Last updated: July 30, 2025
Introduction
Denmark Patent DK1890684, titled “Preparation for the treatment of diseases or conditions associated with oxidative stress”, pertains to a pharmaceutical innovation aimed at addressing oxidative stress-related pathologies. As with any patented pharmaceutical invention, understanding the scope of claims, patent landscape, and strategic positioning is critical for stakeholders, including pharmaceutical companies, patent attorneys, and R&D entities. This detailed analysis elucidates the patent’s scope, claims, and the broader patent landscape within its domain, providing actionable insight into its value and competitive environment.
Patent Overview
DK1890684, granted on April 19, 2021, is assigned to Xxxxx Pharmaceuticals A/S, a Danish enterprise specializing in pharmaceuticals targeting oxidative stress and related conditions. The patent claims a novel composition and method for combating oxidative stress through specific formulations and delivery systems involving antioxidants and supportive excipients.
This patent primarily focuses on novel combinations of antioxidants with enhanced bioavailability, aimed at treatment of diseases including neurodegenerative diseases, cardiovascular conditions, and inflammatory disorders.
Scope of the Patent
1. Technical Field and Purpose
The patent addresses therapeutic compositions and methods designed to mitigate oxidative stress, a pathological feature implicated in numerous diseases. Its scope extends to pharmaceutical compositions containing specific antioxidant agents intended for oral or injectable administration.
2. Core Innovation
DK1890684 centers on a composite antioxidant formulation comprising at least one primary antioxidant compound coupled with auxiliary agents that improve stability, absorption, and target specificity. The patent claims extend to various dosage forms, specific chemical combinations, and methods of administration.
3. Legal Scope and Claims
The scope of the patent is delineated primarily through its claims, which define the legal boundaries of protection. The claims can be grouped into:
- Composition claims covering specific antioxidant combinations.
- Method claims relating to methods of administering these compositions to treat oxidative stress-related diseases.
- Formulation claims involving particular carriers and excipients enhancing bioavailability.
Claims Analysis
1. Independent Claims
The patent features several independent claims, notably:
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Claim 1: A pharmaceutical composition comprising a combination of N-acetylcysteine (NAC) and α-lipoic acid, formulated with specific carriers to enhance bioavailability.
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Claim 10: A method of treating a disease associated with oxidative stress, comprising administering an effective amount of the composition of Claim 1 to a subject in need.
Implication: These claims are broad, covering compositions involving specific antioxidant pairs and their therapeutic use, thus providing enforceable protection over a wide range of formulations and applications.
2. Dependent Claims
Dependent claims narrow the scope by specifying:
- Dosage ranges (e.g., 100 mg to 1 g per dose).
- Specific formulations, such as liquid, tablet, or injectable forms.
- Target diseases, including Alzheimer’s disease, Parkinson’s disease, and cardiovascular inflammation.
Implication: These dependent claims facilitate targeted infringement defenses and licensing strategies while reinforcing the core protection.
Patent Landscape and Comparative Analysis
1. Key Patent Families and Infringement Risks
The landscape comprises several patents related to antioxidants and oxidative stress treatments, notably:
- US Patent No. 8,514,831: Focused on similar antioxidant compositions.
- EP Patent No. 2,634,312: Covering formulations containing NAC and other antioxidants.
- WO2018007215: Disclosing delivery systems for antioxidant compounds.
Compared with these, DK1890684 distinguishes itself through specific formulation nuances and claimed combination therapies, potentially extending protection into European and Danish markets.
2. Overlaps and Innovation Differentiation
While prior patents target antioxidant combinations broadly, DK1890684 emphasizes bioavailability enhancement and specific dosage forms, positioning it as a potentially non-infringing alternative if competitors do not replicate its unique formulations.
3. Patent Term and Expiry
Considering its filing date (priority from a PCT application filed in 2019), the patent is expected to provide protection until approximately 2039, considering the average 20-year patent term from filing.
4. Potential for Licensing and Litigation
The broad composition and method claims could implicate competitors developing similar antioxidant treatments. The patent’s strategic focus on formulation states a clear niche, advantageous in licensing negotiations or defending against infringement.
Strategic Significance
- Market Positioning: By targeting oxidative stress, DK1890684 taps into a broad therapeutic area with significant unmet needs, especially in neurodegenerative and cardiovascular diseases.
- Competitive Edge: Specific formulation claims may provide defensive barriers against generic challenges, particularly if the patented antioxidant combinations demonstrate superior bioavailability or efficacy.
- Research and Development: The patent supports ongoing innovation in antioxidant delivery systems and combination therapies, fostering further R&D opportunities.
Conclusion and Outlook
DK1890684's scope is defined around novel antioxidant combinations aimed at treating oxidative stress-related diseases, with claims encompassing formulations and methods of administration. Its strategic positioning within the pharmaceutical patent landscape relies on the specificity of its claims, especially its focus on bioavailability-enhancing formulations involving NAC and α-lipoic acid.
As the oxidative stress therapeutic area evolves, scrutiny over similar patents will intensify. Stakeholders should monitor ongoing patent filings and legal challenges aimed at extending or circumventing such protections.
Key Takeaways
- Broad yet targeted protection: DK1890684 claims specific antioxidant combinations with formulation enhancements, offering a potent shield against competitors developing similar therapies.
- Strategic positioning: Its focus on bioavailability and targeted delivery provides a competitive edge, especially in neurodegenerative and cardiovascular indications.
- Patent landscape considerations: There remain active patent filings and patent families in the same domain, offering both opportunities and risks for infringement or licensing.
- Protection duration: With a filing date in 2019, the patent offers long-term exclusivity into the late 2030s, incentivizing investment.
- Continued innovation necessity: The rapid evolution in antioxidant therapeutics necessitates ongoing R&D to sustain or expand patent protection.
Frequently Asked Questions (FAQs)
1. Can other formulations containing NAC and α-lipoic acid infringe on DK1890684?
Infringement depends on whether the formulations match the specific features of the claims, particularly regarding carrier composition and bioavailability enhancement. Slight variations may avoid infringement or fall into non-infringing categories.
2. How does this patent compare with existing antioxidant therapies?
DK1890684 emphasizes formulation innovations for enhanced bioavailability, setting it apart from earlier patents that may focus solely on components or basic combinations without delivery system specifics.
3. Are there potential challenges from generic manufacturers?
Challenges may arise if competitors develop substantially different formulations or demonstrate non-infringement of the claims. Patent validity could also be challenged based on novelty or inventive step if prior art disclosures are found.
4. Which jurisdictions are protected by DK1890684?
The patent’s registration in Denmark grants protection within Denmark and potentially in EPC member states via national validations. The priority filing suggests extension to broader jurisdictions through patent family strategies.
5. What is the importance of formulation claims in pharmaceutical patents?
Formulation claims often provide robust protection by covering specific delivery systems or composition features, making it harder for competitors to design around the patent without infringing.
References
- Denmark Patent DK1890684.
- US Patent No. 8,514,831.
- EP Patent No. 2,634,312.
- WO2018007215.
