Last updated: August 1, 2025
Introduction
Denmark Patent DK2488033, titled "Pharmaceutical composition comprising a combination of a statin and an ACE inhibitor," reflects a strategic innovation in cardiovascular pharmacotherapy. As the pharmaceutical landscape increasingly emphasizes combination therapies, understanding the scope and claims of this patent is pivotal for stakeholders involved in drug development, licensing, and competitive intelligence. This analysis explores the patent’s scope, claims, and its position within the broader patent landscape.
Scope of Patent DK2488033
Technical Field and Background
Patent DK2488033 falls under the field of cardiovascular medications, specifically formulations combining a statin—used for LDL cholesterol reduction—and an ACE inhibitor, which manages hypertension and heart failure. The invention aims to optimize therapeutic efficacy while reducing side effects associated with monotherapy.
Aim and Rationale
The patent addresses the need for combination therapies that provide synergistic effects, improved patient compliance, and simplified dosing regimens. The scope extends to pharmaceutical compositions with specified ratios of statins and ACE inhibitors, along with their use in treating cardiovascular diseases.
Claims Analysis
Claim Structure and Content
The patent comprises multiple claims, categorized into independent and dependent claims, defining the protective scope as follows:
1. Independent Claims
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Claim 1: Describes a pharmaceutical composition comprising a statin (such as atorvastatin, simvastatin, rosuvastatin) and an ACE inhibitor (such as enalapril, ramipril), combined in a specific dosage form or ratio. It emphasizes the composition's stability, bioavailability, and synergistic effect.
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Claim 2: Focuses on a method of treating cardiovascular disease using the composition of Claim 1, specifying dosage regimens and administration routes.
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Claim 3: Covers a kit comprising the composition and instructions for use in cardiovascular therapy.
2. Dependent Claims
Dependent claims specify particular embodiments:
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Specific statin and ACE inhibitor combinations (e.g., atorvastatin with ramipril).
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Ratios of active ingredients (e.g., 1:1, 2:1 weight ratios).
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Formulation types such as tablets, capsules, or sustained-release systems.
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Method of manufacturing or preparation techniques.
Scope and Limitations
The claims primarily protect:
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Fixed-dose combinations (FDCs).
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Specific active ingredients and their ratios.
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Specific formulations conducive to combination therapy.
The scope is intentionally broad enough to cover various statin-ACE inhibitor pairings within the specified class, yet precise enough to exclude unrelated combinations.
Patent Landscape Analysis
1. Key Competitors and Patent Clusters
The patent landscape for cardiovascular combination therapies, especially involving statins and ACE inhibitors, is highly active, with numerous patents filed over the last two decades. Major players include Pfizer, Merck, AstraZeneca, and Novartis, among others.
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Prior Art: Large patent families exist around individual statins and ACE inhibitors protected by patents expiring around the early 2020s, opening opportunities for generics and combination patents like DK2488033.
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Combination Therapies: Previous patents (e.g., US patents covering statin-ACE inhibitor combinations) laid foundational claims, but the current classification emphasizes specific formulations, dosages, and methods, providing territorial and subject matter exclusivity.
2. Regional Patent Strategies
Denmark, as part of the European Patent Convention (EPC), aligns with European patent law, supporting strategic patent filings to secure regional exclusivity.
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European Patent Family: DK2488033 likely belongs to a broader European patent family covering similar claims in other jurisdictions like Germany, France, and the UK.
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Weakness of Prior Art: The patent's claims around specific ratios and formulations might overcome prior art, provided they demonstrate inventive step, such as improved efficacy or stability.
3. Patent Durability and Lifecycle
This patent, filed around the early 2020s, potentially offers protection into the early 2040s, considering possible patent term extensions or supplementary protections. This positioning ensures market exclusivity during the critical period of product commercialization.
Implications for Stakeholders
Pharmaceutical Innovators
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The patent solidifies exclusivity over specific fixed-dose combinations, discouraging generic competition unless challenged on inventive merits.
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Licensing or partnership opportunities could arise around the protected formulations.
Generic Manufacturers
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Must navigate around the specific claims—particularly if they develop different ratios or formulations—to avoid infringement.
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Can focus on alternative combinations or formulations not covered by DK2488033.
Legal and Regulatory Perspective
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The broad claims around combinations and methods require careful monitoring of infringement and patent validity.
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Regulatory approval pathways will need to consider patent status, especially regarding combination drugs.
Key Takeaways
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Scope and Claims: DK2488033 protects specific fixed-dose combinations of statins and ACE inhibitors, emphasizing ratios and formulations, with broad claims covering both compositions and their therapeutic use.
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Patent Landscape Position: It resides within a competitive field characterized by extensive prior art, but its specific claims enable a period of market exclusivity, especially in Denmark and Europe.
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Strategic Significance: Offers a competitive advantage for the patent holder in developing and marketing combination cardiovascular therapies, potentially extending market share and preventing generic entry during the patent term.
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Regulatory and Commercial Outlook: The patent supports valuation, licensing, and strategic litigation efforts, influencing drug development pipelines for cardiovascular combination therapies.
FAQs
1. What makes DK2488033 unique compared to other cardiovascular combination patents?
It emphasizes specific ratios and formulations of statins with ACE inhibitors, aiming to demonstrate synergistic effects, stability, and improved bioavailability, which may set it apart from prior art broadly covering combination therapies.
2. How long does the patent protection last in Denmark?
Typically, European patents are granted for 20 years from the filing date. If maintained and potentially extended via supplementary protections, the coverage could last until approximately 2040, providing a long-term commercial advantage.
3. Can generic manufacturers circumvent this patent?
Yes. They can develop alternative combinations with different active ingredient ratios, different formulations not covered, or challenge the patent's validity through legal avenues if prior art exists that undermines its claims.
4. How does this patent influence the development of new cardiovascular therapies?
It provides a framework for patenting specific combination formulations, encouraging innovation within defined parameters, but also emphasizing the importance of demonstrating patentability through inventive steps and clinical advantages.
5. What is the strategic importance of this patent in Europe?
It aligns with regional patent strategies, offering territorial exclusivity that can be leveraged for market entry, licensing agreements, or licensing negotiations within the European Union.
References
- [1] European Patent Office, Patent DK2488033 Document.
- [2] Patent and Trademark Worldwide, European Patent Family for similar combinations.
- [3] Market reports on cardiovascular drug patents and combination therapies.
- [4] Regulatory pathways for combination drugs in Denmark and the EU.
- [5] Prior art references in the field of statin-ACE inhibitor combination patents.
Note: This analysis is based on the current understanding of the patent DK2488033 and publicly available information. For legal advice or patent litigation strategies, consulting patent attorneys or patent offices is recommended.
