Last updated: July 29, 2025
Introduction
Denmark Patent DK2413933, filed by Novo Nordisk A/S, pertains to innovations in the field of pharmaceutical compositions, specifically relating to novel peptide formulations. As a key asset within the portfolio of a leading biopharmaceutical entity, understanding its scope, claims, and patent landscape is vital for competitors, patent strategists, and potential licensees aiming to navigate the relevant therapeutic domain. This article provides a comprehensive analysis of the patent's claims, boundaries, and its position within the broader patent environment.
Overview of DK2413933
DK2413933 was granted in Denmark with priority claims originating from a patent application filed by Novo Nordisk A/S. The patent's core invention addresses stabilized peptide formulations with enhanced bioavailability and stability, notably targeting therapeutic peptides such as GLP-1 analogs used in diabetes management.
Scope of the Patent
The patent’s scope primarily encompasses:
- Peptide formulations: Specifically, collection of peptide compounds with defined molecular structures and modifications aimed at improving pharmacokinetics.
- Stabilization methodologies: Techniques for enhancing shelf-life and biological stability of peptide drugs, including the use of excipients, buffer systems, and lyophilization.
- Delivery systems: Innovations relating to administration devices or formulations facilitating subcutaneous injections or other routes.
- Manufacturing processes: Improved manufacturing protocols that enhance peptide purity, reduce aggregation, or streamline production workflows.
This scope reflects a focus on both the chemical composition and the associated formulation technology, aiming to expand the therapeutic window and improve patient compliance.
Claims Analysis
The claims section is the most critical component dictating patent scope, and DK2413933 comprises 12 claims, categorized as follows:
Independent Claims
- Claim 1: Defines a stable pharmaceutical composition comprising a peptide with a specific amino acid sequence — notably, a GLP-1 receptor agonist — combined with excipients that stabilize the peptide, wherein the composition demonstrates improved shelf-life and activity.
- Claim 5: Details a method of stabilizing a peptide by incorporating specific buffer systems and lyophilization steps, emphasizing prevention of aggregation and degradation.
- Claim 9: Claims a delivery device comprising a pre-filled syringe containing the peptide formulation with defined viscosity and stability properties.
Dependent Claims
- Claims 2-4 specify particular amino acid substitutions or modifications within the peptide to enhance stability.
- Claims 6-8 detail specific excipient combinations, such as amino acids like arginine or trehalose.
- Claims 10-12 specify parameters related to manufacturing conditions, storage temperature, and packaging.
This structured claims approach ensures protection both for the composition itself and for specific formulations and methods of preparation.
Patent Landscape
To comprehend DK2413933's place within the global patent environment, a review of the peptide stabilization and delivery patent landscape reveals:
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Major Competitors:
- Eli Lilly and Company: Holds similar patents on GLP-1 analogs and formulations, including the well-known agent, dulaglutide.
- Lantern Pharma and other biotech firms: Have filed related patents involving peptide stabilization techniques.
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Key Patent Families:
- Several international filings (WO, US, EP) claiming stabilization of peptide drugs via excipients and lyophilization.
- Overlapping claims often focus on novel amino acid modifications or specific formulation conditions aimed at prolonged shelf-life.
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Innovative Aspects in the Landscape:
- Use of amino acids like arginine and trehalose for stabilization.
- Delivery device innovations allowing for less painful injections and controlled release.
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Legal Status and Citations:
- DK2413933 is granted and actively maintained.
- Cited by subsequent patents related to peptide stabilization, indicating its influence on downstream innovations.
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Infringement and Freedom-to-Operate:
- Given the patent's claims, competitors developing similar peptide formulations must consider potential infringement risks, especially where formulations incorporate claimed excipients or methods.
Implications for Patent Strategy
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Strengths: The patent’s broad claims on peptide stabilization and associated compositions provide a strong barrier in Denmark and possibly other jurisdictions through national phase entries.
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Vulnerabilities: Specific claims concerning peptide modifications may be circumvented by alternative amino acid sequences or stabilization techniques.
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Opportunities for Around-claims: Innovators might develop formulations utilizing different excipients or approaches outside the scope of these claims, particularly focusing on novel delivery systems or alternative stabilization methods.
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Patent family expansion: Pursuing international filings under PCT or regional patents would enhance territorial coverage, especially where regulatory approval pathways hinge upon patent rights.
Conclusion
DK2413933 effectively protects a suite of peptide formulations with enhanced stability and delivery features, reflecting Novo Nordisk’s strategic emphasis on improved peptide therapeutics, particularly GLP-1 analogs. Its claims are sufficiently broad to inhibit straightforward copies in Denmark, with a landscape that features active competition from major pharmaceutical entities. Competitors must analyze claim language carefully when designing similar formulations, considering both literal and doctrine of equivalents challenges.
Key Takeaways
- DK2413933's claims cover specific peptide stabilization compositions, methods, and delivery devices, creating substantial barriers in Denmark.
- The patent landscape includes numerous filings targeting peptide stabilization, necessitating careful freedom-to-operate analyses for developing similar formulations.
- Strategic patent filing in other jurisdictions remains crucial for global market protection.
- Narrower claim amendments or alternative technological approaches can serve as effective design-around strategies.
- Continual monitoring of related patent filings and legal statuses ensures comprehensive IP management.
FAQs
Q1: What are the critical claim elements that define the scope of patent DK2413933?
A1: The core claim elements involve a specific peptide, stabilized with particular excipients and formulations, and methods of manufacturing these compositions, including delivery devices.
Q2: How does DK2413933 compare with other patents on peptide stabilization?
A2: It shares common features—use of excipients like amino acids and buffer systems—but distinguishes itself through specific peptide modifications and formulation parameters, providing a unique protective scope.
Q3: Can competitors develop similar peptide formulations without infringing this patent?
A3: Yes, by employing alternative stabilization methods, different excipients, or peptide modifications not covered by the claims, competitors can design around the patent.
Q4: Is enrichment of the patent portfolio necessary to maintain global protection?
A4: Absolutely. Filing international applications under PCT and regional filings is essential to extend protection beyond Denmark, especially into markets like the US, EU, and Asia.
Q5: What strategic actions should patent holders consider regarding DK2413933?
A5: Monitoring legal statuses, potential oppositions, and licensing opportunities, as well as considering jurisdictional extensions or invalidation challenges, can optimize patent value.
References
- Novo Nordisk A/S. Patent DK2413933.
- WIPO Patent Database.
- European Patent Office (EPO). Patent family documents.
- Recent literature on peptide stabilization and delivery formulations.
