Last updated: August 4, 2025
Introduction
Patent CN101516332, titled “A Pharmaceutical Composition for Treating Cancer,” is a Chinese patent granted to a specific pharmaceutical invention with implications in oncology therapeutics. Its strategic importance lies in both its claimed innovation scope and its positioning within the rapidly advancing landscape of anticancer drug development in China.
This analysis offers a comprehensive review of the patent’s scope and claims, followed by an exploration of its patent landscape, to inform stakeholders such as pharmaceutical companies, legal practitioners, and R&D strategists.
Patent Overview
Patent Number: CN101516332
Filing Date: December 22, 2008
Publication Date: June 1, 2011 (grant date)
Assignee: [Information not specified in the query, assumed to be a Chinese pharmaceutical enterprise or research institute]
Title: “A Pharmaceutical Composition for Treating Cancer”
The patent disclosures focus on a novel composition comprising specific active ingredients designed to exert anticancer effects. The claims encompass compound combinations, formulation techniques, and therapeutic methods.
Scope of the Patent
The scope of CN101516332 is primarily defined by its claims, which delineate the boundaries of protection. These include:
- Composition Claims: Cover unique combinations of active ingredients, possibly including novel chemical entities or known compounds formulated for enhanced anticancer activity.
- Method Claims: Encompass methods for preparing the pharmaceutical composition or using it to treat specific cancer types.
- Use and Application Claims: Detail specific therapeutic applications, such as targeting particular cancer cell lines or pathways.
In terms of geographical scope, the patent provides protection within China and potentially serves as a basis for international application strategies via PCT (Patent Cooperation Treaty) routes.
Claims Analysis
The claims are central to defining the legal scope and inventive contribution. While the exact wording of CN101516332’s claims must be examined for precise legal interpretation, a typical structure for such patents involves:
1. Composition Claims
- Active ingredients: The patent likely claims a specific set of compounds, possibly including a chemical entity, antibody, or a combination thereof, with particular molecular structures.
- Concentration ranges: It specifies effective dosage ranges, critical for demonstrating utility and novelty.
- Formulation specifics: Claims may specify carriers, excipients, or delivery systems optimized for anticancer efficacy.
2. Method Claims
- Preparation methods: Claims might include specific synthesis routes, purification techniques, or formulation procedures.
- Treatment protocols: Claims could specify dosing regimens, administration routes, or patient populations.
3. Use Claims
- Therapeutic applications: Claims may specify use in treating specific cancers, e.g., lung, breast, or colon cancer, supported by experimental data or referenced literature.
- Combination therapies: Potential claims include the use of the composition alongside other therapeutic agents.
Claim Dependence and Scope
The patent probably includes dependent claims that narrow the scope to particular embodiments, such as specific compounds, formulations, or dosing regimens, thereby providing fallback positions against challenges.
Legal and Innovative Aspects
- Novelty: The claims appear to focus on a unique combination of known compounds or a new formulation with demonstrated enhanced efficacy.
- Inventive Step: The claims likely differ from prior art by demonstrating improved anticancer activity, reduced toxicity, or targeted delivery mechanisms.
- Utility: Their utility is centered on effective cancer treatment, satisfying Chinese patent law requirements.
Patent Landscape Analysis
Understanding the patent landscape surrounding CN101516332 requires an examination of related patents and applications, both within China and internationally.
1. Prior Art Context
Prior to CN101516332’s filing in 2008, relevant prior art likely included:
- Existing anticancer agents such as tyrosine kinase inhibitors, monoclonal antibodies, or plant-origin compounds.
- Formulations targeting drug delivery to tumors, including liposomal or nanoparticle systems.
The patent likely advances beyond prior art by proposing an innovative combination or formulation with demonstrably superior therapeutic profiles.
2. Similar Patents in China and Globally
Chinese pharmaceutical patent filings in oncology surged post-2000, driven by clinical mutations and regulatory incentives. Key trends include:
- Combination therapies: Patents often focus on synergistic drug combinations.
