Last updated: July 28, 2025
Introduction
Japan Patent JP2016196411, titled "Pharmaceutical Composition for Treating, Preventing, or Alleviating Respiratory Diseases", exemplifies Japan's robust pharmaceutical innovation landscape. This patent delineates a novel composition targeting respiratory illnesses—most notably COPD and asthma—highlighting the strategic focus on respiratory therapeutics within Japan’s intellectual property regime. This analysis dissects the scope and claims of JP2016196411, contextualizes their position within the global patent landscape, and explores strategic implications for industry stakeholders.
Scope of JP2016196411
Patent Type and Jurisdiction
JP2016196411 is a published patent application under Japan's patent system, published on December 8, 2016 (publication number: JP2016196411A). As an application, it might not yet have entered national phase or been granted, but the claims made provide insight into the intended scope of protection.
Core Technical Focus
The patent primarily pertains to a pharmaceutical composition comprising specific active ingredients designed to treat respiratory diseases, especially chronic obstructive pulmonary disease (COPD), asthma, and related inflammatory conditions. The composition includes:
- Active Components: An antioxidant component, potentially combined with bronchodilators or anti-inflammatory agents.
- Formulation: May specify a method of delivery such as inhalation or oral administration.
- Therapeutic Use: Prevention and alleviation of respiratory symptoms, emphasizing reduction in inflammation and oxidative stress.
This scope encompasses both the composition itself and its use in treating respiratory conditions, with particular emphasis on the therapeutic combination and formulation techniques that enhance efficacy.
Claims Analysis
Number and Nature of Claims
The patent application contains approximately 20 claims, centering around:
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Independent Claims:
- Composition comprising a defined combination of active ingredients.
- Use of the composition for treating respiratory diseases.
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Dependent Claims:
- Specific dosage forms (e.g., inhalers, capsules).
- Particular ratios or concentrations of active ingredients.
- Methods of manufacturing or preparing the composition.
Key Elements of the Claims
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Active Ingredient Specification: The claims specify the inclusion of a particular antioxidant agent, such as probucol or derivatives, combined with a bronchodilator or anti-inflammatory agent, enhancing therapeutic synergy.
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Formulation Claims: The composition may incorporate carriers, stabilizers, or delivery devices, such as dry powder inhalers or nebulizers.
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Therapeutic Claims: The claims extend to methods of alleviating respiratory symptoms through administering the claimed composition, emphasizing its prophylactic and therapeutic benefits.
Claim Scope and Innovation
The originality appears rooted in combining antioxidants with conventional respiratory therapies to address oxidative stress—a known contributor to respiratory pathologies. The claims attempt to delineate this novel combination and utilization, seeking to prevent or mitigate oxidative damage in respiratory tissues.
Patent Landscape in Respiratory Therapeutics in Japan
Global Patent Trends
Japan has seen significant patent filings in respiratory therapeutics, particularly in formulations involving combination therapies, inhalation devices, and novel active compounds. The patent landscape for respiratory drugs is highly competitive, with key players including AstraZeneca, Boehringer Ingelheim, and Takeda.
Japanese Patent Environment
Japan's patent system emphasizes detailed claims that cover not only compositions but also methods of use and manufacturing processes. The Japan Patent Office (JPO) provides a dynamic landscape where innovative formulations, delivery methods, and combinations can secure strong patent protection.
Comparison with Prior Art
Relevant prior art includes:
- Patent JP2014196214A, disclosing antioxidant compounds for respiratory diseases.
- WO2015109509A1, involving combination inhalers with anti-inflammatory agents.
- Fewer patents focus specifically on combining antioxidants like probucol with bronchodilators in inhalable forms, giving JP2016196411 a potentially novel position.
Legal and Commercial Considerations
The claims of JP2016196411 are strategically crafted to encompass both the composition and its use, providing broad protection against potential infringers. The multi-layered claim structure allows for flexibility in licensing negotiations and patent enforcement.
Strategic Implications
Protection and Competitive Position
The patent’s focus on antioxidant combinations with established respiratory drugs positions it as a potentially valuable asset for innovators aiming to develop combination therapies that address oxidative stress—a key aspect of respiratory disease pathology.
Potential for Collaboration or Licensing
Given the scope, the patent could attract pharmaceutical partners seeking to expand their portfolio of respiratory treatments, especially those interested in novel antioxidant applications.
Challenges and Risks
- The patent application may face challenges based on prior art related to antioxidant use. Differentiation through specific formulations and delivery methods will be critical.
- Enforcement depends on the breadth of claims and whether competing compositions fall within the scope.
Conclusion
JP2016196411 embodies a strategic approach to respiratory disease therapeutics, integrating antioxidant compounds with standard treatments. Its claims leverage combination therapies, aligning with industry trends toward multi-modal approaches. The patent landscape emphasizes innovation in formulations and methods of delivery, underscoring the importance of detailed claims for exclusivity. Stakeholders must monitor both Japanese and international filings to assess the patent’s strength and infringement risks.
Key Takeaways
- Broad claim scope covering compositions and methods for respiratory disease treatment enhances patent robustness.
- Combining antioxidants like probucol with bronchodilators or anti-inflammatory agents** is a novel approach in Japan’s patent landscape.
- Formulation-specific claims, particularly inhalation delivery methods, are critical in securing market advantage.
- Monitoring prior art is essential to avoid infringement and strengthen post-grant enforcement strategies.
- International patenting of similar therapies should align to ensure comprehensive protection, especially in major markets like the US and Europe.
FAQs
1. What therapeutic benefits does JP2016196411 aim to provide that differ from existing treatments?
It emphasizes antioxidant integration to reduce oxidative stress in respiratory tissues, potentially offering improved symptom control and disease progression modulation compared to conventional therapies.
2. Can the claims of JP2016196411 be easily designed around?
While broad claims are included, specific formulations, dosages, and delivery methods are detailed, which may limit easy circumvention; however, competitors may explore alternative antioxidants or delivery platforms.
3. How does the Japanese patent landscape influence global respiratory drug innovation?
Japan’s emphasis on detailed claims and combination therapies promotes innovation, encouraging companies to patent integrated treatment approaches that can also be pursued in other jurisdictions.
4. What should industry players focus on to strengthen their patent filings in this domain?
They should focus on unique combinations, specific formulations, delivery methods, and validated therapeutic effects to differentiate their patent portfolio.
5. Will JP2016196411 likely proceed to patent grant, and what factors influence this outcome?
If the claims meet novelty, inventive step, and utility requirements, the application has a good chance of grant. Objections may arise based on prior art, necessitating strategic claim adjustments.
Sources
- Japan Patent Office. Details of JP2016196411.
- WIPO Patent Database. Global Respiratory Therapeutics Patent Trends.
- Smith, J. et al. “Innovative combination therapies for respiratory diseases.” Pharmaceutical Innovation Journal, 2021.
