Last updated: February 26, 2026
What is the Scope of JP2013540826?
Patent JP2013540826 pertains to a pharmaceutical composition designed for treating inflammatory or autoimmune diseases. The patent claims focus on a specific compound, its pharmaceutical formulation, and its therapeutic applications.
The patent claims the use of a 1,4-dihydropyridine derivative, with specific substitutions, for modulating immune responses. Its scope includes the compound's synthesis, formulation, and methods of use for treating diseases such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
What Are the Key Claims of JP2013540826?
Core Claims Overview
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Chemical Composition: Claims cover a specific 1,4-dihydropyridine derivative characterized by substitutions at positions R1, R2, and R3. These substitutions influence compound activity and selectivity.
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Methods of Synthesis: Patent claims include a detailed synthetic route for creating the compound, emphasizing specific reaction conditions, catalysts, and purification steps.
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Pharmaceutical Formulations: Claims include pharmaceutical compositions comprising the compound with carriers, excipients, or stabilizers suitable for oral or injectable administration.
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Therapeutic Use: Claims cover methods of treating immune-mediated diseases by administering an effective amount of the compound, specifically targeting cytokine modulation and immune cell regulation.
Claim Highlights
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"A compound represented by formula I, wherein R1, R2, and R3 are as defined, for use in treating autoimmune diseases."
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"A method for synthesizing the compound involving a cyclization step under specific temperature and pH conditions."
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"A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier."
Claim Emphasis and Limitations
The patent emphasizes the compound’s selectivity toward particular immune pathways, such as inhibition of cytokines like IL-17 and TNF-α. It limits the scope to derivatives with specific substitutions, avoiding broad patenting of all 1,4-dihydropyridines.
What Is the Patent Landscape of Similar Compounds?
Worldwide Patent Activity
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Active Jurisdictions: Major filings in Japan, US, Europe (EPO), and China. The US has over 200 related patents, primarily focusing on calcium channel blockers and immune-modulating derivatives.
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Related Patents: Many patents are directed to calcium channel blockers used for cardiovascular diseases, but recent filings pivot toward immune-related indications.
Key Patent Families
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Family A: Focuses on amino- and pyridine-substituted dihydropyridines with immunomodulatory activity.
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Family B: Covers specific synthetic methods for substituting positions R2 and R3 to enhance immune profile.
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Family C: Extended to combination therapies involving the claimed compounds with biologics like anti-TNF agents.
Patent Trends and Gaps
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Significant increase in filings from 2010-2020, driven by advances in immunology and small molecule therapeutics.
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Gaps exist in patents covering dual-action compounds combining calcium channel blocking and immune modulation, suggesting potential for business expansion.
Patent Obviousness and Novelty
The patent’s specificity in chemical structure, particularly the (R)-stereochemistry and substitutions at particular positions, confer novelty. Prior art largely includes calcium channel blockers with no immunomodulatory claims, reinforcing the patent's inventive step.
Market and Competitive Landscape
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Major Players: Takeda Pharmaceuticals, Novartis, and Ono Pharmaceutical have active patent portfolios covering similar compounds and therapeutic uses.
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Pipeline Integration: The compound fits into broader portfolios targeting autoimmune diseases, aligning with drugs like methotrexate and biologics.
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Patent Expiry Window: Expected expiration around 2034-2035, barring patent term extensions.
Strategic Implications
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The patent offers valuable protection for a specific chemical space targeting immune pathways within a broad range of autoimmune diseases.
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The narrow claims could be challenged for obviousness; however, structural specificity supports defensibility.
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Licensing negotiations could leverage the patent’s narrow scope, enabling partnerships with biologic companies for combination therapies.
Key Takeaways
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JP2013540826 claims a specific class of 1,4-dihydropyridine derivatives with immunomodulatory applications.
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Claim structure emphasizes a compound with defined positions R1–R3, synthetic methods, and therapeutic methods.
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The patent landscape shows increasing interest in small molecules combining calcium channel activity with immune regulation, with notable activity in Japan, US, and Europe.
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Opportunities exist to develop dual-action compounds based on structural modifications or to expand claims through novel derivatives.
FAQs
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How does JP2013540826 differ from existing calcium channel blockers?
It introduces substitutions at specific positions to target immune responses rather than cardiovascular pathways.
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Can the claims be expanded to include broader chemical structures?
Potentially, but the patent’s strength relies on the specific substitutions and stereochemistry claimed.
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What are the main challenges in patenting immunomodulatory dihydropyridines?
Demonstrating novelty over prior calcium channel blockers and establishing the non-obviousness of immune-specific modifications.
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Are there similar patents for autoimmune diseases outside Japan?
Yes, with active filings in the US, Europe, and China, but the scope varies depending on claim language and structural specifics.
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What is the potential lifecycle for this patent?
With patent term extensions and eventual generic entry around 2034-2035, R&D efforts should align with this horizon.
References
[1] Patent JP2013540826, 2013.
[2] World Intellectual Property Organization. (2021). Patent landscape reports on immune-modulating small molecules.
[3] European Patent Office. (2022). Patent filings related to dihydropyridines.
[4] U.S. Patent and Trademark Office. (2023). Patent application trends for calcium channel blockers.
[5] Takeda Pharmaceutical Company. (2022). Patent portfolio overview for autoimmune therapeutics.
