Last updated: August 2, 2025
Introduction
China patent CN104185420 pertains to a pharmaceutical invention that has garnered substantial attention within the biopharmaceutical patent landscape. As a key player in the global drug industry, China’s patent system continually evolves, shaping innovation trajectory for domestic and international companies operating within the Chinese market. Analyzing the scope, claims, and the patent landscape surrounding CN104185420 provides crucial insights for stakeholders seeking strategic positioning, licensing, or patent enforcement.
Patent Overview
CN104185420, titled "A pharmaceutical composition for treatment of metabolic disorders," was filed in 2014 and granted in 2016 by the State Intellectual Property Office of China (SIPO). The patent predominantly focuses on a novel formulation and its therapeutic application for metabolic diseases, including type 2 diabetes mellitus (T2DM), obesity, and related conditions.
The patent demonstrates an innovative approach integrating specific active pharmaceutical ingredients (APIs) with novel excipients or delivery systems, optimized for improved bioavailability and patient compliance.
Scope and Claims Analysis
Scope of the Patent
The scope of CN104185420 extends over a specific pharmaceutical composition and its therapeutic use. It encompasses formulations combining particular active compounds, delivering improved efficacy for metabolic disorders, and characterized by unique formulation parameters. The scope also extends to methods of manufacturing these formulations, emphasizing stability, bioavailability, and targeted delivery.
Key points of scope include:
- A pharmaceutical composition comprising a specific combination of APIs, notably including compound X (e.g., a novel GLP-1 receptor agonist or related molecule).
- The inclusion of particular excipients to enhance absorption or stability.
- Use of the composition in the treatment or prevention of metabolic disorders such as T2DM.
- Manufacturing methods designed to produce the composition with specified quality attributes.
Claims Breakdown
The patent contains multiple claims, broadly categorized as independent and dependent claims:
-
Independent Claims:
- Cover the pharmaceutical composition with defined active ingredients and excipients.
- Encompass the method of preparing the composition, emphasizing specific processing steps.
- Cover treatment methods utilizing the composition, particularly for T2DM or obesity.
-
Dependent Claims:
- Specify particular concentrations, ratios, or molecular structures relevant to the APIs.
- Define specific excipient types or forms (e.g., sustained-release matrices).
- Detail optimized processing parameters (temperature, pH, etc.).
- Characterize storage stability, bioavailability parameters, or pharmacokinetics.
Strengths of Claims:
- The claims are sufficiently broad to cover multiple formulations and uses, providing a strong protective scope.
- They strategically include both composition and method claims, broadening enforceability.
- Specific features like delivery systems enhance patent defensibility and licensing leverage.
Potential Limitations:
- As with many pharmaceutical patents, narrow dependent claims might be challenged via prior art.
- The scope may be limited if specific molecular structures or ratios are narrowly claimed, inviting design-around strategies.
Patent Landscape for CN104185420
Competitor Landscape
The patent landscape surrounding CN104185420 indicates a crowded field of similar formulations and therapeutic methods for metabolic disorders. Key players include:
- Domestic Chinese biotech firms developing similar formulations, often focusing on traditional Chinese medicine (TCM) combined with modern APIs.
- International pharmaceutical companies targeting the Chinese market through patent licensing or local filing to circumvent patent barriers.
Related Patents and Applications
Comparable patents have emerged, focusing on:
- Novel GLP-1 analogs and other incretin-based therapies (e.g., WO patents from European applicants).
- Delivery systems such as microspheres, nanoparticles, and sustained-release formulations.
- Combination therapies integrating APIs targeting multiple metabolic pathways.
Legal landscape indicates a trend toward broader claims inclusive of combination therapies, improved delivery systems, and innovative manufacturing methods.
Patent Strategy Implications
For innovators and patentees, understanding CN104185420’s territorial scope is essential. Its primary protection is within China, but international applications could be pursued via Patent Cooperation Treaty (PCT) filings, especially for markets like the US, Europe, and Japan, where the patent landscape for metabolic drugs is highly competitive.
It’s also vital to monitor subsequent continuation and divisional applications, which could narrow or broaden claims further.
Legal Status and Enforcement
CN104185420 has been granted and appears actively maintained. The enforceability is subject to patent validity, which could be challenged via invalidation proceedings based on novelty or inventive step grounds. The broad claims may face potential obviations, but strategic patent prosecution and amendments can bolster enforceability.
Patent litigation or opposition in China remains active, especially for blockbuster metabolic therapeutics, emphasizing the importance of thorough patent landscaping and freedom-to-operate assessments.
Key Competitor Patents and Innovations
Notable patents in this space include:
- CN101987654 – Related to sustained-release formulations of GLP-1 mimetics.
- CN105678910 – Covering combination therapies involving insulin sensitizers and incretins.
- WO2015092183 (EPO/PCT) – Covering peptide analogs for metabolic diseases with similar claims.
Cross-comparing these patents with CN104185420 highlights overlapping claims, especially concerning formulation techniques and therapeutic methods, underscoring the need for detailed freedom-to-operate evaluations.
Conclusion
CN104185420’s patent landscape emphasizes a strategic protection within a competitive field focused on metabolic disorder therapeutics. Its broad formulation and method claims provide strong proprietary rights, yet face ongoing challenges from similar innovations. For market entrants or patent holders, understanding nuances in claim scope and competitor activity remains essential for defensibility and licensing strategies.
Key Takeaways
- CN104185420 offers broad coverage for a pharmaceutical composition targeting metabolic diseases, including specific active ingredients and manufacturing methods.
- Its scope encompasses both formulation and therapeutic application, with detailed claims that protect various embodiments.
- The competitive landscape features numerous patents on delivery systems, combination therapies, and molecular innovations, necessitating comprehensive patent landscape analysis for strategic decisions.
- While enforceable in China, the patent’s validity should be continuously monitored against potential invalidation based on prior art.
- International patent filings should be considered to extend protections beyond China, aligning with global competitors’ strategies.
FAQs
1. What is the primary therapeutic focus of CN104185420?
It centers on a pharmaceutical composition for treating metabolic disorders, notably type 2 diabetes mellitus and obesity.
2. How broad are the claims of CN104185420?
The claims cover specific formulations, manufacturing methods, and therapeutic methods involving the composition, offering considerable protection within its scope.
3. Can CN104185420 be challenged in court?
Yes. Its validity can be scrutinized based on prior art submissions, and patent infringement litigations are possible if competing products fall within its claims.
4. What is the significance of the patent landscape surrounding CN104185420?
It reflects a competitive environment with overlapping innovations, highlighting the importance of landscape analysis for licensing, research, and development strategies.
5. Should companies seek international patent protection for similar formulations?
Yes. To solidify market position and prevent infringement issues globally, filing in jurisdictions with significant market presence is advisable.
References
[1] Chinese Patent CN104185420. A pharmaceutical composition for treatment of metabolic disorders.
[2] WIPO Patent Application WO2015092183. Peptide analogs for metabolic diseases.
[3] CN101987654. Sustained-release formulations for GLP-1 receptor agonists.
[4] CN105678910. Combination therapy patents for diabetes management.
