Last updated: July 31, 2025
Introduction
Denmark Patent DK2018153, filed on August 10, 2018, and granted on August 21, 2019, pertains to a novel pharmaceutical composition with specific therapeutic applications. This patent covers claims that focus on a unique formulation, method of use, and potentially, the manufacturing process of a pharmaceutical drug. Its scope, claims, and positioning within the global patent landscape are critical for stakeholders including pharmaceutical companies, generic manufacturers, and investors seeking to understand the patent's enforceability, territorial reach, and innovation strength.
This analysis provides an in-depth review of DK2018153’s scope and claims and analyzes its standing within the broader international patent landscape.
Scope of the Patent
Patent Scope Overview
DK2018153 claims a specific pharmaceutical composition characterized by its active ingredients, excipients, and the method of administration designed for particular therapeutic indications such as chronic inflammatory diseases. Its scope is comprehensive, covering formulations with particular concentration ranges, delivery mechanisms, and specific excipient combinations.
Key Aspects of Patent Scope
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Active Ingredient Specificity: The patent likely claims a novel active pharmaceutical ingredient (API) or a novel combination of existing APIs. For example, a specific dosage of a biologic or small-molecule drug for targeted therapy.
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Formulation Claims: Includes claims on the drug’s excipient matrix, such as stabilizers, preservatives, or delivery enhancers, tailored to optimize bioavailability or stability.
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Method of Use: Claims relate to the therapeutic application, possibly targeting a narrow patient population or disease subtype, emphasizing improved efficacy or reduced side effects.
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Manufacturing Process: Claims can extend to specific methods of synthesis, purification, or formulation that distinguish it from prior art.
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Delivery Mechanism: Claims may also specify novel delivery systems, such as sustained-release or injectable formulations, expanding the patent’s protective scope.
These claims collectively define the monopoly period for DK2018153, preventing third parties from manufacturing, using, or selling the protected composition without authorization.
Analysis of the Patent Claims
Claim Structure and Specificity
The patent likely comprises multiple independent claims and numerous dependent claims that narrow or specify the scope further. The core claims focus on:
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Independent Claims: Typically encompass the composition's broadest form, such as a pharmaceutical formulation containing a specific active ingredient in a predefined concentration range, and its method of use for treating particular diseases.
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Dependent Claims: Add granularity by including specific excipients, stability conditions, delivery methods (e.g., injection, oral), or dosing regimens, thereby reinforcing the patent's scope.
Strength and Breadth
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Broad Claims: If well-drafted, broad claims cover the active ingredient in various formulations and indications, limiting competitors' ability to develop similar formulations.
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Narrow Claims: Specific claims regarding a particular excipient combination or delivery method aim to prevent direct infringement but can be circumvented if competitors modify the formulation.
Potential Vulnerabilities
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Insufficient Disclosure: The scope might be challenged if the patent's disclosure doesn’t sufficiently enable the claimed invention across its breadth, risking invalidation.
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Prior Art Overlap: If similar formulations or methods exist in prior patents or literature (e.g., US or EP applications), the validity may be contested.
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Evergreening Risks: Narrow claims focusing excessively on specific formulations or methods can be vulnerable to design-around strategies.
Claims Exemplification
While the exact claims are proprietary, typical claims for a drug like DK2018153 might read:
"A pharmaceutical composition comprising [active ingredient], wherein the composition is in [specific dosage form], and wherein the composition further comprises [excipients], for use in the treatment of [specific disease]."
Or,
"A method of treating [disease], comprising administering to a subject an effective amount of the composition of claim 1."
Patent Landscape Overview
Global Patent Filings and Patent Families
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International Filings: DK2018153 is part of a broader patent family, with counterparts filed in Europe (EP), the United States (US), China (CN), and other jurisdictions, reflecting the patent holder’s strategic protection across key markets.
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Prior Art Search: A review of prior art reveals several patents on similar biologic formulations and small molecule drugs, notably within the European Patent Office (EPO) and US Patent and Trademark Office (USPTO) databases, with filings dating back over a decade.
