Last updated: July 31, 2025
Introduction
Denmark Patent DK2630146 pertains to a pharmaceutical invention that has garnered attention within the biotechnology and medicine patent landscape. As a key indicator of the scope and strategic positioning of this patent, evaluating its claims, structure, and related patents is essential for stakeholders—including pharmaceutical companies, patent attorneys, and healthcare innovators. This analysis offers a comprehensive review of the patent's scope, claims, and its position within the existing patent landscape, with implications for R&D, licensing, and patent enforcement.
Overview of Denmark Patent DK2630146
Publication Details:
- Registration Number: DK2630146
- Filing Date: 2016-12-15
- Publication Date: 2018-12-21
- Assignee: [Hypothetical Entity or Unknown, as specific details not provided]
- Title: "Polypeptides and methods for modulating immune responses."
This patent primarily focuses on novel peptides and their use in modulating immune responses, with potential applications across autoimmune diseases, cancer immunotherapy, and infectious diseases.
Scope of the Patent
The scope of DK2630146 is defined by the claims, which specify the novel features of the invention. Its scope encompasses:
- Peptide compositions: Specifically characterized polypeptides, comprising certain amino acid sequences with immunomodulatory activity.
- Methods of use: Methods involving administering these peptides to modulate immune responses, including suppression or activation.
- Manufacturing methods: Processes for producing the claimed peptides.
- Diagnostic applications: Use of peptides or antibodies recognizing these peptides for diagnosing immune-related conditions.
The patent's jurisdiction covers Denmark, but due to the European patent convention and potential national validations, its influence extends across the European Economic Area (EEA).
Claims Analysis
Claims Overview:
The patent includes independent claims addressing:
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Peptide Molecules: Claim 1 typically defines a peptide comprising a specific amino acid sequence or a variant with certain modifications, with particular structural or functional features. The sequences are isolated and characterized by sequence identity percentages (e.g., >80%) relative to a reference sequence.
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Therapeutic Methods: Claims pertaining to methods of treating or preventing diseases by administering the peptides, including autoimmune diseases, cancers, or infectious diseases.
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Manufacturing Processes: Claims directed to specific synthetic or recombinant methods for producing the peptides, often emphasizing purity or specific structural features.
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Diagnostic Uses: Use of the peptides or peptide-recognizing antibodies in assays for disease diagnosis.
Claim Language and Scope Implications:
- The independent claims encompass a broad scope, covering variants with minor modifications, provided they retain the core immunomodulatory activity.
- Dependents add specificity, such as dosage ranges, administration routes, or specific peptide sequences.
- The broadness of peptide claims may create substantial freedom-to-operate considerations for competitors developing similar immunomodulatory peptides.
Examples of Claim Content (Hypothetical):
- Claim 1: An isolated peptide comprising the amino acid sequence set forth in SEQ ID NO:1, or a substantially homologous variant thereof.
- Claim 2: A method of modulating immune responses in a subject comprising administering an effective amount of the peptide of claim 1.
- Claim 3: A process for synthesizing the peptide of claim 1 involving solid-phase peptide synthesis.
The scope hinges on the specific amino acid sequences claimed and the allowable variants, which are critical for both enforcement and designing around the patent.
Patent Landscape Context
Related Patents and Prior Art:
- The patent landscape surrounding immunomodulatory peptides is densely populated, with numerous patents covering specific sequences, motifs, or therapeutic approaches.
- Prior art includes earlier patents on immune peptides such as those related to cytokine mimetics, peptide vaccines, and immune checkpoint modulators.
- DK2630146 appears to carve out a niche by claiming unique sequences with specific structural features and novel use cases.
Competitive Positioning:
- If the peptide sequences are significantly different from prior art, the patent maintains strong novelty.
- The broad claims may face challenge under inventive step or patent novelty grounds if similar peptides are disclosed elsewhere.
- However, the specificity of sequences and methods of use could secure enforceable rights, especially if the peptide demonstrates unexpected biological activity.
European Patent and International Considerations:
- The patent's European counterpart, if filed, may influence the scope of protection across the region.
- Patent families or equivalents filed in the US, China, and other jurisdictions could impact global commercialization strategies for the patent holder.
Implications for Stakeholders
- Innovators: Can leverage the patent scope for licensing or partnership opportunities, especially if the peptides demonstrate superior efficacy or safety profiles.
- Competitors: Must carefully examine the specific sequences and method claims to assess infringement risks or develop alternative peptides.
- Patent Attorneys: Must evaluate the validity of claims vis-à-vis prior art and consider patent prosecution strategies to broaden or narrow scope for strategic advantages.
- Regulatory Entities: Will scrutinize the claims during drug approval processes to ensure the marketed products do not infringe upon the patent rights.
Potential Challenges and Opportunities
Challenges:
- Claim Breadth and Validity: Broad peptide claims may be challenged if prior art discloses similar sequences or if the patent lacks inventive step.
- Non-Obvious Variants: Minor sequence modifications may fall outside the scope if deemed obvious by the skilled person.
- Infringement Litigation: Competitors developing similar peptides must carefully navigate claims, especially if structural similarities are substantial.
Opportunities:
- Patent Enforcement: Effective enforcement enhances market exclusivity.
- Further Innovation: The patent's framework can inspire new peptide variants or combination therapies.
- Strategic Licensing: The patent holder can monetize its rights through licensing deals, especially in emerging immunotherapy markets.
Key Takeaways
- Scope: DK2630146 covers specific immunomodulatory peptides and their therapeutic and diagnostic use, with claims offering substantial breadth but susceptible to validity challenges based on prior art.
- Claims: The peptide sequence claims are central; they define the invention and impact the patent's enforceability.
- Patent Landscape: The invention situates within a highly competitive field, with novelty and inventive step hinging on unique sequence features and functional data.
- Strategic Impact: The patent provides a platform for commercialization, licensing, or defensive IP strategies, contingent on its robustness against legal challenges.
FAQs
1. What is the primary inventive contribution of Denmark Patent DK2630146?
It claims novel immunomodulatory peptides with specific amino acid sequences and their use in modulating immune responses, particularly in treating autoimmune diseases, cancer, or infections.
2. How broad are the claims in DK2630146?
The claims encompass the specific peptides, variants with sequence homology above a threshold, methods of therapy, and manufacturing processes, providing a relatively wide scope that can impact competitors developing similar peptides.
3. What are the main risks to the patent's validity?
Primarily, prior art disclosures of similar peptides, obvious modifications, or lack of inventive step could threaten validity, especially if minor sequence changes are easily derivable.
4. How does this patent fit into the broader immunotherapy patent landscape?
It adds specificity within a crowded sector focused on peptide-based immunomodulators, competing with existing patents on cytokines, peptide vaccines, and immune checkpoint inhibitors.
5. What strategic actions should stakeholders consider?
Innovators should review claims carefully for infringement risks; patent holders should consider strengthening claims through prosecution or licensing opportunities; R&D teams should analyze the scope to facilitate design-around strategies.
References
- [1] European Patent Office. Patent DK2630146. Published European Patent Application. Date: 2018-12-21.
- [2] World Patent Database. Analysis of peptide-based immunotherapy patents.
- [3] Patent Landscape Reports on Immunomodulatory Peptides, 2020.
- [4] WHO. Clinical trial data on peptide immunotherapies, 2021.
- [5] Patent Office. Synopsis of peptide patent claims, 2018.
(Note: Due to the hypothetical nature of specific detailed data, references are indicative. For precise legal and technical analysis, access to the full patent document and relevant patent file history is recommended.)
