Last updated: August 8, 2025
Introduction
The patent CN113286584, titled "Method for Manufacturing a Pharmaceutical Composition," represents an innovative development within China's rapidly evolving pharmaceutical patent landscape. This patent, filed domestically, exemplifies China's strategic focus on enhancing intellectual property (IP) protection for new drug formulations and manufacturing processes. This detailed analysis examines the scope of the claims, the technological emphasis, and the broader patent landscape context in China, offering insights valuable for industry stakeholders involved in pharmaceutical R&D, licensing, and competitive intelligence.
Overview of Patent CN113286584
The patent was granted by the China National Intellectual Property Administration (CNIPA), focusing on a novel method to produce specific pharmaceutical compositions with improved bioavailability and stability. The application emphasizes process innovations, encompassing specific steps and parameters intended to optimize the manufacturing process of active pharmaceutical ingredients (APIs) or drug formulations.
As a process patent, CN113286584 seeks to carve out exclusive rights over unique manufacturing techniques, potentially covering formulations that utilize specific solvents, temperatures, reaction times, or purification steps. The patent's emphasis aligns with China's national priorities to foster domestic pharma innovation and secure IP rights for high-value drug manufacturing technologies.
Scope and Claims of CN113286584
Claims Structure Overview
The patent primarily includes independent claims delineating the core innovation, supported by multiple dependent claims that specify particular embodiments, process parameters, or alternative variants. The claims are crafted to offer broad protection while maintaining technical specificity.
Key Elements of the Patent Claims
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Process Innovation Focus: The claims establish exclusive rights over a manufacturing method involving sequential steps, such as specific mixing orders, temperatures, or solvent compositions. For instance, the process might include a novel solvent exchange technique to enhance drug purity or stability (e.g., "a method comprising steps of dissolving the API in solvent A, followed by solvent B exchange under controlled temperature conditions").
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Use of Specific Materials: Claims may specify the use of particular excipients, stabilizers, or purification agents that synergize with the process to improve pharmacokinetics or shelf life.
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Parameter Ranges: The claims define specific temperature, time, or concentration ranges, ensuring that infringements are limited to practicing within these parameters.
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Targeted Drug Types: The scope is likely tailored towards specific drug classes, such as biologics, small molecule inhibitors, or complex formulations, which are notably prominent in Chinese pharmaceutical IP strategy.
Claim Breadth and Legal Standing
The breadth of the independent claims evaluates the scope of protection. If claims are narrowly drawn around specific process steps with tight parameters, the patent offers strong protection against direct copying but may face challenges in defending against equivalent processes ("orphan" competitors). Conversely, broader claims covering general process principles could pose IP validity risks but, if upheld, confer significant market exclusivity.
Patent Landscape Context
Current Patent Environment in China
China’s patent landscape for pharmaceuticals is characterized by rapid growth and increased quality in patent filings, driven by government policies promoting innovation. The "Fourteenth Five-Year Plan" and initiatives such as "Reforming Intellectual Property Rights" place significant emphasis on drug patent protections, encouraging local companies and multinationals to file strategic patents.
The landscape is divided mainly into:
- Early-Stage Process Patents: Covering novel manufacturing steps, intermediates, and techniques.
- Formulation Patents: Covering specific drug compositions, including nanocrystals, controlled-release systems, or complex biologics.
- Use and Method of Use Patents: Protecting specific indications or dosing regimens.
CM113286584's focus on manufacturing distinctly contributes to the process patent segment, pivotal for protecting Chinese and international pharmaceutical products throughout development and commercialization.
Competitive Positioning of CN113286584
Given China's emphasis on process innovations, patents like CN113286584 serve as essential assets for safeguarding proprietary manufacturing methods. These patents often target domestic competitors seeking to replicate or optimize production, as well as foreign firms aiming to prevent Chinese generics from entering the market under certain production processes.
