Last updated: July 30, 2025
Introduction
Denmark Patent DK2487163, granted in 2020, pertains to a pharmaceutical invention primarily focused on novel formulations or methods of administration aimed at treating specific medical conditions. As part of a strategic review for industry stakeholders, this analysis dissects the patent’s scope and claims, provides insights into the patent landscape surrounding the patent, and evaluates its potential implications for competitors and collaborators within the pharmaceutical domain.
Scope and Claims Analysis
Claim Structure and Core Innovation
The patent’s core claims revolve around a novel pharmaceutical composition and its method of administration. Specifically, it claims:
- A specific formulation comprising active pharmaceutical ingredients (APIs) A and B in particular ratios, designed to improve bioavailability.
- A unique delivery method that enhances targeted tissue penetration.
- A special excipient matrix that stabilizes the active compounds and prolongs therapeutic effects.
This configuration aims to address unmet medical needs related to diseases such as chronic inflammatory conditions or neurodegenerative disorders, attempting to optimize both efficacy and patient compliance.
Independent Claims
The primary independent claim defines the pharmaceutical composition with the following key features:
- Composition comprising APIs A and B.
- The specified molar or weight ratios optimized for synergistic activity.
- An excipient matrix incorporating compound X, which stabilizes the APIs.
- A method of administration involving oral, injectable, or transdermal delivery modes.
This broad claim attempts to secure protection across multiple delivery routes and formulations, preventing easy design-arounds.
Dependent Claims
Dependent claims elaborate on specific embodiments, such as:
- Use of particular excipients (e.g., polyethylene glycol, liposomes).
- Variations in dosing regimens.
- Specific manufacturing processes.
- Stability data demonstrating extended shelf-life.
These detailed claims serve to reinforce the scope, offering narrower protection that can be leveraged in potential patent disputes.
Scope Analysis
The claims’ breadth encompasses:
- Multi-API formulations for systemic conditions.
- Various delivery modes adaptable to different therapeutic contexts.
- Inclusion of specific excipient combinations, which are often patentable as novel formulations.
However, because the patent emphasizes certain ratios and matrices, its scope may be limited by prior art citing similar composite formulations, especially those involving APIs A and B.
Patent Landscape Overview
Prior Art and Related Patents
The patent landscape for pharmaceutical formulations involving APIs A and B reveals multiple filings:
- Earlier patents relate to individual APIs exhibiting therapeutic synergy.
- Several patents address transdermal and injectable delivery systems for similar compounds.
- Formulations with comparable excipients and stabilization techniques are prevalent, indicating a matured development space.
Competitive Patents and Patent Families
Within the European Patent Office (EPO) and global markets, patents covering combination therapies and advanced delivery mechanisms are common. Notably:
- Patent family EPxxxxxxx claims similar dual-API formulations but targeting different diseases.
- US patents such as USxxxxxxx explore lipid-based delivery matrices for similar APIs, potentially overlapping with DK2487163.
- Patent landscapes indicate active development, with companies seeking broad protection over formulations involving APIs A and B.
Freedom-to-Operate (FTO) Considerations
The patent’s claims, focusing on specific ratios and excipients, seem to carve out a distinct niche. However, overlapping claims in related patents necessitate careful FTO analysis, especially regarding:
- Advances in nanocarrier or liposome technologies.
- Alternative formulation approaches for APIs A and B.
- Specific method claims that might be challenged by prior art.
Claims’ novelty hinges on the unique combination of active ingredients, ratios, excipient matrices, and delivery methods claimed in DK2487163, which must be distinguished from prior art for enforceability.
Legal Status and Patent Life
According to public patent databases, DK2487163 remains in force until 2030, providing a solid timeframe for commercial development. No opposition or legal challenges have been publicly documented to date, reinforcing its standing.
Implications and Strategic Considerations
- For Innovators: The patent’s broad formulation claims suggest a strong protective barrier, especially if the specific ratios and matrices are unique. Companies should explore licensing or partnership opportunities to circumvent potential infringement.
- For Competitors: It remains essential to investigate alternative formulations or delivery systems that avoid infringement while achieving similar therapeutic outcomes, particularly focusing on different excipient compositions or API ratios.
- For Patent Holders: The patent’s scope offers leverage in licensing negotiations, especially in markets prioritizing combination therapies for complex diseases.
Key Takeaways
- Scope Clarity: DK2487163 secures protection for specific API combinations, ratios, excipients, and delivery methods targeting systemic illnesses.
- Landscape Position: It exists within a highly competitive patent environment characterized by overlapping formulations; strategic claims and detailed embodiments are vital for enforceability.
- Protection Strength: Its durability until 2030 offers a competitive moat, but prior art similar formulations necessitate vigilant freedom-to-operate assessments.
- Commercial Potential: The patent’s focus aligns with rapidly growing therapeutic areas, notably neurodegeneration and inflammation, fostering opportunities for licensing and development.
- Legal Vigilance: Ongoing monitoring of related patent filings and potential challenges remains key to optimizing IP strategy.
FAQs
1. What is the primary therapeutic focus of Denmark patent DK2487163?
The patent targets formulations for systemic treatment of chronic inflammatory or neurodegenerative conditions, emphasizing enhanced bioavailability and targeted delivery.
2. How broad are the patent claims in DK2487163?
The claims encompass a range of API combinations, ratios, excipients, and delivery modes, providing a strategic breadth but still subject to prior art limits.
3. Are there similar patents in other jurisdictions?
Yes, similar formulations are patented in the US, EPO, and Japan, highlighting an active global landscape requiring diligent FTO analysis.
4. What are the potential challenges in enforcing this patent?
Overlapping claims from prior art, especially in delivery matrices and API combinations, could pose infringement defenses; specificity in claims reduces this risk but does not eliminate it.
5. What strategic steps should patentees or licensees consider?
Monitoring competing filings, exploring alternative formulations, and leveraging the patent’s broad claims for licensing are key to maximizing value.
References
[1] European Patent Office public database, DK2487163.
[2] WHO International Patent Classification system and related literature on combination drug formulations.
[3] Patent landscape reports for pharmaceutical APIs and formulation innovations (2021-2022).
[4] Industry analyses on combination therapies and delivery systems in neurodegenerative treatments.
Note: Actual patent data, claim language, and prior art references should be reviewed directly from patent document DK2487163 and related patent filings for comprehensive legal and technical assessment.
