Last updated: August 3, 2025
Introduction
Patent CN104039358, filed in China, pertains to a pharmaceutical invention with potential implications for drug development, commercialization, and competitive positioning within China’s dynamic biopharmaceutical landscape. Analyzing its scope and claims provides insights into the patent’s strength, breadth, and strategic value. This report offers a comprehensive review, contextualized within the broader patent landscape, to assist stakeholders in assessing the innovation’s enforceability and competitive significance.
Patent Overview
CN104039358 was granted on June 2, 2015, by the State Intellectual Property Office (SIPO). The patent title describes an "antitumor compound or pharmaceutical composition thereof," indicating a focus on oncology—an area with high patent activity in China.
The patent's priority date is approximately August 16, 2012, establishing a prior art baseline for subsequent filings. The patent claims focus on chemical compounds, methods of synthesis, and therapeutic uses, typical of anticancer drug patents aiming to covering both composition and method claims.
Scope of the Patent
1. Patent Type & Coverage
CN104039358 is classified as a composition-of-matter patent, offering protection for specific chemical entities, and extends to pharmaceutical compositions and methods for treating cancer. The scope includes:
- Novel chemical compounds, characterized by specific chemical structures or substitutions.
- Pharmaceutical formulations, potentially encompassing formulations, dosage forms, and delivery systems.
- Therapeutic methods, including administering the compounds for specific cancer indications.
2. Chemical Structure and Definitions
The core claims involve a chemical scaffold, with variations specified via substitution patterns. Generally, the patent covers compounds with structural formulae such as [generic structure], with substituents R1, R2, and R3 varying within defined parameters.
The claims specify:
- Range of substituents, substitutive groups, and their positions.
- Stereochemistry and purity requirements, which impact patent breadth and enforceability.
- Methods of synthesis, delineating how the compounds are produced, potentially broadening patent scope through process claims.
3. Therapeutic Use Claims
In addition to compound claims, the patent asserts "use" claims—a common strategy in pharmaceutical patents—covering:
- The use of the compounds in treating specific cancers such as lung, breast, or colorectal carcinomas.
- Method of administration, dosing regimens, and combination therapies.
Use claims typically have narrower scope but are crucial for lifecycle management and patent extension strategies.
Claims Analysis
1. Independent Claims
The independent claims generally define:
- A chemical compound with specific structural features.
- Pharmaceutical compositions comprising the compound.
- Methods of treatment, involving administering effective amounts of the compound to subjects.
Claim examples:
- "A compound of formula I, wherein R1, R2, R3 are as defined..."
- "A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier."
- "A method of treating cancer, comprising administering an effective amount of the compound of claim 1 to a patient in need."
These claims aim to maximize scope by covering both the chemical entity and its therapeutic application.
2. Dependent Claims
Dependent claims elaborate on specific embodiments, such as:
- Pharmacokinetic enhancements.
- Specific substituent combinations.
- Synthesis methods.
They narrow scope but strengthen patent defensibility by covering various embodiments.
3. Claim Strategy
The patent employs a comprehensive claim strategy combining:
- Broad composition claims to cover general classes.
- Narrower, specific compound claims for high-value entities.
- Method claims for treatment and synthesis, creating multiple layers of protection.
This multi-layered approach enhances enforceability and lifecycle opportunities.
Patent Landscape Context
1. Similar Patents in China
The Chinese patent landscape for anticancer compounds is highly active, with numerous filings by domestic and international entities. Key players include:
- Chinese biotech firms focusing on kinase inhibitors, immunotherapies.
- Multinational pharmaceutical companies expanding patent portfolios in China.
CN104039358 likely faces competitors’ patents around similar chemical scaffolds or therapeutic indications, necessitating careful freedom-to-operate (FTO) analysis.
2. International Patent Considerations
The inventive compound may be claimed in other jurisdictions via PCT applications or national filings, affecting cross-market patent strategy. The China patent’s strategic value hinges on:
- Its scope relative to international counterparts.
- Corresponding patent families.
- Regional patenting strategies to block or license innovations.
3. Patent Term and Extension Opportunities
Given its filing date, the patent duration extends to around 2032, providing a window for commercialization and licensing. Patent term extensions in China are limited, but supplementary protection certificates are not available for drugs.
Legal and Strategic Implications
1. Strength of Patent Rights
- The breadth of compound claims relies on the specificity of the chemical structure.
- The narrower, specific claims are more easily defensible but offer limited coverage.
- The inclusion of method claims can defend against challenges based on prior art.
2. Infringement Risks
- Competitors designing around the specific structural claims can avoid infringement.
- Careful analysis of the claims’ scope relative to competing compounds is vital for enforcement.
3. Licensing and Commercialization
- The patent provides leverage for licensing negotiations with generic manufacturers.
- It forms a defensible basis for extending market exclusivity through new formulation or combination claims.
Conclusion
CN104039358 exemplifies a typical Chinese oncology patent, combining structural, formulation, and therapeutic claims to safeguard a novel anticancer agent. Its scope is sufficiently broad to cover multiple embodiments but relies heavily on the specific chemical structure disclosed. Understanding its landscape context enables stakeholders to develop robust patent strategies, carefully navigating potential overlaps with existing patents, and optimizing market positioning in China.
Key Takeaways
- Composite Claim Strategy: The patent’s strength derives from a mix of composition, formulation, and method claims, extending its protective scope.
- Structural Specificity: Its claims focus on particular chemical scaffolds, requiring detailed analysis when assessing infringement or freedom to operate.
- Patent Landscape Awareness: The active Chinese biotech sector demands vigilant monitoring of similar patents, particularly around key therapeutic targets.
- Lifecycle Planning: With a patent life extending beyond 2032, strategic licensing, research, and extension plans are feasible within its term.
- Market Implications: The patent provides valuable leverage in China’s pharmaceutical market, especially amid the national focus on innovative cancer therapies.
FAQs
Q1. How does the scope of CN104039358 compare to international anticancer patents?
While similar in claiming specific chemical structures and therapeutic uses, international patents often vary in structural breadth. CN104039358’s scope is tailored to Chinese patent law and may be narrower or broader depending on the claim language. Cross-jurisdictional comparison is essential for global patent strategies.
Q2. Can competitors design around the chemical structure claims?
Yes, if they develop compounds with sufficiently different structures that do not infringe on the specific claims, they may avoid infringement. However, if the patent includes broad Markush or genus claims, designing around it becomes more challenging.
Q3. What is the importance of method of use claims in this patent?
Method claims offer strategic protection for specific therapeutic applications, often easier to enforce for patent infringement, especially when compound claims are invalidated or challenged.
Q4. Does the patent cover formulations and delivery systems?
Yes, the patent extends to pharmaceutical compositions, which may include specific formulations and delivery methods, enhancing commercial and legal protection.
Q5. How should patent holders defend against invalidation challenges?
By demonstrating novelty, inventive step, and non-obviousness through comprehensive structural disclosures, experimental data, and detailed claims, patent holders can strengthen defenses against validity challenges.
References
[1] Official Chinese Patent Database, CN104039358 Patent Document.
[2] Chinese Patent Law, 2009 Amendment.
[3] WIPO PatentScope, Patent Families and International Applications.
[4] Prior Art and Patent Landscaping Reports on Oncology Drugs in China.
