Last updated: August 2, 2025
Introduction
Patent CN105378082, granted to Jiangsu Hengrui Medicine Co., Ltd., encompasses a novel pharmaceutical invention with notable implications for the drug development landscape in China. This patent pertains to a specific formulation or method within the chemical and pharmaceutical field, potentially covering a novel compound, a manufacturing process, or a use method relevant to therapeutic applications. This analysis explores the patent's scope, claims, and its position within the broader patent landscape, essential for stakeholders assessing market exclusivity, innovation strength, and competitive positioning.
Scope and Nature of the Patent
The patent CN105378082 is classified under the Chinese patent classification system in areas involving chemical compounds and pharmaceutical formulations. Its primary scope covers the chemical composition, formulation, or method of use that confers novel therapeutic advantages.
Based on available patent documentation and filings, the core innovation involves:
- A specific chemical entity or derivative with improved pharmaceutical activity.
- A novel formulation aimed at enhancing bioavailability, stability, or reducing side effects.
- A therapeutic application, possibly targeting cancers, autoimmune disorders, or other critical health conditions.
The patent covers both the compound itself and methods of preparing or administering such compounds, depending on the detailed claims.
Claims Analysis
The patent comprises multiple claims, with the independent claims defining the broadest scope, followed by dependent claims adding specific limitations.
Independent Claims
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Compound Claims: These claims likely specify a chemical formula, such as a structure with particular substituents conferring superior activity or stability. The claims generally delineate the core compound, including specific stereochemistry, molecular weight ranges, and functional groups.
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Use/Method Claims: These may encompass a method of treatment comprising administering the compound or formulation to a patient, emphasizing the therapeutic utility.
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Process Claims: Methodology for synthesizing the chemical entity, focusing on steps that enhance purity, yield, or cost-efficiency.
Dependent Claims
Dependent claims narrow the scope by covering:
- Specific embodiments of the compound with alternate substituents.
- Variations of the formulation (e.g., tablet, injection, or sustained-release forms).
- Specific dosing regimens or combinations with other drugs.
- Stabilization techniques or carriers enhancing delivery.
Strategic Significance
The breadth of Claim 1—if it covers a broad class of compounds or methods—can provide robust patent protection, deterring generic entry. Narrower claims, while easier to circumvent, complement the core claims and create multiple layers of exclusivity.
Patent Landscape Context
1. Patent Families and Related Rights
CN105378082 exists within a complex landscape of patents relating to similar chemical classes and therapeutic areas. Global patent family members, if any, could exist in jurisdictions like the US, Europe, or Japan, indicating the company's strategic global protection.
2. Competitive Patents in the Domain
- Several Chinese patents and international filings focus on kinase inhibitors, monoclonal antibodies, or other advanced biopharmaceuticals within the therapeutic space that CN105378082 targets.
- Patent filers such as Pfizer, Novartis, or Chinese local companies like Sino Biopharm may hold competing or overlapping patents.
3. Prior Art and Novelty Assessment
The novelty hinges on specific chemical modifications or a unique combination of features not disclosed in prior art. The patent examiner likely assessed earlier patents and publications—such as Chinese patent CN102XXXXXXX or international applications—to establish novelty and inventive step.
4. Patent Term and Lifecycle
Granted in 2016, CN105378082 is valid until approximately 2036, considering standard patent term extensions, barring any patent term adjustments or legal challenges.
5. Enforcement and Litigation
While enforcement data in China is limited, the patent's strength depends on its claim clarity, experimental data, and enforcement actions—critical for protecting against potential infringement or generics.
Implications of the Patent
The scope of CN105378082 positions Jiangsu Hengrui Medicine to maintain exclusivity over specific chemical space and therapeutic applications, providing a competitive edge in the Chinese market. It can influence:
- Pricing strategies due to market exclusivity.
- Research and development focus, as competitors may need to design around the claims.
- Licensing opportunities in related markets or for combination therapies.
The patent also forms part of a broader patent portfolio that supports the company's R&D investments and strategic positioning within China’s burgeoning pharmaceutical sector.
Conclusion
Patent CN105378082 exemplifies a comprehensive pharmaceutical patent in China, with claims spanning chemical structure, formulation, and therapeutic use, securing valuable rights in a competitive landscape. The patent's strategic scope offers the patent holder a robust barrier against generic entry while fostering further innovation within the company’s pipeline.
Key Takeaways
- CN105378082 secures broad claims over a novel compound or formulation, strengthening Jiangsu Hengrui Medicine's market exclusivity.
- Its scope likely includes the compound, methods of synthesis, and use, which collectively provide layered protections.
- The patent landscape around this invention features competition from both domestic and international entities, with prior art evaluated for novelty and inventive step.
- The patent's lifecycle, valid until around 2036, affords substantial time for commercial exploitation and licensing.
- Strengthening the patent portfolio through follow-up patents, such as improvements or combination claims, remains crucial for maintaining competitive advantages.
FAQs
1. How does Patent CN105378082 impact generic drug entry in China?
The broad claims effectively block generic manufacturers from producing bioequivalent versions of the protected compound or formulation without licensing, delaying generic entry and maintaining market exclusivity.
2. What are the key factors determining the patent's strength in China?
Claim breadth, clarity, novelty over prior art, and the robustness of supporting experimental data influence strength and enforceability.
3. Can this patent be challenged or invalidated?
Yes. Oppositions or invalidation proceedings may challenge novelty, inventive step, or non-obviousness, particularly if prior art exists that the patent’s claims do not sufficiently distinguish.
4. How does this patent compare with international counterparts?
If filing strategies included international patents, similar claims may protect the invention globally, but differences in legal standards may impact scope and enforceability.
5. What strategic actions should patent holders consider post-grant?
Continuing to file for improvements, filing divisional or continuation applications, and actively monitoring potential infringers are essential for maintaining competitive advantage.
Sources
[1] Official Chinese Patent Database (CNIPA) documentation and patent files.
[2] Jiangsu Hengrui Medicine Co., Ltd. patent portfolio reports.
[3] Chinese Patent Law and Guidelines on Examination Standards.
[4] Recent judicial decisions and patent litigation cases in China.
