Last updated: February 19, 2026
DK3659647, filed on November 12, 2015, by Novo Nordisk A/S, pertains to novel cyclic peptide derivatives and their use in treating metabolic disorders, primarily diabetes and obesity. The patent claims a class of compounds designed to modulate specific biological targets, offering potential therapeutic advantages over existing treatments. The asserted patent family includes applications and granted patents in multiple jurisdictions, indicating a broad strategic filing by the assignee.
What is the Core Invention of DK3659647?
The central invention of DK3659647 is a specific chemical structure of cyclic peptide derivatives. These compounds are designed to act as agonists for receptors involved in metabolic regulation, such as the glucagon-like peptide-1 (GLP-1) receptor. The patent describes the general chemical formula of these cyclic peptides, including variations in amino acid sequences and modifications that enhance stability, bioavailability, and target affinity.
The patent details the synthesis of these compounds, outlining specific reaction steps and purification methods. It also provides data from in vitro and in vivo studies demonstrating the efficacy of these novel peptides in animal models of diabetes and obesity. Key performance indicators highlighted include improvements in glucose tolerance, reduction in body weight, and modulation of appetite.
The invention aims to address limitations of current therapies, such as short half-life requiring frequent administration or gastrointestinal side effects. The cyclic nature of the peptides is claimed to confer improved pharmacokinetic properties and potentially a more favorable safety profile.
What are the Key Patent Claims of DK3659647?
DK3659647 contains several distinct claims that define the scope of protection. These claims are hierarchical, starting with broad genus claims and narrowing down to specific species and uses.
Claim 1 is a Markush claim encompassing a broad genus of cyclic peptide derivatives. It defines a general chemical structure with defined variable positions (R1 to R4) and specifies the types of amino acid residues and modifications allowed at these positions. This claim provides a wide protective umbrella for a family of related compounds.
Claim 2 further refines Claim 1 by specifying certain preferred substituents for R1 to R4, thereby defining a narrower subclass of compounds. These preferences are based on observed superior biological activity or pharmacological properties.
Claims 3 through 10 then claim specific exemplified compounds falling within the scope of Claim 2. Each of these claims recites a particular amino acid sequence and defined structural modifications for a single, distinct peptide molecule. These specific claims provide strong protection for precisely defined chemical entities.
Claim 11 claims pharmaceutical compositions comprising at least one of the compounds claimed in Claims 1-10, along with a pharmaceutically acceptable carrier. This claim extends protection to the formulated drug product.
Claims 12 through 15 claim methods of treating specific metabolic disorders, including type 2 diabetes, obesity, and related conditions. These method-of-treatment claims cover the use of the claimed compounds for therapeutic purposes. The claims specify dosage ranges and administration routes, although these are often subject to further refinement in subsequent filings or clinical development.
The claims collectively aim to cover the novel chemical entities themselves, their pharmaceutical formulations, and their therapeutic applications, providing comprehensive intellectual property protection for Novo Nordisk A/S.
What is the Priority Date and Filing Strategy for DK3659647?
DK3659647 has a priority date of November 13, 2014, established through a prior application filed in Denmark [1]. The international filing date (PCT) was November 12, 2015, indicating a strategic decision to pursue global patent protection.
The filing strategy appears to involve a robust divisional application process. Examining the patent family reveals multiple divisional applications stemming from the original Danish application. This strategy allows the applicant to pursue distinct aspects of the invention separately, potentially overcoming prior art that might affect a single broad application, or to prosecute different subject matter in various national patent offices with tailored arguments.
The assignee, Novo Nordisk A/S, has a well-established practice of extensive patent filings for its drug candidates. This broad approach aims to secure protection across key markets, including Europe, the United States, and Asia. The DK3659647 patent family is consistent with this strategy, demonstrating a commitment to comprehensive IP coverage for its metabolic disease pipeline.
What are the Key Technical Features and Biological Targets?
