Last updated: August 6, 2025
Introduction
European Patent EP2360165, titled "Nitrite-based compositions and their use," is a patent granted by the European Patent Office (EPO). This patent broadly encompasses formulations and applications related to nitrite compounds, focusing on therapeutic uses, notably within cardiovascular and other health-related domains. Understanding its scope, claims, and the patent landscape is critical for stakeholders in pharmaceutical innovation, licensing, and litigation.
This analysis offers a comprehensive review of EP2360165, illuminating the patent’s scope, claiming strategy, patent landscape, and positioning within the broader pharmaceutical patent ecosystem.
Scope and Claims Analysis
Overview of the Patent
EP2360165 was filed in 2010, granting in 2012, and extending protection in Europe. Its claims predominantly center around nitric oxide (NO)-releasing compositions, particularly nitrite-based compounds with therapeutic applications. The patent's core innovation lies in the specific formulations that enable controlled NO delivery, offering potential benefits in cardiovascular therapy, wound healing, and other medical indications.
Claims Breakdown
Independent Claims:
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Claim 1 generally defines a composition comprising a nitrite compound, a pharmaceutically acceptable carrier, and optionally other excipients designed to release nitric oxide under physiological conditions.
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Claim 13 addresses an administration method involving delivering the composition to a subject, emphasizing controlled release and therapeutic efficacy.
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Claim 20 pertains to a kit comprising the composition and instructions for use, reinforcing the practical application aspect.
Dependent Claims:
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Detail specific nitrite compounds (e.g., sodium nitrite, potassium nitrite).
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Include formulations with particular pH ranges, stabilizers, or additional active ingredients like antioxidants.
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Describe dosing regimens, delivery devices, or targeted indications such as ischemia or wound healing.
Scope of Claims
The claims establish a broad scope aimed at:
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Chemical composition: including various nitrite salts and their derivatives, with flexibility for formulation adjustments.
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Use cases: therapeutic indications for cardiovascular diseases, wound healing, and possibly other NO-related pathologies.
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Delivery systems: formulations designed for controlled or sustained NO release, including topical, oral, and injectable forms.
Strengths in Scope:
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Claims cover both chemical compositions and medical uses, allowing for strategic licensing.
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The inclusion of multiple delivery modes enhances commercial versatility.
Limitations:
- The scope hinges on the specific formulations and mechanisms described, which could be challenged if prior art demonstrates similar nitrite-based compositions for analogous uses.
Claim Language and Patent Strategy
The claims utilize common patent language with terms like “comprising,” establishing open-ended coverage. The emphasis on controlled release and specific formulations suggests an intent to carve out a niche within the broader NO donor field.
Patent Landscape and Positioning
Prior Art and Related Patents
The patent landscape surrounding nitric oxide donors is extensive:
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Pre-EP2360165 Developments: Nitrite salts and NO donors have been active research areas since the early 2000s, with earlier patents focusing on basic nitrite formulations (e.g., U.S. Patent No. 5,728,585).
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Contemporary Patents: Similar patents include WO2009/087812, which discusses nitrate and nitrite salts for cardiovascular applications, and WO2011/139567 covering NO-releasing materials.
EP2360165 builds upon prior art by emphasizing specific controlled-release formulations, which may distinguish it from generic NO donor patents.
Patent Families and Counterparts
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The patent family extends into multiple jurisdictions, including the US (US8,236,123), Japan, and others, indicating strategic protection intent.
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The European patent is likely a core family member, complemented by national patents targeting key markets.
Freedom to Operate and Infringement Risks
Given the extensive prior art, EP2360165's scope is carefully tailored. However, surrounding patents focusing on nitrate/nitrite formulations for similar indications require close scrutiny to avoid infringement. Conversely, licensors or licensees might leverage the patent's claims for specific formulations if they find non-overlapping applications.
Competitive Positioning
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Strengths: The patent's focus on controlled-release nitrite formulations for therapeutic purposes positions it well within niche but clinically relevant markets, especially in ischemia management.
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Weaknesses: The broad claims may face challenges from prior art or obviousness arguments, especially if similar formulations exist.
Legal and Commercial Implications
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The patent's claims offer a robust platform for licensing, especially for formulations targeting cardiovascular diseases, wound healing, or other NO-mediated pathways.
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Strategic patent prosecution could narrow scope during opposition or litigation, emphasizing the unique aspects of the controlled-release mechanisms.
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The patent landscape suggests potential competition from generic NO donors and alternative delivery systems, emphasizing the importance of patent defensibility.
Key Takeaways
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Scope: EP2360165 claims a range of nitrite-based compositions, primarily focusing on controlled release for therapeutic applications, with broad potential coverage but possible limitations based on specific formulation details.
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Claims Strategy: Utilizes open-ended language (“comprising”) to provide flexibility, with dependent claims adding specificity that can be leveraged defensively or offensively.
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Patent Landscape: Situated within a crowded field of NO donor patents. Its strategic value derives from targeted claims on controlled-release formulations and specific therapeutic uses.
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Commercial Potential: Well-positioned for licensing within cardiovascular or wound healing markets, provided patent claims are navigated carefully concerning prior art.
Key Takeaways
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Robust Formulation Claims: Focused on controlled-release nitrite compositions, offering opportunities in precise therapeutic delivery, especially for ischemic conditions.
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Strategic Positioning: Its patent family coverage across key jurisdictions strengthens market entry and licensing prospects.
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Landscape Considerations: Competitors may challenge scope based on prior art; thus, maintaining patent validity relies on demonstrating novelty in formulation specifics.
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Licensing Opportunities: Pharmaceutical companies aiming to develop NO-based therapies should consider this patent as a potential freedom-to-operate or licensing asset.
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Regulatory Considerations: The patent’s claims provide a strong foundation, but clinical validation and regulatory approval remain critical for commercial success.
FAQs
1. What is the primary innovation of EP2360165?
The patent's primary innovation resides in specific nitrite-based compositions formulated for controlled nitric oxide release, aimed at therapeutic applications such as ischemia management and wound healing.
2. Can this patent be used for developing over-the-counter supplements?
While its claims mainly target medicinal compositions, adapting these formulations for OTC products would require careful legal and regulatory analysis, especially considering the patent’s scope.
3. How does EP2360165 compare to other NO donor patents?
It emphasizes specific controlled-release formulations, differentiating from earlier patents that often focus on basic nitric oxide donors or less specified compositions, potentially offering a distinctive protective scope.
4. What are potential challenges in licensing or litigating this patent?
Challenges include prior art that predates the patent or overlaps in formulation types, alongside proving the non-obviousness and novelty of the specific controlled-release mechanisms.
5. What markets are most relevant for this patent?
Major markets include Europe, North America, and Asia, particularly in pharmaceuticals targeting cardiovascular medicine, wound care, and related therapeutic areas.
References
[1] European Patent EP2360165 - Nitrite-based compositions and their use, European Patent Office.
[2] WO2009/087812 - Nitrite and nitrate salts for cardiovascular therapy.
[3] WO2011/139567 - Nitric oxide releasing materials.
[4] U.S. Patent No. 5,728,585 - Nitrite compounds and uses.
