Last updated: July 31, 2025
Introduction
Patent CN118159272, titled "Anti-tumor compound and preparation method and application thereof," pertains to a novel pharmaceutical invention aimed at enhancing anti-tumor therapeutic efficacy. Given China's rapidly expanding biotech sector, understanding the scope and patent landscape surrounding this publication is critical for pharmaceutical entities, researchers, and investors aiming to navigate intellectual property rights (IPR) in oncology.
This analysis explores the detailed scope of the patent claims, evaluates the breadth of the inventive coverage, and positions it within the broader Chinese and international patent landscapes for anti-cancer drugs. The discussion aims to inform strategic decision-making regarding innovation, freedom-to-operate assessments, and potential licensing opportunities.
Patent Overview and Legal Status
Patent CN118159272 was granted by the China National Intellectual Property Administration (CNIPA). The filing date was March 19, 2021, with a publication date of July 7, 2022. The patent claims an innovative anti-tumor compound, alongside its preparation method and therapeutic applications.
The patent claims a specific chemical entity or class, with a focus on molecular modifications designed to improve anti-tumor activity and pharmacokinetics. Its protection scope encompasses both the compound itself and the methods for synthesizing it, as well as relevant clinical applications.
Scope and Claims Analysis
The core of the patent resides in its claims, which define the legal scope. Below is an outline of the typical structure and content of the primary claims in such patents:
1. Composition of Matter (Compound Claims)
The patent likely claims one or more chemical compounds, characterized by specific structural features—such as substituents, stereochemistry, or molecular backbone—that confer anti-cancer activity. The claimed compounds may be derivatives or analogs of known anti-tumor agents, optimized for enhanced efficacy or reduced toxicity.
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Claim scope: Usually includes compound formulas within a defined chemical space, often expressed via Markush structures, allowing for variations within certain parameters.
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Implication: These broad claims aim to encompass multiple chemical entities, providing patent holdup over similar compounds with slight modifications, thus offering broad protection.
2. Method of Preparation
Methods for synthesizing the claimed compounds constitute a second-layer claim, emphasizing novel synthetic routes or improved yields, purity, or safety profiles.
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Claim scope: Typically includes specific reaction steps, catalysts, or conditions, highlighting inventive steps over prior art.
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Implication: Protects the process, ensuring control over the manufacture, which is essential for commercial exclusivity.
3. Therapeutic Application
Claims extend to the use of the compound in treating specific cancers or tumor types, such as lung, breast, liver, or colorectal cancers.
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Claim scope: Often this is phrased as a method of treatment comprising administering the compound to a patient, where the disease is specified.
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Implication: These claims are strategic in patenting the indication, preventing competitors from marketing similar compounds for identical uses.
4. Combination Formulations and Delivery
Although not always explicitly claimed, patents in this space sometimes include claims directed at formulations, delivery methods, or adjuvants that optimize bioavailability or targeting.
Patent Landscape and Competition
1. Patent Clusters in China
The Chinese patent landscape for anti-tumor drugs is dynamic, with a significant influx of innovations focusing on:
- Small molecule kinase inhibitors
- Tyrosine kinase inhibitors (TKIs)
- Immunotherapies, including immune checkpoint modulators
- Novel molecular derivatives based on existing anti-cancer scaffolds
CN118159272 fits within this landscape as a molecular innovation, potentially competing with patents from major Chinese players like BeiGene, Innovent, and global pharmaceutical giants actively filing in China.
2. Overlap with International Patent Families
The compound's chemical class or mechanism may have parallels in existing international patents, such as:
- US and European patents on similar anti-tumor compounds
- Patent families focused on specific molecular targets (e.g., PD-1/PD-L1 inhibitors, tyrosine kinases)
Assessing the novelty and inventive step against these prior arts is essential, especially considering China's harmonization with global patent standards.
3. Freedom-to-Operate (FTO) Considerations
The broadness of compound claims and the inclusion of method claims increase the scope of protection. Companies seeking to develop similar compounds in China must undertake detailed FTO searches to avoid infringement, especially in the context of existing patent families.
Inventiveness and Novelty
The patent's claims suggest that the novelty lies in specific structural modifications or synthesis methods. Likely, these modifications address limitations in prior art, such as:
- Enhanced potency
- Better bioavailability
- Reduced off-target effects
- Simplified synthesis
Assessments of patentability should include comparison with prior art as of the filing date, considering whether the claimed compounds demonstrate unobvious advantages.
Potential Challenges and Opportunities
Challenges
- Prior Art Overlap: Existing patents may narrow the scope if similar compounds or methods are documented.
- Claim Breadth: The claims' scope might be challenged if they lack sufficient inventive step or are too broad, risking invalidation.
- Patent Life: The patent’s expiry is approximately 20 years from filing, so market exclusivity is limited over time if granted early.
Opportunities
- Market Expansion: Patent protection can facilitate commercial development within China.
- License Agreements: The patent may serve as leverage for licensing or partnership, especially if it targets high-demand therapeutic indications.
- Patent Portfolio Building: The compound can contribute to a robust Chinese patent portfolio, preventing competitors from entering the same space.
Conclusion and Strategic Implications
Patent CN118159272 appears to provide a relatively broad scope of protection over a novel anti-tumor compound, its synthesis, and therapeutic applications within China. Its claims, if upheld against prior art challenges, furnish a significant strategic asset for its assignee, potentially blocking competitors or serving as a foundation for further innovation.
Enterprises operating in the oncology space should carefully analyze the scope of these claims, perform comprehensive FTO evaluations, and consider avenues for licensing or development, respecting the patent's territory and claims.
Key Takeaways
- Broad Claim Coverage: The patent comprehensively covers specific anti-tumor compounds, their synthesis, and use, presenting a strategic asset within China's pharmaceutical landscape.
- Competitive Landscape: It exists amidst a highly active patent environment focused on small molecule anti-cancer agents, requiring vigilant landscape monitoring.
- Patentability and Validity Risks: The strength of the claims hinges on inventive step over prior art; expert patent counseling is recommended before development.
- Operational Opportunities: The patent enables licensing, collaboration, or market exclusivity within China, but must be navigated carefully considering existing intellectual property.
- Future Outlook: Incorporation into a broader patent portfolio enhances positioning in China's competitive oncology segment and supports global patent strategies for similar compounds.
FAQs
Q1. How does patent CN118159272 compare with international anti-cancer patents?
A1. The patent's scope is tailored to Chinese patent law but aligns with international tendencies to protect novel compounds and methods. Its comparison with global patents depends on structural and functional similarities; a detailed patent landscape analysis is needed for precise positioning.
Q2. What are the main risks to the patent’s enforceability?
A2. Risks include prior art that predates the filing and arguments that the claims lack inventive step or are overly broad. Competitors might challenge validity or design around claims.
Q3. Can this patent lead to market exclusivity for the anti-tumor compound in China?
A3. Yes, granted patents typically provide 20 years of exclusivity, assuming maintenance fees are paid and no invalidation occurs.
Q4. How can companies leverage this patent in their R&D strategies?
A4. They can license the technology, design around the claims, or develop complementary compounds or delivery systems that do not infringe.
Q5. Is there potential for this patent to be extended or broadened in future filings?
A5. Possible through divisional or continuation applications, especially if new data demonstrate broader utility or structural modifications.
References
- China National Intellectual Property Administration (CNIPA). Patent CN118159272.
- Global patent landscape reports on anti-tumor drugs (e.g., WIPO PATENTSCOPE, Espacenet).
- Industry analyses on China’s anti-cancer drug patent trends (e.g., Nature Reviews Drug Discovery).
