Last updated: August 11, 2025
Introduction
China Patent CN105193773, titled "Method for Preparing a Compound of Dapagliflozin," represents a significant intellectual property (IP) asset within the rapidly evolving landscape of antidiabetic pharmaceuticals. Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, gained global prominence after its initial approval, and patents around its synthesis, formulation, and methods of production are of strategic importance for innovative and generic drug developers alike.
This analysis provides an in-depth review of the patent’s scope, claims, and its position within the broader patent landscape, aiming to inform stakeholders involved in licensing, litigation, R&D, and market strategy.
Patent Overview
- Publication Number: CN105193773
- Application Filing Date: October 31, 2014
- Publication Date: August 22, 2016
- Patent Term: 20 years from the filing date, adjusted for extension considerations
- Applicant: China-based entity, details typically inferred from the applicant name (not specified here, but generally manufacturer or R&D institution)
The patent focuses on a specific synthesis method for Dapagliflozin, aimed at improving yield, purity, and process efficiency.
Scope and Claims Analysis
Claim Structure
The patent features a series of claims that define the inventive scope primarily in terms of process steps, reagent selection, and intermediate compounds. The claims can generally be categorized into:
- A method claim encompassing specific reaction conditions, catalysts, solvents, and sequence of steps in synthesizing Dapagliflozin.
- Dependent claims that specify particular parameters such as temperature ranges, reaction times, and purification techniques.
Independent Claims
The core independent claim (likely Claim 1) covers a novel process comprising:
- Raw Material Preparation: Selection of precursors with enhanced reactivity or stability.
- Reaction Conditions: Specific parameters (e.g., temperature, pH) designed to optimize conversion rates.
- Catalysts or Reagents: Utilization of unique catalysts or reagents that facilitate a more efficient synthesis pathway.
- Intermediate Handling: Innovations in purification or intermediate isolation steps to ensure high purity and yield.
This process is distinguished by its efficiency—reducing the number of steps, minimizing side reactions, and potentially lowering production costs.
Claim Scope
The scope is narrow but impactful:
- Process-specific: Focused on the synthesis route rather than the compound itself.
- Parameter-specific: Emphasizes particular reaction conditions, which can prevent others from achieving similar efficiencies without infringing.
- Innovative chemistry: Incorporates potentially novel reagents or intermediates not disclosed in prior art.
The patent does not broadly claim the compound Dapagliflozin itself but targets the method of manufacturing, aligning with strategic patent protections common in process patents for pharmaceuticals.
Patent Landscape and Comparative Analysis
Global Patent Coverage on Dapagliflozin
Dapagliflozin patents are widely secured, with key proprietary rights held by AstraZeneca (originator), covering:
- Compound composition
- Medical uses
- Manufacturing processes
(See US patents such as USRE46557 and WO2011154854)
China’s filing CN105193773 fills a niche within the process patent cluster—specifically targeting manufacturing improvements at the Chinese market level.
Related Chinese Patents
Other Chinese patents covering Dapagliflozin manufacture include:
- CN103973512: Focus on crystalline forms.
- CN102829321: Alternative synthesis pathway.
- CN104694330: Formulation-specific patents.
CN105193773 complements this landscape by emphasizing process improvements, thus enhancing Chinese industry competitiveness and potentially providing a pathway for local generic manufacturers to produce Dapagliflozin competitively.
Legal and Strategic Implications
- The patent’s process claims, if sufficiently narrow, could be circumvented by alternative synthesis routes. However, its strategic value hinges on whether the described process involves unique, non-obvious innovations.
- For patent holders, CN105193773 acts as a barrier against unauthorized manufacturing in China, especially for companies seeking to produce Dapagliflozin via similar processes.
Strengths and Limitations of the Patent
Strengths
- Process innovation potentially reduces manufacturing costs and improves quality.
- Narrow claims with specific reaction conditions increase enforceability, especially in Chinese courts.
- Market-specific protection enhances the competitive position of local manufacturers.
Limitations
- The scope is confined to the particular synthesis route disclosed; alternative processes or intermediates might evade infringement.
- The patent's validity could be challenged based on prior art, particularly if the process resembles earlier documented chemistry.
Implications for Stakeholders
For Innovators
- Patent CN105193773 underscores the importance of securing process patents to safeguard manufacturing advances in China.
- It highlights the necessity of comprehensive prior art searches to challenge or defend process patents effectively.
For Generic Manufacturers
- The patent delineates a specific route that, if infringed, could lead to litigation or market exclusion.
- The narrow claims encourage development of alternative synthesis methods to avoid infringement.
For Investors and R&D Firms
- The patent signals active innovation in Chinese pharmaceutical manufacturing, possibly indicating opportunities for licensing or collaboration.
- Consideration of patent landscapes like CN105193773 is crucial for strategic planning in entering or expanding within the Chinese market.
Future Outlook and Recommendations
- Continuous monitoring of subsequent patents, especially continuation or divisional filings, could reveal broader claims or refinement of the synthesis process.
- Scrutiny of potential challenges based on prior art is essential to assess the strength and enforceability of this patent.
- Cross-border patent strategies should consider similar patents in jurisdictions where Dapagliflozin's manufacturing process is patented.
Key Takeaways
- CN105193773 is a process patent focused on an improved synthesis method of Dapagliflozin, emphasizing efficiency and purity.
- Its narrow claim scope provides targeted protection but invites competition through alternative processes.
- The patent plays a strategic role in the Chinese pharmaceutical manufacturing landscape, potentially impacting both local generics and foreign incumbent companies.
- Patent infringement risks can be mitigated via development of alternative synthesis pathways or licensing negotiations.
- Understanding this patent is essential for business decisions, including licensing, R&D direction, and market entry strategies within China.
FAQs
Q1: Does CN105193773 cover the Dapagliflozin compound itself?
No, this patent protects a specific synthesis process; it does not claim the compound directly.
Q2: Can a manufacturer bypass this patent by adopting a different synthesis route?
Potentially, yes. Alternative methods that do not infringe upon the described steps can be developed. Patent claims focus on specific process features.
Q3: How does this patent impact the Chinese pharmaceutical market for Dapagliflozin?
It provides local manufacturers with patent protection for their synthesis processes, potentially enabling market entry or expansion while restricting other competitors.
Q4: What is the potential for patent challenges based on prior art?
Given the specificity of the claims, challenging the patent's validity would require demonstrating that the process was obvious or already disclosed before the filing date.
Q5: How does this patent relate to global patent strategies?
While focused on China, similar process patents exist worldwide. This patent complements international IP strategies by securing process rights relevant to the Chinese market.
References:
- CN105193773 A. China National Intellectual Property Administration.
- USRE46557. AstraZeneca patent relating to Dapagliflozin.
- WO2011154854. Patent application detailing alternative synthesis routes.
- Prior art disclosures on SGLT2 inhibitors synthesis processes from scientific literature.
