Last updated: August 10, 2025
Introduction
European Patent EP2426118, granted by the European Patent Office (EPO), pertains to a novel pharmaceutical invention. Understanding its scope, claim breadth, and position within the patent landscape is critical for stakeholders in drug development, licensing, and competitive intelligence. This analysis dissects the patent’s claim structure, evaluates its inventive scope, and charts its relevant patent landscape to inform strategic decisions.
Overview of Patent EP2426118
EP2426118, entitled "Methods of treating or preventing disease using nitric oxide releasing compounds," was granted in 2012, with priority claims dating back to 2010. The patent primarily discloses nitric oxide (NO)-releasing pharmaceutical compositions and treatment protocols targeting conditions such as cardiovascular diseases, infections, and other inflammatory disorders.
Its assignee is Bayer Aktiengesellschaft, a major player in the pharmaceutical sector, signaling the patent’s strategic value in cardiovascular and infectious disease therapeutics.
Scope and Claims Analysis
Independent Claims
The core of EP2426118 resides in its independent claims, which articulate the invention's broadest protective scope:
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Claim 1 (Method Claim):
A method of treating or preventing a disease or condition in a subject, comprising administering to the subject a pharmaceutical composition comprising a nitric oxide releasing compound, where the compound releases nitric oxide in vivo to achieve a therapeutically effective concentration.
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Claim 11 (Composition Claim):
A pharmaceutical composition comprising a nitric oxide releasing compound and optionally other pharmaceutically acceptable excipients.
Claim Language and Breadth
The claims employ broad language, emphasizing "nitric oxide releasing compounds" capable of producing NO in vivo, without tightly limiting the chemical structure. This open-ended language suggests an intent to cover a wide range of NO donors, including organic nitrates, NONOates, S-nitrosothiols, and related prodrugs.
The method claim primarily encompasses therapeutic uses, emphasizing treatment of "disease or condition" broadly, with explicit mention of cardiovascular, infectious, and inflammatory disorders in the description. The composition claim covers pharmaceutical formulations containing NO donors.
Dependent Claims and Specific Embodiments
Dependent claims specify:
- Particular chemical classes, such as S-nitrosothiols and NONOates.
- Specific dosage forms like tablets, injectables, and topical preparations.
- Use in specific disease states, e.g., pulmonary hypertension or ischemic conditions.
The breadth in dependent claims narrows scope to disclosed embodiments, but the independent claims remain broad, covering any nitric oxide releasing agent for therapy.
Infringement and Validity
The broad claims potentially infringe upon other NO-donor patents, especially those with overlapping chemical classes. Validity hinges on whether the claims sufficiently distinguish themselves over prior art, notably existing NO donors known before the priority date.
Patent Landscape and Prior Art Context
Pre-existing NO Donor Patents
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Early NO donors: Organic nitrates (e.g., nitroglycerin), S-nitrosothiols, and NONOates had been extensively studied since the 1980s. Many patents existed covering specific compounds, formulations, and uses.
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Citing prior art: Patents such as US 4,374,925 (nitroglycerin formulations) and WO 2004/058496 (NONOates compositions) involved similar compounds and therapeutic uses.
Novelty and Inventive Step
EP2426118’s novelty depends on demonstrating an unexpected therapeutic benefit or an unexpected compound class. The claims’ broad scope suggests reliance on the general concept of NO delivery rather than a specific novel compound, possibly making inventive step contingent on specific unexpected effects or particular formulations.
Related Patent Families and Continuations
Bayer’s patent family includes:
- Related applications covering specific chemical forms of NO donors.
- Continuations and divisional applications could extend patent protection or refine claim scope.
This patent landscape is highly crowded, with numerous issued patents and published applications at both the EPO and worldwide, reflecting the high innovation activity in NO-based therapeutics.
Legal Considerations
The scope of EP2426118 makes it susceptible to novelty and inventive step challenges, especially concerning prior art with similar chemical classes. However, its broad claims may also serve as a defensive patent or a strategic blocking patent in the NO-donor space.
Implications for Stakeholders
- Pharmaceutical companies should assess how EP2426118’s broad claims might impact their NO donor programs.
- Patent examiners may scrutinize the inventive step due to prior art in NO-releasing compounds.
- Litigation risk exists if the patent overlaps with other active patents, necessitating freedom-to-operate analyses.
Conclusion and Strategic Takeaways
EP2426118 establishes a broad patent footprint in the NO-releasing therapeutics space. Its claims encompass wide classes of nitric oxide donors and their therapeutic uses, affording Bayer comprehensive protection but also posing challenges in validity assessments. The patent landscape is dense with prior art, especially concerning specific chemical classes, so future innovation should focus on novel compounds, unexpected therapeutic benefits, or unique delivery mechanisms to maintain patent robustness.
Key Takeaways
- The patent’s broad claims cover a wide range of NO-releasing compounds and therapeutic methods, reinforcing strategic dominance in the NO-donor field.
- Patent validity hinges on demonstrating novelty over prior existing NO donors; therefore, specificity and unexpected benefits are crucial.
- The extensive patent landscape necessitates thorough freedom-to-operate analyses, especially given prior art in nitric oxide chemistry.
- Future patent filings should aim for narrower, more inventive claims, focusing on specific compounds or targeted indications.
- Legal vigilance is essential to mitigate infringement risks due to overlapping patent rights within this crowded space.
FAQs
1. How broad are the claims of EP2426118?
The independent claims encompass any nitric oxide releasing compound used therapeutically, making them broadly applicable to many chemical classes and use indications, provided the compound releases NO in vivo for treatment.
2. What are the main competitors in the NO-donor patent landscape?
Key players include companies like Pfizer, GlaxoSmithKline, and AstraZeneca, along with numerous academic institutions holding patents on specific NO donor compounds and delivery methods.
3. How does prior art impact the patent's validity?
Prior art involving established NO donors and their uses challenges the novelty and inventive step of EP2426118. Demonstrating unexpected efficacy or novel formulations is critical for maintaining enforceability.
4. Can this patent be circumvented by developing new NO donors?
Yes. Developing compounds with distinct chemical structures or delivering NO via different mechanisms can potentially avoid infringement, assuming claims are sufficiently specific and the new compounds are patentable.
5. What strategic considerations should companies have regarding this patent?
Companies should evaluate their NO donor portfolios for potential overlap, consider licensing opportunities, or focus on developing proprietary compounds with novel features to differentiate from broad patents like EP2426118.
References
[1] European Patent Office. Patent EP2426118.
[2] Prior art references in the field of nitric oxide donors and their therapeutic applications.
[3] Patent landscape reports on nitric oxide-based therapeutics.
