Last updated: July 31, 2025
Introduction
European Patent EP3068371, titled "Method of treating disease with a LEAP inhibitor," was granted by the European Patent Office (EPO). It claims a novel therapeutic approach targeting specific molecular pathways, primarily focusing on the treatment of certain diseases by inhibiting LEAP (LPS-responsive beige-like anchor protein). As a pivotal element in the therapeutic landscape, this patent influences drug development, licensing, and market competition surrounding LEAP inhibitors.
This analysis provides an in-depth review of the scope and claims of EP3068371, contextualizes the patent landscape around LEAP inhibitors, and evaluates its strategic significance for stakeholders.
Scope and Claims of EP3068371
1. Overview of Claims
The patent comprises a series of claims, primarily divided into independent and dependent claims, structured to cover:
- Method of treatment involving administration of a LEAP inhibitor.
- Chemical compounds or compositions that function as LEAP inhibitors, with specific structural features.
- Use of LEAP inhibitors in manufacturing medicaments for particular indications, especially inflammatory and autoimmune diseases.
The core claims revolve around methods of therapeutic intervention and the use of specific LEAP inhibitors for treating diseases characterized by dysregulated immune responses.
2. Independent Claims
Claim 1:
A method of treating a disease associated with LEAP activity, comprising administering a therapeutically effective amount of a LEAP inhibitor to a subject.
Claim 2 (Method of use):
Use of a LEAP inhibitor for manufacture of a medicament for treating a disease associated with LEAP activity.
Claim 3:
A pharmaceutical composition comprising a LEAP inhibitor and a pharmaceutical carrier, intended for use in treating a disease linked to LEAP activity.
These claims are broadly formulated to encompass any LEAP inhibitor capable of modulating LEAP activity, assuming it shows therapeutic efficacy.
3. Dependent Claims
Dependent claims specify particular chemical structures, formulations, or treatment regimens, such as:
- Specific chemical scaffolds exemplifying LEAP inhibitors.
- Dosing protocols, combination therapies, and delivery methods.
- Selection of diseases, notably autoimmune disorders (e.g., rheumatoid arthritis, lupus), inflammatory conditions, and potentially cancer.
The dependent claims serve to sharpen the patent's scope around preferred embodiments, enhancing enforceability.
4. Scope of the Patent
The patent's breadth lies in:
- Therapeutic method coverage: The method claims are broad, encompassing any disease with LEAP involvement.
- Chemical entity claims: While not all chemical structures are detailed here, the patent delineates key structural motifs typical for LEAP inhibition.
- Use claims: Covering uses in specific disease contexts provides an additional layer of protection for inventions involving LEAP inhibitors.
The scope addresses both the general concept of targeting LEAP for therapy and specific compounds and formulations.
Patent Landscape for LEAP Inhibitors
1. Background of LEAP as a Therapeutic Target
LEAP, also known as LPS-responsive beige-like anchor protein, is involved in immune signaling and cellular adhesion, influencing inflammatory pathways. Increasing scientific interest in LEAP has led to various patent filings targeting LEAP-related pathways, especially in autoimmune and inflammatory diseases.
2. Patent Ecosystem
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Key Existing Patents: Prior patents in the space predominantly focus on molecular pathways (e.g., TLR4, NF-kB signaling) and target other immune regulators. Specific LEAP inhibitors remain a relatively nascent patenting area, with EP3068371 among the earliest filings explicitly targeting LEAP.
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Related Patent Applications: Several patent applications have been filed by biotech firms exploring LEAP's role in disease mechanisms, but few have granted broad claims akin to EP3068371. Many of these are still in prosecution or clinical development phases.
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Competitive Inhibitors: Multiple small-molecule inhibitors, peptides, or biologics targeting LEAP are under investigation, yet commercialized drugs specifically targeting LEAP are absent, providing a significant patenting opportunity.
3. Patentability and Novelty
The specificity of the chemical structures claimed in EP3068371, combined with the focus on therapeutic use, generally satisfies novelty and inventive step requirements. The patent’s claims extend over novel uses of known compounds and newly synthesized molecules with characterized activity against LEAP.
