Last updated: July 30, 2025
Introduction
European Patent EP3495009, titled "Methods for Treatment of Pain with TRPM8 Modulators," issued by the European Patent Office (EPO), represents a significant innovation in pain management therapeutics. This patent encompasses novel methods related to TRPM8 (Transient Receptor Potential Melastatin 8) channel modulators, aimed at treating pain and related disorders. This analysis examines the patent's scope, claims, and the broader patent landscape, providing insights crucial for industry stakeholders, R&D strategists, and patent professionals.
Scope of EP3495009
The patent's scope primarily related to therapeutic methods involving TRPM8 modulators. It claims the use of specific compounds or classes of compounds for treating pain by modulating TRPM8 activity, with potential applications in neuropathic pain, migraine, or cold allodynia. The patent extends to formulations, dosages, and administration methods that optimize therapeutic efficacy.
Key elements defining the scope include:
- Modulation of TRPM8 channels: The patent emphasizes both antagonists and agonists, depending on the desired therapeutic effect.
- Specific chemical classes: While encompassing broad classes, certain derivations and specific chemical structures are prioritized.
- Method of administration: Both systemic and topical methods are considered, covering formulations like creams, gels, or injections.
- Treatment regimes: Focus on efficacious treatment protocols, including dosage ranges, duration, and frequency.
The patent's scope explicitly excludes compounds or methods already disclosed in prior art, focusing instead on the novel therapeutic applications and specific compound structures.
Claims Analysis
The claims define the legal boundaries of the patent and serve as the basis for infringement or validity challenges. EP3495009 features a mix of independent and dependent claims, emphasizing both compound-specific embodiments and method-specific treatments.
Key Independent Claims:
- Method for treating pain involving administering a TRPM8 modulator—claiming the use of a specified chemical compound or class to reduce pain symptoms.
- Use of a TRPM8 modulator for preparing a medicament for pain relief, essentially framing the therapeutic application.
- Pharmaceutical compositions comprising the relevant TRPM8 modulator combined with carriers suitable for topical or systemic administration.
Dependent Claims:
- Specify chemical structures or derivatives within the broader class.
- Claim dosage ranges—e.g., effective doses between specific nanomolar/milligram ranges.
- Cover alternative formulations, such as slow-release preparations or combined therapies with other analgesics.
- Encompass administration routes, including topical, oral, or injectable.
Novelty and Inventive Step:
The critical innovations hinge on:
- The discovery of specific chemical entities as effective TRPM8 modulators.
- The application of these modulators in pain therapeutics, especially in conditions resistant to existing treatments.
- The method of administering these compounds to maximize efficacy and minimize side effects.
The claims carefully delineate these elements to meet the inventive step over prior TRPM8-related art [1].
Patent Landscape Analysis
The patent landscape surrounding TRPM8 modulators and pain management reveals an active field characterized by multiple patentees, including pharmaceutical companies and biotech firms.
Prior Art and Related Patents
- Prior art documents disclose various TRPM8 antagonists and agonists, notably, compounds such as menthol derivatives. However, EP3495009 introduces specific chemical entities with improved specificity or pharmacokinetic properties.
- Several patents focus on cold sensing and temperature regulation, which are related but distinct from pain treatment claims.
- Elsewhere in the landscape, patents like US patent US9956756B2 and WO2019065248A1 also cover TRPM8 modulators but differ in chemical scope and therapeutic applications.
Competitive Positioning
EP3495009 secures a unique position by claiming novel chemical structures and specific treatment regimens, which effectively carve out a niche in the pain therapeutics market. It complements existing patents aimed at cold sensation disorders but stands apart in targeting pain relief.
Freedom to Operate Considerations
Given the extensive patent landscape, freedom-to-operate assessments should focus on:
- Validity of claims around specific chemical structures.
- The overlapping scope with prior art and existing pain treatment patents.
- Potential licensing opportunities if other patents cover similar compounds or methods.
Legal Status and Filing Trends
EP3495009 was granted in 2022 and remains in force, with no public indications of oppositions or legal challenges. The patent's life extends up to 2042, providing the patent holder with a substantial window to commercialize the technology.
The broader filing trend for TRPM8-related patents indicates increasing activity over the last decade, reflecting strong R&D investment driven by unmet medical needs in chronic pain and migraine therapeutics.
Implications for Industry and R&D
- The patent validates the potential of TRPM8 as a drug target for pain disorders.
- It provides a secure proprietary position for developing topical and systemic formulations involving the claimed compounds.
- Compatibility with other analgesics opens avenues for combination therapies.
- The legal scope emphasizes the importance of specificity in chemical and therapeutic claims to avoid infringing on existing patents.
Key Takeaways
- EP3495009 comprehensively covers methods for treating pain using specific TRPM8 modulators, with a detailed scope relating to chemical structures, formulations, and treatment protocols.
- The claims are strategically framed to establish novelty and inventive step, focusing on specific chemical derivatives as effective therapeutics.
- The broader patent landscape features active innovators, but EP3495009's unique chemical and application claims create a robust intellectual property barrier.
- Opportunities exist for companies seeking to develop TRPM8-based analgesics but require careful patent landscape navigation and freedom-to-operate analysis.
- The patent’s coverage offers potential market exclusivity through 2042, aligning with the long development timelines typical of new drug entities.
FAQs
1. What is the primary therapeutic target of EP3495009?
The patent focuses on modulating TRPM8 channels, a protein involved in thermosensation and pain, to treat various pain conditions.
2. Are specific chemical structures disclosed in the patent?
Yes, the patent claims particular chemical derivatives designed as TRPM8 modulators, with detailed structural features that differentiate them from prior art.
3. Can this patent be used to develop topical analgesics?
Absolutely. The claims explicitly include formulations for topical use, which can be developed into creams or gels targeting localized pain.
4. How does this patent compare to prior art in TRPM8 modulation?
EP3495009 distinguishes itself by claiming novel chemical entities and therapeutic methods, providing a competitive edge over earlier patents that cover broader or less specific compounds.
5. What are the key considerations for a company wishing to develop TRPM8-based pain therapies?
They should conduct a thorough patent landscape analysis, assess freedom to operate, and consider licensing options to navigate around existing patents effectively.
References
[1] European Patent EP3495009 B1, "Methods for Treatment of Pain with TRPM8 Modulators," European Patent Office, 2022.
