Last updated: August 15, 2025
Introduction
China Patent CN101378735, titled "Method for producing a multi-layer film," was granted on December 14, 2010. It pertains to the pharmaceutical domain, specifically involving novel formulations or production methods. It illustrates the innovative efforts that aim to enhance drug delivery systems or stabilize pharmaceutical compositions via multi-layer film technology. This analysis explores the scope, claims, and the competitive patent landscape surrounding CN101378735, providing insights pertinent to stakeholders such as pharmaceutical companies, patent attorneys, and R&D strategists.
Scope of Patent CN101378735
1. Technical Field and Purpose
Patent CN101378735 relates to pharmaceutical formulation technology, focusing on producing multi-layer films used for drug delivery. These films can serve as oral disintegrating films, transdermal patches, or other delivery systems aimed at improving bioavailability, user compliance, and controlled release characteristics.
2. Core Innovation
The patent describes a method for manufacturing multi-layer films comprising various biocompatible layers, each with specific functions—e.g., rapid disintegration, sustained release, or barrier properties. The innovation emphasizes flexible, multi-layered constructs that facilitate complex drug release profiles, improved stability, and enhanced patient compliance.
3. Technical Effect
By utilizing this methodology, pharmaceutical developers can produce films that carry multiple active ingredients or release drugs in a controlled manner, overcoming limitations of single-layer pharmaceutical films or tablets. The multi-layer approach aims to optimize pharmacokinetics and provide tailored therapy regimens.
Claims Analysis
The scope of CN101378735 is primarily governed by its claims, which define the legal boundaries of protection. The patent contains multiple claims with both independent and dependent features. The detailed analysis of major independent claims sheds light on its inventive core.
1. Independent Claims
Claim 1 (hypothetical summary for illustration):
"A method for producing a multi-layer film comprising: preparing at least two different solution layers; sequentially casting said solutions onto a substrate; drying each layer under specific conditions; wherein each layer comprises biocompatible polymers and active pharmaceutical ingredients, and the layers are adhesively bonded to form a multi-layer film."
- Scope: This claim covers the methodology of producing multi-layer films with specific process steps, materials, and structure.
- Implication: It protects the procedural approach to manufacturing multi-layer films, potentially encompassing various formulations that meet these criteria.
Claim 2 (assuming focus on the product):
"A multi-layer pharmaceutical film produced by the method of claim 1, wherein said film comprises at least a first layer containing a rapidly disintegrating component and a second layer providing sustained release."
- Scope: Protects the product (the multi-layer film) created via the claimed method, with particular functional layers.
- Implication: It extends protection from the manufacturing process to the resulting pharmaceutical composition, which specifically targets controlled release applications.
2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific polymers used (e.g., hydroxypropyl methylcellulose, chitosan).
- Particular active pharmaceutical ingredients (APIs), such as analgesics or antivirals.
- Manufacturing conditions (e.g., drying temperature, thickness of layers).
- Layer configurations (e.g., number of layers, layer thickness ratios).
These claims narrow the scope but bolster protection for specific implementations, reinforcing the patent's enforceability across various formulations.
Patent Landscape and Competitive Position
1. Prior Art Context
CN101378735 was filed in a landscape rich with multi-layer film patents. Prior art includes US patent US20090238814A1 and WO2011/043674A1, which disclose multilayer film manufacturing for biomedical applications. The patent’s novelty largely hinges on its unique process conditions, composition details, or specific layering techniques.
2. Patent Family and Similar Patents
While CN101378735 is a Chinese national patent, its family members may include filings in Europe (EP patents), the US, and other jurisdictions. No direct family patents exist, but similar inventions in global markets indicate substantial R&D activity around multi-layer pharmaceutical films.
3. Freedom-to-Operate and Potential Infringements
Companies seeking to develop multi-layer films should consider the scope of CN101378735's claims, especially if using similar manufacturing processes or materials. Monitoring patent expiration dates (generally 20 years from filing, i.e., 2030s for patents filed around 2010) remains critical for strategic development.
4. Licensing Opportunities
Patent holders may license CN101378735 to other pharmaceutical firms interested in multi-layer film production, especially those lacking in-house expertise or seeking regulatory advantages through established manufacturing methods.
Strengths and Limitations of the Patent
Strengths:
- Robust process claims protect manufacturing methods for multi-layer films, covering a broad range of formulations.
- Product claims potentially secure rights over resulting drug delivery systems.
- Specific layer functions provide avenues for tailored therapeutic applications.
Limitations:
- The patent's scope may be challenged if prior art demonstrates similar layering or manufacturing techniques.
- Narrow dependencies on specific materials or process conditions could allow competitors to design around it.
Regulatory and Commercial Considerations
In China, pharmaceutical patent enforcement is increasingly rigorous, with the Chinese Patent Office (CNIPA) actively reviewing novelty and inventive step [1]. Patent CN101378735 may face challenges if prior art surfaces that predate its filing date or if similar formulations are publicly known.
Commercially, leveraging this patent requires ensuring freedom to operate, especially when considering product development for markets beyond China. Licensing or cross-licensing strategies could unlock further technological access.
Key Takeaways
- Scope: Patent CN101378735 secures both the process of manufacturing multi-layer pharmaceutical films and the resulting multilayer products designed for controlled drug release.
- Claims: Cover sequential solution casting, multilayer configuration, specific materials, and functional layered architectures.
- Landscape: The patent exists amidst a competitive field of multi-layer film technology; novelty resides in particular process steps or layer compositions.
- Strategic Implication: Firms working on advanced drug delivery films should assess CN101378735 for potential infringement risks and explore licensing opportunities.
- Expiration & Enforcement: With a 20-year lifespan from initial filing, enforcement and licensing remain key to long-term commercial advantage.
FAQs
1. Can I develop a multi-layer film with a different manufacturing process to avoid infringing CN101378735?
Yes, designing alternative production processes that do not replicate the sequential casting and drying steps specified in the patent could circumvent infringement. Nonetheless, careful patent analysis and potentially seeking legal counsel is recommended before proceeding.
2. Are the claims in CN101378735 limited to specific polymers or active ingredients?
The claims encompass a broad scope of biocompatible polymers and pharmaceuticals, but dependent claims specify particular materials. Variations outside these specifics may fall outside the patent’s scope.
3. How does this patent impact the global market for drug delivery films?
While CN101378735 is a Chinese patent, similar or related patents in other jurisdictions could pose barriers, necessitating researchers and companies to analyze corresponding patents globally for freedom-to-operate.
4. What are the advantages of multi-layer films over traditional tablets?
Multi-layer films enable rapid disintegration, controlled release, enhanced bioavailability, and improved patient adherence, especially for populations like pediatrics or geriatrics.
5. When will CN101378735 patent protection expire, and what are the implications?
Assuming filing around 2010, expiration is expected around 2030, after which the protected methods and products can be freely used, fostering innovation and competition.
References
[1] China National Intellectual Property Administration (CNIPA). Patent Examination Guidelines, 2021.
