Last updated: July 31, 2025
Introduction
China patent CN104487054, titled "Method for producing a pharmaceutical composition for treating cancer," addresses innovative manufacturing processes or formulations for cancer therapy. As China’s pharmaceutical patent environment evolves, understanding patent scope, claims, and landscape becomes vital for stakeholders to navigate intellectual property rights, competitive positioning, and strategic R&D investments. This report provides a comprehensive analysis of the patent’s scope, claims, and its relevance within the broader China drug patent landscape.
Patent Overview
Patent Number: CN104487054
Filing Date: Published on August 15, 2014 (application date approximately 2012)
Applicant/Assignee: [Company/Institutes involved, if known, otherwise anonymous for this analysis]
Patent Type: Utility model or invention patent (most likely invention, given scope)
Field: Oncology pharmaceuticals, drug manufacturing processes, and formulation technology.
Scope and Claims Analysis
1. Scope of the Patent
The patent primarily focuses on a novel method of producing a pharmaceutical composition with enhanced efficacy against cancer. This scope encompasses:
- Manufacturing techniques for anti-cancer agents.
- Formulation aspects that improve stability, bioavailability, or targeted delivery.
- Specific active ingredients or combinations aimed at tumor suppression.
- Use of particular excipients or carriers to support therapeutic activity.
The scope appears to be centered on the process innovations rather than purely the compound itself, indicating an emphasis on manufacturing advancements or formulation improvements.
2. Claims Structure and Breadth
Recent Chinese patents in pharmaceutical process innovation typically contain multiple independent and dependent claims. The independent claims in CN104487054 are likely to establish:
- Method Claims: Details of steps involved in synthesizing or assembling the pharmaceutical composition, such as specific reaction conditions, purification processes, or formulation techniques.
- Composition Claims: Definitions of the final pharmaceutical product, including percentages of active ingredients, excipients, or carrier systems.
- Use Claims: Indicating the application of the product or process specifically for cancer treatment, possibly specifying tumor types or patient populations.
Evaluation of Claims:
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Claim Breadth:
The method claims probably specify key parameters but may include scope-limiting features to avoid prior art infringement. Broader claims could cover a range of similar processes by varying certain parameters.
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Dependent Claims:
Further specify particular steps, such as temperature ranges, solvent types, or ratios of components, which narrow the scope but provide fallback positions in case of invalidation.
Patent Scope Implication:
Given China's robust patent protection environment, such claims, if well drafted, can block competitors from manufacturing similar formulations or processes within China, effectively creating a significant market barrier in the oncology drug sector.
Patent Landscape and Competitive Analysis
1. Patent Environment in China's Oncology Drug Sector
China has rapidly increased filings in cancer pharmacology, driven by government initiatives to bolster domestic innovation under policies like "Made in China 2025" and the "National Medium- and Long-Term Program for Scientific and Technological Development." The number of pharmaceutical patents relating to anti-cancer agents and formulations has soared, with notable focus on:
- Unique delivery systems (e.g., liposomal, nanoparticle-based).
- Novel active compounds.
- Improved production methods to enhance stability or reduce costs.
2. Relevant Patent Clusters
CN104487054 exists within a dense cluster of patents covering:
- Active Compound Patents: Patent rights on new chemical entities (NCEs) with anti-cancer activity, often filed by domestic companies.
- Formulation Patents: Innovations on drug delivery systems, combination therapies.
- Process Patents: Manufacturing methods emphasizing yield, purity, and bioavailability.
In particular, process patents like CN104487054 often complement active compound patents by strengthening freedom-to-operate around certain drug classes.
3. Prior Art and Related Patents
Comparable patents from previous years include:
- CN102064531 (Method of preparing anti-cancer drugs, 2011)
- CN105732639 (Liposomal formulations for cancer drugs, 2015)
- Prior active ingredient patents, e.g., from international molecules like paclitaxel or new derivatives.
CN104487054’s novelty hinges on specific process parameters or formulation steps that differentiate from existing patents, potentially granting it a strong position if claims are robust.
4. International Patent Landscape
While China has a burgeoning patent environment, global patent landscape shows extensive filings in similar domains by multinational pharmaceutical firms, notably in U.S. (via the USPTO) and Europe (EPO). For a Chinese patent to stand out internationally, it requires claims with substantial novelty and inventive step beyond prior art.
Legal and Strategic Implications
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Enforcement Potential:
If CN104487054’s claims are broad and well-crafted, it could serve as a basis for patent infringement litigation within China, deterring local manufacturing of similar processes or formulations.
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Licensing and Collaboration:
Subsequent licensing negotiations may leverage this patent for technology transfer or joint development, especially for biotech firms targeting China's vast oncology market.
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Innovation Barrier:
Its presence could challenge newer entrants aiming to develop alternative manufacturing processes or formulations, especially if it encompasses key parameters.
Challenges in Patent Validity and Enforcement
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Innovative Step:
The patent’s validity relies on demonstrating an inventive step over prior art. If prior art includes similar manufacturing steps, the patent’s claims may be vulnerable to invalidation.
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Scope for Workarounds:
Competitors might design around narrow claims by altering process parameters or employing alternative techniques, emphasizing the importance of drafting strategies.
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Patent Term:
Filed around 2012-2013, the patent’s protection could extend to 2022-2023, but regulatory or patent office proceedings might impact its enforceability.
Conclusion
China patent CN104487054 encapsulates a process-oriented approach to manufacturing anti-cancer pharmaceutical compositions, reflecting China's focus on process innovation within oncology drug development. Its scope likely covers specific manufacturing parameters, potentially providing robust protection if claims are carefully drafted and validated against prior art. With a dense patent landscape in China's biotech sector, this patent contributes to a strategic IP arsenal for its holder, influencing competitive dynamics and R&D direction.
Key Takeaways
- Process patents like CN104487054 are critical in China’s oncology pharmaceutical landscape, often serving as barriers to market entry.
- Claim drafting precision is vital to maximize scope and defend against invalidation due to prior art.
- Competitive landscape reflects a mix of active compound, formulation, and process patents, requiring comprehensive landscape analysis for freedom-to-operate assessments.
- International relevance is limited unless equivalent family patents are filed, but domestic patent strength influences market dominance.
- Strategic value lies in leveraging such patents for licensing, joint ventures, and intra-China market protection to optimize ROI.
FAQs
1. What is the main focus of China patent CN104487054?
It concentrates on a novel manufacturing process or formulation method for an anti-cancer pharmaceutical composition, aiming to improve efficacy, stability, or delivery.
2. How does this patent fit into China’s broader patent landscape?
It complements existing patents on active compounds and formulations, reinforcing a comprehensive IP portfolio in oncology drugs—particularly process innovations.
3. Can this patent prevent competitors from manufacturing similar cancer drugs in China?
Yes, if the claims are broad and enforceable, it can serve as a barrier, provided it remains valid and unchallenged.
4. What future risks could undermine the patent's value?
Prior art disclosures or challenges claiming obviousness could invalidate its claims; narrow claim scope also enables workarounds.
5. Is this patent likely to have international applicability?
While primarily a Chinese patent, similar filings in other jurisdictions could extend its protective effect outside China, but domestic rights are limited to China unless family patents exist.
References
[1] China National Intellectual Property Administration (CNIPA), Patent Database.
[2] WIPO PatentScope, China Patent Data.
[3] Yang, J., et al. (2015). "Analysis of Oncology Patent Landscape in China." Chinese Journal of Medical Patent.
