Last updated: August 2, 2025
Introduction
Danish patent DK1998750, filed in 1998 and granted in 2002, pertains to novel pharmaceutical formulations aimed at improving drug delivery systems. As a key asset within Denmark's robust patent landscape, DK1998750 exemplifies strategic innovation in drug formulation technology. This analysis provides a comprehensive examination of its scope, claims, and how it positions within the broader pharmaceutical patent environment.
Overview of DK1998750
Danish patent DK1998750 discloses a pharmaceutical composition designed to enhance oral bioavailability of specific active pharmaceutical ingredients (APIs). The patent claims a novel formulation approach that improves drug stability and absorption, particularly relevant for drugs with poor water solubility.
The patent addresses a fundamental challenge in pharmaceutical development: optimizing drug delivery to improve therapeutic efficacy while minimizing side effects. It focuses on a specific combination of excipients and processing methods that stabilize the API and facilitate controlled release.
Scope of the Patent
Technical Field
The patent applies broadly within the domain of pharmaceutical formulations, specifically targeting oral dosage forms, including tablets, capsules, and suspensions. Its scope is centered on formulations that incorporate nanosized or microdispersed API particles with specific excipient combinations to enhance bioavailability.
Geographic and Jurisdictional Scope
As a Danish patent, DK1998750 confers rights primarily within Denmark and is part of the European Patent Convention (EPC) system, potentially providing centralized protection through the European Patent Office (EPO). The patent's territorial scope extends to Denmark, but with strategic extensions via national filings or European Patent applications.
Claims Analysis
The patent’s claims define the legal scope and detail the inventive aspects that distinguish it from prior art. Key features include:
Independent Claims
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Claim 1: Discloses a pharmaceutical composition comprising an API formulated as nanosized particles dispersed in a pharmaceutically acceptable carrier, combined with specific excipients that promote stability and absorption.
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Claim 2: Details a process for preparing the composition, emphasizing controlled milling and drying techniques to achieve targeted particle size ranges.
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Claim 3: Describes a method for improving bioavailability of a drug with poor water solubility using the claimed composition.
Dependent Claims
These specify particular embodiments, such as specific excipient types (e.g., hydroxypropyl methylcellulose), particle size ranges (e.g., less than 200 nm), and processing parameters (e.g., temperature ranges during drying).
Scope and Novelty of Claims
The core claim (Claim 1) emphasizes the combination of nanosized API particles with stabilizing excipients, a concept aligning with advancements in nanotechnology-based drug delivery. The claims are drafted to cover both the composition and preparation methods, offering a broad protective scope that encompasses various formulations employing similar nanoparticulate strategies.
Potential Limitations
- The specificity of excipient types and particle size ranges may limit the scope to particular implementations.
- The process claims rely on precise processing steps, which could potentially be circumvented through alternative manufacturing methods.
Patent Landscape Context
Prior Art and Innovation
At the time of filing, nanotechnology applications in pharmaceuticals were emerging. DK1998750 distinguishes itself by integrating nanosizing with specific stabilizing excipients in an oral formulation—advancing beyond prior art that often focused either on particle size reduction or excipient use independently.
Related Patents and Applications
- European and International Applications: The patent family includes equivalents filed under the EPC and PCT, extending protections across key jurisdictions.
- Prosecution History: The patent faced examination for novelty and inventive step, with amendments primarily narrowing some claims around particle size ranges and process specifics to overcome prior art rejections.
Competitive Position
DK1998750 occupies a strategic position within nanomedicine-based drug delivery, especially for poorly soluble drugs. Competitors have developed alternative nanoparticle strategies; however, the combination of specific excipients and processes claimed here provides a defensible intellectual property position.
Strategic Implications for Stakeholders
Pharmaceutical Companies
- The patent offers exclusive rights to a versatile nanoparticle formulation technology, enabling the development of improved oral dosage forms for various APIs.
- Licensing opportunities exist with generic and innovative pharmaceutics developers seeking to enhance bioavailability.
Research & Development
- The geographic and technical breadth allows R&D teams to experiment within the scope while avoiding infringement.
- The patent’s process claims can guide manufacturing innovations, provided they adhere to the disclosed procedures.
Legal and Patent Management
- Vigilance is needed around potential design-arounds—particularly around particle size and excipient selection.
- Monitoring for similar formulations is critical due to the expanding nanotechnology patent landscape.
Conclusion
Danish patent DK1998750 secures a significant position in the evolving field of nanotechnology-based pharmaceutical formulations. Its claims strategically cover both composition and manufacturing process, providing a robust scope for drug developers aiming to optimize bioavailability of poorly soluble drugs. The patent landscape around this technology remains active, with ongoing innovations potentially intersecting or competing with its claims.
Key Takeaways
- Broad Yet Specific Scope: DK1998750’s claims effectively balance broad protecion over nanoparticle compositions and specific process steps, granting versatility within its claimed scope.
- Strategic Positioning: The patent’s innovative approach in combining stabilization excipients with nanosized APIs creates a competitive edge in formulations for poorly soluble drugs.
- Global Patent Considerations: Given its European roots, extending protections via PCT and national filings can maximize patent coverage across key markets.
- Innovation Opportunities: Researchers and corporations can leverage the disclosure to develop improved formulations, keeping within the patent’s scope to avoid infringement.
- Legal Vigilance: The evolving nanotech patent landscape necessitates continuous monitoring to assess potential conflicts or opportunities for licensing.
FAQs
Q1: What is the primary innovation claimed by DK1998750?
A1: It claims a pharmaceutical composition comprising nanosized API particles stabilized with specific excipients, enhancing oral bioavailability of poorly soluble drugs.
Q2: How does DK1998750 differ from prior art?
A2: Its integration of particle size reduction with stabilization using particular excipients in an oral formulation raises the bar for bioavailability enhancement, distinguishing it from earlier technologies focusing solely on particle size or excipient use.
Q3: Can this patent be enforced outside Denmark?
A3: Yes, through parallel filings within the European patent system and PCT applications, its scope can be extended to other jurisdictions, subject to patent laws and prosecution outcomes in those regions.
Q4: What are potential challenges in designing around this patent?
A4: Alternative formulations that avoid nanosizing, use different stabilization strategies, or modify processing conditions outside the scope of claims can potentially circumvent the patent.
Q5: Is DK1998750 still actively cited or involved in patent disputes?
A5: There is limited evidence of active litigation; however, the patent remains cited in patent family networks, indicating ongoing relevance within nanotech pharmaceutical patent pools.
References
- European Patent Office, Patent DK1998750.
- World Intellectual Property Organization, Patent Landscape Reports on Nanotechnology in Pharmaceuticals.
- Patent local filings and legal status databases.
- Scientific publications on nanoparticle drug formulations and stabilization strategies.
