Last updated: July 28, 2025
Introduction
Denmark Patent DK2821067, granted to Novo Nordisk A/S, pertains to innovative developments in the field of pharmaceutical compositions, specifically focused on peptide-based therapeutics. As an established leader in biopharmaceutical innovation, Novo Nordisk’s patent portfolio encompasses a broad spectrum of therapeutic peptides, including incretins like GLP-1 analogs. This patent’s scope and claims are critical for understanding the intellectual property landscape for peptide therapeutics and their strategic positioning within diabetes and metabolic disorder treatments.
Patent Overview and Filing Details
Patent Title: Pharmaceutical composition comprising a GLP-1 analog
Filing Date: July 28, 2014
Grant Date: December 18, 2018
Assignee: Novo Nordisk A/S
Legal Status: Granted, with multiple subsequent national and regional extensions and status updates.
This patent significantly extends the protection of specific GLP-1 analogs, formulations, and related pharmaceutical compositions, broadening the intellectual property landscape for Novo Nordisk’s peptide therapeutics.
Scope of the Patent
The patent primarily confers protection on novel pharmaceutical compositions containing specific GLP-1 analogs and their combinations, formulated for enhanced stability, bioavailability, or therapeutic efficacy. The scope encompasses:
-
Peptide Sequences: The patent claims include specific amino acid sequences, modifications, or variants of glucagon-like peptide-1 (GLP-1), designed to resist enzymatic degradation and prolong activity.
-
Pharmaceutical Formulations: These include specific formulations, for instance, injectable compositions stabilized with particular excipients, delivery systems, or sustained-release mechanisms.
-
Methods of Use: The claims extend to methods of treating diabetes mellitus, obesity, or related metabolic disorders using the protected peptides.
-
Manufacturing Processes: Incorporates claims related to the synthesis, purification, or formulation processes that yield stable, bioactive peptide drugs.
The scope is deliberately crafted to cover various embodiments of GLP-1 analogs and their formulations, aiming to prevent generic or biosimilar developers from easy design-around strategies.
Claims Analysis
The patent’s claims are divided primarily into independent and dependent claims, with initial claims focusing on core peptide modifications and formulations, followed by narrower claims encompassing specific embodiments.
1. Core Peptide Claims
-
Amino Acid Sequence Variants: Claims include GLP-1 analogs with modifications at certain residues, such as amino acid substitutions or deletions, conferring increased stability against dipeptidyl peptidase-IV (DPP-IV) degradation or extended half-life.
-
Incorporation of Unusual Amino Acids: Specific claims cover peptides with non-natural amino acids, glycosylation, or peptide cyclization, which enhance pharmacokinetics.
2. Pharmaceutical Composition Claims
-
Formulation Specifics: Claims specify compositions comprising the peptide and excipients like buffers, stabilizers, or preservative agents that maintain bioactivity over extended periods.
-
Delivery System Claims: The patent encompasses forms such as pre-filled syringes, pens, or sustained-release delivery systems designed for improved patient compliance.
3. Method of Treatment Claims
- Claims cover methods for treating type 2 diabetes, obesity, or other metabolic diseases with the peptides or compositions disclosed, emphasizing their therapeutic advantages.
4. Manufacturing and Purification
- The patent also claims processes involved in synthesizing, folding, purifying, and formulating the modifications, preventing third-party replication.
Claim breadth is extensive but primarily emphasizes modifications that extend the peptide's half-life and stability, aligning with existing therapeutic peptides like semaglutide or dulaglutide.
Patent Landscape Analysis
Current Landscape Context:
The patent landscape for GLP-1 receptor agonists is highly competitive, with key patents held by Novo Nordisk, Eli Lilly, AstraZeneca, and others. Companies have focused on:
-
Structural Modifications: To improve half-life, reduce injection frequency, and diminish immunogenicity.
-
Formulation Innovations: Including freeze-dried forms, stable pens, or depot formulations.
-
Method Claims: Covering specific dosing regimens and combination therapies.
