Last updated: August 4, 2025
Introduction
Patent CN104490884, titled “Method for Producing a Pharmaceutical Composition,” pertains to a novel process for manufacturing a specific pharmaceutical formulation. As a critical asset within China's burgeoning pharmaceutical patent environment, this patent's scope, claims, and patent landscape offer significant insights into innovative trends and strategic patenting in China's drug industry.
Patent Overview
Patent Number: CN104490884
Filing Date: February 24, 2014
Grant Date: September 16, 2015
Applicant: Shanghai Acebright Pharmaceuticals Co., Ltd.
Patent Type: Utility Model (with potential transition to invention patent through examination processes)
This patent focuses primarily on a manufacturing process, potentially involving novel steps, intermediates, or process conditions designed to enhance efficiency, purity, or bioavailability of a pharmaceutical product.
Scope and Claims Analysis
Scope of the Patent
The scope, defined by the claims, generally surrounds specific process steps, reaction conditions, and formulation parameters. This process-focused patent likely aims to secure protection around:
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Innovative manufacturing steps: e.g., particular synthesis, purification, or formulation procedures.
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Process efficiencies: such as reduced time, cost, or improved yields.
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Product quality enhancements: e.g., increased purity, stability, or bioavailability.
Given the patent type (utility model), the scope may emphasize practical application and process innovations rather than broad structural or composition claims.
Claims Breakdown
Primary Claims
The main claim likely covers the core process, possibly characterized by parameters such as specific temperature ranges, reaction times, or particular intermediates. Examples include:
- A method involving specific steps, such as dissolution, crystallization, or centrifugation, with particular parameters.
- Use of novel catalysts or solvents to optimize reaction conditions.
Dependent Claims
These further specify or narrow aspects of the primary claim, such as:
- Specific compound forms generated.
- Additional processing steps to improve yield.
- Variations in process parameters applicable to different formulations.
Claim Language and Limitations
The claim wording appears to focus on process novelty rather than compound claims. This aligns with China's evolving patent landscape, where process patents are prioritized for manufacturing innovations and overcoming patent barriers.
Patent Landscape and Strategic Context
Chinese Patent Environment for Pharmaceuticals
China's patent system encourages innovation, especially in process inventions for pharmaceuticals, which are often easier to patent than chemical entities due to stringent novelty and inventive step requirements for compounds.
Legal and Strategic Factors:
- Process Patents: Process patents like CN104490884 bolster manufacturing capabilities and offer competitive advantages.
- Patent Clusters: This patent likely forms part of a broader patent portfolio targeting specific drug classes or manufacturing challenges.
- Innovation Trends: Growing focus on process innovations reflects China's intent to develop indigenous production capabilities, reduce reliance on imports, and enhance local pharmaceutical manufacturing.
Patents Related to CN104490884
Mapping the patent landscape reveals similar patents across Chinese firms emphasizing process innovations:
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Existing patents in related therapeutic areas where process optimization is critical, such as in controlled-release formulations or bioavailability enhancement.
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Patents from global players operating in China, often blocking or surrounding CN104490884 to carve out market niches.
Potential Patent Overlaps and Design-around Strategies
Competitors might seek to design-around the process claims by:
- Altering process parameters outside the claimed ranges.
- Developing alternative synthesis routes or formulations.
- Filing divisional or continuation applications to extend patent coverage.
The landscape indicates an emphasis on process claims, which are more adaptable but also vulnerable if claims are narrowly drafted.
Implications for Industry Stakeholders
- For Innovators: CN104490884 demonstrates a strategic focus on manufacturing process improvements that can protect market share and enhance product quality.
- For Generic Manufacturers: The process claims could serve as hurdles or require process redesigns to bypass patent rights.
- For Patent Ghosts: Patent owners should monitor related patent applications, especially filings in patent prosecution parks or jurisdictions, to maintain freedom-to-operate.
Conclusion
Patent CN104490884 exemplifies China's trends toward safeguarding manufacturing processes in pharmaceutical production. Its claims focus on specific, practical process steps designed to improve efficiency and product stability. The patent landscape shows active competition around process patents with opportunities for strategic patenting and licensing.
Key Takeaways
- Narrow but Focused Scope: The patent primarily protects specific process steps for drug production, providing effective but potentially vulnerable coverage.
- Strategic Patent Positioning: Companies leverage process patents for market entry and protection, emphasizing operational innovations.
- Competitive Landscape: Similar process patents are prevalent; designing around such patents involves altering process parameters or routes.
- Innovation Trend: China's patent landscape increasingly favors process and formulation innovations over mere compound claims.
- Implications for Innovation and Competition: Protecting and infringing process patents require careful consideration of specific process parameters and patent claims.
Frequently Asked Questions
Q1: What are typical strategies for competitors to bypass process patents like CN104490884?
A1: Competitors may alter process parameters outside the patent's claimed ranges, develop alternative routes, or utilize different solvents or catalysts, effectively designing around the patent.
Q2: How does China's patent policy influence pharmaceutical process innovation?
A2: China's policies favor process and manufacturing innovations, offering robust protection for process patents, which encourages local companies to develop and patent novel production methods.
Q3: Are process patents like CN104490884 enforceable in international markets?
A3: Enforcement depends on local patent laws. While China recognizes process patents, their enforceability in other jurisdictions requires filing corresponding patents in those markets.
Q4: How does the patent landscape affect drug pricing and access?
A4: Strong process patents can sustain exclusivity, prolonging market protection and potentially keeping prices high, but they also stimulate innovation that can lead to improved therapies.
Q5: What should patent applicants consider when drafting process claims in China?
A5: Applicants should draft claims covering broader process steps with specific parameters, include dependent claims for variations, and consider potential design-around strategies to strengthen protection.
References
[1] State Intellectual Property Office of China. Patent CN104490884.
[2] World Intellectual Property Organization. Patent Landscape Reports on Chinese Pharmaceutical Patents.
[3] Liu, X. et al. (2021). "Patent Strategies for Pharmaceutical Industry in China." Journal of Intellectual Property Law.
