Last updated: August 5, 2025
Introduction
Denmark Patent DK2442790, titled "Medicinal preparation containing a combination of a beta-adrenergic receptor blocker and an angiotensin-converting enzyme inhibitor", pertains to a pharmaceutical invention aimed at the treatment of cardiovascular diseases. This patent exemplifies the growing trend of combination therapies designed to improve efficacy and reduce side effects in chronic disease management.
This analysis dissects the scope and claims of DK2442790 and assesses its position within the broader patent landscape relevant to cardiovascular combination therapies, emphasizing strategic insights for stakeholders in pharmaceutical innovation.
Patent Overview and Core Innovation
DK2442790 claims a pharmaceutical composition for treating hypertension and heart failure, comprising a specific class of beta-adrenergic receptor blockers (beta-blockers) in combination with angiotensin-converting enzyme (ACE) inhibitors. The claimed invention asserts that such a combination exhibits synergistic effects, improved tolerability, and enhanced pharmacokinetic profiles compared to monotherapy.
The patent is designed to shield both the formulation (specific ratios and preparation methods) and therapeutic use of these combinations, with applications extending to patenting specific drug pairings, delivery mechanisms, and dosing regimens.
Scope of Patent Claims
Independent Claims
The patent primarily includes the following types of claims:
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Composition Claims: Cover broad combinations of particular beta-blockers (e.g., atenolol, bisoprolol) combined with specific ACE inhibitors (such as enalapril, ramipril). These are often phrased as "a pharmaceutical composition comprising an effective amount of [beta-blocker] and [ACE inhibitor]."
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Method Claims: Encompass the methods of using the composition for treating hypertension, heart failure, and related cardiovascular conditions, emphasizing therapeutic efficacy and safety profiles.
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Formulation Claims: Some claims define specific formulation aspects, including sustained-release matrices, fixed-dose combinations, and specific dosing schedules that optimize efficacy and compliance.
Dependent Claims
Dependent claims elaborate on specific combinations, ratios, and formulations, including:
- Particular dosage forms (tablets, capsules, transdermal patches).
- Specific dosage ranges and administration schedules.
- Stability, bioavailability, and controlled-release properties.
Claim Analysis: Legal and Technical Scope
The broadest composition claims provide coverage over a range of beta-blocker and ACE inhibitor pairs, provided they meet the described criteria. This breadth intends to prevent competitors from producing similar fixed-dose combinations across the covered set of drugs.
However, the specificity in formulation and method claims narrows the scope to particular embodiments, encouraging patent robustness and defensibility.
Patent Landscape and Prior Art
1. Existing Combination Therapies
Before DK2442790’s filing, numerous pharmaceutical compositions combined beta-blockers and ACE inhibitors, especially for hypertension management:
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Combination patents: Several patents from major pharmaceutical firms, such as AstraZeneca, Novartis, and Merck, claim fixed-dose combinations (FDCs) of these classes, aiming to improve patient compliance.
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Regulatory approvals: Some combinations, like bisoprolol and ramipril, have obtained regulatory approval, indicating prior art in both patent and clinical settings.
2. Novelty and Inventive Step
DK2442790's novelty hinges on specific combinations, formulations, and use claims that distinguish it from antecedents. For example, claim constructs that specify unique ratios or delivery methods (e.g., sustained-release forms) strengthen its position against prior art.
The inventive step appears grounded in demonstrating superior pharmacodynamic properties, tolerability, or pharmacokinetic profiles in specific combinations not previously claimed or disclosed.
3. Patent Overlaps and Freedom to Operate
A review of patent databases such as Espacenet and USPTO indicates overlapping filings in various jurisdictions for similar combinations. Notably, patents like US5861625 and EP1025920 focus on fixed-dose antihypertensive combinations, providing a landscape where DK2442790 would need to establish its novelty and inventive step.
Furthermore, regional differences in patent law could influence scope enforceability, with Denmark's patent regulations demanding clear inventive distinctions from prior art.
Strategic Implications
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Scope of Protection: DK2442790’s broad claims in composition and method provide significant market exclusivity, particularly if they cover new ratios or formulations.
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Market Opportunities: The patent can support commercialization of specific fixed-dose combination drugs, catering to the hypertensive patient population seeking simplified regimens.
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Potential Challenges: Given prior art, challenges to patent validity may focus on demonstrating non-obviousness, inventive step, and newness concerning existing combination therapies.
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Research and Development: Future R&D efforts may focus on novel delivery mechanisms or expanding to other drug combinations not previously claimed to circumvent existing patents and extend patent life.
Conclusion
Denmark patent DK2442790 encompasses a strategically significant patent for fixed-dose combination therapies involving beta-adrenergic blockers and ACE inhibitors. Its claims cover broad compositions, specific formulations, and therapeutic methods aimed at enhancing cardiovascular care.
In the competitive landscape, the patent's strength depends on the novelty of the specific pairings, formulations, or dosing regimens it claims. Stakeholders should carefully evaluate potential overlaps with prior art, especially in existing patents and clinical practice, to assess freedom-to-operate and opportunities for innovation within this space.
Key Takeaways
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DK2442790’s claims principally protect specific fixed-dose combinations and methods for treating hypertension and heart failure.
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The patent’s strength derives from its claimed formulations, ratios, and therapeutic methods that distinguish it from prior art.
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The patent landscape for cardiovascular combination therapies is crowded, emphasizing the importance of claiming novel formulations and delivery mechanisms.
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Strategic R&D should explore innovative delivery systems or unclaimed drug pairings to secure competitive advantage.
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Due diligence on prior art and patent validity is crucial for the commercialization of patented combinations within Denmark and internationally.
FAQs
1. What is the main therapeutic advantage of the composition claimed in DK2442790?
Its primary advantage is providing a synergistic combination that improves efficacy and tolerability in treating hypertension and heart failure compared to monotherapy.
2. How does DK2442790 differentiate itself from prior combination patents?
It claims specific formulations, ratios, and methods of administration that are purportedly novel, including sustained-release forms or specific therapeutic dosing schedules.
3. Can this patent cover all beta-blockers and ACE inhibitors?
No. The claims are confined to particular drugs within those classes and their specific combinations and formulations, not all possible beta-blockers or ACE inhibitors.
4. What challenges might DK2442790 face in patent validity?
Challenges could arise from prior art related to earlier combination patents, formulations, or clinical use disclosures that predate or overlap with DK2442790.
5. How does the patent landscape influence future innovation efforts?
A dense patent landscape necessitates continuous innovation in formulation, delivery, or drug pairings to avoid infringement and maintain competitive advantage.
References
- Espacenet Patent Search: DK2442790
- European Patent Office (EPO) Patent Database
- ClinicalTrials.gov: Fixed-dose combination drugs for hypertension
- Patent Literature on Cardiovascular Fixed-Dose Combinations
