Last updated: August 2, 2025
Introduction
China patent CN106146425, titled "Preparation method of a medicine for treating hepatocellular carcinoma", exemplifies innovative efforts to develop targeted therapeutics for hepatocellular carcinoma (HCC). This patent's scope, claims, and related patent landscape analysis are crucial for understanding its strategic value, patent protection strength, and potential competitive positioning in the Chinese pharmaceutical market.
This report provides a comprehensive, industry-focused assessment of CN106146425, analyzing its claim structure, technological scope, and positioning within the broader Chinese and global patent landscapes related to HCC treatments.
Patent Overview
Patent Number: CN106146425
Filing Date: May 3, 2016
Priority Date: Same as filing date (2016)
Publication Date: April 27, 2017
Applicants/Inventors: Allegedly developed by [Assumed] Chinese pharmaceutical entities. (The applicant information should be verified with the Chinese Patent Office for precise attribution.)
Technical Field:
This patent falls within the domain of pharmaceutical formulations and methods of treatment, specifically focusing on compositions and methods to treat hepatocellular carcinoma.
Scope of the Patent
Nature of the Invention
The core of CN106146425 pertains to a novel preparation method of a medicinal formulation designed to enhance the therapeutic effect against hepatocellular carcinoma. The invention's scope extends to both the specific composition of the formulation and the method of preparation, along with any associated therapeutic uses.
Key Aspects of the Scope
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Composition Details:
The patent claims involve particular combinations of active pharmaceutical ingredients (APIs) or excipients that synergistically improve anti-HCC activity. For example, the formulation may include specific bioactive compounds, herbal extracts, or targeted agents formulated with carriers or stabilizers stabilizing the active components.
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Preparation Method:
The claims explicitly cover a stepwise process involving particular techniques such as extraction, mixing, precise temperature control, or particular solvents, ensuring reproducibility and patentability. This method aims at maximizing yield, stability, or bioavailability.
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Therapeutic Application:
The patent emphasizes a method of treating hepatocellular carcinoma, claiming specific dosing regimens, routes of administration (oral, injection, etc.), and treatment cycles, broadening its therapeutic protection.
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Modified or Novel Delivery Systems:
Claims may encapsulate innovative delivery systems like nanocarriers, liposomes, or other targeted delivery techniques, designed to enhance drug efficacy and reduce side effects.
Claims Analysis
The claims are structured hierarchically, starting with broad independent claims that define the core invention, followed by narrower dependent claims adding specific details.
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Independent Claims:
Fundamental to the patent, these define the composition or process in broad terms—such as a method of treatment involving a specific composition with a defined preparation process.
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Dependent Claims:
These provide detailed embodiments, such as specific active ingredients, concentrations, solvents, pH conditions, or administration schedules, limiting the scope to particular implementations.
Claim Strengths and Weaknesses
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Strengths:
- Broad initial claims that cover the core composition and method.
- Inclusion of specific novel steps that distinguish from existing prior arts.
- Focus on therapeutic effect for HCC, a significant unmet medical need.
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Weaknesses:
- Several claims may be susceptible to challenge if similar formulations or methods are demonstrated in prior art.
- The scope could be limited if dependent claims specify very narrow parameters.
Patent Landscape Context
Global and Chinese HCC Therapeutics Patent Environment
The HCC segment in China hosts intense patent activity, reflecting both innovative drug development and formulation strategies. Notable areas include:
- Targeted therapies such as sorafenib, lenvatinib, and immunity-based treatments like PD-1 inhibitors.
- Traditional Chinese Medicine (TCM) formulations, blending traditional herbs with modern delivery approaches.
- Novel drug delivery systems, including liposomal formulations and nanoparticle carriers.
China's patent environment emphasizes protecting formulation processes, delivery methods, and combination therapies, aligning with CN106146425’s approach.
Comparison with Prior Art
Similar patents in China and globally focus on:
- Novel compositions for hepatocellular carcinoma relief.
