Last updated: July 27, 2025
Introduction
Denmark Patent DK2318419, granted on September 22, 2021, pertains to a novel pharmaceutical compound and its therapeutic applications. This patent represents a strategic intellectual property asset with implications across the biopharmaceutical sector, particularly in treatments centered on the patent’s core therapeutic area. This report analyzes the scope and claims of DK2318419, reviews its positioning within the existing patent landscape, and discusses its implications for stakeholders.
Scope and Claims of DK2318419
Patent Abstract and Core Invention
DK2318419 focuses on a beta-agonist compound designed for use in respiratory diseases, notably asthma and chronic obstructive pulmonary disease (COPD). The patent claims a specific chemical formula with unique substituents that confer enhanced selectivity and reduced side effects compared to conventional beta-agonists such as salbutamol or formoterol.
Claims Analysis
The patent’s claims can be broadly categorized into the following types:
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Compound claims: These define the core chemical structure, including specific substitutions at various positions on the core heterocyclic scaffold. Claim 1, the broadest, covers a group of 2-alkyl-phenylethanolamine derivatives with particular substitutions that optimize receptor binding and pharmacokinetic profiles.
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Method of use claims: Cover methods for treating respiratory conditions in mammals, including humans, using the claimed compounds. These claims specify administration routes, dosages, and treatment regimens.
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Formulation claims: Extend protection to pharmaceutical compositions comprising the compounds and auxiliary excipients, highlighting inhalation powders, aerosols, or nebulizer solutions.
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Process claims: Detail the synthesis routes for the claimed compounds, emphasizing efficiency and purity, with a focus on environmentally benign manufacturing conditions.
Scope of Protection
The patent’s claims exhibit a moderate breadth, covering not only the exact chemical entities but also a subset with minor modifications. This range of claims provides a strategic barrier against direct generics, while the process and formulation claims support strong product lifecycle management.
The chemical scope includes derivatives with specific substitution patterns designed to enhance receptor selectivity and safety. The method claims provide coverage over all approved treatment methods utilizing these compounds, which is critical in clinical development and commercialization.
Patent Landscape Context
Pre-existing Patent Environment
In the respiratory drug domain, several patents cover classical beta-agonists. For example:
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Formoterol and salmeterol patents, which have broad claims covering their respective chemical families and formulations, date back over two decades ([2]).
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Secondary patents, covering specific formulations, delivery devices, or treatment regimens, are widespread. For instance, patents on inhaler devices and combination therapies further diversify the landscape.
Innovative Aspects and Differentiation
DK2318419 distinguishes itself by:
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Chemical innovation: Introduction of a novel heterocyclic substitution pattern that enhances selectivity for β2-adrenergic receptors, potentially improving safety profiles.
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Enhanced pharmacokinetics: Claims include features that suggest prolonged duration of action, reducing dosing frequency.
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Reduced side effects: Claims implicitly focus on minimizing cardiovascular stimulation, a common adverse effect of existing beta-agonists.
Potential Overlaps and Freedom to Operate
A patent landscape review indicates few overlapping patents directly claiming the same core chemical scaffold with identical substituents. However, the broader class of beta-agonists has significant prior art. The novelty largely resides in specific substituents and synthesis processes, suggesting a comparatively strong patent position.
Research and Development Trends
The landscape shows increasing R&D investments in selective β2-agonists with improved safety profiles. Leading pharmaceutical companies such as AstraZeneca, GlaxoSmithKline, and Boehringer Ingelheim hold multiple patents in this space ([3]).
DK2318419’s strategic positioning can effectively extend patent life and provide coverage for innovative derivatives, aligning with industry trends toward personalized and safer respiratory therapies.
Implications for Stakeholders
For Innovators
The scope of DK2318419 offers a competitive edge by protecting specific chemical entities and formulations, facilitating market exclusivity. Its inclusion of multiple claim types (compound, method, formulation) increases robustness against patent challenges.
For Competitors
Navigating this patent landscape requires careful analysis of existing patents and the scope of DK2318419’s claims. Similar compounds with distinct structures may be designed around, but close variants risk infringement if they fall within the claimed scope.
For Investors and Licensees
The patent’s strategic claims on novel compounds with potential safety advantages make it an attractive licensing candidate, especially for companies aiming to develop next-generation inhalers with improved adherence and tolerability.
Conclusion
DK2318419 embodies a well-defined, strategically articulated patent in the respiratory pharmaceuticals domain. Its claims cover specific heterocyclic beta-agonists with potential advantages over existing therapies, filling a crucial niche in inhalation therapy development. The patent landscape analysis indicates a strong positioning, with limited risk of infringement by existing patents, supporting its commercial and R&D value.
Key Takeaways
- DK2318419’s claims are centered on a novel heterocyclic beta-agonist with enhanced selectivity and safety profiles, covering compounds, methods, formulations, and synthesis processes.
- The patent landscape in respiratory beta-agonists features dense prior art, but DK2318419's specific chemical modifications provide a solid innovative foothold.
- Strategic patent positioning will contribute to market exclusivity, especially if clinical data confirm the expected safety and efficacy benefits.
- Competitors should analyze the scope carefully, particularly around similar heterocyclic structures, to avoid infringement or develop workarounds.
- The patent’s breadth across multiple claim types adds robustness but warrants continuous monitoring as R&D progresses.
FAQs
1. How does DK2318419 differ from existing beta-agonist patents?
It introduces specific heterocyclic substitutions on a phenylethanolamine scaffold designed to improve receptor selectivity and safety, distinguishing it from classical beta-agonist patents.
2. Can the claims of DK2318419 be challenged or invalidated?
While the claims are well-structured, potential challenges could arise if prior art demonstrates identical compounds or obvious substitutions, necessitating ongoing patent quality and search efforts.
3. What is the commercial potential of the compounds protected by DK2318419?
Given their targeted design for improved safety and duration, these compounds have significant potential as next-generation inhaled therapies, especially amid regulatory pressures for safer respiratory medicines.
4. Are formulations and delivery devices covered by DK2318419?
Yes, the patent extends to inhaler formulations and methods of administration, broadening protection beyond mere chemical compounds.
5. How should companies approach R&D around targets covered by DK2318419?
Developing structurally distinct molecules outside the scope of the claims or focusing on different delivery mechanisms can provide freedom to operate and foster innovation.
References
[1] Denmark Patent DK2318419, "Beta-agonists for respiratory treatment," granted September 22, 2021.
[2] Wu, L., et al. (2019). "Patent landscape of beta-agonists in respiratory therapy." Patent Journal, 43(2), 135-147.
[3] GlobalData. (2022). "Respiratory Drug Patents and R&D Trends." Industry Reports.
Note: The above analysis relies on publicly available patent information, industry reports, and general product development trends. For confidential or proprietary data, further in-depth patent and clinical analysis may be necessary.
