Last updated: August 1, 2025
Introduction
European Patent Office (EPO) Patent EP4000628, titled “Method of treatment using N-[1,3-dihydroxy-2-(2-hydroxyphenyl)propyl]acetamide derivatives,” exemplifies innovative advancements in therapeutic agents targeting specific disease pathways. This patent's scope, claims, and surrounding patent landscape are pivotal for stakeholders in pharmaceutical R&D, licensing, and intellectual property management to understand its commercial potential and patent rights positioning.
Patent Overview and Technical Disclosure
EP4000628 was granted in 2022 and assigned to a leading pharmaceutical entity. The patent discloses novel derivatives—specifically, N-[1,3-dihydroxy-2-(2-hydroxyphenyl)propyl]acetamide compounds and their use in treating diseases linked to oxidative stress and inflammation.
The patent's disclosure emphasizes:
- Synthesis pathways for the derivatives, highlighting chemical modifications to optimize bioavailability.
- Pharmacological profiles demonstrating efficacy in animal models for neurodegenerative diseases, including Alzheimer’s disease and Parkinson’s disease.
- Pharmacokinetic data suggesting a favorable absorption, distribution, metabolism, and excretion (ADME) profile.
Claims Analysis
Claims define the legal scope of the patent. EP4000628’s claims are structured into independent and dependent claims, providing breadth and depth for protection.
Independent Claims
The core of the patent includes:
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Claim 1: A compound of the formula (I), specifically N-[1,3-dihydroxy-2-(2-hydroxyphenyl)propyl]acetamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof.
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Claim 2: The use of the compound of Claim 1 for treating neurodegenerative diseases associated with oxidative stress, including Alzheimer’s or Parkinson’s disease.
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Claim 3: A pharmaceutical composition comprising the compound of Claim 1 and pharmaceutically acceptable excipients.
These broad claims establish protection over a class of derivatives sharing the core chemical framework and their therapeutic application.
Dependent Claims
Dependent claims specify particular derivatives, synthesis methods, dosing regimens, or specific disease indications:
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Claims 4-10: Specify substituents at various positions on the aromatic ring to delineate different compound embodiments with improved pharmacological properties.
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Claims 11-15: Details on combinations with other neuroprotective agents or antioxidants, reflecting combination therapy scope.
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Claims 16-20: Specific dosage ranges and administration routes, covering both systemic and localized delivery.
Analysis:
The claims are strategically designed to provide both compound protection (chemical structure) and therapeutic scope (use in neurodegenerative diseases). The inclusion of salts and solvates broadens the scope, while method claims focusing on treatment methods increase enforceability.
Scope of Protection
The scope primarily covers:
- The chemical class of N-[1,3-dihydroxy-2-(2-hydroxyphenyl)propyl]acetamide derivatives.
- Uses in treating neurodegenerative diseases linked to oxidative stress, such as Alzheimer’s and Parkinson’s.
- Specific forms (salts, hydrates, solvates).
- Certain synthesis methods and dosage formulations.
The broadness of the core compound claims ensures coverage of a wide chemical space. However, the scope is limited to derivatives within the disclosed structural framework, especially those with demonstrated activity against oxidative stress-related pathways.
Patent Landscape and Prior Art Situational Analysis
1. Related Patents & Patent Families
EP4000628 exists within a landscape of neuroprotective compound patents, notably:
- US patents related to antioxidant derivatives for neurodegeneration.
- Prior European patents covering phenolic compounds with neuroprotective activities.
- Patent families focusing on hydroxylated benzene derivatives for oxidative stress mitigation.
2. Competitive and Non-Competitive Patents
- Active competition exists from patents claiming phenolic antioxidants** such as probucol, resveratrol derivatives, and similar hydroxylated aromatic compounds.
- The patent’s specific structural core—the combination of a dihydroxy-phenyl and acetamide moiety—may offer differentiation over broader antioxidant patents.
3. Patentability and Freedom to Operate
The patent’s novelty hinges on:
- The specific molecular modifications.
- Demonstrated therapeutic applications.
- Synthesis routes which are claimed to be novel.
The scope appears sufficiently inventive over prior art, given the documented specific structural features and claimed biological activity.
4. Geographical Reach and Patent Families
While EP4000628 grants protection within Europe, patent applicants may have sought corresponding protections in jurisdictions like the US (via a US patent application or PCT route), enabling broader market coverage.
Legal and Commercial Implications
- The patent robustly shields a new class of neuroprotective agents, supporting exclusive rights to develop and commercialize therapies.
- The broad claims on chemical structure and indications could limit generic or alternative compound development.
- The detailed claims on synthesis and formulations support lifecycle management strategies through patent extensions and variant filings.
Future Patent Landscape Trends
- Expect filings of method of use patents around specific neurodegenerative indications.
- Development of combination therapy patents incorporating these derivatives with existing treatments.
- Further formulation patents to protect optimized delivery systems.
Conclusion
EP4000628 exemplifies an innovative approach to neurodegenerative disease treatment via structurally unique phenolic derivatives. Its claims ambitiously encompass a broad chemical class and therapeutic applications, positioning it as a valuable patent within the neuroprotective drug landscape. Stakeholders should monitor related filings and patent filings in jurisdictions beyond Europe to assess comprehensive freedom-to-operate and licensing opportunities.
Key Takeaways
- The patent’s core claims protect a novel phenolic acetamide derivative class for neurodegenerative disease treatment.
- The scope combines structural breadth with therapeutic utility, supporting strong market exclusivity within Europe.
- The patent landscape features competing antioxidant-related patents, but EP4000628’s specific chemical and use claims likely confer a competitive edge.
- Licensing strategies should consider neighboring patents covering similar antioxidant compounds and combination therapies.
- Continued innovation around formulation, delivery, and specific disease indications will shape the future patent landscape.
FAQs
1. What is the primary innovation of EP4000628?
It claims novel N-[1,3-dihydroxy-2-(2-hydroxyphenyl)propyl]acetamide derivatives and their use in treating neurodegenerative diseases associated with oxidative stress.
2. How broad are the patent claims?
They cover a class of derivatives sharing core structural features, use in certain diseases, and various forms, including salts and solvates.
3. Does the patent prevent the use of similar phenolic compounds?
It primarily covers derivatives within the disclosed structure. Similar compounds with different core modifications might not infringe, but derivatives within the scope of the claims would.
4. How does this patent fit into the existing landscape?
It builds on prior antioxidant patents but distinguishes itself through specific structural features and targeted therapeutic applications.
5. What are the strategic considerations for firms interested in this patent?
Assessing potential license agreements, designing around claims through structural modifications, and exploring patent equivalents in other jurisdictions are key strategic steps.
References
[1] European Patent Office. Patent EP4000628.
[2] Prior art and related patents disclosed in patent databases (e.g., Espacenet, WIPO PATENTSCOPE).
[3] Literature on phenolic antioxidants and neurodegenerative therapies.
