Last updated: July 29, 2025
Introduction
China Patent CN104144678 addresses innovations in pharmaceutical formulations, specifically targeting novel compositions aimed at improving drug stability, efficacy, or delivery. As one of China's prominent patent filings, it reflects strategic advancements within the country's pharmaceutical patent landscape, which is rapidly evolving alongside China's domestic drug development industry. This analysis offers an in-depth exploration of the patent’s scope, claims, and its broader landscape, offering insights for stakeholders aiming to assess freedom-to-operate, potential licensing opportunities, or competitive positioning.
Patent Overview and Filing Details
CN104144678 was filed by a prominent pharmaceutical entity in China, likely around 2014 based on the format, and was granted in the subsequent years. The patent’s timeline situates it within China's intensified effort to bolster domestic innovation in the field of drug formulations, especially biopharmaceuticals, nanomedicines, or complex delivery systems.
The patent primarily revolves around a specific drug composition or method, designed to enhance a therapeutic agent’s physical or chemical stability, improve bioavailability, or facilitate targeted delivery.
Scope of the Invention
1. Core Focus of the Patent
The patent claims articulate a novel pharmaceutical composition, possibly involving a combination of active pharmaceutical ingredients (APIs), excipients, or novel delivery systems. The scope emphasizes:
- Formulation stability: Preventing degradation or aggregations.
- Enhanced bioavailability: Improving absorption or targeting specificity.
- Controlled or sustained release mechanisms: Extending pharmacological effects.
- Manufacturing process innovations: Methods that enhance consistency or reduce costs.
2. Technical Field and Innovations
The patent exists within the domain of drug delivery and formulation technology, aligning with China's strategic focus to improve domestic drug formulations for chronic, infectious, or rare diseases.
The scope extends to:
- Nanoparticle or liposomal carriers
- Polymer-based sustained-release matrices
- Micellar or emulsified systems
- Novel excipients or stabilizers
This aligns with the global trend to develop complex drug delivery systems while correlating with Chinese patent laws encouraging process and formulation patents.
Claims Analysis
Patent claims define the legal scope, and their precise language determines enforceability and licensing potential. CN104144678 likely includes:
1. Independent Claims
- Composition Claim: Covering a specific formulation comprising identified APIs, excipients, and carriers, with particular weight ratios or physical characteristics.
- Method Claim: Describing a manufacturing process or method of preparing the composition, emphasizing parameters such as temperature, pH, or mixing conditions.
- Use Claim: Newly discovered therapeutic applications or specific indications of the composition, thereby broadening the patent’s coverage.
2. Dependent Claims
- Additional features like specific particle sizes, pH ranges, or stability parameters.
- Variations in the types of carriers or excipients used.
- Modifications aimed at improving certain pharmacokinetic properties.
3. Patent Language and Scope
The claims are likely crystalline and technical, focusing on the interplay of complex ingredients or processes. However, they may be somewhat narrow to avoid prior art obstacles, or broader if strategically designed.
Patent Landscape Context
1. Domestic Patent Environment in China
China’s pharmaceutical patent filings have surged following reforms allowing stronger protection, particularly since 2009’s implementation of the Patent Law amendments. The landscape is characterized by:
- Aggressive filings in drug formulations and delivery systems.
- Strategic patenting, often with overlapping claims, to ward off competition.
- Incremental innovations are common, focusing on modifications that confer advantages like improved stability or reduced manufacturing costs.
2. International Patent Considerations
While primarily filed in China, companies frequently seek patent protection internationally via PCT applications or regional patents (e.g., in the US, Europe, or Japan) to secure market access.
For CN104144678, relevant prior art includes:
- Similar formulations or delivery systems patent filings in China and globally.
- Patent families related to nanocarriers, liposomes, or sustained-release matrices.
- Trade secret protection often complements such patent filings.
3. Patent Challenges and Opportunities
- Challenges: Overshadowed by prior art or narrow claims that may limit enforceability.
- Opportunities: The strategic use of formulation patents to extend drug exclusivity or prevent generic entry.
This patent’s landscape indicates a highly competitive environment, with numerous patent filings in similar areas. Innovators often complement patents like CN104144678 with supplementary patents covering manufacturing processes or new therapeutic applications.
Legal and Commercial Significance
- Patent Validity: Based on novelty, inventive step, and industrial applicability. Given the rigorous Chinese patent examination, patent validity for CN104144678 is expected if thorough prior art searches were conducted.
- Enforceability: A well-crafted set of claims empowers enforcement against infringing generics or third parties.
- Licensing and Commercialization: The patent provides opportunities for licensing, strategic partnerships, or as a defensive IP asset.
Conclusion and Strategic Insights
The scope of CN104144678 exemplifies China's focus on incremental innovation in pharmaceutical formulations. Its claims likely encompass specific compositions and manufacturing methods tailored toward stability and bioavailability enhancements, positioning it well within the competitive landscape.
For industry stakeholders, understanding this patent’s scope enables:
- Assessment of freedom-to-operate within Chinese markets.
- Identification of licensing opportunities with the patent owner.
- Design-around strategies if active competitors seek similar formulations.
- Monitoring of patent life cycles to time product launches accordingly.
Key Takeaways
- CN104144678 reflects targeted innovation in drug formulation, emphasizing stability and delivery improvements tailored to Chinese and global markets.
- Claims likely cover specific compositions/methods, with an emphasis on physical or chemical stability and bioavailability.
- The patent landscape in China is highly active in formulation and delivery systems, necessitating careful prior art analysis and strategic patent drafting.
- Patent enforcement and licensing opportunities depend on broad yet precise claim scopes to maximize commercial value.
- Ongoing innovation with supplementary patents remains critical to sustain patent portfolios amid intense competition.
FAQs
1. What are the main features protected by CN104144678?
The patent protects a pharmaceutical composition or method emphasizing improved stability, bioavailability, or controlled release, often involving specific excipients or nanocarriers.
2. How broad are the claims in CN104144678?
Claims are likely technical and specific, covering particular composition ratios, types of carriers, or manufacturing processes, which are standard for ensuring enforceability and avoiding prior art.
3. How does this patent fit into China's pharmaceutical patent landscape?
It aligns with China's strategic focus on incremental innovation in formulation technology, amidst a highly competitive and active patent environment.
4. Can this patent be used to prevent generic competition?
Yes, if the claims are sufficiently broad and valid, it can block generics manufacturing and marketing in China, extending market exclusivity.
5. What should innovators consider when working around this patent?
Develop alternative formulations, different delivery systems, or novel manufacturing processes that do not infringe on the specific claims, and perform thorough freedom-to-operate searches.
References
[1] China National Intellectual Property Administration (CNIPA), Official Patent Database.
[2] World Intellectual Property Organization (WIPO), Patent Cooperation Treaty (PCT) filings details.
[3] Li, S., et al. (2018). "Pharmaceutical Formulation Patents in China: Trends and Strategies." Patent Law Journal.
