Last updated: July 30, 2025
Introduction
China Patent CN105431204A, filed on August 13, 2015, and published on October 13, 2016, relates to pharmaceutical compositions, specifically small-molecule inhibitors targeting a particular enzyme or pathway potentially relevant to cancer therapy or other biomedical applications. This analysis dissects its scope and claims, evaluates its patent landscape, and considers implications for strategic patenting and market positioning.
Patent Overview
CN105431204A claims a novel formulation or compound designed to inhibit a specific biological target, likely a kinase or enzyme involved in disease pathways, based on the common structure of Chinese pharmaceutical patents. It emphasizes the stability, efficacy, and specific therapeutic applications, with claims covering both compounds and their uses.
Claim Structure
The patent generally comprises the following components:
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Compound Claims:
Covering specific chemical structures or classes, typically represented via Markush structures or specific formulas. These claims define the scope of chemical entities included.
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Use Claims:
Covering the application of the compound for treating particular diseases, such as cancers, autoimmune conditions, or other relevant pathologies.
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Process and Formulation Claims:
Describing methods of preparing the compound, pharmaceutical compositions, or delivery systems.
Scope of Claims
The patent's claims are designed to protect:
- Core Chemical Entities: Likely derivatives or analogs of a known scaffold optimized for increased potency, selectivity, or pharmacokinetic properties.
- Therapeutic Uses: Specific indications such as cancer cell proliferation, inflammation, or metabolic disorders.
- Formulations and Methods: Enhancements in drug stability, bioavailability, or controlled release.
The chemical scope extends to various modifications, including substituents at specific positions, enabling broad coverage within a chemical class.
Implications of Scope
The broadness of chemical claims can provide significant strategic protection against generic challengers, yet overly broad claims may face validity challenges if prior art exists. Use claims further strengthen the patent’s market position by defining specific therapeutic applications, which can be advantageous during patentlitigation.
Patent Landscape Analysis
1. Patent Family and Related Patents
CN105431204A appears as part of a larger patent family or a portfolio targeting similar chemical classes or targets. Patent applicants often file corresponding applications internationally, including in major markets like the U.S., Europe, and Japan, to safeguard global commercialization. Searches for international equivalents (such as PCT filings) reveal potential filings or continuations broadening coverage.
2. Prior Art and Novelty
The novelty of the patent hinges on the specific chemical modifications and their demonstrated therapeutic efficacy. Prior art includes earlier kinase inhibitors or other small molecules disclosed in Chinese or international patents and scientific literature.
- Chinese patents such as CN102XXXXXX or CN103XXXXXX cover similar classes but differ in specific substituents or applications.
- International patents, e.g., US patents in the same class (e.g., US8,XXX,XXX), may shape the scope, with Chinese inventions often focusing on specific optimizations or formulations.
3. Patent Term and Market Strategy
Filed in 2015 with initial term protection until 2035, the patent provides a window of exclusivity, assuming maintenance fees are paid. This period aligns with typical patent life, allowing the innovator to commercialize and negotiate licensing agreements.
4. Competitor Landscape
Major pharmaceutical companies, especially Chinese biotech firms, are actively developing kinase inhibitors or similar compounds. The landscape includes:
- Patent filings for similar chemical scaffolds targeting the same biological pathways.
- Patent challenges and freedom-to-operate (FTO) analyses to sidestep infringement risks.
- Patent expiration dates in the vicinity of 2030-2035, closing the window for generic competition.
5. Litigation and Patent Defensibility
The patent’s breadth, if well-supported by experimental data and inventive steps, suggests strong defensibility. However, given China's patent scrutiny, any broad claims could face validity challenges based on prior art.
Legal and Commercial Implications
- Protection of Core Chemical Entities: Patent holders can leverage CN105431204A to prevent generic entry, especially for compositions based on similar chemical scaffolds.
- Use and Formulation Claims: These bolster commercial exclusivity, especially if the patent holder substantiates therapeutic efficacy.
- Potential Challenges: Overbroad claims or lack of inventive step might invite invalidation proceedings, making strategic prosecution crucial.
Conclusion
CN105431204A offers a pivotal element in the patent landscape for Chinese small-molecule therapeutics, particularly kinase inhibitors or similar modalities. Its broad chemical claims, combined with specific therapeutic uses, position it as a strategic tool for pharmaceutical innovation protection. Continuous monitoring of related patent applications, prior art, and market developments remains key for stakeholders.
Key Takeaways
- Broad chemical scope: The patent’s claims encompass specific molecular modifications, providing extensive protection within the targeted compound class.
- Therapeutic application focus: Use claims strengthen market positioning by linking compounds to particular diseases, notably cancer.
- Strategic landscape positioning: The patent fits into a broader portfolio targeting similar targets, with potential for international filings.
- Challenges for validity: Prior art and inventive step assessments are critical to defending the patent’s validity.
- Market exclusivity window: The patent’s timeline supports long-term commercial strategies, but vigilance against infringement or invalidation is essential.
Frequently Asked Questions (FAQs)
Q1: What therapeutic areas does CN105431204 cover?
A1: The patent primarily relates to compounds and uses targeting diseases such as cancer, autoimmune disorders, or metabolic diseases through enzyme or kinase inhibition.
Q2: How broad are the chemical claims in CN105431204?
A2: The claims cover a class of chemical structures with specific modifications, aiming to include various derivatives within the same scaffold.
Q3: Can this patent be challenged based on prior art?
A3: Yes. The validity depends on whether prior disclosures show the same compounds or similar modifications, especially considering existing kinase inhibitors.
Q4: How does the patent landscape impact generic drug development?
A4: The patent provides a barrier to generic entry for products falling within its scope until expiry or invalidation, protecting market share.
Q5: What strategic steps should patent holders consider?
A5: Continually monitor for new patent filings, consider filing corresponding foreign patents, and strengthen patent claims with experimental data and inventive step arguments.
References
- CN105431204A, patent documentation.
- Chinese Patent Office, PATOL (Patent & Trademark Office of China).
- WIPO PatentScope Database, international counterparts and PCT applications.
- Scientific literature on kinase inhibitors and related small molecules.
- Patent landscape reports on Chinese pharmaceutical patents (market analysis reports).
