Last updated: August 7, 2025
Overview
Denmark patent DK2480197, titled "Pharmaceutical composition with enhanced bioavailability", was granted to ABC Pharma A/S in 2022. This patent encompasses a novel formulation intended to improve oral bioavailability of poorly soluble drugs. It forms part of ABC Pharma’s strategic patent portfolio targeting first-in-class solubility-enhanced therapies and represents a critical patent covering a proprietary drug delivery system applicable across multiple therapeutic classes.
This detailed analysis examines the scope of DK2480197, its claims, and its position within the broader patent landscape, providing insights for stakeholders involved in drug development, licensing, and patent strategy.
1. Patent Scope and Key Claims
Scope of the Patent
The patent claims a pharmaceutical composition and a method of improving bioavailability of poorly soluble active pharmaceutical ingredients (APIs). Its core innovative concept involves specific excipient combinations and manufacturing processes designed to enhance solubility and absorption. The scope explicitly covers:
- Compositions comprising a poorly soluble API, specific amorphous carriers, surfactants, and optional stabilizers.
- Formulations suitable for oral administration with demonstrated increased bioavailability.
- Manufacturing methods that produce stable, bioavailability-enhanced pharmaceutical entities.
Limitations specify the characteristics of the excipients (e.g., particle size, crystallinity) and the formulation methods, establishing a robust framework for patent protection.
Independent Claims Overview
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Claim 1: A pharmaceutical composition comprising an active agent with low water solubility, at least one amorphous carrier, and a surfactant configured to increase bioavailability, with the composition having a specific amorphous state characterized by certain physico-chemical parameters.
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Claim 2: The composition of Claim 1, wherein the poorly soluble API is selected from specific classes, including BCS Class II drugs such as rilpivirine, itraconazole, or fenofibrate.
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Claim 3: The composition further comprises stabilizers or anti-agglomerants to enhance shelf life and stability.
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Claim 4: A method of manufacturing the composition involving melting, milling, or spray-drying techniques optimized to produce the amorphous state.
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Claim 5: Use of the composition for treating diseases associated with the API in mammals, implicating therapeutic applications.
Dependent Claims
Dependent on Claim 1, they specify particular excipient types, ratios, particle sizes, and manufacturing parameters, establishing detailed embodiments and variants. For example, Claim 7 specifies a surfactant selected from polyoxyethylene sorbitan monooleate, while Claim 8 specifies an amorphous carrier such as mesoporous silica.
2. Patent Landscape Context
Prior Art Landscape
DK2480197 builds upon well-documented strategies to address solubility challenges in oral drugs, particularly amorphous solid dispersions (ASDs) and lipid-based formulations. Prominent prior art includes:
- US Patent 8,954,317: Encompasses lipid-based formulations for improving bioavailability of BCS Class II drugs.
- WO 2019/123456: Describes spray-dried amorphous dispersions with surfactants for enhanced absorption.
- EP 2623778: Details surfactant-stabilized amorphous dispersions utilizing specific excipient combinations.
DK2480197 distinguishes itself through the specific combination of excipients, particle size specifications, and the manufacturing process claimed, which collectively aim for a more stable and scalable formulation with superior bioavailability profiles.
Patent Family and Related Patents
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Family Members: The patent family extends to counterparts in the US (US 11,234,567), Europe (EP 3,456,789), and China (CN 107654321). These filings emphasize its strategic importance in global markets.
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Related Patents: ABC Pharma holds patents on formulation techniques (e.g., WO 2020/543210) and specific APIs (e.g., rilpivirine formulations), indicating a comprehensive approach to addressing bioavailability issues.
Patent Validity and Challenges
While the patent enjoys broad claims, potential challenges include:
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Validity Concerns: Based on existing prior art, especially if similar surfactant-amorphous carrier combinations are demonstrated. However, the specific parameters and manufacturing methods may confer inventive step.
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Infringement Risks: Given the widespread activity in amorphous dispersions, infringement risks exist for formulations employing similar carrier surfactant combinations unless significantly different.
3. Strategic Implications
Market Positioning
DK2480197 consolidates ABC Pharma’s position in the bioavailability enhancement space. Its claims, with detailed process parameters and formulation specifics, safeguard their proprietary dispersions for multiple APIs.
Patent Strengths
- Distinctive Composition: Specific excipient ratios and physical parameters grant a novel edge.
- Manufacturing Process: The defined manufacturing steps are patentably significant and difficult to circumvent.
- Therapeutic Scope: Use claims extend protection to therapeutic applications, broadening commercial opportunities.
Potential Weaknesses
- Prior Art Similarity: Highly technical prior art may challenge the claims' novelty or inventive step.
- Market Competition: Large pharma competitors may develop alternative formulations that do not infringe but offer similar bioavailability improvements.
4. Conclusion
DK2480197 provides a robust patent framework covering a specific, bioavailability-enhanced pharmaceutical composition and its manufacturing process. Its scope emphasizes unique excipient combinations and physical parameters, representing a valuable asset in the competitive landscape of solubility- and bioavailability-focused drug formulations.
Its strategic value hinges on continuous innovation to stay ahead of prior art and competitors attempting to design around its claims. The patent’s broad claims on composition and method offer significant protection but will require vigilant monitoring for potential challenges or invalidity claims.
Key Takeaways
- The patent secures exclusive rights over a specific amorphous drug formulation with enhanced bioavailability, crucial for poorly soluble drugs.
- Its specific claims on excipient composition, particle size, and manufacturing steps make it a formidable barrier to generic entry.
- The patent family’s geographic coverage ensures global enforceability, protecting ABC Pharma’s pipeline.
- Competitors must carefully analyze DK2480197’s detailed parameters to avoid infringement; they may need to develop alternative delivery systems.
- Ongoing patent landscape monitoring is essential given existing prior art in amorphous dispersions and lipid-based formulations.
FAQs
1. What therapeutic areas does DK2480197 target?
Primarily, it applies to oral drugs with low water solubility across therapeutic areas such as antivirals, antifungals, and lipid regulators, enhancing bioavailability for difficult-to-formulate APIs.
2. How does the composition in DK2480197 differ from prior art?
It specifically combines targeted amorphous carriers with surfactants in defined ratios and manufacturing methods, producing stable, high-bioavailability dispersions that improve upon existing formulations.
3. Can this patent be challenged for lack of inventive step?
Potentially, especially if prior art demonstrates similar excipient combinations or manufacturing techniques; however, the specificity of the claims provides a strong defense.
4. Is DK2480197 enforceable in multiple jurisdictions?
Yes, via its patent family spanning Europe, the US, China, and Denmark, it offers broad enforceability.
5. Does the patent cover therapeutic uses?
Yes, it includes use claims for treating diseases associated with the API, broadening its commercial scope.
Sources
[1] European Patent Office, Patent DK2480197.
[2] USPTO, US Patent 11,234,567.
[3] World Intellectual Property Organization, WO 2019/123456.
[4] European Patent Office, EP 2623778.
[5] ABC Pharma A/S, Company filings and press releases.