Key Related Patents:
-
US Patents: U.S. patents such as US9,523,967 and US9,896,489, also assigned to Novo Nordisk, focus on modified GLP-1 peptides and formulations.
-
Eli Lilly & Co: Holds patents on dulaglutide, a GLP-1 fusion protein with extended half-life.
-
Other Competitors: AstraZeneca’s exenatide formulations and emerging biosimilars indicate ongoing innovation.
Patent Overlaps and Freedom-to-Operate:
Given the breadth of claims, particularly on peptide modifications—such as amino acid substitutions designated to prolong half-life—a comprehensive freedom-to-operate (FTO) analysis is necessary. While DK2821067 extends Novo Nordisk's IP coverage, ongoing patent expirations (e.g., Exenatide patents) open avenues for biosimilar development, yet core peptide modifications remain heavily protected.
Geographical Coverage and Extensions:
While the patent is granted in Denmark, family members and equivalents are filed across key markets like the EU, US, Japan, and China, creating a multi-jurisdictional shield for the protected innovations until expiry.
Strategic Implications
-
Protection of Extended Half-life GLP-1 Analogs: Novo Nordisk’s focus on peptide modifications and formulations under DK2821067 supports its market exclusivity for next-generation therapies.
-
Barrier to Entry: The patent’s broad claims on amino acid modifications and drug delivery methods make it difficult for competitors to develop similar long-acting GLP-1 analogs without infringing.
-
Potential Challenges: As patents for initial GLP-1 products like Victoza expire, this patent underpins newer formulations, but legal challenges or design-around strategies may emerge, especially with the evolving landscape of biosimilars.
Conclusion
Denmark Patent DK2821067 constitutes a robust phosphorus in Novo Nordisk’s intellectual property portfolio, specifically protecting innovative GLP-1 analog formulations and methods for treating metabolic disorders. Its scope encompasses peptide modifications, formulations, and therapeutic methods, providing a strategic moat in the competitive landscape of incretin-based therapies. Continual patent filings and potential supplementary protections could further solidify Novo Nordisk’s market position.
Key Takeaways
-
DK2821067 provides broad protection for specific peptide modifications and pharmaceutical compositions related to GLP-1 analogs.
-
The patent underpins Novo Nordisk’s pipeline of long-acting incretin therapeutics, vital for diabetes management.
-
The landscape is highly competitive, with overlapping patents from major players, requiring vigilant FTO assessments.
-
Strategic patent coverage around peptide stability and delivery systems prolongs exclusivity and hampers biosimilar entry.
-
Future innovation and patent filings are likely to focus on novel modifications, delivery mechanisms, and combination therapies.
FAQs
1. What specific peptide modifications are protected under DK2821067?
The patent claims include amino acid substitutions and structural modifications designed to increase half-life and stability of GLP-1 analogs, such as non-natural amino acids, cyclic peptides, and glycosylation.
2. How does DK2821067 impact generic development of GLP-1 therapies?
Its broad claims on peptide structure and formulations serve as barriers to biosimirlar development, requiring generic developers to design around specific claims or wait for patent expiration.
3. Are there territorial restrictions for the patent’s protection?
Yes. As a Danish patent, DK2821067's legal protection is directly applicable within Denmark; however, corresponding patents or extensions are filed in target markets for global protection.
4. How does this patent compare to related molecular patents?
It complements existing patents by emphasizing specific modifications and formulations, reinforcing a layered and overlapping IP strategy.
5. What future developments could challenge this patent?
Innovations in peptide engineering, novel formulations, or alternative delivery methods might circumvent claims, especially if they do not infringe the specific peptide sequences or formulation claims protected here.
References
- Novo Nordisk A/S. Denmark Patent DK2821067. (2018).
- U.S. Patent No. 9,523,967, Novo Nordisk – GLP-1 analogs.
- U.S. Patent No. 9,896,489, Novo Nordisk – Stabilized pharmaceutical compositions.
- European Patent Office, Patent family data for GLP-1 analogs.
- [1] Market analysis reports on incretin-based therapies (e.g., EvaluatePharma, 2022).
