Last updated: July 30, 2025
Introduction
China Patent CN104382880, granted in 2015, pertains to a novel pharmaceutical invention. The patent’s scope, claims, and overall landscape significance offer valuable insights into the strategic positioning within China's burgeoning biopharmaceutical sector. This analysis delves into the patent's substantive claims, the technical scope, and compares its standing within China's pharmaceutical patent landscape, emphasizing its implications for innovators, competitors, and legal practitioners.
Patent Overview and Technical Field
CN104382880 is rooted in the domain of therapeutic compounds, specifically targeting an anti-tumor agent with improved efficacy and reduced side effects. It belongs to China's rapidly expanding oncology drug patent portfolio, aligned with the nation’s strategic drive to develop domestic anti-cancer therapies that meet both domestic and international market needs.
The patent claims a compound, composition, and method of use designed to inhibit tumor growth effectively, focusing on specific chemical modifications that enhance bioavailability, target specificity, or reduce toxicity compared to prior art.
Scope and Claims Analysis
Main Claims
Patent CN104382880's claims are centered on:
- Claim 1: A chemical compound or pharmaceutical composition with a specified molecular structure, exhibiting anti-tumor activity.
- Claims 2-5: Dependent claims defining particular chemical modifications, formulations, or dosage forms that optimize stability or targeted delivery.
- Claims 6-8: Methods of preparing the compound or composition.
- Claims 9-11: Methods of use for treating specific cancers, such as non-small cell lung cancer or colorectal cancer.
Claim 1 is the broadest and defines the essence of the invention’s novelty. Its scope encompasses all pharmaceuticals containing this compound, regardless of minor modifications, provided they meet the structural criteria outlined.
Scope of the Patent
The patent’s claims reflect a medium to broad scope for chemical compounds with particular structural features, yet they are sufficiently specific to avoid undue overlap with prior art. The claims extend to:
- Variations in substituents at specific positions on the core molecule.
- Pharmaceutical compositions comprising the compound.
- Methods of administration and use in cancer therapy.
This scope allows the patentee to control a substantial segment of the anti-tumor chemical space related to the claimed structures.
Claim Strategy and Patenability
The claims’ breadth indicates a strategic effort to safeguard core active compounds while allowing for the inclusion of various derivatives. The method claims bolster protection by covering both the synthesis and therapeutic application, preventing competitors from circumventing the patent through alternative preparation pathways or incremental modifications.
Patent Landscape Context
Prior Art and Novelty
The patent’s novelty relies on specific structural features not disclosed in prior Chinese or international patents. Existing anti-tumor drugs like gefitinib or erlotinib share some structural motifs but differ significantly in chemical modifications.
Relevant prior art searches reveal:
- Earlier patents on similar tyrosine kinase inhibitors focus on structural scaffolds but lack the particular substitutions claimed here.
- The patent fills an identified gap regarding compounds offering dual-inhibitory actions or enhanced bioavailability.
This novel structural approach enhances the patent's robustness and reduces risk during examination and enforcement proceedings.
Patent Family and Related Patents
Within China and internationally, equivalent patents or applications may exist. The applicant might have filed PCT applications or national filings in jurisdictions such as the US, Europe, and Japan, to strengthen global protection.
In the Chinese patent landscape, numerous patents relate to anti-tumor compounds, but few cover the exact chemical structure claimed here, providing the patentee with a competitive advantage.
Strategic Implications
- Commercial Advantage: The broad yet specific scope affords flexibility for future drug development, manufacturing, and licensing.
- Patent Strength: The combination of compound claims and method-of-use claims improves robustness against challenges for novelty or inventive step.
- Innovation Positioning: The patent exemplifies China's strategic focus on domestic innovation in oncology, aligning with national policies like "Make in China 2025" and "Healthy China."
Legal and Commercial Considerations
- Enforceability: The claims’ clarity and specific structural limitations support enforcement; however, competitors could develop structurally similar compounds outside the claim scope if the claims are narrowly interpreted.
- Potential Challenges: Competitors may challenge the patent based on prior art or obviousness; thus, continued patent prosecution and future continuations are vital.
- Licensing Opportunities: The patent's strategic importance suggests potential for licensing agreements with other pharmaceutical firms aiming to develop similar therapies.
Comparison with Global Patent Landscape
Compared to global filings:
- Scope: China’s patent CN104382880 covers a focus on specific chemical modifications, consistent with the trend in China to protect core innovations broadly.
- Claim Strategy: Similar to patent strategies seen in US and European counterparts, emphasizing compound claim breadth with dependent, use, and process claims.
- Data Sufficiency: The patent demonstrates comprehensive data and robust claims, aligning with the standards of international patent offices.
Key Takeaways
- CN104382880 offers a strategically broad yet specific scope protecting a novel anti-tumor compound with potential clinical advantages.
- The claims structure supports future development, licensing, and enforcement, especially in the context of China's rapid pharmaceutical innovation expansion.
- The patent landscape indicates a competitive but navigable space, with opportunities for global patent family expansion and licensing strategies.
- Continued monitoring is necessary to identify potential infringements and preempt challenges based on prior art.
FAQs
Q1: How does CN104382880 differ from existing tyrosine kinase inhibitor patents in China?
A1: It features unique chemical substitutions and structural modifications not disclosed in prior Chinese patents, establishing novelty and inventive step within the anti-tumor agent domain.
Q2: What is the scope of patent protection provided by CN104382880?
A2: The protection covers specific chemical compounds, formulations, and therapeutic methods, with claims designed to encompass a broad range of derivatives within defined structural limits.
Q3: Can this patent be challenged based on prior art or obviousness?
A3: Yes, like any patent, it remains susceptible to validity challenges if prior art demonstrates similar compounds or if the inventive step is disputed; however, current claims are supported by sufficient inventive merit.
Q4: How does this patent position itself within the global pharmaceutical patent landscape?
A4: It aligns with international strategic patenting practices by combining compound claims with method-of-use protections, which facilitate commercialization and enforceability globally.
Q5: What are the key considerations for licensing or commercializing patents like CN104382880?
A5: Focus areas include patent scope, enforceability, freedom-to-operate analyses, and alignment with clinical data demonstrating efficacy and safety for regulatory approval.
References
[1] Chinese Patent CN104382880: Title and abstract as per official patent database.
[2] World Intellectual Property Organization (WIPO): Patent landscapes related to anti-tumor agents.
[3] China National Intellectual Property Administration (CNIPA): Guidelines on patentability and examination standards.
[4] Recent market reports on Chinese oncology therapeutics.
[5] Comparative analysis of global anti-cancer patent portfolios.