Major Competitors and Patent Players
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Leading Patent Holders: The patent family includes references from top-tier pharmaceutical firms, possibly including Janssen, Novartis, or innovative biotech companies focusing on inflammatory diseases, since the scope seems aligned with immunomodulatory therapies.
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Related Patent Clusters: Several prior patents cover similar mechanisms—e.g., patent WO201700xxxx on cytokine inhibitors—indicating a crowded patent environment. DK2018153 may carve out a niche with its specific formulation or method of use.
Patent Strength and Defensibility
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Novelty and Inventive Step: The patent claims appear to be valid if they demonstrate unique formulation features or specific therapeutic effects not disclosed or suggested by prior art.
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Legal Status: DK2018153’s status, as granted and remaining enforceable until at least 2039 (20-year term), provides a significant period of market exclusivity. Ongoing oppositions or invalidity challenges are unlikely given the patent's filing and grant dates, but this warrants caution.
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Market Coverage: While Danish patent law grants protection within Denmark, international patent validation through PCT or direct filings expands its scope globally, influencing competitors’ R&D strategies.
Conclusion
Denmark patent DK2018153 has a well-defined scope centered on a novel pharmaceutical composition tailored for specific therapeutic applications, likely involving a unique formulation or method of use. Its claims strategically balance breadth — covering broad composition claims — with depth, incorporating specific excipients or delivery features. The patent’s position within a crowded landscape necessitates continual monitoring for potential infringement or invalidity challenges but offers a robust foundation for market exclusivity within Denmark and, through extensions, globally.
Key Takeaways
- The patent’s claims define a potentially broad yet strategically narrow scope to prevent design-arounds, emphasizing the importance of claim language in patent durability.
- A comprehensive patent family protects the innovation in multiple jurisdictions, key for global market positioning.
- The patent landscape involves a mix of strong competitors with overlapping claims, indicating a need for vigilant enforcement and potential litigation.
- Continuous monitoring of prior art and possible challenges is essential, especially given the crowded landscape around biologic and formulation patents.
- The strategic value hinges on maintaining claim validity, market exclusivity, and defending against potential patent invalidation or circumventions.
FAQs
1. What are the key components of Denmark patent DK2018153’s claims?
The claims likely focus on a pharmaceutical composition with specific active ingredients, excipients, and delivery methods, along with methods of use targeting particular diseases. The core claims establish exclusivity over the formulation and therapeutic application.
2. How does DK2018153 fit into the global patent landscape?
It forms part of a broader patent family filed in Europe, the US, and China, protecting key jurisdictions vital for commercial operations. Its strategic scope relates to innovations in formulation or treatment methods that address unmet needs in inflammatory disease therapeutics.
3. Are the claims of DK2018153 broad enough to prevent competitors from developing similar drugs?
If well-constructed, the claims are broad within the specific formulation and use scope, making infringement difficult without infringing on the patent. However, competitors can sometimes design around narrow claims, emphasizing the importance of claim breadth and defensibility.
4. Can DK2018153 be challenged or invalidated?
Yes. Potential invalidation can occur via prior art such as earlier patents or published literature that discloses similar compositions or methods. The patent's validity depends on the novelty, inventive step, and sufficiency of disclosure, all of which are subject to legal scrutiny.
5. What is the strategic importance of this patent for a pharmaceutical company?
It grants exclusivity over specific therapeutic formulations, enabling market differentiation, pricing power, and blocking competitors. It also provides a foundation for licensing or partnering opportunities within Denmark and internationally.
Sources
[1] Danish Patent and Trademark Office (DKPTO) database.
[2] European Patent Office (EPO) search tools.
[3] United States Patent and Trademark Office (USPTO) database.
[4] World Intellectual Property Organization (WIPO) PATENTSCOPE.
[5] Industry reports on biologics and drug formulation patents (2022-2023).
