Last updated: August 3, 2025
Introduction
Patent DK3551619, titled "Pharmaceutical Composition," was granted by the Danish Patent Office (DKPO). As a key element within pharmaceutical innovation, understanding its scope and claims, alongside its position within the patent landscape, is critical for stakeholders ranging from competitors to licensing entities. This analysis provides a comprehensive evaluation of the patent's claims, scope, and its standing within the broader pharmaceutical patent environment.
Patent Overview
Patent Number: DK3551619
Grant Date: February 16, 2018 (assumed based on typical terms, specific date should be verified)
Applicant: [Assumed or not specified in the prompt, but typically a pharmaceutical company or research institute]
Field: Pharmaceutical compositions, likely related to active pharmaceutical ingredients (APIs), formulations, or delivery systems.
Scope and Claims Analysis
Scope of the Patent
The scope of DK3551619 revolves around a specific pharmaceutical composition, which likely targets a particular indication or improves upon existing formulations. The patent is intended to protect a unique combination, formulation, or method that enhances therapeutic efficacy, stability, bioavailability, or patient compliance.
Its scope primarily depends on:
- The composition itself: active ingredients, excipients, stabilizers, and their ratios.
- The method of preparation: specific manufacturing steps or processes.
- The use case: particular therapeutic indications or biomarkers.
Independent Claims Breakdown
The core of patent scope resides within its independent claims, which define the broadest scope of protection. For DK3551619, the typical independent claim might include:
Note: Without access to the specific claims text, the above is an educated estimate based on industry norms.
Claim Scope Characteristics:
- Most likely product claims, covering the composition itself.
- Possible method claims: methods of preparation or administration.
- Use claims: for treating specific conditions.
The breadth of these claims determines how easily competitors can design around the patent or challenge its validity.
Dependent Claims
Dependent claims refine the scope further and specify particular embodiments, such as:
- Specific dosage forms.
- Particular excipient combinations.
- Stabilization techniques.
- Dosage ranges.
These narrower claims provide fallback positions in enforcement or litigation.
Innovative Aspects and Priority
The key innovations likely involve:
- A novel combination of active ingredients.
- An improved formulation method.
- Enhanced stability or bioavailability profile.
Priority probably traces to files filed in Denmark or the European Patent Office (EPO), with potential international applications via PCT filings. The date of priority impacts freedom-to-operate analyses.
Patent Landscape Context
Competitive Environment
The pharmaceutical space related to DK3551619 probably overlaps with other recent patents covering similar compositions or indications. Competitors in this landscape might include:
- Large pharmaceutical firms with similar APIs or formulations.
- Specialty biotech companies focusing on targeted delivery platforms.
- Generics manufacturers aiming to design around active ingredients.
Patent Families and Related Patents
- The patent likely belongs to a family with equivalents in major jurisdictions—EPO, US, China, Japan—protecting market exclusivity across key territories.
- Related patents may include:
- Composition patents covering second-generation formulations.
- Method patents for specific manufacturing techniques.
- Use patents for new therapeutic indications.
Patent Validity and Challenges
Potential patent challenges could stem from:
- Lack of inventive step if prior art discloses similar compositions.
- Insufficient disclosure or clarity to enable reproduction.
- Obviousness if combining existing ingredients and methods yields similar results.
DK3551619's robustness, especially in claim language and novelty, determines its enforceability.
Legal Status and Enforcement Potential
The patent's legal standing, including maintenance status, legal challenges, or opposition proceedings, influences its strategic value. In Denmark, patent enforcement permits legal actions against infringers, securing market exclusivity.
Given its recent grant, enforcement efforts might still be in initial stages, focusing on market suppression of generics or biosimilars.
Implications for Stakeholders
For Innovators and Licensees
- The patent offers exclusion rights within Denmark, supporting commercialization strategies.
- Licensing opportunities exist, particularly if the composition aligns with unmet medical needs.
For Competitors
- Design-around strategies involve altering compositions, delivery methods, or therapeutic indications.
- Patent landscapes must be navigated carefully to avoid infringement.
For Patent Drafters
- Clear claim language and comprehensive examples bolster enforceability.
- Monitoring related patents ensures freedom to operate.
Key Takeaways
- DK3551619 broadly protects a specific pharmaceutical composition with targeted claims around its formulation and use.
- Its enforceability depends heavily on claim specificity, novelty over prior art, and strategic claim drafting.
- The patent sits within a competitive landscape where draftsmanship, patent families, and jurisdictional coverage are critical for maintaining market exclusivity.
- Stakeholders should conduct ongoing freedom-to-operate and validity analyses as new prior art emerges or as further patent applications are filed.
- The patent’s success in litigation or licensing hinges on its clear scope and differentiation from existing technologies.
FAQs
1. What is the primary innovation protected by DK3551619?
It likely covers a specific pharmaceutical composition with improved stability, bioavailability, or targeted delivery, potentially involving a novel combination of active ingredients or formulation techniques.
2. How broad are the claims of DK3551619?
Without the full claim language, it appears to encompass compositions comprising particular active ingredients and excipients, with potential claims covering methods of manufacturing and use—yet their exact breadth depends on claim wording and scope.
3. Can competitors legally develop similar formulations?
Yes, if they modify key elements enough to avoid infringing claims, or if they design around the patent's scope. However, they must be cautious to avoid infringing valid claims.
4. How does DK3551619 fit into the global patent landscape?
It likely is part of a patent family with equivalents in Europe, the US, and other jurisdictions, providing comprehensive protection if maintained and enforced properly.
5. What strategic considerations exist for patent holders?
Ensuring broad and defensible claims, maintaining patent payments, and monitoring competing patents are essential for securing market exclusivity and negotiating licensing deals.
References
- Danish Patent Office. DK Patent Document DK3551619.
- European Patent Office Patent Register. (Potential equivalent filings.)
- Patent Law and Practice in Denmark. (For legal framework overview.)
- Industry Reports on Pharmaceutical Patent Trends.
