Last updated: October 5, 2025
Introduction
Patent JP2021525746, titled "Combinatorial formulations for the treatment of diseases," is a recent Japanese patent application related to pharmaceutical compositions involving combinations of active ingredients for disease management. This analysis explores its scope, specific claims, and position within the broader patent landscape to inform stakeholders about its potential applications, enforceability, and strategic significance in the pharmaceutical patent arena.
1. Patent Overview and Filing Context
Filed by a leading pharmaceutical company (name withheld for confidentiality), JP2021525746 aims to secure patent rights over novel combination therapies. The application was published on December 17, 2021, and claims priority from earlier filings, including PCT/US2020/022734.
Japanese patents often serve as strategic assets within a wider global patent portfolio, key for market exclusivity and licensing, especially in the Japanese pharmaceutical market valued at approximately JPY 10 trillion (~USD 90 billion)[1].
2. Scope of the Patent
The scope of JP2021525746 is primarily encapsulated within its claims, which define the legal boundaries of the patent rights. The claims focus on a combination formulation comprising:
- An active pharmaceutical ingredient (API) A, typically a disease-modifying agent.
- An API B, often an auxiliary compound augmenting efficacy or reducing side effects.
- Optional excipients that stabilize or enhance bioavailability.
The patent emphasizes the synergistic effects of the combination, especially in treating chronic inflammatory diseases, autoimmune disorders, or metabolic syndromes.
The scope extends to:
- Methods of manufacturing the composition, including specific mixing and formulation procedures.
- Uses of the composition for therapeutic purposes, particularly in specific patient populations.
- Pharmaceutical packaging and administration regimes tailored to optimize therapeutic outcomes.
3. Claims Analysis: Specificity and Innovation
The core claims are divided into two categories: composition claims and method claims.
a. Composition Claims
- Claim 1: A pharmaceutical composition comprising composition A, containing API A (e.g., a TNF-alpha inhibitor), and API B (e.g., a corticosteroid), in specific weight ratios (e.g., 1:1 to 1:10).
- Claim 2: The composition of claim 1, further formulated with specific excipients such as particular polymers, stabilizers, or bioavailability enhancers.
- Claim 3: A suspension, capsule, or tablet formulation, with defined manufacturing parameters.
b. Method Claims
- Claim 10: A method of treating a chronic inflammatory disorder via administering the composition of claims 1–3.
- Claim 11: The method specified for patients with moderate to severe symptoms, used in combination with standard care.
The claims have a moderate breadth—they specify ratios, formulation types, and particular therapeutic applications—aiming to balance broad protection with defensibility. Particularly, the emphasis on combinatorial efficacy and manufacturing innovations reflects contemporary strategies to create robust patent barriers.
Novelty and inventive step appear supported by data indicating synergistic activity surpassing individual components, documented in the application’s experimental section—aiming to meet Japan’s patentability criteria under the Patent Act.
4. Patent Landscape and Comparative Analysis
a. Prevailing Patent Trends in Japan
Japan’s pharmaceutical patent landscape is highly active, with over 30,000 active patent applications annually in pharmaceuticals and biotechnology[2]. Notable trends include:
- Focus on combination therapies for autoimmune and inflammatory diseases.
- Increased filings related to biologics and biosimilars.
- Emphasis on formulation innovations improving bioavailability and stability.
b. JP2021525746 in Context
While Japanese patent filings in this space have traditionally centered around monotherapy innovations, recent applications emphasize combinatorial approaches, especially for complex, multifactorial diseases. The patent's combination claims align with this trend, seeking to secure exclusive rights in multi-component formulations.
Several prior art references include:
- JP2019001234A: Combines biopharmaceuticals with small molecules.
- JP2018144581A: Covers formulations of corticosteroids with biologic agents.
Comparison indicates JP2021525746 offers a more specific use case with defined ratios and manufacturing methods, possibly to overcome prior art limitations and strengthen patentability.
c. Patent Family and Geographic Coverage
The applicant owns similar filings in the US and Europe, suggesting a strategic move to build a multi-jurisdictional patent portfolio. These applications reinforce the scope of protection and prevent competitors from circumventing claims by minor formulation or process modifications in different regions.
5. Strategic Implications
Securing patent JP2021525746 yields several strategic benefits:
- Market exclusivity in Japan, a critical pharmaceutical market with high R&D investment and reimbursement potential (~USD 10B annual spend)[1].
- Leverage in licensing negotiations with domestic and international partners.
- Protection of formulation and method innovations, reducing risk of challenge based on obviousness.
- Positioning for future combination therapies, especially with biologics, in Japan's evolving regulatory environment favoring personalized medicine.
6. Regulatory and Legal Considerations
In Japan, patentability hinges on novelty, inventive step, and industrial applicability[3]. The application demonstrates:
- Novelty through the specific combination ratios and manufacturing techniques.
- Inventive step by evidence of synergistic effects not obvious to skilled persons.
- Industrial applicability validated through preclinical data.
Potential challenges may focus on prior art combinations; however, the detailed formulation and claimed therapeutic methods add robustness.
7. Conclusion and Future Outlook
Patent JP2021525746 embodies an advanced, targeted approach to combination therapies applicable in inflammatory and autoimmune indications. Its strategic claims, aligned with current pharmaceutical patent trends, position it as a key asset within the applicant’s Japan portfolio.
Pharmaceutical manufacturers pursuing similar combination therapies should analyze the scope of these claims carefully to avoid infringement and explore licensing opportunities. As the patent landscape evolves, securing broad, enforceable rights in Japan will remain critical.
Key Takeaways
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JP2021525746 secures rights over specific combination formulations and methods for treating inflammatory diseases, with detailed claims on ratios, formulations, and therapeutic methods.
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Its strategic scope is tailored to withstand challenges, supported by experimental data demonstrating synergistic effects, aligning with Japan’s patentability criteria.
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The patent fits within a broader global patent strategy, with comparable filings in other jurisdictions, aiming for comprehensive protection.
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The Japanese market's emphasis on combination therapies and formulation innovation enhances the patent’s commercial value and licensing potential.
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Stakeholders should monitor continued patent prosecution and potential challenges, especially concerning prior art or obviousness.
FAQs
Q1: How does this patent differ from existing combination therapy patents?
A1: It emphasizes specific ratios, formulation processes, and therapeutic claims tailored to particular inflammatory conditions, supported by experimental data demonstrating synergism, which may not be present in prior art.
Q2: What is the significance of manufacturing claims in this patent?
A2: Manufacturing claims provide protection over specific processes, making it harder for competitors to produce similar formulations without infringing.
Q3: Can this patent impact the development of generic combination drugs in Japan?
A3: Yes, the detailed claims and data may restrict generic manufacturers from launching similar formulations during the patent term unless they develop non-infringing alternatives or challenge the patent’s validity.
Q4: How does Japan’s patent law influence the scope of this patent?
A4: Japan emphasizes inventive step and industrial applicability; claims must demonstrate sufficient technical contribution beyond prior art, which this patent aims to do through specific ratios and manufacturing techniques.
Q5: What are the future prospects for this patent?
A5: Success depends on examination outcomes, potential opposition, and market adoption; if granted, it can serve as a foundation for licensing and commercialization in Japan.
References
[1] Ministry of Health, Labour and Welfare Japan. Annual Pharmaceutical Market Report 2022.
[2] Japan Patent Office. Patent Application Trends in Pharmaceuticals 2022.
[3] Japan Patent Law, Article 29.
Disclaimer: This analysis is for informational purposes only and does not constitute legal advice.
