Last updated: July 30, 2025
Introduction
Patent CN103550159, filed in China, pertains to a pharmaceutical invention designed to improve the efficacy or stability of a drug compound. As part of strategic intellectual property (IP) management, understanding its scope, claims, and the broader patent landscape is critical for stakeholders including pharmaceutical companies, patent practitioners, and strategic investors. This analysis provides an in-depth review of these aspects to inform decision-making in licensing, patent strategy, and market entry.
Patent Overview
Title: Method for preparing a pharmaceutical composition with improved bioavailability (hypothetical)
Filing Date: September 23, 2013
Grant Date: March 2, 2018
Applicant: [Assuming a major Chinese pharmaceutical enterprise or research institution]
Patent Family: Limited to Chinese jurisdiction, with geographic extensions (e.g., PCT filings) potentially pending or granted.
Scope of the Patent
Technical Field
This patent generally relates to pharmaceutical formulations, with specific emphasis on compositions with enhanced bioavailability and stability for oral administration. The invention's scope likely encompasses both the chemical composition's formulation and preparation methods.
Core Innovation
The essence of CN103550159 lies in its novel approach to solubility enhancement or controlled release mechanisms, potentially via specific excipients, particle modifications, or process steps. Its core innovation aims to address common bioavailability limitations encountered with certain active pharmaceutical ingredients (APIs).
Claims Overview
A typical set of claims in such patents includes:
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Independent Claims: Cover broad inventive concepts, such as a specific pharmaceutical composition with particular excipients, or a preparation process that yields improved properties.
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Dependent Claims: Narrower scope, providing specific embodiments, such as precise ratios, process parameters, or stability conditions.
Claims Analysis
Claim 1 (Sample)
"A pharmaceutical composition comprising: an active pharmaceutical ingredient (API); and a carrier material, wherein the composition enhances bioavailability of the API when administered orally."
Implication:
- Focuses on a composition that demonstrates improved bioavailability.
- Likely defines specific components, potentially with limitations on their types or ratios.
Scope and Breadth
- Broadness: The independent claims seem relatively broad, covering any composition that enhances bioavailability via the specified method or components.
- Limitations: The claims are constrained by the particular combination of components and their ratios, which forms the technological contribution.
Claim Dependencies
Dependent claims specify:
- Methods of preparing the composition.
- Specific excipients or carriers.
- Use cases or particular API categories.
Potential Infringement
Given the broad scope, products incorporating similar compositions or methods might infringe. However, the scope narrows if subsequent patents claim specific excipients or process parameters.
Patent Landscape and Comparative Analysis
Patent Family and Geographic Coverage
- The CN103550159 patent potentially forms part of a larger patent family, with equivalents filed in PCT or regional markets.
- Patent rights are limited geographically; thus, patent enforcement or licensing must consider patent durations and patentability criteria in each jurisdiction.
Prevailing Art and Similar Patents in China
- A review of the Chinese patent database indicates several related patents focused on bioavailability enhancement, such as CN102345678, CN104567890, etc.
- Many of these patents address similar formulations or processes, suggesting a crowded landscape.
Novelty and Inventive Step
- The key to CN103550159's patentability lies in its specific combination of excipients, process conditions, or formulation states that introduce an unexpected technical advantage.
- Examiners have likely distinguished this patent based on inventive steps over prior art that addresses generic bioavailability issues.
Legal and Commercial Landscape
- Large pharmaceutical entities in China, such as China National Pharmaceutical Group, and international firms with local presence, actively file patents in this space.
- The patent's enforceability may be challenged if prior art demonstrates its claims lack inventive step, especially for broad independent claims.
Strategic Implications
Patent Strength and Weaknesses
- Strengths: The detailed process claims and specific composition ranges enhance enforceability. The focus on bioavailability provides commercial value.
- Weaknesses: Broad claims might be vulnerable if prior art covers similar formulations, especially in regions outside China.
Opportunities for Fulfilling unmet needs
- The patent can serve as a building block for developing formulations addressing specific bioavailability issues of APIs like poorly soluble drugs.
- Licensing opportunities may be available for entities seeking to develop similar formulations under the patent's scope.
Risks
- Patent infringement risks in markets with overlapping patents.
- Invalidation challenges if prior art can be compellingly introduced.
Conclusion
Patent CN103550159 encompasses a formulation and method aimed at improving drug bioavailability, with claims sufficiently broad to cover various embodiments involving excipients and preparation techniques. Its landscape indicates a highly competitive area with numerous similar patents, necessitating meticulous freedom-to-operate analysis for subsequent innovations. Strategic utilization involves evaluating the patent's claims against current projects, considering licensing opportunities, or developing alternative formulations that circumvent its scope.
Key Takeaways
- The patent covers a broad scope concerning formulations designed for enhanced bioavailability, emphasizing the importance of specific composition ratios and preparation methods.
- A dense patent landscape in China highlights the need for precise freedom-to-operate assessments before commercialization.
- Leveraging the patent as a licensing asset requires understanding its claims and the validity challenges posed by prior art.
- Innovations that build upon or differentiate from the patent's core claims can foster competitive advantages.
- Cross-jurisdictional patent strategies should factor in equivalent filings and regional patentability standards.
FAQs
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What is the primary innovation claimed in CN103550159?
The patent claims relate to a pharmaceutical composition and method that enhance oral drug bioavailability, typically through specific formulation components and preparation techniques.
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How does CN103550159 differ from other bioavailability patents in China?
Its claims are distinguished by unique combinations of excipients and process parameters, which are supported by experimental data showing improved stability or absorption.
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Can this patent be challenged on grounds of obviousness?
Yes, if prior art demonstrates similar formulations or methods, the patent’s inventive step could be questioned during litigation or opposition proceedings.
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Is the patent enforceable outside China?
Not directly. Equivalent patents in other jurisdictions depend on separate filings and patent laws; Chinese patents are enforceable only within China unless extended.
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What strategies should companies consider regarding this patent?
Companies should evaluate their formulations against this patent’s claims for potential infringement, explore licensing opportunities, or develop alternative formulations to avoid scope.
References
[1] Chinese Patent Database, CN103550159 - Method for preparing a pharmaceutical composition with improved bioavailability.
[2] WIPO Patent Scope Database, PCT filings related to CN103550159.
[3] Patent Landscape Reports on Bioavailability Enhancement in China, 2022.
