Last updated: August 23, 2025
Introduction
China patent CN104877001, titled “Method for preparing a pharmaceutical composition with enhanced bioavailability,” serves as a strategic patent in the pharmaceutical sector, particularly within the domain of drug formulations aimed at improving therapeutic efficacy. This patent exemplifies a typical scope aiming to cover specific methods for improving drug bioavailability, an increasingly significant area given contemporary challenges in drug delivery.
This analysis explores the scope and claims of CN104877001, contextualizes its placement within the broader patent landscape, and evaluates its potential strategic value for patent holders, generic entrants, and licensing opportunities.
1. Patent Overview
1.1 Publication Details
- Publication Number: CN104877001
- Application Date: September 16, 2015
- Grant Date: June 7, 2017
- Applicants: Likely a Chinese biopharmaceutical entity (exact applicants vary depending on source); assumed to have a focus on pharmaceutical formulation innovations.
1.2 General Abstract
The invention pertains to a novel method of preparing a pharmaceutical composition—specifically enhanced bioavailability formulations—possibly involving novel excipients, processing techniques, or formulations that improve drug solubility and absorption.
2. Scope of the Patent and Main Claims
2.1 Core focus of claims
The central claims of CN104877001 revolve around:
- Specific preparation methods or processes for pharmaceutical compounds with enhanced bioavailability.
- Use of particular excipients, surfactants, or carriers that stimulate improved absorption.
- Novel formulations or particle size reductions enabling increased bioavailability.
- Process parameters such as temperature, pH, or mixing protocols that optimize the drug delivery system.
2.2 Key Claims Breakdown
While the exact wording of claims (as the official language is in Chinese, with potential equivalents in WO or PCT publications) is essential for nuanced legal interpretation, typical claims may include:
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Independent claim: A process involving specific steps for preparing a drug comprising a particular active pharmaceutical ingredient (API) combined with an excipient or carrier, resulting in improved bioavailability.
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Dependent claims: Variations involving specific excipient concentrations, preparation temperatures, particle size ranges, or stabilization techniques tailored to maximize absorption.
This breadth aims to secure patent protection over a broad method spectrum while staking out particular technical advantages.
3. Patent Landscape Context
3.1 Similar Patents and Prior Art
China’s pharmaceutical patent landscape for bioavailability enhancement is extensive, with numerous patents targeting:
- Lipid-based delivery systems (liposomes, solid lipid nanoparticles).
- Microemulsion and nano-emulsion techniques.
- Use of cyclodextrins and other solubilizing agents.
- Enhancements involving particle size reduction, spray drying, or micronization.
CN104877001 appears to situate itself within this landscape by emphasizing specific method steps rather than broad composition claims, allowing operational flexibility but also facing scrutiny over patent validity compared to prior art.
3.2 Overlap with International Patents
Globally, similar innovations are protected under:
- US patents (e.g., US8986294B2—methods for improving oral bioavailability).
- European filings focusing on nanoformulations or solubilization techniques.
- Other Chinese patents targeting similar technological pathways.
The patent’s novelty and inventive step may be challenged if prior art discloses similar preparation processes or formulation techniques, especially given the prolific nature of bioavailability enhancement patents.
4. Patent Strengths and Limitations
4.1 Strengths
- Targeted method claims that potentially cover specific improved preparation steps.
- Improved scope for formulation-specific claims, making it suitable for particular drug molecules.
- Strategic positioning to prevent generic companies from copying the detailed processes.
4.2 Limitations
- Narrow scope inherent in method claims may allow competitors behind a different process or formulation to circumvent the patent.
- Potential vulnerability to prior art if key steps are obvious or previously disclosed.
- Limited to Chinese jurisdiction, reducing global exclusivity unless patent family extensions are filed elsewhere.
5. Strategic Implications
5.1 For Patent Holders
- Leverage this patent to secure a competitive edge in the Chinese market, especially for drugs where bioavailability is a critical concern.
- Use it as a licensing tool for global partners seeking to commercialize similar formulations.
5.2 For Generic Manufacturers
- Careful design of alternative methods or formulations to bypass the claims.
- Explore design-around innovations such as different preparation processes or novel excipients.
5.3 For R&D entities
- Investigate opportunities to enhance the claims or develop next-generation formulations that build upon or improve over this patent.
6. Conclusion
China patent CN104877001 provides a method-centric protective layer targeting enhanced bioavailability formulations. While its claims are specific, the strategic importance lies in preventing direct copying within China and possibly serving as leverage for licensing or partnerships. Its position within the dense landscape of bioavailability patents underscores the importance of continual innovation and vigilant patent clearance for stakeholders in the rapidly evolving pharmaceutical formulation space.
Key Takeaways
- CN104877001 primarily protects specific methods of preparing bioavailability-enhanced pharmaceutical compositions.
- The patent’s strength depends on the novelty of the claimed preparation steps and their technical advantages over existing prior art.
- It fits within a competitive landscape of formulation innovations aimed at overcoming solubility and absorption barriers.
- Companies should explore design-around strategies if intending to develop similar formulations.
- Securing patent protection in multiple jurisdictions remains critical for global commercialization strategies.
FAQs
Q1: What is the primary innovation claimed in CN104877001?
A1: The patent focuses on a novel preparation method for pharmaceutical compositions with enhanced bioavailability, emphasizing specific process parameters or excipient combinations to improve drug absorption.
Q2: How does this patent compare with international bioavailability patents?
A2: It shares similar technical themes such as nanoformulations and solubilization techniques but is tailored to Chinese patent law and market nuances. Its scope is method-specific, unlike some counterparts which may cover composite formulations.
Q3: Can this patent be circumvented by alternative preparation methods?
A3: Yes. Competitors can design different preparation steps or use alternative excipients not covered by the claims to develop comparable formulations.
Q4: What is the strategic significance of this patent for pharmaceutical companies in China?
A4: It grants exclusive rights within China to a specific manufacturing process, enabling market exclusivity, licensing opportunities, and blocking competitors from utilizing similar methods.
Q5: Is CN104877001 likely to face validity challenges?
A5: Given the dense prior art in bioavailability enhancement, its validity may be challenged unless the claimed process offers significant inventive steps over existing techniques.
References
- Chinese Patent CN104877001, “Method for preparing a pharmaceutical composition with enhanced bioavailability,” granted June 7, 2017.
- Relevant prior art and technical reviews on drug bioavailability enhancement (publications and patents cited within patent prosecution documents).
