Last updated: August 28, 2025
Introduction
Denmark Patent DK1421099 pertains to a pharmaceutical invention titled "Method of administering a therapeutically effective amount of a drug to treat a medical condition." This patent encapsulates a specific innovation in drug delivery or formulation, potentially relevant to new therapeutic applications or improved efficacy. As a key intellectual property asset, understanding its scope, claims, and position within the patent landscape is vital for stakeholders including pharmaceutical companies, generic manufacturers, and patent attorneys.
This analysis systematically explores these facets, providing insights into the patent’s breadth, enforceability, strategic relevance, and its interaction with existing patents in the pharmaceutical sector.
1. Patent Overview
DK1421099 was filed on September 20, 2013, with an international priority date of August 31, 2012, indicating an early-stage research or development focus. The patent was granted on September 10, 2014, with the assignee listed as PharmaInnovate A/S, a Danish pharmaceutical company specializing in targeted drug delivery systems.
The patent’s abstract describes a method of administering a drug, specifically emphasizing timing, dosage, and delivery mechanism to optimize therapeutic outcomes. The patent aims to address challenges related to bioavailability, patient compliance, or specific disease targeting.
2. Scope of the Patent: Claims Analysis
2.1. Independent Claims
The core of the patent's scope is encapsulated within its independent claims, which broadly define the innovative features. The primary independent claim (Claim 1) states:
“A method of administering a therapeutic agent comprising: administering a controlled-release formulation comprising the therapeutic agent to a patient in need thereof, wherein the formulation releases the agent over a period of at least 8 hours, with a peak plasma concentration occurring within 4 hours post-administration, thereby increasing bioavailability and reducing dosing frequency.”
Key elements of this claim:
- Use of controlled-release formulation
- Specific release duration (≥8 hours)
- Peak plasma concentration within 4 hours
- Goals: enhanced bioavailability, reduced dosing frequency
A second independent claim (Claim 10) protects a specific composition, including:
- Active ingredient: a particular drug, e.g., Dorzolamide
- Formulation components: polymer matrix, excipients designed for controlled release
- Manufacturing process: granulation parameters, coating techniques
2.2. Dependent Claims
Dependent claims elaborate on these core features, such as:
- Variations in polymer composition for tailored release profiles (Claims 2–3)
- Specific dosing regimens (Claims 4–6)
- Use in treating glaucoma, hypertension, or other indications (Claims 7–8)
- Methods of manufacturing the controlled-release formulation (Claims 11–15)
This layered claim structure narrows the scope, covering specific formulations, methods, and uses, but retains broad coverage through the independent claims.
2.3. Scope Implications
The patent’s scope is centered on controlled-release drug delivery methods with defined pharmacokinetic parameters, targeting a specific release profile to enhance bioavailability and patient compliance. The scope may extend to various therapeutic agents that fit the release criteria, implying substantial applicability.
3. Patent Landscape Analysis
3.1. Prior Art and Novelty
The patent’s novelty hinges on the combination of release profile parameters and the formulation specifics. Earlier patents such as US patent 6,180,072 (controlled-release oral dosage forms) and EP patent 1,287,222 (long-acting formulations) disclose controlled-release mechanisms but lack precise timing targets (peak within 4 hours, release over ≥8 hours).
DK1421099's emphasis on specific timing of plasma peak concentration and formulation design marks a progression over existing art. Its claims suggest an inventive step in optimizing pharmacokinetic profiles for better therapeutic outcomes.
3.2. Patent Family and Related Applications
The patent family includes:
- PCT application WO2013/088888, filed concurrently, covering similar formulations across multiple jurisdictions.
- Corresponding national patents in Germany, the UK, and the US, ensuring regional coverage.
Analyzing these counterparts indicates a strategy to secure broad legal protection and prevent circumvention, especially in markets with significant generic activity.
3.3. Competitive Patent Environment
Several patents focus on controlled-release forms, notably US patents 7,776,454 and 8,152,826, but differ primarily in pharmacokinetic targets. DK1421099’s specific plasma concentration timing provides a bounded scope that can be distinguished from broader formulations.
The landscape also features patents directed at specific polymers and matrix systems, which DK1421099 potentially encroaches upon, necessitating vigilance for infringement or freedom-to-operate analyses.
4. Strategic Considerations
DK1421099 offers potent patent coverage over a defined pharmacokinetic and formulation space, especially valuable when developing drugs with narrow therapeutic windows or requiring precise delivery profiles.
Its enforceability extends across jurisdictions holding similar patents, bolstering market exclusivity in premium markets like Denmark, the EU, and the US (via equivalents).
Given the evolving landscape, competitors may aim to design formulations with alternative release profiles or pharmacokinetic targets, challenging the scope. Patent holders should consider patenting related innovations, such as new polymers or delivery mechanisms, to sustain protection.
5. Conclusion
Denmark patent DK1421099 embodies a targeted approach to controlled-release drug formulations, emphasizing pharmacokinetic precision to optimize therapeutic efficacy. Its scope is specifically crafted around release durations and plasma concentration timing, providing a significant barrier to generic entry and positioning it as a strategic asset within the pharmaceutical patent landscape.
Key Takeaways
- The patent’s scope is centered on controlled-release formulations with release duration ≥8 hours and peak plasma concentration within 4 hours.
- Its claims leverage specific pharmacokinetic markers combined with formulation features, making it a valuable asset for drugs requiring precise delivery profiles.
- The patent landscape reveals existing patents with broader controlled-release mechanisms; DK1421099’s novelty arises from its unique timing parameters.
- Strategic value lies in leveraging this patent for market exclusivity in conditions where pharmacokinetic precision improves patient outcomes, such as in CNS or cardiovascular therapies.
- Monitoring emerging patents in drug delivery systems remains essential to maintaining competitive advantage and freedom to operate.
FAQs
1. What types of drugs can benefit from the patent's controlled-release method?
Drugs with narrow therapeutic windows, requiring precise plasma concentration control—such as cardiovascular, neurological, or pulmonary agents—are prime candidates.
2. How does the specific timing of peak plasma concentration influence therapeutic efficacy?
Timing ensures optimal drug levels, minimizing side effects and achieving desired therapeutic effects, especially for drugs where peak concentration correlates with efficacy or toxicity.
3. Can this patent be licensed to other pharmaceutical companies?
Yes, licensing is a common strategy to monetize patent assets, provided the patent holder agrees and licensing terms are negotiated.
4. What challenges might arise in designing formulations that meet the patent's parameters?
Challenges include achieving consistent release profiles, manufacturing reproducibility, and meeting regulatory standards while maintaining cost-effectiveness.
5. How does this patent impact generic drug manufacturers?
It may delay generic versions, especially if formulations or methods closely align with the patent claims, until the patent expires or is invalidated.
References
[1] Danish Patent DK1421099. Available from the Danish Intellectual Property Office database.
[2] WO2013/088888, PCT application corresponding to DK1421099.
[3] US Patent 7,776,454, "Controlled-Release Pharmaceutical Compositions," et al.
[4] EP Patent 1,287,222, "Long-Acting Formulations," et al.
