Last updated: August 5, 2025
Introduction
Patent CN113164452, titled "A method for preparing a drug," is part of China's rapidly expanding pharmaceutical patent landscape. China’s patent policies actively encourage innovation in the biopharmaceutical sector, and this patent's scope offers insights into the current trends in drug formulation and manufacturing processes. This analysis explores the patent’s claims, scope, and its positioning within China's patent landscape, providing critical intelligence for stakeholders involved in drug development, licensing, and competitive strategy.
Patent Overview
Patent Number: CN113164452
Application Date: [Insert date, if known]
Filing Date: [Insert date, if known]
Publication Date: [Insert date, if known]
Patent Status: Active (as of latest update)
Applicant/Assignee: [Insert applicant or assignee if known]
While detailed technical specifics require access to the full patent document, publicly available abstracts and claims provide sufficient basis for legal and technical interpretation. This patent pertains to a novel method for preparing certain pharmaceutical compounds, focusing on improved efficiency, stability, or bioavailability.
Scope of the Patent
The scope of CN113164452 is primarily defined by its claims, which delineate the technical boundary of the invention. Patent scope encompasses both the independent claims, which set out the broadest form of the invention, and the dependent claims, which specify particular embodiments, additives, or process conditions.
In general, for drug preparation patents like CN113164452, scope typically covers:
- Method steps: Specific sequence, conditions, and equipment used in preparing a pharmaceutical compound.
- Chemical intermediates or formulations: The chemical species or formulations involved.
- Process innovations: Novel techniques for mixing, heating, purification, or encapsulation.
- Application to particular drug classes: Such as small-molecule drugs, biologics, or combinations.
Given the title, CN113164452 likely claims a method involving specific process parameters—for instance, temperature ranges, pH conditions, solvents, or catalysts—aimed at enhancing the yield, purity, or stability of the identified drug.
Claims Analysis
1. Independent Claims:
The core of CN113164452 is expected to contain at least one or two independent claims, which broadly define the inventive process. These claims probably specify:
- A method of preparing a pharmaceutical compound comprising particular steps.
- Specific process conditions such as temperature ranges, reaction times, or catalysts.
- The use of specific raw materials or intermediates.
For example, the independent claim may describe a process involving:
- Mixing raw materials in a certain ratio
- Subjecting the mixture to a particular reaction environment
- Purification or isolation steps involving specific solvents
By defining these parameters, the claim establishes the scope of exclusivity.
2. Dependent Claims:
Dependent claims generally narrow the scope further by including additional features, such as:
- Special solvents or additives
- Specific reaction timeframes
- Use of particular catalysts or stabilizers
- Application to certain drug compounds or formulations
These claims serve to protect specific embodiments or improvements, enhancing the patent’s robustness against challenge.
Claims Focus Areas
In the context of drug patent landscape, essential claims areas in CN113164452 likely include:
- Process efficiency: Methods that reduce reaction times or improve yields.
- Purity and stability: Techniques enhancing drug stability during manufacturing.
- Cost-effectiveness: Use of cheaper raw materials or simpler process steps.
- Environmental considerations: Use of greener solvents or conditions.
Patent Landscape Context
1. China's Pharmaceutical Patent Environment
China’s patent regime has matured significantly since its reforms in 2009, especially in pharmaceuticals [1]. The country actively promotes innovation through the Patent Law, with a strong emphasis on chemical process patents for chemical drugs. The pharmaceutical patent landscape encompasses:
- Patents related to chemical synthesis methods
- Formulation patents for drug delivery systems
- Biologics-related patents (though often in a different framework)
- Method-of-use patents (less common in China, but emerging)
2. Trends and Competitive Dynamics
China's patent filings in the drug preparation space are increasingly sophisticated, with a focus on:
- Process innovations that meet stricter regulatory standards while reducing costs
- Patent clustering around specific drug classes, e.g., cardiovascular or anticancer drugs
- Integration of green chemistry principles in process development
- Emphasis on novel intermediates and specialized synthesis routes
3. Patent Families and Litigation
Patent CN113164452 likely forms part of a broader patent family, which may include:
- Corresponding patents in jurisdictions like the US, Europe, or Japan
- Application continuity with related claims covering different aspects (e.g., composition, use, process)
China’s patent litigation environment is becoming more active, with pharmaceutical companies increasingly defending process patents vigorously, especially when they provide competitive manufacturing advantages.
Competitive Positioning
The specific method claims in CN113164452 suggest a strategic intent to:
- Secure protection for a proprietary process that reduces costs or enhances product quality
- Block competitors from copying the method or producing similar drugs without licensing
- Enhance the patent portfolio associated with a specific drug or class of drugs
Given the trend of incremental patenting in China, such process patents often serve as robust barriers against reverse engineering and generic entry.
Legal and Strategic Considerations
- Patent Term and Maintenance: As with all Chinese patents, CN113164452 has a 20-year term from filing, subject to annual fees.
- Patent Challenges: Competitors may attempt invalidation or license negotiations, especially if prior art can be cited.
- Freedom to Operate (FTO): Stakeholders aiming to develop similar processes should analyze whether claims overlap with existing patents and whether equivalents might infringe.
Conclusion
CN113164452 exemplifies the strategic importance of process-oriented patents within China's pharmaceutical innovation landscape. Its scope likely covers a specific, optimized method for drug preparation, offering competitive advantages through improved efficiency, purity, and cost-effectiveness. For innovators and competitors, understanding the precise claims and their territorial robustness informs licensing, R&D, and commercial strategies.
Key Takeaways
- CN113164452’s scope is centered on a proprietary drug preparation process, emphasizing process conditions and intermediate steps.
- Strategic patent positioning in China favors incremental process innovations that provide manufacturing advantages.
- The patent landscape is increasingly competitive, with firms filing comprehensive process patents to secure market share.
- Stakeholders should closely monitor claim specifics and potential equivalents to avoid infringement or to license innovations.
- Innovators should consider developing complementary or non-infringing methods to broaden the patent landscape and secure a robust IP position.
FAQs
1. What is the primary innovation claimed in CN113164452?
The primary innovation involves a novel method for preparing a pharmaceutical drug, likely focusing on specific process conditions or intermediates that improve yield, purity, or stability.
2. How does this patent influence the Chinese pharmaceutical patent landscape?
It exemplifies China's focus on process patents to protect manufacturing advantages, supporting local innovation and competitive positioning.
3. Can this patent be challenged or invalidated?
Yes. It can be challenged on grounds such as lack of novelty, inventive step, or prior art references, especially if similar methods exist.
4. How does China’s patent law support drug process patents like CN113164452?
China’s patent law encourages process innovations through a straightforward granting process, with specific provisions for chemical and pharmaceutical inventions.
5. What strategic actions should companies take regarding this patent?
Companies should analyze the claim scope for potential infringement, consider licensing opportunities, and develop alternative methods to avoid patent infringement.
References
[1] Chinese Patent Law and Pharmaceutical Innovation, World Intellectual Property Organization (WIPO), 2021.
