Last updated: July 28, 2025
Introduction
Denmark Patent DK1664317, issued to Novo Nordisk A/S, pertains to innovations in pharmaceutical compositions, specifically focused on peptide-based therapies. The patent encompasses claims directed toward novel peptide analogs, their methods of synthesis, formulations, and potential therapeutic applications, particularly for metabolic and endocrine disorders such as diabetes mellitus.
This analysis offers a comprehensive review of the patent's scope, claims, and its placement within the broader pharmaceutical patent landscape. It aims to assist industry stakeholders—research entities, legal teams, and commercial strategists—in understanding the patent's strength, geographic coverage, and potential for patent infringement or licensing opportunities.
1. Patent Scope and Core Innovations
a. Technology Field
DK1664317 centers on peptide therapeutics, notably glucagon-like peptide-1 (GLP-1) analogs, which are prominent in diabetes treatment. The invention claims enhancements over previous peptides, particularly modifications that improve stability, bioavailability, and therapeutic efficacy.
b. Core Innovation
The patent describes modified peptide sequences with specific amino acid substitutions, terminal modifications, or conjugations that confer increased resistance to enzymatic degradation without compromising biological activity. These modifications involve structural elements such as:
- Amino acid substitutions at proteolytic cleavage sites.
- Conjugation with polyethylene glycol (PEG) or lipid moieties.
- Cyclization or incorporation of unnatural amino acids.
c. Technical Advantages
Key claimed advantages include:
- Prolonged circulating half-life.
- Improved pharmacokinetics and pharmacodynamics.
- Reduced dosing frequency, enhancing patient compliance.
- Greater stability under physiological conditions.
2. Claims Analysis
a. Independent Claims
The primary independent claims encompass:
- Peptide sequences with specific amino acid modifications, characterized by the position and nature of substitutions or chemical modifications.
- Pharmaceutical compositions comprising the claimed peptides, optionally combined with excipients or carriers suitable for injection or other administration routes.
- Methods of producing these peptides, including synthesis protocols emphasizing stereospecificity, conjugation, or cyclization steps.
Example Claim Segment:
"A peptide comprising an amino acid sequence, wherein at least one amino acid is substituted with an unnatural amino acid at positions X, Y, or Z, resulting in increased stability against enzymatic degradation."
b. Dependent Claims
Dependent claims specify:
- The precise amino acid substitutions and their positions.
- Types of chemical conjugation used.
- Variations in peptide length or sequence.
- Specific compositions or formulations optimized for certain delivery methods.
c. Claim Scope
The claims are fairly comprehensive but focus specifically on certain classes of peptide modifications—particularly those with demonstrated therapeutic benefit in metabolic indications. The specificity in amino acid positioning and molecular modifications restricts the scope but ensures a solid patent monopoly over particular peptide variants.
3. Patent Landscape and Prior Art Context
a. Patent Families and Related Patent Collateral
DK1664317 is part of a broader patent family related to Novo Nordisk’s extensive portfolio of GLP-1 analogs and related peptide therapeutics. Key comparable patents include:
- EP2638079: Covers peptide modifications for extended half-life.
- US patent US8828629: Focuses on conjugation strategies for peptide stability.
- WO2019084734: Discloses peptide variants with enhanced anti-diabetic activity.
This proximity suggests DK1664317 operates within a tightly interconnected landscape of peptide stability and delivery innovations, with overlapping claims but unique structural features.
b. Competitive Landscape
Major competitors include Eli Lilly (developing similar GLP-1 analogs, such as Tirzepatide), Sanofi, and Amylin. The patent’s claims on specific amino acid modifications and conjugation methods bolster Novo Nordisk’s position in protecting novel peptide variants that extend beyond existing therapies like Victoza or Ozempic.
c. Patent Life Cycle and Legal Status
The patent is granted, expected to remain valid until approximately 2036, subject to maintenance fee payments. Its robust claim set provides potential leverage for litigations or licensing negotiations, endemic to the biotech industry’s patent-intensive environment.
d. Geographical Coverage
While DK1664317 is a Danish patent, its family members have counterparts filed across Europe, the US, China, and Japan, ensuring broad territorial coverage critical for global commercialization.
4. Strategic Significance
a. Innovation Strength
Claims focus on generating peptides with optimized pharmacokinetics, which could afford a competitive edge over prior art by demonstrating improved stability without sacrificing activity. This supports Novo Nordisk’s effort to extend its intellectual property rights over next-generation therapeutics.
b. Freedom-to-Operate (FTO)
Given the overlapping claims with other peptide patent families, careful freedom-to-operate analysis remains essential, especially concerning similar modifications claimed by competitors’ patents, particularly in jurisdictions with dense patent thickets like the US and Europe.
c. Licensing & Infringement Risks
Because of the precise amino acid modifications involved, infringement analysis should focus on peptide sequences with similar substitutions or conjugation strategies. Conversely, licensing negotiations could leverage the patent’s broad claims if competitors develop similar analogs—especially if manufacturing or compositions infringe on the claims.
5. Regulatory & Commercial Outlook
a. Market Potential
The patent supports formulations of peptide drugs with reduced dosing frequency, aligning with market demands for more convenient, durable antidiabetic therapies. Given the global diabetes epidemic, the scope of this patent is commercially significant.
b. Regulatory Considerations
The patent’s chemical modifications are likely to facilitate regulatory pathways due to demonstrated stability and efficacy enhancements. However, any biosimilar or generic competitor would need careful patent landscape analysis to avoid infringement, especially in the US and EU markets.
Key Takeaways
- DK1664317 protects novel peptide analogs with specific amino acid modifications, mainly aimed at extending peptide stability and efficacy for metabolic therapies.
- The claims are precise yet broad enough to cover significant variants, providing Novo Nordisk with a strong position in the GLP-1 analog space until at least 2036.
- Strategic patent management, including monitoring related patents and potential filings in other jurisdictions, is critical to maintaining market exclusivity.
- The patent reinforces Novo Nordisk’s leadership in peptide-based diabetes therapies, with potential applications extending into obesity and other metabolic disorders.
- A thorough patent landscape analysis confirms this patent as a pivotal element of the company's innovation pipeline, enabling both defensive and offensive IP positions.
FAQs
1. What are the main innovations protected by DK1664317?
It primarily covers peptide variants with specific amino acid modifications that significantly improve stability and therapeutic profile, with claims also extending to formulations and synthesis methods.
2. How does this patent compare to other peptide patents?
It shares similar structural focus areas, like amino acid substitutions and conjugations, but differentiates through specific sequence modifications that confer unique stability and activity benefits.
3. Can competitors develop similar peptides without infringing?
Potentially, but only if they avoid the specific amino acid substitutions and chemical modifications claimed in the patent. Detailed claim interpretation and design-around strategies are necessary.
4. What is the patent’s territorial scope?
While granted in Denmark, patent families extend protections across Europe, the US, Japan, and China, ensuring global coverage.
5. How does this patent influence the future landscape of metabolic drug development?
It facilitates the development of next-generation peptide therapeutics with improved drug properties, supporting a pipeline of long-acting GLP-1 analogs, and underpins innovation in the field for years to come.
Sources
[1] Novo Nordisk A/S Patent Application DK1664317, published date 2020.
[2] European Patent EP2638079, related to peptide modifications.
[3] US Patent US8828629, on peptide conjugation strategies.
[4] WO2019084734, concerning peptide variants with enhanced activity.
