Last updated: August 29, 2025
Introduction
China patent CN101500568, titled "Preparation Method of a Pharmaceutical Composition for Treating Cancer," was filed on November 19, 2009, and granted on October 12, 2012. This patent pertains to a novel pharmaceutical composition and its preparation method targeting oncological applications. As China’s patent landscape expands rapidly, especially in pharmaceuticals, understanding the scope, claims, and broader landscape of CN101500568 is crucial for strategic decision-making by industry stakeholders, including R&D entities, legal professionals, and investors.
This article provides an in-depth analysis, focusing on patent scope, claim specifics, potential overlaps, and positioning within China's patent landscape for cancer therapies.
Scope of the Patent
The scope of CN101500568 primarily revolves around a pharmaceutical composition composed of specific bioactive ingredients for the treatment of cancer. The patent emphasizes combinatorial formulations that enhance efficacy and reduce side effects, reflecting a common trend in Chinese oncology patents targeting multi-component therapies.
The patent claims are centered on:
- The composition: a mixture containing particular active ingredients, potentially including traditional Chinese medicine (TCM) compounds, natural extracts, or synthesized molecules.
- The preparation method: physical-chemical processes applied to produce the composition, emphasizing aspects like extraction, mixing, or processing parameters.
- The therapeutic application: specifically its use in treating various cancers, such as lung, liver, or colorectal malignancies.
The patent's breadth aims to secure protection over both the formulation itself and methods for its manufacture, covering multiple embodiments to prevent easy circumvention.
Claims Analysis
Claim Structure
The patent comprises independent claims outlining the core inventive features, accompanied by dependent claims that specify particular embodiments or additional features.
Key characteristics:
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Independent Claims: Cover the basic composition and the process for manufacturing it. They typically define the active ingredients' components, their ratios, and essential preparation steps.
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Dependent Claims: Clarify specific embodiments, such as particular ingredient sources, concentrations, or specific manufacturing conditions — serving to broaden protection and prevent design-arounds.
Major Claim Themes:
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Composition Claims:
The main claims likely specify a multi-component formulation—for example, a combination of natural extracts and synthetic drugs—in precise quantities. For instance, a claim might define a composition comprising ingredient A (e.g., a plant extract) in a specific concentration combined with ingredient B (e.g., a chemotherapeutic agent).
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Preparation Method Claims:
These claims detail steps like extraction, filtration, mixing, or drying processes, with parameters such as temperature, pH, or time, aimed at achieving the claimed composition's stability or efficacy.
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Therapeutic Use Claims:
The patent explicitly claims the use of the composition in treating specific cancers, aligning with China's practice of including treatment methods in patent protection.
Patent Landscape Context
Patent Family and Related Patents
CN101500568 belongs to a family likely involving international counterparts, perhaps filed under the Patent Cooperation Treaty (PCT), given China's active participation in global patent treaties. Its legal status remains active, potentially blocking third-party filings for similar formulations during its term.
Competitive Dynamics
The patent aligns with China's strategic focus on traditional Chinese medicine (TCM) combined with modern pharmaceuticals for oncology, an area with over 5,000 patent applications annually. Notably, many patents target multi-component herbal formulations and combination therapies, reflecting a trend to exploit synergies between natural and synthetic medicines.
Major competitors include firms such as Tasly, Sinopharm, and Guangzhou Pharmaceutical, which have extensive oncology patent portfolios. CN101500568’s broad claims may act as ‘blocker’ patents, making subsequent development of similar compositions challenging without license.
Legal and Patentability Considerations
The patent maintains patentability by emphasizing:
- The novel combination of ingredients or preparation process not documented prior.
- The unexpected synergistic effect observed in preclinical or clinical studies, supporting inventive step.
- Clear descriptions and enabling disclosures meet Chinese patent law requirements, reinforcing enforceability.
However, given China's evolving patent examination practices, particularly regarding combination drugs and natural products, its scope may face challenges if prior similar compositions are identified.
Potential Infringements and Freedom-to-Operate
A thorough prior art search would reveal competing patents or applications in oncology formulations involving similar components. Yet, the claims’ specific ratios, unique preparation processes, or therapeutic applications could serve as defensible IP rights.
Monitoring recent filings in Chinese and international patent offices indicates a growing corpus of oncology patents, including multi-component herbal formulations and analogs of CN101500568. This landscape warrants continuous legal vigilance.
Strategic Implications
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Patent Monopolization: The broad scope grants substantial protection, potentially deterring competitors from exposing similar formulations.
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Licensing Opportunities: Given China's emphasis on TCM, partnering or licensing may be feasible from patent holders exploiting traditional ingredients.
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Innovation Limitations: The scope’s breadth may provoke patent challenges, especially if the claimed composition overlaps with prior art, emphasizing the importance of patent prosecution strength.
Conclusion
China patent CN101500568 exhibits a comprehensive scope covering a multi-component pharmaceutical composition and its preparation method for cancer treatment. Its claims are structured to prevent easy workaround, reflecting a strategic patent to bolster market exclusivity in a highly competitive domain. The patent landscape in Chinese oncology therapeutics emphasizes multi-component formulations, especially those combining TCM and modern drugs, with this patent standing as a pertinent example.
Business professionals and R&D entities must conduct diligent freedom-to-operate analyses, considering the patent's broad claims and the active patent environment, particularly within traditional medicine and combination therapies.
Key Takeaways
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Broad scope enhances exclusivity, covering both composition and manufacturing method; this can serve as a substantial barrier for competitors.
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The patent aligns with China's strategic focus on integrating traditional Chinese medicine with modern oncology therapies.
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Potential for patent challenges exists given China's increasing scrutiny of multi-component natural product patents, requiring ongoing monitoring.
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Strategic licensing or collaboration could maximize value, especially given the traditional medicine components.
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Continued patent landscape analysis is essential to navigate overlapping rights and maintain freedom to operate.
FAQs
Q1: What are the key components typically claimed in CN101500568?
A1: Claims generally specify active ingredients—possibly herbal extracts combined with synthetic agents—along with their ratios and preparation process specifics, aimed at maximizing anti-cancer efficacy.
Q2: How does CN101500568 compare to international oncology patents?
A2: It shares common features with global multi-component cancer drug patents, emphasizing combination therapies. Its Chinese language claims may include traditional medicine elements less prevalent in Western patents.
Q3: What challenges could arise in enforcing this patent?
A3: Challenges may include prior art that overlaps in composition or process, or claims deemed too broad and lacking inventive step; ensuring detailed disclosures enhances enforceability.
Q4: Can this patent block subsequent innovations?
A4: Yes, its broad scope can inhibit the development of similar formulations unless licensing agreements are secured or the patent is invalidated through legal challenges.
Q5: What trends in China’s patent landscape does this patent exemplify?
A5: It exemplifies the trend toward protecting multi-component, TCM-integrated formulations targeting cancer, reflecting policy incentives for natural medicine innovations.
References
[1] Chinese Patent CN101500568.
[2] State Intellectual Property Office of China (SIPO). Official patent database.
[3] WIPO PATENTSCOPE database.
[4] Nanjing University of Science and Technology: Patent analysis reports on China's oncology sector.
[5] China National Knowledge Infrastructure (CNKI) on TCM patents.
This detailed analysis equips professionals with strategic insights into CN101500568’s scope and position within China’s dynamic patent landscape, enabling informed decision-making in drug development, licensing, and legal assessments.
