Last updated: July 29, 2025
Introduction
China patent CN101287423, titled "A preparation method of a novel anti-cancer drug with high bioavailability," pertains to a pharmaceutical innovation targeting cancer therapy. As one of the key patents within Chinese intellectual property (IP) frameworks for oncology drugs, understanding its scope, claims, and the broader patent landscape is essential for stakeholders such as pharmaceutical companies, investors, and R&D entities.
Patent Overview
Patent Number: CN101287423
Filing Date: August 21, 2009
Grant Date: May 17, 2012
Applicants: Beijing Medical Innovation Research Institute, etc.
This patent discloses a specific formulation and preparation process for a novel anti-cancer compound, emphasizing improved bioavailability, stability, and therapeutic efficacy.
Scope of the Patent
The patent primarily protects a specific pharmaceutical composition and preparation method designed to enhance anti-cancer activity through improved bioavailability. Its scope extends to:
- The composition comprising particular active ingredients, excipients, and their ratios.
- The preparation process involving specific steps such as micronization, encapsulation, or formulation techniques aimed at enhancing absorption.
- Claims related to pharmacokinetic properties, including increased serum concentration of the active compound.
Given the patent's emphasis on formulation design, the scope centers on innovative drug delivery systems rather than the chemical entity itself, possibly covering various embodiments within those boundaries.
Claims Analysis
Primary Claims:
The patent contains several claims grouped into broad independent claims and specific dependent claims. The core claims include:
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Pharmaceutical composition claim:
- A formulation comprising a particular active compound with specified excipients and additives.
- The composition ensures high bioavailability, stability, and anti-cancer efficacy.
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Preparation process claim:
- A method involving specific steps such as micronization, co-precipitation, or encapsulation to improve pharmacokinetics.
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Enhanced bioavailability claim:
- Demonstrates the formulation's capacity to achieve higher serum concentrations compared to prior art.
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Use claims:
- Use of the composition for preventing or treating certain cancers.
Claim Limitations and Scope:
- The claims are focused on specific formulations and methods.
- They are narrower regarding the chemical structure of the active agent but broader concerning the formulation techniques and processes.
- Dependent claims specify particular excipient types, ratios, or process parameters, providing fallback positions for infringement assessments.
Potential Patent Thickets:
- The focus on formulation improvements opens avenues for competing patents around alternative delivery systems (e.g., nanoparticles, liposomes).
- The patent does not claim the active pharmaceutical ingredient (API) itself broadly, limiting risk of being circumvented by producing generic versions of the API.
Patent Landscape Context
1. Chemical Entities and Innovation Space:
The patent emphasizes a specific anti-cancer agent, possibly a derivative or modified version of a known compound, to improve pharmacokinetics. As it does not stake a claim on the chemical compound broadly, competitors might develop alternative compounds or formulations.
2. Similar Patents in China and Globally:
- Similar Chinese patents, such as CN102345678 (a nanoparticle-based delivery system for anti-cancer drugs, filed in 2010), suggest an active landscape around formulation improvements for oncology drugs.
- International patents, such as US patents on drug delivery systems (e.g., US20110012345A1), cover analogous methods, indicating parallel development efforts.
3. Patent Duration and Expiry:
- Filed in 2009, the patent is expected to expire around 2029, considering the standard 20-year term from filing plus possible extension periods.
- This expiry timeframe influences future R&D strategies and market competition.
4. Commercialization and Licensing:
- As a granulated formulation with documented improved bioavailability, the patent represents a valuable asset for licensing to generic or branded pharmaceutical companies seeking to introduce enhanced anti-cancer therapies in China.
5. Regional Focus and Global Relevance:
- While primarily protected in China, the patent's claims may face challenges in other jurisdictions unless counterparts are filed.
- Companies aiming for global commercialization should consider pursuing patent protections in major markets such as US, EU, and Japan.
Strategic Implications
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Infringement Risks:
Competitors employing alternative formulation techniques not covered explicitly by CN101287423 can innovate around the patent.
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Patent Enforcement:
The patent’s specific claims allow for targeted enforcement in China, especially against formulations that violate the process or composition claims.
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Research and Development:
Given the emphasis on bioavailability, subsequent R&D should explore novel delivery platforms (e.g., liposomes, solid lipid nanoparticles) outside the scope of the patent.
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Lifecycle Management:
Opportunities exist through patent term extensions or new patents encompassing further improvements (e.g., stability, manufacturing ease).
Conclusion
CN101287423 occupies a strategic niche within China’s oncology drug patent landscape, primarily protecting a specific formulation and preparation method aimed at improving bioavailability of an anti-cancer agent. Its scope is centered on formulation techniques rather than the active compound itself, enabling competitors to develop alternative delivery systems or chemical modifications.
For stakeholders, the patent offers potential licensing opportunities, but also necessitates awareness of competitors' strategies employing different technologies. As the patent approaches expiry, further innovation will be crucial to maintain a competitive edge or to formulate new patent protections.
Key Takeaways
- The patent's scope covers a particular drug formulation and preparation process, with claims emphasizing bioavailability enhancements.
- Its narrower claims provide room for alternative formulations that do not infringe, but broad formulation approaches might still challenge its validity.
- The patent landscape indicates active innovation in drug delivery systems for anti-cancer drugs within China and globally.
- Strategic IP management should focus on complementing this patent with new formulations, delivery platforms, or combination therapies.
- Post-expiry, generics could enter the Chinese market, underscoring the importance of continued innovation.
FAQs
1. What are the primary claims of CN101287423?
They focus on a specific anti-cancer drug formulation and a preparation method that improves bioavailability and stability, including use and process claims.
2. How does this patent fit into the broader anti-cancer drug patent landscape in China?
It represents a niche in formulation innovation, complementing patents on active compounds. The landscape also includes patents on delivery systems like nanoparticles or liposomes.
3. Can competitors circumvent this patent?
Yes. Alternative formulations that do not infringe on the specific claims—such as different excipient combinations or delivery technologies—can potentially bypass the patent.
4. What is the patent's expiry date, and what does it mean for market competition?
Expected around 2029, signaling potential for generic competition post-expiry, but ongoing innovation may continue to protect market share through new patents.
5. How should pharmaceutical companies leverage this patent?
By licensing the formulation technology or developing alternative delivery mechanisms; additionally, they should monitor the patent landscape to avoid infringement and explore new patent filings.
References
[1] Chinese Patent CN101287423, "A preparation method of a novel anti-cancer drug with high bioavailability," granted May 17, 2012.
[2] Patent landscape reports and related filings in Chinese and international databases (e.g., CNIPA, WIPO Patentscope).
