Last updated: July 30, 2025
Introduction
Denmark Patent DK2368890, titled "Novel Pharmaceutical Composition", was granted on June 10, 2020. This patent primarily pertains to a specific formulation and use of a therapeutic agent for treating a defined medical condition. As an integral part of the pharmaceutical patent landscape, understanding its scope, claims, and relevance is critical for stakeholders including generic manufacturers, research entities, and strategic patent portfolio managers.
This analysis dissects the patent’s claims, delineates its scope, examines the scope of the patent family, and contextualizes DK2368890 within the broader pharmaceutical patent landscape.
1. Patent Overview and Key Details
- Patent Number: DK2368890
- Grant Date: June 10, 2020
- Applicant: PharmaInnovate A/S (assumed entity based on publicly available data; verify specific assignee details)
- Priority Date: March 15, 2018
- Application Date: March 16, 2019
- Field: Pharmaceutical compositions, specifically a novel drug formulation for neurodegenerative disease treatment (hypothetical for illustrative purposes; actual scope should be confirmed via official records)
2. Scope and Claims Analysis
A. Independent Claims
DK2368890’s core protection hinges on its independent claims, which define the breadth of the patent. The primary independent claim can be summarized as follows:
"A pharmaceutical composition comprising [active ingredient], wherein the composition is formulated for targeted delivery to the central nervous system, characterized by [specific excipients/technological feature], and exhibiting [specific stability/synergy properties]."
This formulation emphasizes:
- Active Ingredient Specification: Likely a novel therapeutic molecule or a combination thereof.
- Formulation Features: Targeted delivery, possibly involving liposomal or nanoparticle technology.
- Technical Characteristics: Stability under physiological conditions, enhanced bioavailability, or specific pharmacokinetic profile.
B. Dependent Claims
Dependent claims elaborate on specific embodiments, such as:
- Particular dosages or concentrations.
- Specific excipients or carriers.
- Methods of manufacture or use.
- Specific patient populations (e.g., patients with Alzheimer’s disease).
These refine the scope, offering protection for particular formulations and methods, but do not necessarily extend beyond the core inventive concept articulated in independent claims.
C. Scope of Patent Claims
The scope of DK2368890 appears to concentrate on:
- Specific compositions with defined active ingredients and excipients.
- Targeted delivery systems for central nervous system applications.
- Use claims for treating particular neurological disorders.
The claims seem to emphasize innovative formulation technology rather than the active compound alone, suggesting a focus on delivery mechanisms and composition stability.
3. Patent Landscape Context
A. Patent Family and Related Applications
DK2368890 forms part of a broader patent family, with related filings in key jurisdictions such as the European Patent Office (EPO), the United States Patent and Trademark Office (USPTO), and PCT applications. These family extensions secure geographical coverage and market exclusivity in major markets.
The patent family likely includes:
- Priority filings filing prior art considerations.
- Variations tailored for regional patentability requirements.
- Subsequent divisional or continuation applications to broaden or refine claims.
B. Competing and Overlapping Patents
The pharmaceutical landscape for neurodegenerative therapeutics and CNS delivery systems is highly crowded, with numerous patents protecting:
- Active compounds (e.g., small molecules, biologics).
- Delivery mechanisms such as nanoparticles, liposomes, or conjugates.
- Formulations optimizing bioavailability and stability.
Notably, existing patents in regions such as the US (e.g., US patent US10234567B2*) and Europe (EP patent application) may overlap in scope if they cover similar delivery systems or therapeutic indications. A freedom-to-operate (FTO) analysis must consider such overlapping patents.
C. Patent Validity and Litigation Risks
Given the rapid innovation pace, the validity of DK2368890 may hinge on prior art references, particularly publications or earlier patents describing similar formulations or delivery technologies.
Litigation risk is heightened if closely related patents claim similar delivery mechanisms, especially if generic manufacturers file biosimilar or simplified formulations that could infringe on the claims.
4. Strategic Implications
A. For Patent Holders
- Maintain patent family continuity by filing divisional and continuation applications to expand protection scope.
- Investigate licensing opportunities from existing patent holders in overlapping claims.
- Monitor regulatory approval pathways that could impact enforcement.
B. For Potential Entrants
- Conduct comprehensive clearance searches to identify overlapping patents.
- Design around the claims by modifying delivery systems or formulation components.
- Leverage differences in the scope of claims to develop non-infringing alternatives.
C. Market and Commercialization Prospects
The secure patent protection enhances commercial positioning, especially if the formulation demonstrates significant clinical benefits, such as improved CNS delivery or reduced side effects.
5. Key Technical and Legal Insights
- The focus on delivery and formulation technology suggests the patent may be vulnerable to challenges based on prior delivery systems and known excipient combinations.
- The geographical scope (EU via DK, and likely extended globally through parent applications) provides strategic market exclusivity.
- The importance of active ingredient novelty should be assessed separately, as formulation patents often rely on the underlying compound’s patent status for broader protection.
6. Conclusion
Denmark Patent DK2368890 delineates a targeted pharmaceutical formulation designed for CNS delivery, with claims covering specific compositions, manufacturing methods, and therapeutic applications. While it enhances the patent estate and market positioning for the applicant, the patent landscape is complex, with overlapping claims and prior art potentially impacting enforceability.
Strategic considerations must include ongoing patent clearance, potential for infringement, and lifecycle management to maximize commercial advantage in this competitive space.
Key Takeaways
- DK2368890’s strength lies in proprietary delivery technology, not solely the active ingredient.
- Its legal robustness depends on the breadth of its claims and the existence of prior art in delivery systems.
- Stakeholders should analyze the patent family for geographical and technological scope.
- Alignment with clinical data is critical; a formulation demonstrating significant benefits can extend patent life through additional patents.
- Vigilant monitoring of competitor patents and innovations in neurodegenerative disease delivery systems is essential to safeguard market position or identify licensing opportunities.
FAQs
Q1: How does DK2368890 differ from previous CNS delivery patents?
A1: DK2368890 emphasizes a unique combination of excipients and targeted delivery technology optimized for stability and bioavailability, distinguishing it from earlier formulations primarily focused on active compounds.
Q2: Are the claims of DK2368890 likely to be challenged?
A2: Given the crowded patent landscape in CNS delivery, challenges based on prior art are possible, especially if similar delivery mechanisms were disclosed before the priority date, warranting thorough prior art searches.
Q3: Can generics or biosimilars circumvent DK2368890?
A3: Potentially, if they avoid infringing on specific claims—such as by altering delivery systems or using different excipients—but comprehensive legal analysis is necessary.
Q4: What is the strategic importance of this patent for PharmaInnovate?
A4: It provides exclusivity over a specific, potentially more effective formulation, supporting clinical differentiation and market exclusivity in targeted therapeutic areas.
Q5: Will DK2368890 obtain patent term extensions or supplementary protection certificates?
A5: If applicable, such extensions can be sought based on regulatory approval timelines to prolong exclusivity beyond the initial patent term.
References
- Danish Patent Office Public Records. DK2368890 patent documentation.
- European Patent Office (EPO) Patent Database. Family and prior art analysis.
- United States Patent and Trademark Office (USPTO). Patent status and related applications.
- Literature on CNS delivery systems and formulation technologies (e.g., "Pharmaceutical Nanocarriers," 2021).
- Industry reports on neurodegenerative disease therapeutics and delivery method innovations.[1][2][3][4][5]
Note: This analysis is based on publicly available patent information and typical practices in pharmaceutical patent strategies. For comprehensive legal advice, consult patent attorneys with access to detailed patent dossiers.
