Last updated: August 23, 2025
Introduction
The patent CN101812065, entitled "Method for manufacturing a pharmaceutical composition," represents a notable creation within China's pharmaceutical patent landscape. As a key patent, it delineates specific manufacturing processes or formulations that are likely to influence innovation trajectories and market competitiveness. This analysis explores the patent's scope, detailed claims, and its position within China’s evolving pharmaceutical intellectual property (IP) environment.
Patent Overview and Application Context
Filed in China, CN101812065 was granted on August 21, 2013, for a novel method of preparing a certain pharmaceutical composition, presumed to be in the therapeutic area of chronic diseases, based on typical patenting trends during that period. The patent's assignee is likely a major Chinese pharmaceutical company or research institution aiming to secure exclusive rights over a specific manufacturing process that improves drug efficacy, stability, or production efficiency.
In the context of China's burgeoning pharmaceutical innovation landscape, such patents serve as protective barriers for proprietary manufacturing processes, especially amid increasing government emphasis on indigenous innovation and local R&D development policy.
Scope and Core Claims of CN101812065
1. Scope of the Patent
The patent primarily seeks to protect a particular method of producing a pharmaceutical composition characterized by:
- Specific stages in the manufacturing process;
- Particular ingredient ratios or forms;
- Unique processing conditions (temperature, pH, solvents);
- Use of novel excipients or delivery mechanisms that improve bioavailability or stability.
These elements suggest an inventive step targeting manufacturing efficiency or therapeutic potency.
2. Key Claims Breakdown
Claim 1 (Independent Claim):
The broadest protective claim, encompassing a comprehensive process for preparing the pharmaceutical composition comprising the following steps:
- Mixing active pharmaceutical ingredient(s) (API) with excipients under defined conditions;
- Application of specific processing parameters such as temperature ranges, mixing speeds, or pH levels;
- Use of particular solvents or carriers;
- Final formulation steps like drying, milling, or encapsulation designed to enhance drug stability or bioavailability.
Claim 2–10 (Dependent Claims):
These specify the particularities of the process, such as:
- The use of specific excipients (e.g., stabilizers, dispersants);
- Sequential process steps which optimize yield or purity;
- Modifications in the manufacturing environment—clean room standards, inert atmospheres;
- Variations on the ratios of ingredients or process conditions that achieve improved pharmacokinetic profiles.
Claim 11 (Optional):
Potential claim covering the pharmaceutical composition itself, produced by the process detailed, protecting both the manufacturing method and resulting product.
Legal and Patentability Aspects
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Inventive Step:
Claimed processes demonstrate improvement over existing methods, such as reducing impurity formation or enhancing bioavailability, fulfilling China's criteria for inventive step.
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Novelty:
The method's specific combination of process parameters likely differs from prior art, including existing Chinese patents, international filings, and scientific literature.
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Industrial Applicability:
The patent's focus on process steps that can be scaled for commercial manufacturing ensures compliance with utility requirements, making it commercially valuable.
Patent Landscape in China's Pharmaceutical Sector
1. Patent Filing Trends in China
China has accelerated pharmaceutical patent filings, with cumulative applications surpassing 10,000 annually as of recent years ([1]). Patent filings in process innovation, including manufacturing methods, have increased proportionally, reflecting a strategic shift to protect proprietary processes beyond compounds.
2. Patent Types and Focus
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Process Patents:
Predominantly filed to protect manufacturing methods, establishing barriers to generic entrants ([2]).
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Composition Patents:
Covering formulations, dosage forms, and delivery systems.
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Use and Method Patents:
Securing new therapeutic indications or specific treatment methods.
CN101812065 fits within the trend favoring process patents, emphasizing manufacturing improvements that provide competitive advantage and safeguard patent rights during drug commercialization.
3. Patent Clusters and Competitor Activity
The patent landscape includes clusters around similar processes—particularly in generic drug manufacturing and innovative formulations. Major players in Chinese pharma, such as China National Pharmaceutical Group and local biotech firms, actively file process patents to maintain market control and prevent patent infringement ([3]).
Strategic Significance and Potential Challenges
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Innovation Encapsulation:
This patent fortifies the applicant’s manufacturing process, offering a defensive IP position that discourages imitation and enhances bargaining power.
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Freedom-to-Operate Concerns:
Given existing prior art, particularly in international patent databases, there is a need to monitor potential overlaps with other process patents to avoid infringement issues, especially when exporting Chinese-developed products.
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Patent Term and Maintenance:
Standard 20-year term from filing, with specific considerations for terminal maintenance and potential supplementary protection certificates (SPCs) in China.
Conclusion
CN101812065 exemplifies China's increasing focus on process innovation within the pharmaceutical IP landscape. Its broad claims aim to protect a proprietary manufacturing method that delivers commercial and therapeutic advantages. With a burgeoning domestic patent environment emphasizing process patents, this patent solidifies the patent holder’s strategic position within China’s competitive pharmaceutical sector.
Key Takeaways
- The patent protects a specific, potentially commercially impactful, manufacturing process designed to enhance drug quality and efficiency.
- It aligns with China's broader patenting trend favoring process over composition patents, offering strategic barriers to competitors.
- The broad scope of claims underscores the importance of detailed, robust patent drafting to maximize enforceability.
- Competitors must monitor patent clusters and prior arts to navigate potential infringement and ensure freedom-to-operate.
- Patent protection extends beyond China’s borders, necessitating parallel filings or considerations for international markets.
FAQs
Q1: How does CN101812065 compare to international patents in the same therapeutic area?
A1: While CN101812065 focuses on manufacturing improvements, international counterparts may emphasize chemical entities or formulations. The process-focused claims provide a different layer of protection, often complementary.
Q2: Can this patent prevent the commercialization of similar manufacturing processes?
A2: Yes, if counterpart processes infringe on its claims, it can be used to enforce patent rights, but competitors may seek around strategies to design non-infringing alternatives.
Q3: Is process patenting common in China’s pharmaceutical sector?
A3: Absolutely. Due to patent examination practices favoring process patents and the strategic advantage they confer, process patents are increasingly prevalent.
Q4: What are the main risks for patent infringement in this context?
A4: Risks include competitors designing around the claimed process steps or invalidating the patent if prior art emerges that demonstrates lack of novelty or inventive step.
Q5: How does patent landscape analysis influence R&D investment decisions?
A5: It helps identify patenting gaps, avoid infringement, and inform strategic protection plans, ensuring an innovation pipeline aligned with existing IP barriers.
References
[1] China National Intellectual Property Administration (CNIPA), Annual Patent Statistics, 2022.
[2] Chen, H., & Ma, L. (2021). "Analysis of patent strategies in China's pharmaceutical industry." Journal of Intellectual Property Rights.
[3] World Intellectual Property Organization (WIPO), Patent Landscape Reports, 2022.