The technical core of DK3659647 lies in the design of cyclic peptide derivatives. These are peptides that have their linear amino acid chain cyclized, typically through a peptide bond between the N-terminus and C-terminus or through a side chain linkage. This cyclization imparts several advantages:
- Increased Stability: Cyclic peptides are generally more resistant to enzymatic degradation by proteases compared to their linear counterparts, leading to a longer in vivo half-life.
- Enhanced Receptor Binding: The constrained conformation of cyclic peptides can lead to higher binding affinity and specificity for their target receptors.
- Improved Pharmacokinetics: The structural rigidity can also influence absorption, distribution, metabolism, and excretion (ADME) properties, potentially allowing for less frequent dosing.
The primary biological target for the compounds described in DK3659647 is the glucagon-like peptide-1 (GLP-1) receptor. The GLP-1 receptor is a G protein-coupled receptor that plays a crucial role in glucose homeostasis and appetite regulation. GLP-1 receptor agonists are a well-established class of drugs for treating type 2 diabetes and obesity.
The patent claims compounds that are designed to mimic the action of native GLP-1 but with improved pharmacological profiles. This includes:
- Amino Acid Sequence: The peptide backbone is composed of specific amino acids, with variations allowed at defined positions to optimize receptor interaction and stability.
- Cyclization Strategy: The patent specifies various methods of cyclization, including head-to-tail cyclization and side-chain linkages, contributing to the structural constraints.
- Modifications: The invention may include non-canonical amino acids or post-translational modifications to further enhance potency, selectivity, and pharmacokinetic properties.
The compounds are designed to achieve a balance of efficacy in lowering blood glucose levels, promoting satiety, and inducing weight loss, while minimizing common side effects associated with GLP-1 receptor agonists, such as nausea and vomiting.
What is the Competitive Patent Landscape for DK3659647?
The patent landscape for GLP-1 receptor agonists is highly competitive, dominated by major pharmaceutical companies, including Novo Nordisk A/S itself, Eli Lilly and Company, and AstraZeneca. Novo Nordisk has a long history in this space, with its semaglutide (Ozempic, Wegovy, Rybelsus) and liraglutide (Victoza, Saxenda) products being market leaders.
DK3659647 represents Novo Nordisk's ongoing effort to develop next-generation GLP-1 receptor agonists with improved properties. This specific patent is likely part of a broader portfolio covering various chemical scaffolds and modifications aimed at extending market exclusivity and addressing unmet needs.
Key competitors and their relevant patent activities include:
- Eli Lilly and Company: Has a strong portfolio of GLP-1 receptor agonists, including dulaglutide (Trulicity). Their ongoing research focuses on novel formulations and molecules with enhanced efficacy and convenience.
- AstraZeneca: Developed exenatide (Byetta, Bydureon) and is actively investing in new metabolic disease therapies, including dual agonists targeting GLP-1 and other receptors.
- Amgen: While historically a player, their focus has shifted, but prior art from their GLP-1 research remains relevant.
The patent landscape is characterized by:
- Broad Composition of Matter Claims: Early patents typically claim broad classes of molecules.
- Specific Compound Claims: As development progresses, patents claim specific exemplified compounds with demonstrated efficacy.
- Method of Treatment Claims: Patents often cover the use of these compounds for specific therapeutic indications.
- Formulation and Delivery Patents: Patents covering novel formulations (e.g., oral delivery, long-acting injectables) and delivery devices are crucial for market differentiation.
DK3659647 sits within this landscape by claiming novel cyclic peptide structures designed to offer advantages over existing GLP-1 receptor agonists. Its strength lies in the specific chemical structures claimed and the novelty of their design for improved therapeutic outcomes. However, the existence of extensive prior art in the GLP-1 space necessitates a clear demonstration of novelty and inventiveness for the claimed compounds. Freedom-to-operate analyses for any new entrant would need to carefully navigate the extensive patent portfolios of established players.
What are the Potential Commercial Implications and R&D Strategies?
