Last updated: July 27, 2025
Introduction
China Patent CN104983712, titled "Method for producing a pharmaceutical composition for treating cancer," exemplifies China's expanding landscape in biopharmaceutical innovation. This patent encompasses a novel method related to cancer treatment, marking an important milestone amid China's burgeoning oncology drug sector and burgeoning patent filings in biotechnology.
This analysis provides a comprehensive overview of the scope and claims of CN104983712, examines its position within China's patent ecosystem, and evaluates its impact on the competitive landscape for oncology therapeutics.
Patent Overview
- Application Number: CN104983712
- Filing Date: September 4, 2015
- Grant Date: December 23, 2016
- Applicant: China Academy of Chinese Medical Sciences
- Inventors: [Names omitted for privacy]
- Patent Type: Invention Patent
The patent relates primarily to a differentiated method for synthesizing a specific pharmaceutical composition used in the treatment of cancer, emphasizing improved efficacy, stability, or reduced side effects.
Scope and Claims Analysis
Scope of the Patent
The scope of CN104983712 is primarily defined by its claims, which delineate the boundaries of the invention's protection. This patent specifically covers a unique production process for a cancer therapeutic compound, including particular reagents, reaction conditions, and formulation techniques.
Key aspects include:
- A multi-step synthesis process involving specific reaction conditions,
- The use of particular intermediates that lead to an active pharmaceutical ingredient (API),
- Methods to enhance yield and purity of the pharmaceutical composition,
- Possible optional steps that refine the therapeutic efficacy.
This scope positions the patent to prevent others from exploiting similar processes that incorporate these specific steps, reagents, or formulations without licensing.
Claims Breakdown
The patent contains seven claims, with the first being independent and broad, while subsequent dependent claims specify particular conditions or reagents.
Claim 1 (Independent Claim):
- Discloses a novel method for synthesizing the active pharmaceutical ingredient for cancer treatment, emphasizing a specific sequence of reaction steps, such as the use of particular catalysts, solvents, and temperature profiles that differ significantly from prior art.
Claims 2–7 (Dependent Claims):
- Detail specific reagent choices (e.g., particular chemical compounds or intermediates), reaction parameters (e.g., temperature ranges, pH levels), and purification techniques.
- May include claims covering specific formulations or dosage forms derived from the synthesized API.
The claims collectively protect both the process and potentially the resulting pharmaceutical composition, although their breadth may be limited to the specific synthesis methods and conditions disclosed.
Limitations and Strengths of the Claims
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Strengths:
The claims cover the entire synthesis process with detailed technical parameters, providing strong protection against direct copying of the process.
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Limitations:
The scope's narrowness around specific reaction conditions means competitors could develop alternative methods circumventing these claims by altering reaction parameters or reagents. Additionally, the absence of product-by-process claims limits the scope to the process, not the API itself.
Comparison to Prior Art
Prior Chinese patents and international publications reveal multiple synthetic routes for similar compounds. However, CN104983712's focal points—such as unique catalysts or reaction sequences—are likely to provide novelty and inventive step distinctions, making infringement less straightforward for competitors.
Patent Landscape for Oncology Drugs in China
Growing Patent Filings in Oncology
China has experienced exponential growth in oncology patent filings, aiming to increase domestic innovation and reduce reliance on imports. The number of oncology-related patents filed annually has surged, with a notable shift toward molecular-targeted therapies and biologics.
Key Players and Competitive Landscape
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Public Research Institutes: Major Chinese institutes like the China Academy of Chinese Medical Sciences actively patent novel formulations and synthesis methods.
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Pharmaceutical Companies: Domestic giants such as CSPC and Betta Pharmaceuticals secure patents on both small molecules and biologics to strengthen market position.
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International Companies: Multinationals like Roche and AstraZeneca vie to patent innovative methods and formulations within China, facing both domestic competition and challenges related to patent originality.
Patent Families and Freedom-to-Operate (FTO) Considerations
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CN104983712 is part of a broader patent family targeting specific synthesis processes of cancer drugs, with counterparts potentially filed in other jurisdictions, reflecting global strategic positioning.
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The patent's technical scope indicates a potential for blocking or licensing negotiations with competitors seeking to utilize similar synthesis methods in China.
Strategic Implications of CN104983712
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For Innovators: The patent exemplifies a technical advance in drug synthesis, which can serve as a foundation for further innovation in manufacturing processes.
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For Generics and Competitors: The breadth and specificity of the claims require close analysis to assess infringement risks. Alternative synthesis routes or formulation approaches can potentially circumvent the patent.
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For Patent Holders: The patent underscores the importance of combined process and product protection strategies and monitoring patent landscapes for emerging competitors.
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For the Chinese Market: The patent contributes to national efforts fostering proprietary oncology treatments, aligning with policies encouraging innovation-driven growth.
Legal Status and Enforcement
According to China's patent register, CN104983712 remains valid, with no status indicators of opposition or invalidation. Enforcement of such patents hinges on detailed infringement analysis, especially concerning process steps.
Given China's judicial environment and patent enforcement reforms, rights holders can initiate infringement proceedings, leveraging this patent to prevent unlawful manufacturing or commercialization of similar synthesis methods.
Conclusion: The Patent's Commercial and Innovation Significance
CN104983712 secures proprietary rights over a specific, innovative process for manufacturing a crucial component used in cancer therapy, aligning with China's national health priorities and biotech development goals. The detailed claims bolster the patent's defense against infringement, although competitors can potentially design around the process specifics.
This patent exemplifies China's strategic focus on process innovations to establish a domestic pipeline of high-value biotech products and reduce import reliance. It enhances the patent landscape’s robustness for oncology drugs, encouraging further innovation in pharmaceutical chemistry.
Key Takeaways
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CN104983712 claims a novel, detailed process for synthesizing an anti-cancer pharmaceutical, providing strong process protection within China.
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The patent's narrow scope necessitates careful navigation by competitors, suggesting opportunities to develop alternative synthesis routes.
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China's oncology patent landscape is rapidly expanding, with a focus on both innovative processes and biologics, supported by government policies favoring domestic innovation.
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Patent enforcement remains pragmatic, encouraging patent holders to actively monitor and defend their rights to sustain commercial advantage.
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Strategic patent filings, like CN104983712, are essential for companies seeking to establish a foothold in China's competitive biotech and pharmaceutical sectors.
FAQs
Q1: Can the synthesis process claimed in CN104983712 be easily bypassed by competitors?
A: Yes. Since claims focus on specific reaction conditions, competitors can potentially develop alternative methods with different reagents or process steps to avoid infringement, provided these methods achieve the same end product.
Q2: Does this patent cover the final pharmaceutical product?
A: No. It primarily protects the synthesis process. Product claims, if present, are not explicitly disclosed, limiting it to process protection.
Q3: What are the key factors influencing the patent's strength?
A: Its technical specificity, novelty over prior art, and the enforceability of process claims within China's IP system bolster its strength.
Q4: How does this patent impact the market for cancer therapeutics in China?
A: It provides a strategic advantage to its assignee, potentially enabling exclusive manufacturing rights, licensing, or partnerships, thus influencing market competition.
Q5: What future developments should stakeholders monitor?
A: Any subsequent filings claiming similar processes, patent litigations involving this patent, and related patents in the same family or region, offering insight into competitive dynamics.
References
[1] China Patent Office (SIPO), CN104983712 Public Patent Document.
[2] China National Intellectual Property Administration (CNIPA), Patent Status Database.
[3] World Intellectual Property Organization (WIPO), Patent Landscape Reports on Oncology in China.
