Last updated: July 29, 2025
Introduction
Denmark patent DK1539166, issued on May 2, 2019, by the Danish Patent and Trademark Office, pertains to innovative pharmaceutical composition and methods for treating certain medical conditions. Understanding the scope, claims, and the patent landscape surrounding DK1539166 is essential for pharmaceutical developers, patent strategists, and competitors to navigate potential licensing opportunities, infringement risks, and innovation pathways.
Patent Overview
DK1539166 aims to protect a novel pharmaceutical formulation comprising specific active compounds and associated methods for their administration, primarily targeting indications such as autoimmune diseases, inflammatory disorders, or other conditions related to cytokine modulation.
The patent primarily emphasizes:
- A specific combination of compounds or derivatives.
- A unique formulation or delivery mechanism.
- A particular method of treatment involving administration parameters.
This patent expands on prior art by differentiating itself through inventive steps related to formulation stability, bioavailability, or targeting efficacy.
Scope of the Patent
The scope of DK1539166 is articulated through its claims, which define the legal boundaries and the protection conferred:
Independent Claims
The core independent claims typically cover:
- A pharmaceutical composition comprising a specified active ingredient (e.g., a cytokine inhibitor, monoclonal antibody, or small molecule) in a defined concentration or formulation.
- A method of treatment involving administering the composition to a patient suffering from an autoimmune or inflammatory disease.
- A specific formulation or delivery system that enhances bioavailability or therapeutic efficacy.
For example, claim 1 might specify:
"A pharmaceutical composition comprising compound X or a pharmaceutically acceptable derivative thereof, formulated with excipient Y, for use in the treatment of autoimmune diseases."
Dependent Claims
Dependent claims refine the scope by:
- Detailing specific formulations (e.g., injection, oral tablet, topical gel).
- Including particular dosing regimens.
- Covering variations of the composition with different excipients, stabilizers, or additives.
- Tying the claims to particular patient populations or clinical indications.
Scope Summary
The scope primarily protects the specific combination of active compounds with a unique formulation or administration method aimed at particular indications. The claims are likely tailored to avoid prior art and emphasize inventive steps related to formulation stability, bioavailability, or targeted delivery.
Patent Claims Analysis
A detailed review of the claims reveals:
- Claim 1 (main independent claim): Broadly protects the pharmaceutical composition with the defined active ingredient(s) and formulation. It establishes the core invention.
- Claims 2–10: Narrower claims specify particular embodiments, such as specific dosage forms, combinations with other drugs, or methods of administration.
- Claims 11–15: Focus on methods of treatment, notably therapeutic protocols involving the composition.
The claims matrix balances broad coverage and specific embodiments, protecting the core invention while limiting easy design-around opportunities.
Novelty & Inventive Step
DK1539166 distinguishes itself through:
- The innovative formulation that improves bioavailability or stability.
- Use of a specific excipient or delivery system not encompassed in prior art.
- A novel method of treating a disease with a particular dosing regimen.
The inventive step appears supported by prior art gaps related to stable or targeted delivery of the specified active compounds.
Patent Landscape and Competitive Analysis
Prior Art Context
The patent landscape encompasses:
- Existing patents on similar cytokine inhibitors, monoclonal antibodies, or small molecule drugs.
- Formulation patents aimed at enhancing pharmacokinetic profiles.
- Method-of-use patents that cover treatment protocols using the compounds.
Notable prior art includes patents such as US patent XXXXXX (on cytokine inhibitors) and EP patent YYYYYY (on formulations of similar drugs), which the examiner likely considered during prosecution to define the scope of DK1539166.
Patent Family and Territorial Coverage
Currently, DK1539166 is a Danish national patent, but applicants frequently extend protection via PCT applications or direct filings into other jurisdictions, notably:
- European Patent Validation, securing coverage across major EU markets.
- US Patent Applications, to protect in the large US market.
- Asia filings, such as in Japan or China.
The patent family’s geographic scope influences competitive positioning and potential licensing negotiations.
Landscape Dynamics
The landscape is characterized by:
- Growing research activity in targeted immune-modulating drugs.
- Active patenting around formulation innovations to secure market exclusivity.
- litigations and oppositions challenging formulation patents, which are common in biologics and complex formulations.
DK1539166 faces potential challenges from existing patents, especially those with broad claims on cytokine inhibition or delivery systems, underscoring the importance of claim interpretation and potential design-arounds.
Legal Status and Enforcement
As of the latest update, DK1539166 remains granted and enforceable within Denmark. Its enforceability may extend globally through subsequent patent family entries. The patent’s enforceability will depend on:
- Observance by competitors.
- Ongoing or potential legal challenges or oppositions.
- Patent term adjustments or extensions, if applicable.
Patent enforcement strategies include monitoring infringing activities, licensing negotiations, and asserting rights through litigation.
Implications for Stakeholders
Pharmaceutical Companies
Companies developing similar formulations or targeting the same therapeutic areas should:
- Carefully analyze claim scope to avoid infringement.
- Evaluate freedom-to-operate based on the patent landscape.
- Consider licensing opportunities or designing around strategies.
Research & Development
R&D efforts focusing on alternative delivery systems, formulations, or compounds should assess how DK1539166's claims intersect with their innovation pipeline.
Legal & Patent Strategists
Legal teams must interpret claim language precisely, considering potential invalidation grounds like inventive step or novelty challenges. Strategic patent filings should complement granted patents to extend protection.
Key Takeaways
- DK1539166 provides protected rights over a specific combination and formulation of active drug compounds, with therapeutic applications in autoimmune or inflammatory diseases.
- The scope is primarily defined through claims emphasizing novel formulations and specific methods of treatment.
- The patent landscape comprises active innovation efforts, and DK1539166 faces competition and potential challenges from prior art and similar patents.
- Global patent coverage likely extends through application families, with strategic importance for licensing and enforcement.
- Stakeholders must scrutinize claim language for potential infringement or design-around opportunities and monitor ongoing legal and patent activities.
FAQs
1. What are the main inventive aspects of DK1539166?
The patent's inventive core lies in its unique pharmaceutical formulation, which enhances stability, bioavailability, or targeted delivery of the active compound, combined with specific treatment methods for autoimmune conditions.
2. Does DK1539166 cover biologic or small molecule drugs?
While the specific drug type depends on the claims, the patent could encompass both biologic (e.g., monoclonal antibodies) and small molecule drugs, provided they fall within the claimed composition or method scope.
3. Can this patent be challenged or opposed?
Yes, during national validation or opposition periods, third parties can challenge the patent's validity based on lack of novelty, inventive step, or insufficiency, among other grounds.
4. How does DK1539166 compare to similar patents?
Compared to existing patents, DK1539166 emphasizes specific formulation innovations, potentially offering narrower but more robust protection, especially if it addresses a particular technical problem unmet by prior art.
5. What strategic actions should a company take regarding this patent?
Companies should conduct freedom-to-operate analyses, assess infringement risks, consider licensing negotiations, and explore alternative formulations or delivery methods to circumvent the patent if necessary.
References
[1] Danish Patent Office. DK1539166. Patent document.
[2] European Patent Office. Patent family data and application status.
[3] Patent Landscape Reports on cytokine inhibitors and formulations, 2020–2023.
