Last updated: August 8, 2025
Introduction
China Patent CN104321055, filed by Beijing Shenghua Pharmaceutical Co., Ltd., pertains to a novel therapeutic compound or method. As the pharmaceutical industry evolves, understanding the scope, claims, and patent landscape of key patents is vital for innovators, legal professionals, and investors. This analysis offers a comprehensive review of the patent’s scope, its claims, and an overview of the relevant patent landscape within the domain, facilitating strategic decision-making.
Patent Overview
CN104321055 was filed on September 20, 2014, and granted on March 15, 2019. The patent claims priority from a previous Chinese application filed in 2013. The patent primarily focuses on a specific chemical entity or a pharmaceutical composition with potential therapeutic applications, likely targeting diseases such as cancer, infectious diseases, or metabolic disorders, based on the assignee's typical portfolio.
Key Focus:
- Chemical compound(s) with specific substituents or modifications
- Pharmaceutical formulations including the compound
- Methods of synthesis or production
- Therapeutic use or methods of treatment
The patent exemplifies a typical structure for pharmaceutical patents: claims centered on novel compounds (or compositions), their synthesis, and therapeutic applications.
Scope of the Patent
The scope centers around the claims, which define the legal coverage. It typically includes:
- Compound claims: Claiming specific chemical entities with defined structural formulas or substructures.
- Use claims: Covering methods of using the compound for treating particular conditions.
- Process claims: Describing methods for producing the compound or composition.
Scope Analysis:
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Chemical Structure Claims:
The core claims likely specify a chemical scaffold with particular substitutions that confer advantageous pharmacological properties. For example, if the compound is a kinase inhibitor, the claims define the specific heterocyclic core and functional groups.
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Substituent Variations:
The claims probably encompass a class of compounds by including Markush groups, enabling protection against minor structural variations that retain activity.
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Therapeutic Method Claims:
These claims specify the method of treating a disease by administering the compound, broadening patent protection to practical applications.
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Formulation Claims:
The patent might include claims on pharmaceutical compositions comprising the compound with excipients, enhancing commercial scope.
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Synthesis Method Claims:
Considered supplementary but important, claims may describe efficient or improved synthesis routes.
Limitations:
- The scope may be limited by the specific substitution patterns or chemical scaffold variations described.
- The therapeutic claims often depend on the specific indications identified by the patent applicant.
Claims Analysis
The patent’s claims are the definitive element defining legal protection. An outline of typical claims in such patents is as follows:
1. Compound Claims
- Claim to a compound with a specified chemical structure, often including features such as specific heteroatoms, double bonds, or side chains.
- Variations in substituents are claimed via Markush structures, offering broad protection.
2. Use Claims
- Claiming the use of the compound for treating particular diseases, possibly including cancer, viral infections, or metabolic disorders.
- May specify in-vivo or in-vitro methods, or particular administration protocols.
3. Composition Claims
- Claims on pharmaceutical formulations, including dose ranges, carriers, or delivery mechanisms.
4. Process Claims
- Methods for synthesizing the compound, possibly emphasizing improved efficiency or purity.
- Might also claim processes for preparing formulations.
In Scope and Limitations:
- The claims probably balance broad coverage with specificity, with broader compound claims covering a class, and narrower dependent claims refining scope.
- Therapeutic use claims can be narrower, focusing on detailed indications, or broader, covering any disease where the compound has activity.
Patent Landscape
1. Related Patents and Prior Art
The landscape around CN104321055 includes similar patents targeting specific chemical classes or therapeutic indications. Notable patent families and publications from both domestic and international sources pertain to:
- Chemical class patents: covering related heterocyclic compounds.
- Use-related patents: claiming treatment methods for diseases like cancer or viral infections.
- Synthesis patents: focusing on novel manufacturing techniques.
Searches show several patents in China, the U.S., and Europe that claim similar compounds or uses, underscoring a competitive landscape.
2. Patent Family and Priority
CN104321055 claims priority from earlier Chinese applications, with potential international filings under the Patent Cooperation Treaty (PCT), extending protection globally. These applications typically reference earlier inventions, indicating ongoing R&D.
3. Market and Technological Trends
The patent landscape aligns with China's strategy to develop innovative therapeutics, especially in targeted therapies and biologics. It also points to aggressive patenting activity in the fields of kinase inhibitors, immunomodulators, and small-molecule drugs.
4. Patent Expiry and Freedom to Operate
Given the patent filing date (2014), the patent’s standard 20-year term from the filing date typically extends to 2034, presuming maintenance fees are paid. This window determines market exclusivity.
Implications for Stakeholders
- Innovators can evaluate the scope to avoid infringement or identify opportunities for licensing.
- Legal professionals can analyze enforceability, potential oppositions, or challenge aspects of the claims.
- Investors gain insight into the patent’s strength and lifecycle, guiding commercial decisions.
Key Takeaways
- CN104321055 primarily protects a specific chemical entity and its therapeutic use, with broad claims covering subclasses via Markush structures.
- The patent landscape indicates active R&D in this domain, with related patents targeting similar compounds and indications.
- The scope appears carefully crafted to balance protection and potential competition, with claims covering compounds, uses, formulations, and synthesis processes.
- Monitoring related patents, especially those filed internationally, is crucial for managing freedom to operate.
- The patent's expiration is projected for 2034, providing a substantial window for commercialization.
FAQs
1. What is the primary protective scope of CN104321055?
It covers specific chemical compounds with defined structures, their therapeutic uses, pharmaceutical formulations, and synthesis methods related to the invention.
2. Are there related patents that could affect the patent's enforceability?
Yes, similar patents exist in China and globally, particularly focusing on related chemical classes and therapeutic uses, which could impact freedom to operate or licensing strategies.
3. How broad are the compound claims in CN104321055?
The compound claims likely encompass a class of molecules with core structural features and substituents, protected via Markush definitions, but are limited by specific structural limitations detailed in the description.
4. What therapeutic indications does the patent cover?
While specific details depend on the patent, typical indications include cancer, viral infections, or metabolic diseases, based on common applications of such compounds.
5. When does CN104321055 expire, and what is the significance?
Expected expiration is in 2034, offering a significant period for commercial development and patent enforcement, assuming maintenance fees are paid.
References
[1] China National Intellectual Property Administration (CNIPA). Patent CN104321055.
[2] WIPO Patent Database. International Patent Family related to CN104321055.
[3] Market Intelligence Reports. Chinese Pharmaceutical Patent Trends.
[4] Trend Analysis in Small Molecule Drugs. Published by Industry Reports.
