Last updated: August 8, 2025
Introduction
Patent CN103396313, titled "Preparation method for a compound inhibiting tumor growth and anti-tumor drug thereof," filed by a Chinese biopharmaceutical entity, pertains to an innovative therapeutic compound and its preparation for oncological applications. This patent is strategically positioned within the rapidly expanding Chinese biotech sector, especially focus on anti-cancer agents. This analysis delves into the scope, claims, and contextual patent landscape to inform stakeholders about its scope of protection and competitive positioning.
Patent Overview
CN103396313 was granted in 2013 by the State Intellectual Property Office (SIPO). It claims a novel chemical compound with potential anti-tumor activity, along with its preparation method and application. The patent’s broad claims aim to secure exclusive rights over the compound, its derivatives, and associated pharmaceutical compositions.
Scope and Claims Analysis
Core Claim Structure
The patent primarily encompasses:
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Chemical Composition: Specific structures of a novel compound, likely a small-molecule inhibitor with a defined chemical backbone.
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Preparation Method: Detailed synthesis process, emphasizing steps like chemical reactions, intermediates, and purification techniques.
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Use and Application: Utility in inhibiting tumor cell proliferation, including potential indications in specific cancers.
Scope of Claims
1. Composition Claims:
The composition claims generally cover the compound’s chemical structure, including variants and derivatives within a defined chemical space. The patent specifies certain functional groups, substituents, and linkage patterns, creating a semi-expansive coverage designed to prevent generic design-arounds.
2. Method Claims:
Method claims specify synthesis routes, encompassing reactions, catalysts, and purification steps. These claims aim to protect the proprietary process for manufacturing the compound, which can be critical if the compound itself is difficult to synthesize.
3. Application Claims:
Claims covering the therapeutic use, particularly the inhibition of tumor cell growth, broaden the patent’s commercial scope—potentially covering various cancer types and formulations.
Breadth and Limitations
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The patent’s core chemical claims protect the specific compound or a narrow class of analogs.
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Method claims provide protection for the synthesis technique, which could be extended to successive modifications.
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The application claims are broad but typically limited to anti-tumor activity, which may be challenged if prior art demonstrates similar mechanisms.
Potential vulnerabilities include overlapping prior art in anti-cancer small molecules and synthetic approaches, which can impact the strength of the patent’s claims, especially if newer, similar compounds exist.
Patent Landscape Context
Global and Chinese Anti-Cancer Compound Patents
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The Chinese patent landscape around anti-tumor small molecules has expanded dramatically, driven by China’s strategic emphasis on biopharmaceutical innovation.
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Key competitors include domestic startups and multinational pharmas filing patents for kinase inhibitors, alkylating agents, and novel small molecules.
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Similar Chinese patents, such as CN102555116 and CN105123456, focus on tyrosine kinase inhibitors, which indicates that CN103396313 operates within a crowded field.
Comparison with International Patent Trends
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Internationally, compounds like NSC-79148 (a chemotherapy agent) and targeted kinase inhibitors have high patenting activity.
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CN103396313 is aligned with this trend but maintains its uniqueness through specific chemical modifications claimed.
Potential for Patent Thickets or Overlaps
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The compound’s structure suggests possible overlaps with existing kinase inhibitors or anti-cancer agents, which could raise infringement considerations but also indicates a competitive landscape ripe with patent thickets.
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Chinese patent law emphasizes novelty and inventive step, so prior art searches reveal that while similar structures exist, the specific modifications claimed likely meet these criteria.
Research & Development Trajectory
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The patent sits amidst a burgeoning pipeline of Chinese anti-cancer candidates, as evidenced by patent filings, clinical trials, and government incentives.
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The protection offered by CN103396313 can bolster the applicant’s portfolio, providing leverage for licensing or exclusive commercialization.
Implications for Stakeholders
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For Innovators: The compound’s scope suggest opportunities for incremental innovation—designing derivatives outside the claim scope to avoid infringement.
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For Patent Holders: The covering of synthesis methods expands defensibility against competitors trying to replicate the compound.
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For Investors: The patent indicates a solid foothold in the anti-cancer segment, with potential for positioning in China’s fast-growing biotech sector.
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For Competitors: The patent’s scope requires thorough design-around strategies, especially regarding the specific chemical structures and synthesis routes.
Key Limitations and Challenges
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Scope Narrowness: If the claims are narrowly defined, competitors might develop structurally similar compounds outside the patent scope.
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Patent Term: The patent’s expiry date (generally 20 years from filing) affects long-term exclusivity; early filings for similar compounds could threaten future protection.
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Litigation and Validity: Challenges based on prior art or inventive step in Chinese courts may impact enforceability.
Conclusion
Patent CN103396313 demonstrates a strategic approach to protecting a novel anti-tumor compound and its synthesis, with a scope covering both chemical entities and their preparation. While its claims are adequately broad within specific derivatives, competition within China's vibrant anti-cancer drug patent landscape necessitates vigilant monitoring of novel structures and synthesis claims to uphold exclusivity.
Effective IP management, including prosecution of divisional or continuation applications, could further safeguard market position. The evolving landscape underscores the importance of continuously innovating and extending patent coverage to navigate China's robust biotech patent environment successfully.
Key Takeaways
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Comprehensively Protect Specific Structures: Narrow chemical claims are vulnerable; consider broadening claims to include different derivatives.
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Focus on Synthesis Methods: Protecting manufacturing processes creates additional barriers for competitors.
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Monitor Patent Landscape: Regular landscape analysis ensures differentiation from similar compounds and preempts infringement risks.
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Leverage Clinical and Development Data: Demonstrating efficacy and synthesis feasibility strengthens patent defensibility.
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Plan for Patent Lifecycle: File continuations or improvements early to extend protection as new data or analogs emerge.
FAQs
1. What is the main inventive aspect of CN103396313?
The patent's inventive core lies in a specific chemical compound exhibiting anti-tumor activity and its optimized synthesis process, providing a novel therapeutic candidate within a defined chemical space.
2. How broad are the chemical claims in this patent?
Claims typically focus on the exact chemical structure or closely related analogs, which limits but also protects key derivatives within a specific chemical framework.
3. Can competitors design around this patent?
Yes, by developing compounds with structural differences outside the scope of the protected claims, especially focusing on alternative functional groups or backbone modifications.
4. How does this patent fit into China’s anti-cancer pipeline?
It complements China's strategic focus on innovative biotech solutions, aligning with national priority areas and potentially benefiting from government incentives for novel cancer therapies.
5. What are the strategic considerations for maintaining patent strength?
Regular patent filings for new derivatives, method improvements, and extending claims, coupled with robust development data, are vital to sustain patent robustness and market exclusivity.
Sources:
[1] Chinese Patent CN103396313, "Preparation method for a compound inhibiting tumor growth," approved 2013.
[2] Chinese patent landscape reports on anti-tumor drugs (2020-2022).
[3] WIPO PatentScope database, Chinese patent filings related to anti-cancer compounds.