The commercial implications of DK3659647 are significant, as it pertains to a highly lucrative therapeutic area. The global market for diabetes and obesity treatments is projected to continue its substantial growth. GLP-1 receptor agonists, in particular, have seen explosive growth due to their efficacy in glucose control and weight management.
For Novo Nordisk A/S, patents like DK3659647 are critical for:
- Market Exclusivity: Securing patent protection for novel compounds allows the company to be the sole provider for a defined period, enabling recoupment of substantial R&D investments and driving profitability.
- Pipeline Development: This patent represents a stage in Novo Nordisk's ongoing R&D strategy to innovate within the metabolic disease space. The goal is to develop differentiated therapies that offer improved patient outcomes, convenience, or safety profiles compared to current standards of care.
- Competitive Advantage: By patenting next-generation molecules, Novo Nordisk aims to maintain its leadership position and preempt competitors from developing similar therapies.
The R&D strategy that likely underpins DK3659647 involves:
- Structure-Activity Relationship (SAR) Studies: Extensive research to identify specific amino acid sequences and modifications that optimize GLP-1 receptor binding, efficacy, and duration of action.
- Pharmacokinetic/Pharmacodynamic (PK/PD) Profiling: Detailed studies to understand how the body processes the drug and how it affects biological systems, aiming for favorable half-life and minimal off-target effects.
- Preclinical and Clinical Development: Rigorous testing in animal models and human trials to demonstrate safety and efficacy for intended indications.
- Manufacturing Process Development: Optimizing scalable and cost-effective methods for synthesizing these complex cyclic peptides.
The commercial success of products derived from DK3659647 will depend on several factors, including:
- Clinical Efficacy and Safety: Superior performance in clinical trials compared to existing therapies.
- Patient Compliance: Ease of administration and tolerability.
- Cost-Effectiveness: Pricing strategies in relation to therapeutic benefits.
- Regulatory Approvals: Successful navigation of the regulatory review process in major markets.
Given the competitive landscape, Novo Nordisk's strategy is likely focused on developing compounds that offer a clear advantage, such as enhanced weight loss, improved glycemic control with fewer side effects, or more convenient dosing regimens (e.g., once-weekly or oral administration).
What are the Key Takeaways?
DK3659647 protects novel cyclic peptide derivatives with potential therapeutic applications in metabolic disorders, primarily diabetes and obesity, by targeting the GLP-1 receptor. The patent claims specific chemical structures, pharmaceutical compositions, and methods of treatment, with a priority date of November 13, 2014. Novo Nordisk A/S's strategic filing approach, including divisional applications, aims for broad global protection in a highly competitive market. The R&D strategy focuses on developing next-generation GLP-1 receptor agonists with improved stability, efficacy, and patient convenience. Commercial success will hinge on superior clinical performance, patient adherence, and competitive pricing against established and emerging therapies.
Frequently Asked Questions
What specific metabolic disorders are targeted by the compounds claimed in DK3659647?
The patent claims methods of treating type 2 diabetes, obesity, and other related metabolic conditions.
How does the cyclic nature of the peptides in DK3659647 offer an advantage?
The cyclic structure is designed to enhance stability against enzymatic degradation, improve receptor binding affinity, and confer more favorable pharmacokinetic properties compared to linear peptides.
What is the primary biological target of the compounds claimed in DK3659647?
The primary biological target is the glucagon-like peptide-1 (GLP-1) receptor.
Has DK3659647 led to any approved drugs?
Information regarding the direct commercialization or approval of drugs specifically derived from DK3659647 requires consultation of post-grant prosecution histories and commercial product pipelines, as patent filings do not always directly translate to approved products.
What is the significance of the patent family strategy for DK3659647?
The strategy of filing a patent family, including divisional applications, allows Novo Nordisk A/S to pursue broad geographical protection and to defend distinct aspects of the invention, potentially navigating complex prior art and regulatory requirements across different jurisdictions.
Citations
[1] Novo Nordisk A/S. (2015). DK3659647. Patent application filed November 12, 2015. (Priority application filed November 13, 2014).
