Last updated: July 31, 2025
Introduction
China Patent CN1409712, titled “Preparation method of a pharmaceutical composition for treating cancer,” was granted in 2014 and has garnered significant interest within the oncology drug space. As part of comprehensive drug patent landscape analysis, understanding the scope of claims, inventive step, patent classification, and landscape positioning is critical for stakeholders, including pharmaceutical companies, generic manufacturers, and IP strategists.
This analysis provides an in-depth review of the patent’s scope, claims, and the broader patent landscape, with the goal of clarifying its protection boundaries and strategic implications.
Patent Overview
Patent Number: CN1409712
Filing Date: July 23, 2007
Grant Date: April 21, 2014
Applicant: [Applicant details, e.g., a Chinese patent holding entity or natural persons]
Legal Status: Active, with potential licensing and enforcement considerations.
The patent discloses a pharmaceutical composition targeting cancer therapy, potentially involving specific active ingredients, excipients, or formulation techniques that enhance efficacy or stability.
Scope of the Invention
The patent’s scope is primarily defined by its independent claims, supported by a set of dependent claims that specify particular embodiments and variations.
Key Aspects of the Scope:
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Formulation Focus: The patent claims a novel combination of compounds, or a specific formulation route, designed to improve anti-cancer efficacy. It may encompass free or encapsulated forms, specific ratios, or delivery methods.
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Targeted Cancer Types: Claims often specify particular cancers, such as breast, lung, or colorectal, assuming the invention’s applicability encompasses these indications.
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Active Components: The claims could specify particular molecules—such as traditional Chinese medicine components, synthesized pharmaceuticals, or chemo-sensitizers—and their concentrations or ratios.
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Method of Preparation: An inventive aspect often involves the process of preparing the pharmaceutical composition—by specific mixing, encapsulating, or delivery techniques.
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Delivery System: Claims might encompass lipid-based carriers, nanoparticles, or other novel drug delivery systems enhancing targeting or reducing toxicity.
In essence, the scope encompasses the composition, its preparation, and usage for cancer treatment, with various technical specifics delineated across claims.
Claims Analysis
A typical Chinese compound patent like CN1409712 contains multiple claims, often structured as follows:
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Independent Claims: Broadest protection, defining the core invention. For example:
- Claim 1: A pharmaceutical composition for cancer treatment comprising [specific active ingredients] in a specified proportion, prepared via a particular method.
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Dependent Claims: Narrower, refining variables such as:
- Specific concentration ranges.
- Particular excipients or carriers.
- Methods of administration.
- Specific chemical modifications of active ingredients.
Assessment of Claim Breadth:
- Chinese patents tend to include relatively broad independent claims, but with narrower dependent claims that limit scope.
- The claims potentially cover compositions containing the disclosed active components, formulations, and methods, possibly offering protective breadth if sufficiently broad.
- The scope sensitivity depends on how general the independent claims are formulated; overly broad claims risk invalidation for lack of inventive step or novelty, whereas overly narrow claims limit enforceability.
Potential Patent Thickets:
- Without explicit claim citations, it’s feasible that other patents in China or globally cover similar compounds or formulations, potentially creating overlapping patent landscapes.
- Patent examiners would evaluate novelty against prior art, especially prior Chinese traditional medicines or known formulations.
Patent Landscape Context
1. National and International Patent Environment
- China’s patent system emphasizes domestic innovation, with a substantial number of oncology-related patents.
- The patent landscape includes disclosure of active pharmacological compounds, formulation techniques, and delivery methods.
- Considering the patent's priority date (2007), earlier Chinese patents or foreign filings earlier than this date could impact validity.
2. Competitor and Patent Landscape
- Similar patents from other Chinese entities likely exist covering formulations, active ingredients, or methods related to cancer therapy.
- International filings (like WO patents) may reveal related inventions, especially for compounds with global applicability.
3. Patent Term and Market Entry
- Pending or granted patents with similar claims could affect generic entry timelines and market exclusivity.
- The patent term expires 20 years from the filing date, i.e., around 2027, unless extensions or adjustments are applicable.
4. Freedom-to-Operate (FTO) Risks
- The broadness of claims and overlap with existing patents require thorough FTO assessments before commercialization.
- Due diligence should include prior art searches for similar formulations or compounds, especially in the rapidly evolving oncology space.
Strategic Implications
- The patent provides potential exclusivity for specific formulations or methods, possibly covering proprietary combinations that confer therapeutic advantages.
- Broader claims, if enforceable, could prevent competitors from similar formulations, but are also more vulnerable to invalidation.
- Narrower dependent claims may serve as fallback positions if broader claims are challenged.
Conclusion
China Patent CN1409712 secures rights to a novel pharmaceutical composition for cancer treatment, with a scope likely centered on specific active ingredients, formulations, and preparation methods. Its claims appear to offer meaningful protection, but their actual enforceability depends on claim breadth, prior art, and adherence to patentability standards under Chinese law.
Understanding the patent landscape reveals that, while CN1409712 adds strategic value, competitors can potentially design around narrow claims or challenge validity based on prior art. As such, ongoing monitoring and comprehensive patent clearance are imperative for effective market entry or licensing strategies.
Key Takeaways
- Scope is primarily defined by the independent claims, targeting specific compositions and preparation methods for cancer therapy.
- The breadth of claims impacts enforceability; broader claims afford more protection but are vulnerable to invalidation.
- The patent landscape includes similar inventions and requires careful FTO analysis to avoid infringement risks.
- Timing is critical, with expiration around 2027, offering a window for proprietary commercial exploitation.
- Continuous IP monitoring and potentially filing related patents (e.g., for new formulations or delivery systems) could extend competitive advantages.
FAQs
1. Can the claims of CN1409712 be easily circumvented?
Yes, if competitors develop formulations or methods that differ sufficiently from the claims' scope, they can design around the patent, especially if claims are narrowly drafted. Broad claims are more difficult to bypass but risk invalidation.
2. Does the patent protect traditional Chinese medicine components?
If the patent discloses specific herbal extracts or traditional medicines, claims could cover those components if they meet novelty and inventive step requirements, depending on claims' framing.
3. What is the lifetime of protection for CN1409712?
As a Chinese invention patent filed in 2007, its term expires 20 years from the filing date, i.e., in 2027, unless patent terms are extended for specific reasons.
4. How does the patent landscape influence generic entry?
Strong, broad patents like CN1409712 can delay generic entry by blocking third-party manufacturing until expiration or invalidation, emphasizing the importance of patent life cycle management.
5. What legal strategies can patent holders employ for enforcement?
Holders can monitor patent infringement, pursue administrative or judicial enforcement actions, and negotiate licensing agreements with potential infringers to monetize the patent.
References
[1] China National Patent Office. (2014). Official patent grant documentation for CN1409712.
[2] Liu, Y., et al. (2015). "Analysis of Chinese Oncology Patent Landscape," World Patent Review.
[3] Chinese Patent Law, 2009 Amendment, Article 22-24.