4. Geographical and Jurisdictional Scope
While EP3068371 is a European patent, its family members and equivalent filings in jurisdictions such as the US, China, and Japan extend the patent rights globally, contingent on corresponding national filings.
Strategic Implications
1. For Innovators and R&D Organizations
The patent situates the holder as a strategic player in the emerging LEAP inhibitor landscape. It provides competitive exclusivity potentially spanning 20 years from the filing date, with the possibility of patent term extensions.
2. For Pharmaceutical Companies
- The broad claims underpin potential licensing agreements and collaboration opportunities.
- The patent’s focus on autoimmune and inflammatory diseases aligns with unmet medical needs, offering high commercial value.
3. For Generic and Biosimilar Manufacturers
The patent delineates clear boundaries on the chemical space and therapeutic methods, informing potential design-arounds or licensing negotiations.
Conclusion and Key Takeaways
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Scope: EP3068371 broadly secures a therapeutic approach of using LEAP inhibitors for disease treatment, covering both specific compounds and their use in disease management. Its claims emphasize versatility, spanning method and composition claims.
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Claims: The claims are well-structured to safeguard multiple embodiments — chemical molecules, formulations, methods, and uses — crucial for comprehensive protection in a competitive landscape.
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Patent Landscape: The patent fills a niche in LEAP-related therapeutics, an emerging area with limited prior art, offering a strong foothold for future drug candidates.
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Strategic Value: For patent holders, EP3068371 positions them strongly in the immune-modulation space, with potential to influence future drug development, licensing, and market entry strategies.
Key Takeaways
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Broad Claims Signal Future Flexibility: The wide-ranging claims covering different methods and compounds ensure broad patent protection and defense against infringement.
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Emerging Space; High Patentability: Given the nascent state of LEAP-targeted therapeutics, patent filings like EP3068371 enhance the likelihood of establishing foundational rights in this field.
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Strategic Importance for R&D Investment: Companies investing in LEAP inhibitors should consider the patent’s scope in shaping research directions and IP strategies.
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Regulatory and Market Potential: Therapeutic applications in autoimmune and inflammatory diseases offer significant market opportunities, contingent upon successful clinical development.
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Competitive Edge: Navigating patent landscapes like EP3068371 will be critical for gaining regulatory approvals and market exclusivity in the increasingly competitive immuno-oncology and autoimmune space.
FAQs
1. What distinguishes EP3068371 from prior LEAP-related patents?
EP3068371 uniquely combines broad method claims with specific chemical and use embodiments, emphasizing therapeutic intervention in immune-related diseases, unlike prior applications that mostly focus on pathway targeting without explicit claims on LEAP inhibitors.
2. Are chemical compounds protected under the patent claims?
Yes, the patent delineates specific chemical structures and scaffolds regarded as LEAP inhibitors, ensuring protection for novel molecules within this chemical space.
3. How does this patent impact competitors developing LEAP inhibitors?
Competitors must design around the broad claims or seek licensing. The patent effectively sets a legal barrier, incentivizing R&D efforts within defined chemical and therapeutic boundaries.
4. Can this patent be enforced globally?
While EP3068371 grants protection in Europe, equivalent patent families filed in other jurisdictions could provide broader global rights, depending on filing and grant statuses.
5. What are the next steps for companies interested in LEAP inhibitors?
Monitoring the patent's enforcement, developing patentable alternatives, and engaging in licensing negotiations will be critical. Simultaneously, advancing clinical trials for novel LEAP inhibitors can strengthen market position.
References
[1] European Patent EP3068371 – Method of treating disease with a LEAP inhibitor.
[2] Patent landscape reports on immune signaling pathway inhibitors.
[3] Scientific literature on LEAP protein's role in autoimmune diseases.
[4] Market analyses of immunomodulatory therapeutics targeting novel pathways.
Note: As the analysis is based on publicly available patent information, ongoing developments and clinical data may influence the patent’s landscape and strategic implications.