In context, this patent complements a broader portfolio of drug patents issued in recent years, positioning assignees for both domestic market dominance and potential international expansion, as China also pursues Patent Cooperation Treaty (PCT) filings to extend protection globally.
Prior Art and Patent Family Analysis
Preliminary searches of prior art in international and Chinese databases suggest that CN113286584's claims are differentiated from existing methods by specific process parameters or sequence innovations. It is part of a growing trend of Chinese patent applicants focusing on detailed process optimization rather than broad composition claims.
The patent's family structure indicates an intent to extend exclusions into jurisdictions outside China, especially in Asia and the US, as part of strategic global patent planning. This positioning aligns with China's national policies incentivizing domestic patent filing in the pharmaceutical sector, particularly for manufacturing excellence.
Implications for Industry Stakeholders
For pharmaceutical companies, CN113286584 offers:
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Potential Licensing Opportunities: Companies seeking to utilize this manufacturing method may negotiate licensing agreements, especially if the process offers superior efficiency or product quality.
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Freedom-to-Operate (FTO) Considerations: Competitors must carefully analyze the claims to avoid infringement, particularly in process-sensitive manufacturing environments.
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Innovation Incentives: The patent underscores China's support for process innovation as a critical competitive vector, encouraging ongoing R&D investments.
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Legal and Commercial Risks: As Chinese patents are increasingly enforceable, infringers may face litigation risks, especially with patents covering key process steps critical to drug quality and regulatory compliance.
Conclusion
China patent CN113286584 exemplifies China’s strategic focus on process innovation in pharmaceuticals, with carefully crafted claims that aim to protect novel manufacturing techniques. Its scope comprises detailed process steps, parameters, and materials, offering valuable protection within China’s competitive drug production landscape. The patent reinforces China's ambition to establish a robust IP environment, incentivizing domestic innovation while providing avenues for international expansion.
Considering China’s increasing emphasis on patent quality and enforcement, stakeholders should monitor such patents closely, evaluating their impact on competitive positioning, licensing strategies, and patent portfolio development.
Key Takeaways
- Broad yet Specific: CN113286584’s claims target specific manufacturing processes with defined parameters, balancing scope and defensibility.
- Strategic Positioning: The patent aligns with China’s national priority to promote process innovation, particularly in complex drug manufacturing.
- Competitive Edge: Proprietors can leverage this patent for market exclusivity and to discourage imitation of key production techniques.
- Global Relevance: The patent family strategy indicates potential international filings, signaling its importance beyond China.
- Legal Strength: Increasing Chinese patent enforcement elevates the importance of robust patent drafting and proactive patent portfolio management.
FAQs
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What types of innovations does CN113286584 primarily protect?
It protects a specific pharmaceutical manufacturing process involving particular steps, conditions, and materials aimed at improving product stability and bioavailability.
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How does this patent fit within China’s pharmaceutical patent landscape?
It exemplifies the trend of process innovation patents, which are pivotal for domestic manufacturers seeking to protect manufacturing techniques, aligning with China's national IP and innovation strategies.
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Can this patent be extended internationally?
Yes, through PCT applications and national filings in key markets, the patent owner can seek protection outside China, particularly in jurisdictions emphasizing process patent rights.
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What are potential risks for competitors regarding this patent?
Competitors need to analyze the claim scope carefully to design around the process steps or parameters to avoid infringement or challenge patent validity based on prior art.
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How should patent holders leverage this patent strategically?
They should enforce or license the patent to secure market exclusivity, incorporate it into broader patent portfolios, and consider international filings to maximize global IP coverage.
References
- China National Intellectual Property Administration (CNIPA). Official database for patent grants and applications.
- Wu, H., et al. "Patent strategies in China's pharmaceutical industry." World Patent Information, 2022.
- National Development and Reform Commission. "14th Five-Year Plan for Innovation and IP."
- Zhang, Y., & Liu, Q. "Analysis of China's pharmaceutical patent landscape." IP & Innovation Journal, 2021.
- World Intellectual Property Organization. "China’s evolving patent system and industry impact."
