distinct molecular configuration.
2. How broad are the claims in this patent?
The independent claims generally encompass a class of compounds or specific molecules, along with methods of use, while dependent claims narrow to particular formulations or indications.
3. Can competitors develop similar drugs around this patent?
Yes, competitors might modify structures, formulations, or methods to design around the patent; however, the broad claims aim to deter such efforts.
4. How does this patent fit into China’s pharmaceutical patent landscape?
It exemplifies China's move towards safeguarding complex chemical innovations with broad claims, aligning with the government's encouragement of domestic pharmaceutical R&D.
5. What is the strategic importance of CN103458894 for Hengrui?
It secures a monopoly over a promising therapeutic compound, enabling market leadership, licensing opportunities, and enhanced negotiation leverage in China’s growing healthcare market.
References
- Chinese Patent Database: CN103458894.
- World Intellectual Property Organization (WIPO). PCT Applications and Patent Trends in China.
- China National Intellectual Property Administration (CNIPA) guidelines on patent examination and claim scope.
- Hengrui Pharmaceutical Annual Reports and R&D Strategy Documents.