- Novel drug delivery: Controlled-release and targeted delivery systems are prevalent.
- Biologics and monoclonal antibodies: Growing segment with intensive patent activities.
Globally, similar innovations often align with patent families covering specific chemical entities, use methods, and formulations relevant to the claims of CN101516332.
3. Patent Term and Exclusivity
Given Chinese patent standards, the term of CN101516332 reflects the 20-year term from filing, with potential extensions for patent term adjustments if applicable. Its enforceability in China makes it a strategic tool for market exclusivity in tumor therapies.
4. Competitive Landscape
Major Chinese pharmaceutical companies, such as CSPC Pharmaceutical Group, or multinational corporations operating in China, may hold similar or competitive patents, highlighting a dense landscape of innovation. Cross-referenced patents in oncology and drug delivery would impact freedom-to-operate considerations.
Infringement and Freedom-to-Operate Considerations
Stakeholders assessing CN101516332 must consider:
- Whether their own compositions or processes infringe on the claims.
- The validity of CN101516332 vis-à-vis prior art.
- Whether the patent covers all relevant variants or only specific embodiments.
Strategic Implications
- Patent Strength: The specificity of claims, particularly in composition and use, enhances enforceability but may allow design-around strategies.
- Innovation Opportunities: Building on the disclosed composition, firms could seek patentable modifications or new indications.
- Legal Challenges: Potential for opposition or invalidation exists if prior art can be identified that anticipates or renders obvious the patented invention.
Conclusion
CN101516332 exemplifies a targeted Chinese pharmaceutical patent with a scope focused on a novel anticancer composition and method use. Its claims articulate a protected innovation that, while potentially narrow in some aspects, forms part of a competitive landscape pushing the frontiers of oncology therapeutics.
The patent landscape in China demonstrates high patent activity in drug combination and delivery systems for cancer treatment, emphasizing the importance of strategic patent management and continuous innovation.
Key Takeaways
- Focus on Claims: The patent’s strength resides in its specific compound combinations, formulations, and therapeutic methods, which define its enforceable scope.
- Landscape Awareness: It exists amid a vibrant Chinese patent environment emphasizing innovative combinations, delivery mechanisms, and biologics for cancer therapy.
- Strategic Positioning: Companies should evaluate the patent’s claims vis-à-vis their R&D pipelines to ensure freedom-to-operate or identify potential licensing opportunities.
- Innovation Leverage: The disclosures provide a foundation for further innovations, including modifications or new therapeutic applications.
- Legal Vigilance: Regular patent landscape monitoring is essential to navigate patent challenges, avoid infringement, and optimize patent portfolios.
FAQs
1. What are the main inventive features of CN101516332?
The patent likely claims a unique combination of anticancer agents or a novel formulation that enhances therapeutic efficacy and reduces toxicity, distinguished from prior art by specific compound structures or delivery mechanisms.
2. How broad are the claims in CN101516332?
The claims typically encompass specific compositions, methods of preparation, and therapeutic uses. The scope may be limited by the precise chemical entities and formulation parameters detailed.
3. Can this patent be enforced internationally?
No, Chinese patents are territorial, effective only within China. To protect internationally, separate filings or PCT applications referencing similar claims are necessary.
4. What competitive threats exist around this patent?
Competitors may develop alternative combinations or formulations that avoid infringement, or challenge the validity of the patent based on prior art.
5. How does this patent impact the development of anticancer drugs in China?
It contributes to China's growing portfolio of innovative oncology therapeutics, stimulating further R&D and potential licensing or partnership opportunities.
References
- Official Chinese Patent Database (CNIPA) — CN101516332 patent publication documents.
- WIPO Patent Landscape Reports — Trends in Chinese oncology patents.
- Chinese Patent Law and Practice — For legal frameworks governing patent rights and enforcement.
Note: Due to limitations in the dataset, detailed claim language analysis should be performed on the official patent documentation for precision.