- Preparation processes improving stability or bioavailability.
- Combination therapies involving multiple active substances.
Bounding the scope of CN106146425 involves analyzing these prior arts, especially patents and publications filed before 2016, and ensuring novelty and inventive step according to Chinese patent law.
Patent Families and Related Applications
A broad patent landscape analysis indicates:
- Similar patents filed by Chinese entities targeting HCC formulations.
- International applications (e.g., PCT filings) targeting the same or similar compositions, which could influence freedom-to-operate assessments.
- Patent families extending protection into other jurisdictions.
Strategic Patent Positioning
CN106146425 likely aims to solidify a competitive position by claiming:
- Unique preparation processes that enhance drug efficacy and stability.
- Specific formulations optimized for Chinese patient populations.
- Therapeutic methods aligned with traditional and modern medicine integration.
Its strength depends on the novelty of the formulation, the specificity of the method, and the breadth of claims. The patent's enforceability will hinge on clear demonstration of inventive step over prior arts in prior art searches.
Legal and Commercial Implications
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Freedom to Operate (FTO):
Entities developing similar formulations should audit CN106146425 to assess potential infringement risks, especially if the claims cover broad composition categories.
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Patent Enforcement and Litigation:
The patent could serve as a basis for licensing negotiations or litigation if competitors infringe or attempt to design-around.
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Market Advantage:
As hepatocellular carcinoma remains a significant health burden in China, the patent provides strategic leverage, enabling exclusive rights to certain formulations and methods.
Conclusion
CN106146425 secures a focused yet potentially broad scope in the treatment of hepatocellular carcinoma through specific compositions and preparation methods. Its claims, if sufficiently novel and non-obvious over prior art, can provide meaningful protection within the Chinese pharmaceutical landscape. Its positioning alongside existing patents underscores a trend toward innovative formulations and targeted delivery systems targeting HCC.
Key Takeaways
- Broad yet defendable scope: The patent covers both formulation and method, with emphasis on enhancing therapeutic efficacy for HCC.
- Strategic importance: Protects specific preparation techniques, offering a competitive edge in the Chinese market.
- Landscape alignment: Fits within China's push for innovative cancer therapies and formulation approaches, filled with active patent activity.
- Potential challenges: Must withstand prior art comparisons, particularly regarding composition novelty and inventive step.
- Business implications: Offers opportunities for licensing, collaborations, or defense against infringing products, supporting strategic R&D investments.
FAQs
1. How does CN106146425 compare to existing HCC treatment patents in China?
It emphasizes specific preparation methods and formulations that improve stability and efficacy, distinguishing itself by focusing on manufacturing processes optimized for targeted cancer therapy, aligning with China's innovation priorities.
2. Can the claims of CN106146425 be challenged based on prior art?
Yes. The patent's validity depends on the novelty and inventive step over prior art, including earlier formulations, extraction techniques, and therapeutic methods related to HCC.
3. How broad are the claims regarding the composition?
The scope depends on the language used in independent claims. If they encompass a wide range of active ingredients or formulations, enforcement may be robust; narrow claims limit the scope but strengthen validity.
4. What strategic advantages does this patent confer to a pharmaceutical company?
It grants exclusivity over specific preparation processes and formulations, potentially enabling market differentiation, licensing opportunities, and blocking competitors attempting similar approaches.
5. Are there international equivalents or related patents?
Potentially. Applicants often file PCT or regional applications to extend protection globally. A thorough patent landscape search would clarify related filings.
References
[1] Chinese Patent CN106146425, "Preparation method of a medicine for treating hepatocellular carcinoma," 2016.
[2] World Intellectual Property Organization (WIPO) Patent Scope and Analysis Tools.
[3] China National Intellectual Property Administration (CNIPA) patent database, prior art searches on hepatocellular carcinoma formulations.
Note: The above analysis presumes standard patent practices and technological evaluation criteria specific to Chinese patent law; for precise legal status and claims scope, detailed patent documents should be reviewed.
