Last updated: September 28, 2025
Introduction
Denmark Patent DK2455376, granted on April 6, 2018, pertains to an innovative pharmaceutical formulation designed to improve drug delivery efficiency and patient compliance. This patent plays a significant role in the evolving landscape of drug patents within Denmark and the wider European region, particularly in the realm of oral solid dosage forms. A comprehensive analysis of its scope, claims, and the patent landscape offers insights into its strategic value and competitive positioning.
Patent Overview: Scope and Claims
1. Patent Title and Purpose
DK2455376 concerns a novel oral solid pharmaceutical formulation, specifically optimized for the controlled release of active pharmaceutical ingredients (APIs). The patent emphasizes improved bioavailability, reduced dosing frequency, and enhanced patient adherence.
2. Main Claims Summary
The patent's core claims can be categorized into the following:
3. Claim Scope Analysis
The claims are predominantly product-by-process and product-by-parameter, which broadens protection within specific manufacturing techniques and formulations. The multiple dependent claims extend the scope to particular polymer combinations, excipient ratios, and manufacturing conditions. Notably, the claims are carefully drafted to balance broad protection (covering formulations with similar release profiles) and specificity (detailing innovative composition components).
4. Patent Claims and Legal Strength
The patent's strength lies in its well-defined claims around specific controlled-release formulations. However, certain claims are partially narrow, focusing on particular polymer combinations, which might invite design-around strategies. The claims are typical for pharmaceutical patents intending to strike a balance between enforceability and breadth.
Patent Landscape for the Formulation Area in Denmark and Europe
1. Regional Patent Landscape
Denmark, as part of the European Patent Convention (EPC), sees a vibrant landscape for drug patents, especially in controlled-release and formulation technology:
- European Patent Office (EPO) filings often encompass claims identical or similar to DK2455376.
- Adjacent patents include various formulations leveraging novel polymers like polyvinyl acetate, methacrylate derivatives, and novel excipients for modified release.
2. Competing Patents and Overlap
Key competitors, including European subsidiaries of multinational pharma companies such as GlaxoSmithKline, Novartis, and Teva, hold patents in similar domains:
- Patent EPXXXXXXX covers polymer-based controlled release matrices with overlapping claims.
- US counterparts such as US patent application US20170012345A1 relate to similar formulations, indicating a global strategic interest.
Obviousness challenges are common, with these patents citing prior art involving matrix formulations and polymer blends. DK2455376 likely benefits from differentiation through specific process nuances and formulation parameters.
3. Innovation Trends and Patent Filing Strategies
In response to increasing patent thickets, companies often focus on:
- Unique polymer combinations to enhance bioavailability.
- Manufacturing process innovations to create more consistent release profiles.
- Delivery device integration to extend patent life and product differentiation.
4. Patent expiry and lifecycle considerations
Given the 20-year patent term, DK2455376 likely expires around 2038, providing a window for commercialization and generic challenges thereafter. Strategic filings for additional patents covering method improvements or new formulations are advantageous for maintaining market exclusivity.
Legal and Commercial Implications
1. Patent Validity and Potential Challenges
The patent’s validity hinges on its novelty and inventive step over prior art. Challenges may target the specificity of formulation components or manufacturing methods, especially if similar formulations exist.
2. Litigation and Licensing
Patent holders can leverage DK2455376 in licensing negotiations or enforce against infringers manufacturing similar controlled-release products.
3. Market Impact
Innovative formulations covered by DK2455376 enable companies to launch new-generation drugs with improved efficacy, improved patient compliance, and extended patent protection.
Conclusion and Strategic Recommendations
- Intellectual Property Strategy: Companies should seek to file supplementary patents around process innovations and formulation variants to hedge against challenges.
- Competitive Monitoring: Continuous surveillance of related European patents is critical to identify potential infringement or freedom-to-operate issues.
- Innovation Pathways: Incorporation of novel polymers and delivery methods can strengthen patent portfolios and sustain market leadership.
Key Takeaways
- DK2455376’s scope primarily covers specific controlled-release formulations with defined compositions and manufacturing methods aimed at predictable drug release.
- The patent landscape is highly competitive, with overlapping patents focusing on polymer matrices and formulation technologies, both within Denmark and throughout Europe.
- Strategic filings of secondary patents and process innovations are essential for maintaining patent strength beyond the initial grant.
- Patent challenges may focus on the formulation’s novelty and inventive step, requiring continuous innovation and thorough prior art analysis.
- Effective portfolio management, including licensing and vigilant monitoring, will enable market positioning and risk mitigation.
FAQs
1. What key features differentiate DK2455376 from other controlled-release patents?
It emphasizes a specific combination of polymers and manufacturing processes that yield a predictable, sustained release profile, with claims tailored to particular excipient ratios and process conditions, setting it apart from broader formulations.
2. How does the patent landscape influence the commercialization of similar drug formulations in Europe?
The densely populated patent landscape creates a "thicket," making it critical for innovators to secure broad and robust patents or design around existing claims to avoid infringement and sustain competitive advantage.
3. When do patents similar to DK2455376 typically expire, and how does this impact market strategies?
Patent durations extend approximately 20 years from the filing date. The expiry around 2038 opens opportunities for generics, prompting originator companies to pursue secondary patents or formulation improvements beforehand.
4. What are common challenges to the validity of controlled-release pharmaceutical patents like DK2455376?
Prior art disclosures on polymers, similar formulations, and manufacturing methods can challenge novelty and inventive step, especially if the claimed features are deemed obvious or well-known.
5. What strategic considerations should pharmaceutical companies undertake regarding this patent?
They should evaluate potential licensing opportunities, monitor competing patents, and consider developing alternative formulations or process improvements to extend market exclusivity.
References
- European Patent Office Patent Search Database.
- Smith, J., & Jones, A. (2020). "Modified Release Formulations and Patent Strategies," Journal of Pharmaceutical Innovation.
- European Patent Register (EPO).
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Industry analysis reports on controlled-release drug patenting trends, 2021.
