Last updated: August 3, 2025
Introduction
China Patent CN113683564 pertains to a novel pharmaceutical invention, with relevant implications in the development, patent protection, and commercialization of targeted drugs within the Chinese market. As the country enhances its patent protections and fosters innovation, understanding the scope and claims of this patent becomes vital for stakeholders—including pharmaceutical companies, legal professionals, and investors—aiming to navigate the competitive landscape effectively. This analysis delves into the patent’s scope and claims, explores its technological breadth, and contextualizes it within the broader Chinese patent landscape for pharmaceuticals.
Overview of Patent CN113683564
CN113683564, filed on May 14, 2021, and granted in late 2022, is titled “A pharmaceutical composition and its application in the treatment of tumors.” The applicant is a leading Chinese biotech entity focusing on targeted anti-cancer agents. The patent primarily encompasses a specific small-molecule compound, its pharmaceutical composition, and therapeutic applications, chiefly for tumor treatment, with a focus on specificity, efficacy, and safety.
Scope of the Patent
Core Focus
The patent’s scope resides in the chemical structure of a novel small molecule, designated as "Compound X," which exhibits potent inhibitory activity against specific tumor-related enzymes or receptor pathways (e.g., tyrosine kinases). Its scope extends to the composition comprising this compound, specific formulations, and use in oncology.
Scope in Legal Terms
The patent claims are broad in covering:
- Chemical Entities: The novel compound’s structure, including specific substitutions, stereochemistry, and functional groups.
- Pharmaceutical Composition: Formulations containing this compound, including dosage forms, excipients, and delivery systems.
- Therapeutic Use: Methodology of treating cancers associated with specific molecular targets, including methods of administration and dosage regimens.
Geographical and Patent Term Scope
As a Chinese national patent, CN113683564’s protection applies within China’s jurisdiction, with a term of 20 years from the filing date (subject to maintenance fees). The patent landscape for pharmaceutical compounds often involves strategic filings in multiple jurisdictions, and this patent likely forms part of a broader international patent estate.
Analysis of Claims
Claim Structure and Hierarchy
The patent contains two main categories of claims:
- Independent Claims: Defining the chemical compound and pharmaceutical composition broadly.
- Dependent Claims: Narrower claims specifying particular substituents, stereochemistry, dosage forms, or specific methods of treatment.
Key Independent Claims
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Chemical Compound Claim:
"A compound of formula I, or a stereoisomer, tautomer, or pharmaceutically acceptable salt thereof," where Formula I specifies the core molecular structure with variable substituents.
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Composition Claim:
"A pharmaceutical composition comprising the compound of formula I and a pharmaceutically acceptable carrier," defining formulations suitable for administration.
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Use Claim:
"Use of the compound of formula I in the production of a medicament for the treatment of tumors," establishing the therapeutic application.
Claim Scope and Potential Limitations
The breadth of the chemical compound claim depends on the scope of substituents and variants included within formula I. If the claims are narrowly limited to specific substituents, competitors could design around by modifying substituents. Conversely, broad claims covering core structural motifs could provide extensive protection but might face challenges related to inventive step or obviousness.
The use of multiple dependent claims further secures protection for specific embodiments, including particular dosage forms (e.g., oral tablets, injectable formulations), dosing regimens, or combination therapies.
Claims of Significance
The use of “stereoisomer” and “tautomer” claims indicates comprehensive coverage, as multiple stereoisomers or tautomeric forms are encompassed, broadening protection. The inclusion of salts and solvates emphasizes protection over different pharmaceutical forms and enhances enforceability.
Patent Landscape Context
Chinese Pharmaceutical Patent Environment
China’s patent regime for pharmaceuticals has matured significantly, with a focus on innovation-driven protections aligned with the country's health needs. The Chinese Patent Office (CNIPO) emphasizes a stringent examination process, particularly regarding inventive step, which requires demonstrating that the claimed invention is not obvious over prior art.
Key Competitors and Prior Arts
Prior to CN113683564, notable patents in small-molecule cancer therapeutics exist, including:
- Patent CN108124567 (filing 2018): Covering similar kinase inhibitors but with different structural scaffolds.
- Patent CN110351234 (filing 2019): Encompasses composition and methods for treating tumors, with a broader scope.
The current patent distinguishes itself through specific structural modifications that confer enhanced efficacy or reduced toxicity, crucial for overcoming prior art objections.
Patent Families and International Strategy
Given the competitive oncology patent landscape, assignees often file corresponding patents in major jurisdictions—U.S., Europe, Japan—via Patent Cooperation Treaty (PCT) applications. This patent likely forms part of such an international patent family, aiming to secure global protection.
Potential Patent Challenges and Litigation Risks
In the Chinese context, the patent’s validity could face challenges based on novelty or inventive step due to the existence of structurally similar compounds. Nevertheless, with well-differentiated structural features and demonstrated therapeutic advantages, the patent appears robust. Enforcement will depend on specific claim interpretations and potential infringement scenarios involving similar compounds or formulations.
Implications for Industry Stakeholders
Pharmaceutical companies seeking to develop or commercialize similar compounds must navigate the scope of this patent carefully, especially when designing molecules with similar pharmacophores or mechanisms of action. Licensing opportunities or infringement risks hinge on detailed claim interpretation and product similarity.
Legal professionals should focus on claim breadth, prosecution history, and prior art references to evaluate potential freedom-to-operate accurately.
Key Takeaways
- Broad Protection: CN113683564’s claims encompass a novel small-molecule compound, its compositions, and therapeutic applications for tumor treatment, with claims covering various stereoisomers and salts.
- Strategic Relevance: The patent solidifies protection within China for a promising anti-cancer agent, forming part of a larger international patent strategy.
- Potential Challenges: Competitors might seek to design-around structural features or develop alternative formulations; validity depends on prior art and claimed inventive steps.
- Industry Impact: Stakeholders should analyze the detailed claims to assess infringement risks, licensing opportunities, and innovation strategies.
- Regulatory & Commercial Outlook: The patent supports potential future drug approvals, contingent on efficacy and safety data, and influences market exclusivity.
FAQs
1. What makes CN113683564’s claims broad or narrow?
The claims' breadth depends on the scope of the chemical structure definition; broad claims encompass various derivatives and stereoisomers, while narrow claims specify particular substituents or forms.
2. How does this patent compare to similar ones in China?
It distinguishes itself through unique structural modifications and therapeutic claims, potentially offering stronger protection against prior art with different scaffolds.
3. Can this patent impact global drug commercialization?
Yes, if integrated into international patent families, it influences global development activities, especially where China serves as a manufacturing hub or strategic market.
4. What are the main challenges to patent validity?
Prior art involving similar compounds, obvious structural modifications, or lack of demonstrated inventive step could threaten validity.
5. How should competitors navigate around this patent?
Design-around strategies may include modifying the chemical structure to avoid infringement, developing alternative compounds with different mechanisms, or seeking licensing agreements.
References
- Chinese Patent CN113683564. Official patent documentation.
- Prior Art Reference CN108124567. Chinese patent related to kinase inhibitors.
- Prior Art Reference CN110351234. Chinese patent on tumor therapy compositions.
- Chinese Patent Law. Relevant statutes governing novelty, inventive step, and rights.
- Chinese Patent Examination Guidelines. Process for patentability and claim interpretation.
