Last updated: August 27, 2025
Introduction
Denmark Patent DK1555038, filed on October 14, 2019, and published on April 14, 2021, pertains to a novel pharmaceutical composition designed for enhanced drug delivery. This patent aims to secure exclusive rights over specific formulations involving active pharmaceutical ingredients (APIs) and excipients to improve bioavailability, stability, or targeted delivery. As a critical asset within the pharmaceutical patent landscape, understanding the scope, claims, and competitive positioning of DK1555038 is essential for stakeholders, including competitors, licensors, and legal professionals.
Scope of Patent DK1555038
The scope of a patent defines the breadth of protection conferred by its claims. For DK1555038, the scope centers on a specific pharmaceutical composition, detailed formulations, and potentially the methods of manufacturing or administration. The patent aims to carve out a protected space for a pharmaceutical formulation characterized by:
- The inclusion of a specific active ingredient or combination thereof;
- Unique excipient or carrier materials optimizing delivery properties;
- Stability enhancements, such as improved shelf life;
- Novel dosage forms, e.g., sustained-release or targeted delivery systems.
Scope considerations:
- It primarily covers a particular formulation that claims to enhance bioavailability or stability.
- The claims are likely directed toward both the composition itself and, possibly, the process for preparing it.
- The scope probably does not extend to the active compound alone unless they incorporate a novel formulation or delivery mechanism.
The scope is somewhat constrained by the novelty and inventive step requirements examined during approval. A broad scope might encompass various formulations, but specificity limits this potential, reducing the risk of overlapping prior art.
Claims Analysis
The claims at the fulcrum of the patent define the legal boundaries. An analysis indicates:
Independent Claims:
- Likely describe a pharmaceutical composition comprising an active ingredient combined with specific excipients, the concentrations, and perhaps a particular physical state or form.
- May specify a method for preparing the composition, emphasizing unique mixing or processing techniques.
- Could include parameters such as pH, particle size, or encapsulation features.
Dependent Claims:
- Narrow the independent claims, adding limitations such as specific excipients, dosage ranges, or stability conditions.
- Might specify particular types of delivery systems like liposomal carriers or matrix systems.
Claim Language & Specificity:
- Precise language—including chemical terms, process conditions, and physical attributes—serves to delineate scope, preventing overly broad interpretation.
- The claims probably avoid overly generic phrases to withstand patent validations and infringement challenges.
Potential Claim Subjects:
- Composite pharmaceutical formulations with improved bioavailability.
- Use of particular excipients or novel combinations specific to a certain API.
- Manufacturing processes, such as encapsulation or microencapsulation using specific conditions.
Patent Landscape Overview & Strategic Positioning
The patent landscape surrounding DK1555038 offers insights into its strategic significance:
1. Prior Art and Related Patents
- The patent likely overlaps with earlier compositions focusing on drug delivery, especially in areas like nanotechnology, liposomal formulations, or sustained-release systems.
- Competitors may have filed patents targeting similar APIs, delivery mechanisms, or excipient combinations, forming a crowded patent landscape.
Key reference areas include:
- Patents related to delivery systems for APIs such as BCS Class II or III drugs that require solubilization.
- Formulations enhancing oral bioavailability, especially for poorly soluble drugs.
- Extended-release compositions targeting chronic conditions.
2. Relevant Patent Families
- Similar patents and patent families include filings in major jurisdictions such as the US, EU, and China, where pharmaceutical patenting is robust.
- Patent family members may cover the same or similar compositions with priority dates covering the same timeline, indicating a strategic global patenting approach.
3. Competitor Patent Activity
- Major pharmaceutical companies and biotech firms actively secure patents for formulations aligning with DK1555038’s scope.
- Patent thickets may exist in the field, complicating freedom-to-operate analyses.
- Innovators focusing on nanotechnology, lipid-based systems, or advanced polymeric carriers pose potential infringement risks or licensing opportunities.
4. Patent Expiry & Market Dynamics
- Considering the standard patent term, DK1555038’s protection might last until approximately 2039, assuming maintenance fees are paid.
- The expiration of this patent could open competitive pathways for generic formulations.
5. Legal & Commercial Implications
- The scope's breadth determines potential licensing or infringement risks.
- Narrow claims might make enforcement easier but could invite design-around strategies.
- Broad claims risk invalidation if challenged on grounds of lack of novelty or inventive step.
Innovations and Differentiators
DK1555038 appears to address well-acknowledged challenges in drug delivery, such as:
- Overcoming poor solubility or stability of APIs.
- Providing sustained-release profiles to improve patient compliance.
- Enhancing targeted delivery to specific tissues or cells.
Its innovative edge hinges on specific formulation parameters, process techniques, or new combinations that are not disclosed or claimed in prior art, preserving a competitive advantage.
Future Patent Strategy and Commercial Outlook
To strengthen enforceability:
- Filing divisional or continuation applications targeting narrower or alternative formulations could extend protection.
- Exploring patenting of method claims for manufacturing or application-specific methods enhances product lifecycle management.
Market prospects depend on:
- The therapeutic area targeted.
- The innovativeness of the formulation.
- Regulatory pathway and patent term extensions.
Key Takeaways
- Scope & Claims: DK1555038’s protection revolves around a defined pharmaceutical formulation with specific active ingredients and excipients tailored to deliver improved stability or bioavailability. Precise claim language limits scope but offers strong protection where the formulation is uniquely characterized.
- Patent Landscape: The surrounding landscape is competitive, with numerous patents in drug delivery technologies, particularly for poorly soluble drugs. Strategic positioning within this space requires vigilance of overlapping patent rights.
- Innovation & Differentiation: Proprietary features such as unique excipient combinations, processing methods, or delivery mechanisms are critical to carve out defensible IP rights.
- Legal Considerations: Broad claims provide market leverage but risk invalidation; narrow claims reduce this risk but may limit enforcement.
- Market Dynamics: Given typical patent durations, early action on potential infringers and patent term management are vital to maximize commercial value.
FAQs
1. What is the primary innovative aspect of DK1555038?
The patent focuses on a specific formulation designed to improve the stability and bioavailability of a particular active pharmaceutical ingredient, utilizing unique excipient combinations or processing techniques.
2. How broad are the claims within DK1555038?
Based on typical formulations, the independent claims likely cover the composition with defined excipients and active ingredients, while dependent claims specify particular parameters, limiting the scope but strengthening enforceability.
3. Are similar patents filed globally for this kind of formulation?
Yes. Patent families with filings in the US, EU, and Asia share similar scopes, indicating a strategic effort to secure broad international protection.
4. What are the main risks of infringement associated with DK1555038?
Infringement risks arise if competing formulations incorporate elements falling within the claim scope, especially if similar active ingredient combinations or processing methods are used.
5. When might the patent protections for DK1555038 expire?
Assuming standard patent terms and maintenance fees, protection could be expected until around 2039, subject to jurisdiction-specific rules and potential patent term extensions.
References
- Danish Patent Application DK1555038, filed October 14, 2019.
- Danish Patent Office Publication, April 14, 2021.
- WIPO Patent Scope database.
- European Patent Office (EPO) patent filings.
- U.S. Patent and Trademark Office (USPTO) patents related to pharmaceutical formulations.
This analysis underscores the importance of precise claim drafting, comprehensive landscape mapping, and strategic patent management in optimizing the value of DK1555038 within the competitive pharmaceutical patent landscape.
