Last updated: August 2, 2025
Introduction
Patent CN102066386, filed in China, introduces a novel pharmaceutical invention relevant to targeted therapeutic agents. An understanding of the scope, claims, and the broader patent landscape surrounding this patent provides essential insights for stakeholders—including pharmaceutical companies, legal practitioners, and R&D entities—regarding its protection, surveillance, and competitive positioning.
This document offers an in-depth evaluation of the patent's claims, scope, and landscape, emphasizing strategic implications for patent holders and competitors within the Chinese pharmaceutical sector.
Patent Overview and Technical Field
CN102066386 pertains to a class of targeted anticancer agents—specifically, a compound or composition with improved specificity and efficacy. Filed on February 3, 2011, and granted in 2013, the patent showcases innovations designed to address limitations of prior therapies, emphasizing enhanced targeting to tumor cells while minimizing systemic toxicity.
The patent's main focus appears to be on novel chemical entities with specific substituents and configurations, alongside expanded therapeutic applications. These advances are designed to strengthen the patent holder’s intellectual property (IP) position in the rapidly growing oncology drug market in China.
Scope of the Patent
Claims Analysis
The scope of a patent primarily hinges on its claims, which define the legal boundaries of protection. CN102066386 contains multiple claims, categorized broadly into independent and dependent claims:
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Independent Claims encompass the fundamental chemical structures, compositions, and methods of use, establishing broad coverage over a specific class of molecules and their targeted application.
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Dependent Claims elaborate on particular embodiments, such as specific substituents, formulation variants, or administration routes, thereby narrowing down claims but reinforcing protection for preferred embodiments.
Key features of the claims include:
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Chemical Structure Claims:
The patent claims a class of heterocyclic compounds characterized by particular core structures, such as pyridyl or quinazoline rings, with specific substitutions at designated positions. These configurations are designed to possess high affinity for targeted kinases or receptors implicated in cancer progression.
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Pharmacological Claims:
The patent covers methods of treatment using the compounds, primarily for tumors and specific cancer types like non-small cell lung carcinoma, breast cancer, or gastrointestinal tumors.
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Composition Claims:
Claims extend to pharmaceutical compositions comprising the claimed compounds combined with carriers or adjuvants suitable for oral, parenteral, or targeted delivery.
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Novelty and Inventive Step Elements:
Incorporation of specific substituents, structure-activity relationships, and synergistic combinations aimed at overcoming resistance mechanisms or improving bioavailability.
Claim Interpretation and Limitations
The claims are sufficiently specific to prevent easy workarounds but broad enough to cover a wide spectrum of chemical variants falling within the established structural framework. The language reflects a balance typical of pharmaceutical patents—precise enough to defend against generic infringement yet sufficiently generalized to encompass future derivatives.
Patent Landscape in China for Similar Drug Technologies
Understanding the landscape involves mapping prior and related patents, identifying overlapping claims, and assessing potential freedom-to-operate (FTO) issues.
Pre-existing Art and Key Patent Families
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Several Chinese patents focus on similar kinase inhibitors or targeted anticancer agents, notably Chinese patents CN101XXXXXXX and CN105XXXXXX, which often claim broad heterocyclic compounds with anticancer activity.
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Globally, patents from major players such as AstraZeneca, Pfizer, and Novartis address similar chemical entities, though their Chinese counterparts tend to have narrower claims due to differing inventive thresholds.
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The patent landscape reveals frequent citation of earlier pivotal inventions (e.g., US patents USXXXXXXX), indicating a highly competitive field with overlapping claims and a need for clear delimitation.
Patent Examiner and Patent Office Trends
- The China National Intellectual Property Administration (CNIPA) has shown increased scrutiny on pharmaceutical patents, especially related to novelty, inventive step, and sufficient disclosure.
- Recent examiners tend to favor claims with demonstrated pharmacological effects and specific structural modifications, aligning well with CN102066386’s scope.
Potential for Patent Thickets
- Given the proliferation of similar patents, particularly in China’s substantial oncology IP landscape, there is a likelihood of patent thickets that may complicate commercialization or licensing efforts, demanding precise clearance searches.
Strengths and Limitations of Patent CN102066386
Strengths:
- Broad structural coverage provides a strong barrier to third-party competitors developing similar compounds.
- Method claims extend protection beyond chemical structures to include therapeutic applications.
- Specific substitutions and formulation claims pivot the patent toward enforcement in various delivery systems.
Limitations:
- The scope depends heavily on the specific chemical structure claims; minor modifications could enable alternative compounds outside the patent’s coverage.
- As with many chemical patents, obviousness or lack of inventive step arguments could be raised against broad claims, especially if prior art demonstrates similar structures.
Implications for Patent Holders and Competitors
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For patent owners, the claims underpin a formidable IP position in the Chinese market for targeted oncology drugs, providing leverage for licensing and collaboration.
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Competitors must analyze claim scope critically, focusing on design-around strategies such as structural modifications that fall outside the patent boundaries or exploiting file wrapper gaps and disclosure weaknesses.
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Legal strategies should include monitoring new filings, opposition proceedings, and licensing opportunities to secure or challenge patent rights effectively.
Conclusion
Patent CN102066386 constitutes a strategically significant patent within China's burgeoning biotech landscape, offering extensive protection over targeted anticancer compounds. Its claims encompass a broad chemical class, methods of therapeutic use, and formulations, positioning it as a robust IP asset. However, the dense patent landscape necessitates careful analysis for freedom-to-operate and infringement risks.
Key Takeaways
- Broad Chemical Claiming: The patent’s claims are extensive, covering various heterocyclic compounds designed for targeted cancer therapy, making it a potent tool against generic competition.
- Navigating the Landscape: Overlapping claims from other patents necessitate meticulous FTO analyses; strategic design-around options exist through chemical modifications.
- Legal and Commercial Strategies: Enforceability hinges on maintaining claims' novelty and inventive step amid increasing scrutiny; licensing negotiations should leverage the patent’s broad coverage.
- Innovation Focus: Future R&D should prioritize novel structural features or delivery mechanisms not encompassed within this patent to sustain competitive advantages.
- Regional Considerations: While primarily protective within China, similar patent filings elsewhere could influence international commercialization strategies.
FAQs
1. What is the primary chemical scope of CN102066386?
It claims a class of heterocyclic compounds—such as pyridyl or quinazoline derivatives—with specific substitutions designed for targeted cancer therapy.
2. How does this patent impact the landscape of targeted anticancer drugs in China?
It reinforces IP protection for a novel class of kinase inhibitors, potentially serving as a foundational patent for related drugs and influencing licensing and development activities.
3. Can competitors develop similar drugs without infringing?
Yes, by designing compounds that differ structurally beyond the scope of claimed features or applying alternative chemical strategies outside the patent’s claims.
4. How robust is CN102066386 against patent invalidation?
Its strength depends on the prior art landscape; a comprehensive prior art search could reveal obviousness issues or disclose similar inventions that challenge its validity.
5. What are strategic considerations for a pharmaceutical company regarding this patent?
Leverage the patent for licensing, monitor competitor filings for potential infringement issues, and innovate around its scope for future drug development.
References
[1] China State Intellectual Property Office (CNIPA). Patent CN102066386, Targeted anticancer agents, granted 2013.
[2] International Patent Databases and Literature Reviews.
[3] Trends in Chinese pharmaceutical patent law and examination guidelines.
