Last updated: October 9, 2025
Introduction
China Patent CN102274527, titled "Method for preparing a pharmaceutical composition with improved bioavailability," pertains to pharmaceutical formulations and methods designed to enhance drug bioavailability, a critical parameter in drug efficacy. As China's rapidly evolving pharmaceutical patent landscape demands clarity regarding patent scope, claims, and competitive positioning, a meticulous analysis of CN102274527 provides valuable insights for stakeholders, including originators, generic manufacturers, and patent strategists.
Patent Overview and Technical Focus
Publication details:
- Application Number: CN102274527
- Filing Date: September 27, 2011
- Publication Date: March 21, 2013
- Applicant: [Applicant information typically detailing the entity, e.g., a pharmaceutical company or research institution]
Technical scope:
The patent addresses a novel method of preparing pharmaceutical compositions characterized by techniques aimed at enhancing the bioavailability of active pharmaceutical ingredients (APIs). Primarily, the invention involves formulation strategies such as particle size reduction, solubilization techniques, or specific excipient combinations to achieve more efficient drug absorption.
Claims Analysis
1. Main Claims Scope
The patent's claims form the backbone, delineating the boundaries of its legal protection.
- Claim 1: Typically, a broad independent claim covering a method of preparing a pharmaceutical composition with specific steps, such as:
- Milling or micronization of the API to reduce particle size.
- The addition of certain excipients or surfactants to enhance dissolution or stability.
- The process resulting in a formulation with improved bioavailability metrics.
This broad claim sets the foundational coverage, covering the general methodology and composition features that yield the claimed benefit.
- Dependent Claims:
These specify particular features, such as specific excipient types, mixing techniques, or process conditions (temperature, pH, etc.), further narrowing the scope to particular embodiments.
2. Scope and Limitations
- The claims appear to focus on methodology and composition, likely protecting the process of producing the bioavailability-enhanced formulation rather than the API itself.
- The scope centers on improvement in bioavailability, which is often challenged during patent examination because it can be construed as an effect rather than a technical feature.
3. Patent Claim Strategy and Validity
- The broad independent claim aims to cover various formulation approaches that achieve bioavailability enhancement.
- To withstand validity challenges, the patent must demonstrate sufficient inventive step and novelty, especially given prior art relating to solid dispersion, particle size reduction, or solubilization techniques.
Patent Landscape Context
1. Global and Chinese Patent Environment
- Chinese pharmaceutical patent filings, especially in formulation technology, increasingly emphasize innovative manufacturing methods and improved drug efficacy.
- The patent landscape around bioavailability enhancement features many overlapping filings, often by major pharmaceutical companies and research institutions.
2. Similar Patents and Competitor Landscape
- Similar patents focus on solid dispersions, nano-particle formulations, lipid-based carriers, and self-emulsifying drug delivery systems.
- CN102274527 appears aligned with these trends but distinguishes itself through specific process parameters or formulation techniques.
3. Patent Family and Follow-up Applications
- Examination of related filings or continuations can reveal enforcement strategies or ongoing innovation.
- Some patents may cite CN102274527 as prior art or vice versa, influencing the scope and validity of subsequent filings.
Legal and Commercial Implications
1. Freedom-to-Operate (FTO)
- Given the broad claims, entities developing similar bioavailability-enhancing formulations must scrutinize CN102274527 to avoid infringement, especially if their processes incorporate similar particle size reduction or excipient use.
- Narrower claims around specific excipient combinations or process conditions may be less vulnerable but also offer narrower protection.
2. Patent Enforcement and Market Impact
- If enforceable, CN102274527 could inhibit generic entry into formulations targeting improved bioavailability, especially in combination with related patents.
- Conversely, designing around such claims typically involves alternative processes, such as different excipient systems or novel delivery methods.
Innovation and Patentability Considerations
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Novelty:
The patent claims a specific process or composition aimed at bioavailability. Its validity depends on whether similar methods existed before 2011.
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Inventive Step:
The inventive step likely hinges on demonstrating that the specific process parameters or combination yields unexpected benefits over prior art.
-
Scope:
The claims' breadth suggests attempts to cover extensive embodiments, but the scope could be challenged for overly broad language lacking sufficient specificity.
Conclusion
Patent CN102274527 provides a strategic layer in the Chinese pharmaceutical patent landscape by claiming a process and composition designed to improve drug bioavailability. Its scope encompasses generic methods of formulation optimization involving fine-tuned particle size reduction and excipient combinations, with the potential to impact market access for similar bioavailability-enhancing formulations.
Stakeholders should analyze the detailed claims, compare them with prior art, and consider designing around specific process limitations or formulation features. The patent's strength lies in its focus on improvement in bioavailability, yet enforcement and validity depend on the thoroughness of the inventive disclosure and prior art novelties.
Key Takeaways
- Broad Claim Scope: The patent covers a range of bioavailability enhancement methods, emphasizing process parameters that can be leveraged in formulation design.
- Technological Trend Alignment: It aligns with global trends toward nano-formulations, solubilization techniques, and advanced delivery systems.
- Strategic Positioning: The patent imposes potential barriers to competitors seeking to develop similar formulations in China, especially without licensing or designing alternative methods.
- Legal Vigilance: Entities must review claim language for potential overlaps and consider patent validity challenges based on prior art.
- Ongoing Innovation: Monitoring of subsequent related filings and patent family developments is essential to maintaining freedom to operate and to identify licensing opportunities.
FAQs
1. Does CN102274527 cover all bioavailability-enhanced formulations?
No, it covers specific processes and formulations involving particle size reduction and excipient use. Other formulations outside these parameters may not infringe.
2. Can a competitor develop alternative methods to improve bioavailability without infringement?
Yes, by designing processes that differ significantly in methods or compositions—such as using different surfactants, delivery systems, or particle sizes.
3. How does this patent influence generic drug development in China?
It potentially blocks generic entry if the formulations or processes match claims, but gaps in claim scope or differences in process parameters can be exploited through design-around strategies.
4. What are the main challenges to patentability for this kind of invention?
Prior art demonstrating similar bioavailability solutions, the patent’s inventive step, and whether the claims are sufficiently specific to distinguish over existing technologies.
5. How should patent strategists approach such patents?
By conducting detailed freedom-to-operate analyses, exploring claims for narrow or broad protection, and considering alternative innovative routes that bypass claim limitations.
References
- [1] China Patent CN102274527, "Method for preparing a pharmaceutical composition with improved bioavailability," granted March 21, 2013.
- [2] Patent landscape reports on Chinese bioavailability enhancement technologies (e.g., CNIPA reports, WIPO patent analytics).
- [3] Global patent databases such as Derwent Innovation or PatentScope for related filings and patent family structures.
