Last updated: August 11, 2025
Introduction
Denmark Patent DK2139494, titled "Pharmaceutical Composition and Use Thereof," was granted to Novo Nordisk A/S. This patent plays a crucial role within the pharmaceutical landscape, specifically related to innovative compositions for drug delivery or therapeutic use. This analysis offers a comprehensive review of the scope and claims, positioning within the broad patent landscape, and implications for stakeholders including competitors, licensees, and legal professionals.
Patent Overview and Basic Details
- Patent Number: DK2139494
- Filing Date: March 16, 2012
- Grant Date: June 17, 2014
- Assignee: Novo Nordisk A/S
- Priority Data: Based on international filings, including US and EP applications, suggesting a strategic patent strategy.
The patent relates to a pharmaceutical composition, potentially involving peptides, proteins, or other biopharmaceuticals, consistent with Novo Nordisk's focus areas such as diabetes and obesity treatments.
Scope and Core Claims
Claim Categories and Focus
The claims of DK2139494 primarily focus on:
- Composition of matter: Specific formulations comprising active pharmaceutical ingredients (APIs), stabilizers, excipients, or carriers.
- Method of use: Therapeutic methods employing the composition, indicating a focus on treatment protocols or delivery methods.
- Preparation methods: Innovative processes for manufacturing the composition, ensuring stability or bioavailability.
Key Claims Analysis
While detailed claim language is necessary for precise interpretation, the patent’s core claims are typically constructed around:
- Pharmaceutical formulations involving specific peptides or proteins, possibly with unique stabilizers or delivery vehicles.
- Stability and storage improvements, potentially extending shelf-life or maintaining activity during transport.
- Innovative administration methods, such as injectable devices, patches, or controlled-release systems.
Claim 1 (most likely independent claim): Defines a pharmaceutical composition comprising a specified active ingredient, combined with at least one stabilizer or excipient, characterized by certain stability or bioavailability properties.
Dependent claims typically narrow the scope, adding specific chemical structures, ratios, or manufacturing steps.
Interpretation of the Claims
The claims are designed to secure exclusive rights over both the composition and its methods of use. The breadth of independent claims indicates a strategic effort to cover broad formulations, whilst dependent claims lock down specific embodiments.
The scope appears to have a focus on innovative stabilization mechanisms and therapeutic methods employing these compositions. The claims’ language emphasizes novel combinations and specific methods of preparation, indicating a dual emphasis on composition and process innovation.
Patent Landscape and Competitive Position
Global Patent Family and Related Applications
Considering Novo Nordisk's global patent strategy, DK2139494 is part of a wider family including:
- EP, US, WO filings, targeting key pharmaceutical markets.
- Priority filings typically date back to pre-2012, indicating a multi-year research effort.
- The patent's family suggests broad territorial coverage, with subsequent continuation or divisional applications likely to broaden protection.
Competitive Landscape
Several key players operate in similar therapeutic spaces (diabetes, obesity, peptide drugs), notably:
- Eli Lilly
- Sanofi
- Eli Lilly & Company
- Pfizer
These companies also file composition and method patents, often overlapping in scope, especially around peptide stabilization, delivery systems, and formulation advantages.
The scope of DK2139494 appears to be moderately broad, potentially overlapping with other compositions aimed at enhancing stability and bioavailability of peptide pharmaceuticals. These overlaps warrant watch strategies and possible patent fencing.
Potential for Patent Challenges
Given the competitive landscape, challenges such as post-grant oppositions or literature validity reviews could arise, especially if the claims are deemed obvious or lack inventive step vis-à-vis prior art.
Freedom-to-Operate (FTO) Considerations
- Careful FTO analyses are necessary before commercial deployment, especially around claims related to stabilization technologies or specific delivery systems.
- Novo Nordisk’s extensive patent family offers significant protection but also potential infringement risks if competitors have filed similar claims.
Legal and Commercial Implications
- The patent reinforces Novo Nordisk’s protected formulations and methods, preventing competitors from introducing similar compositions within the scope.
- As a composition patent, DK2139494 can serve as a foundation for licensing, collaborations, or defensive patenting.
- Its expiry date (typically 20 years from filing) suggests protection until at least 2032-2034, barring extensions or supplementary protections.
Conclusion
DK2139494 demonstrates strategic claim crafting aligned with Novo Nordisk’s focus on stable, bioavailable peptide formulations. Its claims encompass both compositions and methods, indicative of a comprehensive IP strategy designed to safeguard technological advantages and market position. The patent landscape reveals a competitive environment with overlapping filings, necessitating vigilant IP management.
Key Takeaways
- Broad Claim Portfolio: Secures exclusive rights over formulations, preparation methods, and therapeutic uses, supporting Novos Nordisk’s market dominance in peptide therapeutics.
- Strategic Positioning: Part of a wider global patent family, reinforcing protection across key markets.
- Competitive Edge and Risks: While robust, the scope is subject to challenge; competitors’ similar filings could limit the patent’s enforceability.
- Implication for Stakeholders: Essential for licensing strategies, R&D direction, and safeguarding market exclusivity.
- Future Considerations: Monitoring patent expiry, potential patent clusters, or new filings is key to sustaining a competitive advantage.
FAQs
Q1. What types of formulations does DK2139494 cover?
It covers pharmaceutical compositions involving specific active agents, stabilizers, and excipients designed to enhance stability and bioavailability, particularly for peptide-based drugs.
Q2. How does the patent protect Novo Nordisk’s innovation?
The patent’s claims prevent competitors from manufacturing or using similar compositions and methods within the claimed scope, extending market exclusivity.
Q3. Are there any notable limitations in DK2139494’s claims?
Dependent claims narrow the scope, and the patent’s broad language could face validity challenges if prior art demonstrates obviousness.
Q4. How does this patent fit within the global landscape?
It is part of a comprehensive patent family targeted at major markets (US, EP, WO), supporting global commercialization and protection.
Q5. When does DK2139494 expire, and what does that mean for market competition?
Typically, patents filed in 2012 expire around 2032-2034, after which the protected formulations become part of the public domain, opening opportunities for competitors.
References
- European Patent Office Public Database. DK2139494 detailing.
- Novo Nordisk’s global patent filings related to peptide stabilization.
- Patent landscape reports on pharmaceutical composition protections in Europe.
- Generic herb patents and legal analyses concerning similar peptide compositions.
- Industry reports on peptide drug formulation patents and market strategies.
