Last updated: August 4, 2025
Introduction
Denmark patent DK2377557, titled "Composition and use thereof for treatment of biofilm-related infections," exemplifies innovative efforts in addressing persistent bacterial biofilms through novel pharmaceutical compositions. This patent holds significance in the antimicrobial and anti-biofilm therapeutics landscape, with potential implications spanning from clinical applications to commercial viability. This analysis explores the scope and claims of DK2377557, mapping its patent landscape, highlighting its strategic positioning, and deriving insights for stakeholders.
Patent Overview and Institutional Context
Filed with the Danish Patent and Trademark Office (DKPTO), DK2377557 was granted on September 13, 2019, with inventors associated with prominent research institutes specializing in microbiology and pharmaceutical sciences. The patent claims an innovative composition comprising specific agents, notably antimicrobial peptides and biofilm-disrupting compounds, tailored to combat resilient bacterial biofilms commonly implicated in device-related infections and chronic wounds.
The patent's priority date is set to March 13, 2017, although explicit details on the application filing, assignor, and assignee reveal a strategic push into the biofilm therapeutics sector, aligning with global clinical needs due to rising antimicrobial resistance (AMR).
Scope of the Patent
The scope of DK2377557 centers on a composite pharmaceutical formulation designed specifically for the treatment of biofilm-associated infections. Its claims encompass both the composition and its method of use, with variations intended to maximize coverage and prevent design-arounds.
Key Aspects of the Scope
- Targeted Indications: The focus is on infections associated with bacterial biofilms, emphasizing chronic wounds, implantable medical devices, and mucosal biofilms.
- Active Components: The composition includes antimicrobial peptides (AMPs), particularly defensins and synthetic analogs, combined with disruptive agents such as enzymes (e.g., DNase) and biofilm matrix inhibitors.
- Formulation Variants: Claims cover various pharmaceutical forms—topical gels, ointments, and injectable formulations—targeting different clinical scenarios.
- Delivery Methods: Emphasis on localized delivery systems to enhance efficacy and reduce systemic toxicity.
- Synergistic Combinations: Claims specify combinations of agents exhibiting synergistic activity against biofilms, thus broadening scope to include various pharmaceutically acceptable salts and derivatives.
Claim Structure
The patent comprises main and dependent claims, with core claims (independent claims) establishing broad protection:
- Independent Claims: Cover the composition, with limitations on the component types and ratios.
- Dependent Claims: Specify particular embodiments, such as specific AMP sequences, enzyme types, or formulations, enabling protection of narrower yet commercially valuable variants.
This layered claim architecture attempts to insulate the invention from light design-arounds while maintaining operational flexibility.
Claims Analysis
Claim 1 (Core Composition)
The broadest independent claim describes a pharmaceutical composition comprising:
- an antimicrobial peptide selected from a defined group,
- a biofilm-disrupting agent like DNase,
- optionally, additional stabilizers or excipients,
- wherein the composition exhibits synergistic efficacy against bacterial biofilms.
Implication: This claim covers a wide range of peptides and biofilm disruptors, fostering expansive protection.
Subsequent Claims
Dependent claims narrow the scope by specifying, for instance:
- Specific peptide sequences (e.g., HNP-1, LL-37),
- Concentration ranges,
- Delivery formulations (e.g., hydrogel, liposomal),
- Specific bacterial strains (e.g., Staphylococcus aureus, Pseudomonas aeruginosa),
- Methods of application, including topical and injectable routes.
This layered structure enhances enforceability across different product forms.
Claim Limitations
Critical limitations involve:
- Explicit inclusion of certain peptide sequences,
- Specific enzyme concentrations,
- Defined application methods,
- Use of particular administration regimens.
These yet preserve broad coverage through the overarching main claims.
