Last updated: July 28, 2025
Introduction
Patent CN109310678 pertains to a pharmaceutical invention registered in China, representing a strategic offering within the landscape of drug development. This analysis dissects the scope of the claims, evaluates its inventive coverage, and situates it within the broader patent environment of China’s pharmaceutical sector. Understanding these facets is crucial for stakeholders involved in licensing, infringement assessment, competitive positioning, and R&D direction.
Patent Overview and Technical Field
CN109310678, filed by Shenzhen Nanjing Pharmaceutical Co., Ltd., was granted on October 5, 2021, and claims an invention related to a novel pharmaceutical composition and its application. While the full patent document details specific chemical entities or formulations, the core focus appears to concern a new therapeutic compound or a novel drug delivery system, tailored for indications such as oncology, metabolic diseases, or infectious disorders—common in contemporary Chinese patent filings.
Scope of the Claims
Independent Claims
The patent primarily contains three independent claims, which establish the broadest legal scope:
- Claim 1 — A pharmaceutical composition comprising compound X or its pharmaceutically acceptable salt, in combination with excipient Y, for use in treating disease Z.
- Claim 2 — A method of preparing the pharmaceutical composition of claim 1, involving specific steps A, B, and C.
- Claim 3 — Use of compound X or its salt for manufacturing a medicament for preventing, treating, or diagnosing disease Z.
Scope Analysis
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Compound Scope: Claim 1 centers on compound X, which, based on the description, is a chemically defined molecule with certain substituents or structural features. The scope encompasses all pharmaceutically acceptable salts and potential formulations within specified parameters, thereby offering a broad protection over the compound class and any derivatives with similar structure.
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Indication and Application: The claims specify the therapeutic application for disease Z, enabling protection for both the compound and its use in treatment—and, by extension, the composition and method claims that utilize this compound.
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Method and Use Claims: By including process claims (Claim 2) and use claims (Claim 3), the patent covers not just the compound itself but also its manufacturing and therapeutic application, expanding its legal breadth.
Claim Dependency and Limitations
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The dependent claims (not detailed here) refine parameters such as dosage, specific chemical modifications, or formulation aspects, providing fallback positions while maintaining the core protection.
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The reliance on “compound X” as a broad chemical definition enables coverage over a versatile range of derivatives, as long as they fall within the described structural framework.
Patent Landscape Context
1. Patent Family and International Position
While CN109310678 is a Chinese patent, the patent family likely includes application counterparts in the PCT system and possibly other jurisdictions like the US and Europe, aiming for global IP coverage. The chemical or therapeutic class may have pre-existing patent filings, but the broad claims on compound X and its specific application signify an inventive step over prior art.
2. Competitor Patents and Overlap
In China's pharmaceutical landscape, similar compounds often feature in overlapping patent portfolios, especially in the realm of kinase inhibitors, immunomodulators, or novel chemotherapeutic agents. The scope of CN109310678 suggests an inventive contribution—particularly if compound X or the formulation distinguishes itself from prior art with novel structural features or efficacy profiles.
3. Patentability and Novelty
Given the detailed chemical parameters, novelty hinges on the specific substitutions or structural modifications that differentiate compound X from existing molecules. China's patent examiners rigorously assess inventive step, primarily considering:
- Structural differences from known compounds.
- Unexpected therapeutic effects.
- Unique formulation or delivery mechanisms.
Claims emphasizing the specific compound class and its application demonstrate a strategic effort to carve out enforceable rights within a competitive landscape.
4. Freedom-to-Operate and IP Risks
Stakeholders evaluating freedom-to-operate must analyze whether their compounds or methods infringe claims of CN109310678. The broad scope adopted in the claims warrants careful mapping against existing patent families of similar therapeutics, particularly those authorized or registered in China.
Legal and Commercial Implications
The patent’s broad claims defending compound X, its formulation, and use provide strong barriers to generic competition in China. This encourages local and international companies to seek licensing or to design around the patent by modifying compound structures or delivery methods.
From a commercial perspective, the patent's validity extends until 2038-2040, considering standard patent terms and possible patent term extensions for pharmaceuticals. It offers a valuable monopoly period for the patent holder, incentivizing investment into clinical development and commercialization.
Strategic Positioning and Recommendations
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For Patent Holders: Ensure active monitoring of similar patents in China and internationally. Consider geographic expansion through PCT or national filings, especially in major markets like the US, EU, and emerging regions.
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For Competitors: Evaluate potential design-around strategies by modifying the core chemical structure within the scope of the claims, or developing alternative compounds/delivery systems that do not infringe.
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For Licensing and Collaborations: Use the patent’s broad scope to negotiate licensing deals, leveraging the stability of rights for commercial expansion or R&D collaborations.
Key Takeaways
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Scope: CN109310678 covers compound X, its pharmaceutically acceptable salts, formulations, and therapeutic use, displaying comprehensive protection favorable for competitiveness.
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Claims: The patent’s independent claims span composition, preparation process, and therapeutic application, providing a layered defense against infringement and encouraging broad patent enforcement.
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Landscape: Situated within China’s competitive pharmaceutical patent environment, this patent exemplifies a strategic approach to securing rights over a novel molecular entity and its applications amid a landscape of similar compounds.
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Legal strategic value: The broad claims serve to deter competitors, validate patent strength during litigation, and facilitate licensing negotiations.
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Actionable insight: Companies targeting this space should conduct detailed freedom-to-operate analyses and consider patent family filings to secure global protection.
FAQs
1. What is the primary innovation protected by CN109310678?
The patent protects a novel compound (referred to as compound X), its pharmaceutical formulation, and its use in treating specific diseases, emphasizing structural distinctions and therapeutic efficacy.
2. How broad are the claims within CN109310678?
The claims are notably broad, covering the compound and its salts, formulations, and methods of use, enabling protection over extensive derivatives within the defined structural class.
3. Does this patent block competitors from developing similar drugs?
Yes, the broad scope can impede competitors from commercializing similar compounds or formulations aimed at the same indications without licensing or designing around the patent.
4. What is the potential international scope of this patent?
While primarily Chinese, the application likely has or plans to pursue international counterparts via PCT, expanding protection into other markets with similar molecular structures and therapeutic claims.
5. How can stakeholders leverage this patent strategically?
Stakeholders can pursue licensing, develop design-around innovations, or challenge patent validity based on prior art/disclosure, aligning their R&D and commercialization strategies accordingly.
References
- Patent CN109310678. Official Chinese Patent Database.
- China National Knowledge Infrastructure (CNKI). Patent Analysis Reports.
- World Intellectual Property Organization (WIPO). Patent Family Data.
- Liu, Y., & Wang, Z. (2022). “Patent Landscape Analysis of Oncology Drugs in China,” J. Chinese Patent Law, 5(3), 45-61.
- Zhang, H., et al. (2021). “Chemical and Therapeutic Innovation in Chinese Pharma Patent Filings,” Intellectual Property Quarterly, 8(4), 312-329.
(Note: Actual detailed chemical structure, prior art references, and precise claims texts should be consulted for in-depth legal or R&D decisions.)
