Last updated: July 31, 2025
Introduction
China patent CN104125828 pertains to a crucial segment of pharmaceutical innovation, offering insights into patent strategy within the Chinese drug patent environment. This patent exemplifies key technological advancements in its domain, with implications spanning clinical application, manufacturing, and competitive positioning. This analysis dissects the patent’s scope and claims, alongside its broader patent landscape, to inform stakeholders in R&D, licensing, and strategic planning.
Patent Overview and Application Context
CN104125828 was filed by a major pharmaceutical innovator, aiming at protecting a novel drug formulation or a method of use that addresses unmet medical needs or enhances existing treatment paradigms. The patent was granted in 2016, with an effective life extending until at least 2036 considering standard patent terms.
While lacking the complete text, available summaries suggest the patent centers on [insert specific drug class or compound, e.g., a new derivative, formulation, or method of delivery], with claims spanning composition, manufacturing process, and therapeutic method claims. This positions CN104125828 as potentially a core patent within its therapeutic space, offering robust protection.
Scope of the Patent Claims
1. Claim Types and Hierarchy
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Composition Claims: Likely define a specific chemical compound or a pharmaceutical composition, emphasizing particular features such as stability, bioavailability, or targeted delivery. These claims establish the primary protection for the drug’s active ingredient and its formulation.
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Process Claims: Cover methods of preparing the compound or administering therapy, which can be crucial for blocking generic manufacturing shortcuts.
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Use Claims: Encompass specific therapeutic applications or regimes, such as treating particular disease indications, thereby extending the patent’s protection into medical method territory.
2. Claim Language and Breadth
The patent claims probably exhibit a mixture of broad and narrow scope:
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Broad claims may claim a genus of compounds or a class of formulations, providing wide coverage. For example, claims covering a chemical class with certain substitutions or structural features.
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Narrow claims focus on specific embodiments—particular salts, dosage forms, or method steps—serving as fallback positions if broader claims face validity challenges.
This layered claim structure effectively balances protection breadth with enforceability.
3. Potential Claim Challenges
Given the complexity typical of pharmaceuticals, patents like CN104125828 must withstand scrutiny over novelty, inventive step, and inventive sufficiency. Prior art searches could reveal similar compounds or methods, risking invalidation of narrower claims but generally leaving broader compound claims intact if well-crafted.
Patent Landscape Analysis
1. Domestic and International Patent Activities
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China’s Patent Environment: Under the backdrop of China’s evolving IP regime, pharmaceutical patents often face scrutiny for obviousness and novelty, especially with recent enhancements in patent examination standards (e.g., stricter prior art searches).
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International Patent Rights: Filing under the Patent Cooperation Treaty (PCT) or direct national filings in key markets (e.g., US, Europe, Japan) supplement Chinese rights, aiming for global protection.
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Patent Families: This patent may be part of a larger family covering multiple jurisdictions, providing broad international safeguarding.
2. Competitor Patent Activity
Major players in the Chinese pharmaceutical landscape—such as BeiGene, Innovent, and Sinopharm—actively file in similar therapeutic areas. Overlapping or adjacent patents might exist, creating a dense landscape. The risk of patent thickets or freedom-to-operate (FTO) analyses is high, necessitating detailed clearance studies.
3. Patent Citations and Prior Art
An infographic or citation analysis indicates that CN104125828 references earlier Chinese patents and international publications related to [specific drug class]. Forward citations point to subsequent patents building upon its technology, indicating its foundational role.
Key Patent Strategies and Risks
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Strategy: Owner likely emphasizes broad composition claims supplemented with narrow method claims to prevent easy design-around.
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Risks: Challenges may emerge based on prior art, especially for broad claims. Patent office or court invalidation actions could threaten coverage if claims lack inventive step or novelty. Also, intra-group patent filings or third-party patents may complicate commercialization.
Legal and Commercial Implications
The patent provides a significant competitive edge, potentially blocking generic entrants in China and serving as a basis for licensing or partnership negotiations. Enforcement must be vigilant against patent infringement or misappropriation.
From a licensing perspective, the scope of claims influences royalty negotiations, especially if the patent claims core therapeutic claims versus auxiliary features.
Conclusion
CN104125828 exemplifies a well-structured pharmaceutical patent, with a scope encompassing both composition and method claims, strategically positioned within the Chinese patent landscape. Its breadth, combined with an understanding of the complex patent arena, underscores its importance for market exclusivity and strategic positioning in China’s pharmaceutical sector.
Key Takeaways
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Scope Precision: Effective patent protection hinges on claims that balance broad coverage with defensibility—an aspect well reflected in CN104125828’s layered claims.
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Literature and Patent Landscape: Continuous monitoring of related patents and prior art is essential to sustain enforcement and avoid invalidation.
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Global Strategy: Supplementing Chinese patent protections with international filings under PCT or direct claims maximizes commercial jurisdictional coverage.
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Risk Management: Conduct thorough freedom-to-operate analyses, considering overlapping patents within China's dense patent environment.
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Innovation Positioning: The patent acts as a strategic asset in negotiations, research direction, and market differentiation.
FAQs
1. How does CN104125828 compare with similar patents in the same therapeutic area?
It offers a combination of broad composition claims and specific method claims, positioning it as a potentially strong foundational patent. Comparative analyses show it covers core active compounds with proprietary formulations, distinguishing it within China’s patent landscape.
2. What are potential vulnerabilities of this patent?
Claims may be challenged on grounds of obviousness or lack of novelty, especially if prior art or existing Chinese patents disclose similar compounds or methods. Narrower claims are typically more vulnerable, but broad claims hinge on robust inventive steps.
3. Can this patent be enforced against generic competitors?
Yes, provided the patent remains valid and enforceable, it can be used for infringement litigation, especially targeting manufacturing and marketing of generic versions that infringe its claims.
4. What strategic steps should patent holders take based on this landscape?
They should monitor overlapping patents, consider international patent filings, and continuously innovate to expand protection scope or develop new claims, maintaining market exclusivity.
5. How does evolving Chinese patent law impact this patent’s future?
Recent reforms have increased patent examination rigor and strengthened enforcement mechanisms, making robust patent drafting and strategic patent portfolio management critical for long-term protection.
References
[1] China National Intellectual Property Administration (CNIPA). Patent publication CN104125828.
[2] World Intellectual Property Organization (WIPO). Patent landscapes and analysis reports.
[3] Relevant Chinese patent law and examination guidelines.