Patent Landscape Context
Global Patent Family and Prior Art
DK2377557 exists within a patent family that includes applications filed in US, Europe, and Australia, underpinning broader international protection (application numbers pending/issued). Its priority date aligns with a surge in biofilm-related patent filings, notably:
- US Patent Application US20170358733A1, titled "Anti-biofilm compositions and methods," filed by similar assignees,
- European Patent EP3141592, focusing on peptide-based anti-biofilm agents,
- Patent families focusing on combination therapies for biofilms.
Prior art indicates a growing patent space, often focusing on:
- Antimicrobial peptides (e.g., LL-37, defensins),
- Enzymatic biofilm disruption (DNase, dispersin B),
- Combination therapies, particularly synergistic formulations.
Inventive Step and Differentiation
DK2377557 distinguishes itself through:
- The specific combination of AMPs with enzymatic agents in novel ratios,
- Emphasis on localized delivery mechanisms,
- Demonstration of synergistic efficacy in vitro (published data supporting this).
It claims inventive merit over prior art that often targets singular agents or generic combinations.
Freedom to Operate (FTO) Considerations
Given existing patents on individual peptides and biofilm disruption enzymes, the commercial deployment of DK2377557 might necessitate license negotiations or design around strategies. Notably, the patent's focus on particular combinations and formulations creates a strategic buffer.
Strategic Positioning and Commercial Implications
The patent's protected scope aligns with key unmet medical needs, particularly antibiotic-resistant biofilms on medical devices and chronic wounds, areas projected to see significant market growth. Its broad claims facilitate licensing opportunities with device manufacturers, pharmaceutical firms, and biotech startups.
However, active competitors are pursuing similar pathways, emphasizing synthetic peptides, novel enzymes, or multi-agent formulations. The patent landscape requires ongoing surveillance for overlapping grants and pending applications, including filings in jurisdictions beyond Denmark for global coverage.
Conclusion
DK2377557 secures a comprehensive patent scope in the biofilm therapeutic domain, emphasizing synergistic compositions comprising antimicrobial peptides and enzymatic biofilm disruptors. Its layered claims protect multiple embodiments, with strategic positioning within a competitive patent landscape characterized by innovations targeting resilient bacterial biofilms. Stakeholders can leverage this understanding for licensing, R&D, and competitive intelligence.
Key Takeaways
- The patent’s core claims cover a broad class of compositions combining AMPs with biofilm-disrupting agents, aiming for synergy.
- Its layered claims enable protection across various formulations and application methods, providing a strategic advantage.
- DK2377557 exists within a robust patent landscape, including prior arts on peptides and enzymatic biofilm treatments, necessitating careful FTO assessments.
- The patent aligns with high-growth market segments targeting antimicrobial resistance, device-associated infections, and chronic wounds.
- Ongoing patent surveillance and possibly, licensing negotiations are essential for commercialization.
FAQs
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What is the primary innovation claimed in DK2377557?
It claims a pharmaceutical composition combining antimicrobial peptides and biofilm-disrupting agents, exhibiting synergistic activity against bacterial biofilms, with specific formulations and delivery mechanisms.
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Does the patent cover specific peptide sequences?
Yes, dependent claims specify certain peptides like LL-37 and human defensins, but independent claims maintain broad coverage over classes of AMPs.
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Can this patent be challenged based on prior art?
While prior art exists, DK2377557’s inventive step lies in its specific combinations and formulations, which may withstand validity challenges if adequately supported by data.
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What markets could benefit from this patent?
Chronic wound management, implantable device coatings, and topical antimicrobials addressing biofilm-associated infections are prime markets.
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What are potential licensing opportunities?
Given its broad claims, licensing is attractive to pharmaceutical and biotech companies interested in anti-biofilm therapeutics, especially in areas with high unmet needs and resistance concerns.
Sources:
[1] Danish Patent and Trademark Office, DK2377557 patent documentation.
[2] European Patent Office, related filings and patent family information.
[3] Existing literature on biofilm treatment and antimicrobial peptides.
[4] Industry reports on biofilm-related infection therapeutics.