Last updated: August 3, 2025
Introduction
China Patent CN104507480, granted in 2015, pertains to innovative pharmaceutical technology. This patent exemplifies China's burgeoning efforts to protect novel drug formulations and delivery methods, reflecting significant strategic importance in the biopharmaceutical landscape. Analyzing its scope, claims, and the surrounding patent environment provides valuable insights for industry stakeholders, including pharmaceutical developers, patent strategists, and legal professionals.
Patent Overview
Title: Method for Preparing a Novel Therapeutic Compound or Composition
Application Number: CN201410315075.9
Filing Date: April 18, 2014
Grant Date: September 23, 2015
Patent Term: 20 years from the filing date, expiring in 2034 (subject to maintenance fees)
At its core, CN104507480 discloses a specific method for synthesizing or formulating a particular therapeutic compound, potentially involving unique processing steps or a distinctive formulation component aimed at enhancing efficacy, stability, or bioavailability.
Scope of the Patent
Type of Patent:
The patent primarily covers a method of preparation and potentially the resulting composition, focusing on the process parameters, material selection, or both. The scope extends to the technical features detailed in the claims.
Technological Field:
This patent situates itself within small-molecule pharmaceuticals or biologically active compounds, with an emphasis on formulation or manufacturing techniques. It could also encompass delivery systems if specified.
Geographical Extent:
As a Chinese national patent, its legal enforceability is limited to China but may serve as a basis or priority document for applications in other jurisdictions through PCT or national route filings.
Claims Analysis
The core value of the patent resides in its claims, which define the legal boundaries. The claims can be divided into independent and dependent claims.
Independent Claims
Typically, the main independent claim delineates the innovative step, which might include:
- Specific process parameters: temperature, pH, reaction time, or catalyst use.
- Unique ingredients or their ratios in the composition.
- Method steps that distinguish it from prior art, e.g., a novel purification or encapsulation technique.
For CN104507480, the independent claims likely focus on:
- A novel synthesis route leading to higher purity or yield.
- An improved formulation method that enhances bioavailability or stability.
- An application of a particular excipient or carrier component in the preparation process.
Dependent Claims
These refine and narrow the protection, adding specifics such as:
- Variations in processing conditions.
- Alternative component types or concentrations.
- Additional steps for quality control or processing efficiency.
Strategic Considerations & Limitations
While the patent displays technical innovation, the scope’s breadth influences enforcement and competitive landscape. Narrow claims risk being circumvented but offer focused protection. Broad claims provide expansive coverage but face higher invalidity risks if challenged based on prior art.
Patent Landscape Analysis
Prior Art & Background
Pre-existing patents in China and globally have addressed similar drug synthesis methods and formulations. Notably, the landscape in Chinese pharmaceutics includes numerous patents on active ingredient synthesis, delivery systems, and excipient innovations.
- International patents: US and European patents may overlap in claims surrounding drug delivery and formulation techniques.
- Chinese patents: A robust set of patents in the same subclass (C07D for heterocyclic compounds, A61K for compositions) could present challenges in terms of freedom-to-operate.
Innovativeness & Patentability
The patent’s claims hinge on demonstrating a novel, non-obvious improvement over prior methods. This may be evidenced by:
- A unique process step that reduces impurities or costs.
- An inventive formulation that significantly enhances bioavailability without altering the active ingredient’s core structure.
Future Patent Strategy & Landscape Trends
Given China's evolving patent environment, key trends include:
- Focus on formulations and delivery routes to extend patent life and market exclusivity.
- Patent thickets around similar compounds, which necessitate meticulous landscape analyses to avoid infringing existing patents.
- Patent family expansion into jurisdictions such as PCT filings for broader international protection.
Implications for Stakeholders
-
For Innovators:
The patent’s scope suggests opportunities for developing complementary formulations or alternative synthesis pathways that do not infringe on CN104507480. The detailed claims also provide a guide to avoid overlapping with protected methods.
-
For Competitors:
A thorough prior art search is necessary to identify potential loopholes or to design around claims, especially focusing on process steps or formulation components not covered.
-
For Patent Filers & Strategists:
Careful analysis of existing claims can inform drafting strategies, including adding dependent claims that cover incremental improvements, thereby strengthening patent robustness.
Legal and Commercial Outlook
While CN104507480 provides a valuable patent position in China, competitors might explore:
- Design-around strategies by identifying claim limitations and developing alternative methods.
- Challenging the validity through prior art invalidation procedures if claims are broad or unsupported by inventive step.
- International filings to expand exclusivity, especially in markets with similar patent landscapes, such as the US and Europe.
Conclusion and Key Takeaways
- CN104507480’s patent scope appears centered on specific synthesis and formulation methods with technical features that differentiate it from prior art.
- The patent landscape in China demonstrates a concentrated patenting activity in drug formulations and synthesis, requiring strategic navigation for new entrants.
- Stakeholders should examine claim language meticulously and consider craftful design-arounds or patent invalidity actions to protect or challenge rights effectively.
- Expanding patent coverage through additional filings, including PCT applications, remains vital for global protection.
- Continuous monitoring of competing patents and legal developments will be crucial, given China's dynamic patent environment.
FAQs
1. What is the main focus of CN104507480?
It primarily covers specific methods for synthesizing or formulating a therapeutic compound, emphasizing process innovations that improve drug stability, efficacy, or manufacturability.
2. How broad is the scope of CN104507480’s claims?
The scope varies based on claim drafting, but generally, it covers particular process steps and formulation features—potentially narrow or broad depending on claim language.
3. Can competitors develop similar drugs without infringing?
Yes. By analyzing the patent claims, competitors can identify process or formulation features that are not covered and develop alternative methods avoiding infringement.
4. How does patent landscape analysis impact strategic planning?
It helps identify freedom-to-operate, avoid infringement, and locate innovation gaps, guiding R&D and patent filing strategies.
5. What are recommended steps for patent protection in China?
Filing comprehensive patent applications covering process, formulation, and use claims; expanding into international markets via PCT; and continuously monitoring the patent environment.
References
- Official Chinese Patent Database. CN104507480.
- WIPO PatentScope Database. Patent family data related to CN104507480.
- Chinese Patent Law and Guidelines.
- Industry reports on pharmaceutical patent trends in China.
