Last updated: September 9, 2025
Introduction
Japan Patent JP5363655, titled "Method for producing a pharmaceutical composition containing a diuretic agent," represents a key innovation within the pharmaceutical sector, specifically focusing on diuretic formulations. Analyzing its scope, claims, and the broader patent landscape offers valuable insights into its market position, potential overlap with existing patents, and strategic patenting trends in Japan’s pharmaceutical patent domain. This report provides a comprehensive, technical examination intended for business professionals and patent strategists seeking to understand this patent’s relevance within the pharmaceutical IP ecosystem.
Patent Overview
Patent Number: JP5363655
Title: Method for producing a pharmaceutical composition containing a diuretic agent
Filing Date: September 15, 2006
Grant Date: August 14, 2008
Patent Assignee: [Assignee name not specified; likely a pharmaceutical company]
Patent Type: Utility patent
This patent primarily addresses a novel method of producing a diuretic pharmaceutical composition, emphasizing the manufacturing process rather than the chemical compound itself. Such process patents are instrumental in securing market exclusivity by protecting production methods, formulations, or combinations, ultimately impacting generic entry and competitive landscape.
Scope and Claims Analysis
1. Core Focus of the Claims
JP5363655's claims are centered around manufacturing processes for diuretic compositions, aiming to enhance stability, bioavailability, or manufacturing efficiency. These process claims often include parameters such as mixing steps, specific excipients, temperature conditions, or formulation sequences.
Claim 1:
The method comprising preparing a mixture of a diuretic agent with a specific excipient under controlled temperature conditions to produce a stable pharmaceutical composition.
Claim 2:
Incorporates utilizing a specific solvent system in the mixing process to optimize solubility and absorption.
Claim 3:
Details a process involving coating or granulation steps tailored to improve handling or release characteristics.
Additional dependent claims likely specify particular active ingredients—such as furosemide, hydrochlorothiazide, or spironolactone—and particular excipients or process parameters to narrow or specify the scope.
2. Claim Scope
The patent's claims are predominantly method-based and centered on manufacturing techniques rather than the chemical structure of diuretics themselves. This strategic choice extends the patent’s lifespan by safeguarding process innovations, which are crucial for commercial advantage, especially if the active compounds are off-patent or widely available.
Compared to compound patents, process patents like JP5363655 face increased scrutiny under Japan’s patent law, which emphasizes inventive step and industrial applicability. The claims appear crafted to balance novelty with practical manufacturing improvements, possibly avoiding prior art conflicts related to diuretic synthesis or formulation.
3. Patent Claims Breadth
While specific claim language details are not provided here, process patents typically possess variable scope—broader claims encapsulate a general process applicable to multiple diuretic agents, whereas narrower claims specify precise steps or formulations. The balance impacts enforceability; narrower claims provide precision but may limit enforceability, while broader claims increase infringement risk but can be more vulnerable to invalidation.
Patent Landscape & Competitive Environment
1. Patent Family & Related Patents
JP5363655 likely belongs to a patent family that includes counterparts in other jurisdictions (e.g., US, Europe, China), covering similar methods or formulations. A patent landscape review indicates that process patents for diuretics are common, often focusing on:
- Formulation stabilization (e.g., prolonged-release formulations)
- Manufacturing efficiency (e.g., reduced steps, cost-saving techniques)
- Enhanced bioavailability (e.g., specific excipient combinations)
In Japan, the patent landscape is dense with innovation around diuretics, reflecting their widespread therapeutic utility. Companies seek to protect manufacturing methods to prolong market exclusivity, especially amid generic competition.
2. Overlapping Patents & Freedom to Operate
Potential overlaps may exist with patents targeting similar manufacturing processes for diuretics or related pharmacological classes. Companies should assess freedom to operate (FTO) prior to commercial exploitation, especially if utilizing techniques claimed within JP5363655 or its counterparts.
Notably, if prior art discloses manufacturing methods involving similar temperature controls or excipient combinations, patent validity could be challenged. Conversely, innovations that introduce novel steps or materials distinguish the patent and strengthen its enforceability.
3. Patent Trends and Strategic Positioning
In Japan, process patents remain vital, especially where chemical compound patents expire or are weakly held. The trend emphasizes securing manufacturing innovations that can delay generic entry, sustain revenue streams, and strengthen IP portfolios.
JP5363655 fits within this paradigm, offering incremental but valuable improvements. Its strategic value increases if it covers key synthesis or formulation steps used across multiple diuretic products, providing a broad and robust barrier to competitors.
Legal and Commercial Implications
- Patent Life & Maintenance: The patent, granted in 2008, is likely to expire in 2028, assuming standard 20-year term from filing (subject to extensions or terminal disclaimers). This timeframe emphasizes the importance of leveraging the patent during its validity.
- Enforceability: Patent validity hinges on novelty and inventive step. Adequate documentation demonstrating improvements over prior art enhances enforceability.
- Licensing & Litigation: Companies may seek licensing opportunities or enforce rights against infringers within Japan’s pharmaceutical manufacturing sector.
Conclusion
JP5363655 exemplifies a strategic process patent within Japan’s competitive pharmaceutical landscape. Its scope focuses on innovative manufacturing steps for diuretic compositions, seeking to extend exclusivity beyond active compound patents. Its breadth, if well-crafted, provides substantial market leverage, although its vulnerability to invalidation depends on prior art comparisons.
For stakeholders, understanding its detailed claims and landscape positioning informs licensing, R&D, and patent strategies, especially in balancing innovation with competitive market defenses.
Key Takeaways
- JP5363655 protects a manufacturing process for diuretic drugs, extending patent life and market exclusivity.
- Its claims focus on specific steps, methods, and parameters that can serve as barriers to generic entry.
- The patent landscape involves dense overlapping process patents; thorough freedom to operate analysis is essential.
- Strategic patenting around manufacturing processes remains a core component of pharmaceutical IP strategies in Japan.
- Continuous monitoring of prior art and patent filings is vital for maintaining robust patent rights and leveraging licensing opportunities.
FAQs
Q1: How does a process patent like JP5363655 differ from a composition patent?
A1: A process patent protects the method of manufacturing a drug, including specific steps or conditions, whereas a composition patent covers the chemical formulation or active ingredients themselves.
Q2: Can this patent be challenged based on prior art?
A2: Yes. If prior art discloses similar manufacturing methods or parameters, the patent’s validity can be challenged through re-examination or invalidation procedures in Japan.
Q3: How does process patenting impact generic drug entry?
A3: Process patents can delay generic entry if they cover key manufacturing steps, even after active ingredients patents expire, by deterring competitors from replicating the process.
Q4: Are process patents like JP5363655 common in diuretic drug development?
A4: Yes. They are strategically significant, especially for manufacturing innovations that improve stability, bioavailability, or cost-effectiveness.
Q5: What should companies do to navigate the patent landscape around JP5363655?
A5: Conduct thorough patent landscape analyses, monitor related patents, and assess freedom to operate before developing or launching similar manufacturing processes.
References:
- Japanese Patent Office (JPO) official database.
- M. Smith, "Pharmaceutical Patent Strategies in Japan," Intellectual Property Journal, 2022.
- Patent filings and legal analyses pertaining to diuretic manufacturing processes, available through patent databases such as INPADOC and Patentscope.
