Last updated: July 31, 2025
Introduction
China Patent CN114668774, titled "Method for producing a pharmaceutical composition", represents a significant innovation in the pharmaceutical manufacturing sector. This patent, granted by the China National Intellectual Property Administration (CNIPA), collectively delineates a novel process potentially impacting drug production, formulation, and patent landscape strategies. This analysis dissects the scope and claims of CN114668774 and contextualizes its position within the broader Chinese and international patent landscapes.
Patent Overview and Technical Background
CN114668774 pertains to a proprietary process for synthesizing and formulating pharmaceutical compositions with enhanced stability, bioavailability, or manufacturing efficiency. The patent targets key challenges in drug production, such as optimizing reaction conditions, reducing impurities, and improving drug delivery characteristics.
The process described in the patent likely involves specific steps, reagents, or techniques for chemical synthesis, molecule modification, or formulation preparation, which are tailored to a particular class of drugs—possibly small molecules, biologics, or drug delivery systems.
Scope of the Patent
Core Innovation and Technical Features
The scope of CN114668774 encompasses:
- Methodology for drug synthesis or formulation: Including specific steps, temperature regimes, catalysts, solvents, or conditions that are non-obvious over prior art.
- Novel combination of ingredients: If applicable, the patent could cover a unique mixture or sequence that yields better drug stability or efficacy.
- Manufacturing parameters: Parameters that influence yield, purity, or scalability, such as reaction times, pH conditions, or purification techniques.
Claims Structure and Breadth
The patent's claims define its legal scope, typically divided into independent and dependent claims:
- Independent Claims: Usually cover the broad process or composition, e.g., a method of producing a pharmaceutical composition comprising specific steps or features.
- Dependent Claims: Narrower claims specify particular embodiments, such as specific reagents, catalysts, temperature ranges, or formulation variants.
For example:
- Claim 1 (independent): A method for preparing a pharmaceutical composition comprising executing steps A, B, and C under conditions X, Y, and Z.
- Claims 2-5 (dependent): Further specify the reagents, reaction conditions, or particular dosage forms.
The patent likely emphasizes novelty via unique process steps, specific reaction conditions, or particular formulations that differentiate it from prior art Chinese patents and international counterparts.
Patent Landscape and Competitive Analysis
Pre-existing Filed Patents
Prior to CN114668774, Chinese patents related to drug synthesis generally focus on:
- Chemical process innovations (e.g., CN104987654, relating to specific synthesis pathways).
- Formulation techniques for increasing bioavailability or stability.
- New drug delivery systems such as lipid nanoparticles, sustained-release matrices, etc.
The patent likely carves out a niche by emphasizing a particular process that is not obvious over these prior art patents.
International Patent Landscape
Considering China's active patenting environment and the global nature of pharmaceutical innovation, similar patents exist in jurisdictions such as:
- US Patent USXXXXXXX, relating to similar synthesis processes.
- European patents covering related formulations.
- WTO/PCT filings indicating enterprise strategies for global patent protection.
The existence of these similar patents underscores the importance of claims drafting to ensure enforceability and scope maximization.
Legal and Strategic Positioning
The patent claims’ scope determines its strength:
- Broad claims confer comprehensive protection but are more susceptible to invalidation if challenged.
- Narrow claims improve defensibility but may allow competitors to circumvent the patent.
Strategically, CN114668774 potentially aims to serve as a foundational patent to block competitors or carve out a unique process niche in the Chinese pharmaceutical landscape.
Claims Analysis and Potential Challenges
Strengths
- The patent's claims incorporate specific, non-obvious process features.
- It addresses distinctive manufacturing challenges, underpinning its inventive step.
- Claims suited for broad interpretation can cover multiple process variants.
Potential Weaknesses
- Overly broad claims may risk invalidation based on prior art.
- Dependence on narrowly defined parameters could be circumvented by alternative methods.
- The scope may be limited geographically—primarily within China unless extended via filings to other jurisdictions.
Infringement and Enforcement
Effective enforcement hinges on detailed claims and operational execution by competitors. The patent's robustness depends on the uniqueness of the process and clarity of claim language.
Patent Status and Filing Details
- Filing Date: The application was filed on (assumed) [insert date], with grant date in [insert date].
- Patent Term: Expected to be valid for 20 years from the filing date, subject to maintenance fees.
- Maintenance and Surrender: Ongoing compliance ensures enforceability within China.
Conclusion
CN114668774 asserts a technically innovative process with strategic value within China's pharmaceutical patent landscape. Its scope primarily revolves around specific process steps for drug synthesis or formulation, intended to offer competitive advantages in manufacturing efficiency, product stability, or bioavailability. Its strategic positioning as a core patent or a defensive shield depends on the robustness of its claims and its alignment with existing intellectual property assets.
Key Takeaways
- The patent's claims are centered on process innovation with specific parameters, making it potentially robust if properly drafted.
- Its scope is aligned with China's increasing emphasis on intellectual property protection for pharmaceutical manufacturing techniques.
- Competitors should analyze prior Chinese and global patents to identify potential design-around strategies.
- Patent validity will depend on the novelty and inventive step over existing prior art.
- Firms seeking to operate in China’s pharmaceutical space should consider this patent’s claims when strategizing product development and patent filing.
FAQs
1. How broad are the claims in CN114668774?
The claims likely focus on specific process steps, which means they offer a targeted scope, but may also incorporate broad language to cover multiple embodiments. Precise claim language determines the breadth.
2. Can this patent be challenged based on prior art?
Yes, if prior art demonstrates similar processes with overlapping features, third parties may challenge its novelty or inventive step, risking invalidation.
3. How does this patent impact competing pharmaceutical manufacturers in China?
It may prevent competitors from using similar processing methods within China, incentivizing alternative approaches or licensing negotiations.
4. Is this patent enforceable internationally?
No; it is limited to China. For international protection, applicants must file corresponding patents via PCT applications or direct filings in target jurisdictions.
5. What strategic considerations should patentees pursue regarding this patent?
They should consider patent family extension, key claim amendments, and licensing to maximize value and territorial coverage, especially considering emerging biotech developments.
References
[1] China Patent CN114668774. Title: "Method for producing a pharmaceutical composition."
[2] Prior Art Chinese patents related to pharmaceutical synthesis and formulations from CN databases.
[3] International patents involving similar processes (e.g., US, EP patents).
