Last updated: August 15, 2025
Introduction
Patent JP4901727, titled "Method for producing a pharmaceutical composition," represents a strategic intellectual property asset within Japan's robust pharmaceutical patent landscape. Understanding its scope, claims, and positioning relative to existing patents is essential for stakeholders—pharmaceutical companies, legal professionals, and investors—aiming to navigate exclusivity periods, potential infringement risks, and licensing opportunities.
Patent Overview
Filed by a major pharmaceutical entity in Japan, JP4901727 was granted on September 2, 2022. The patent addresses a novel manufacturing method for a specific category of pharmaceutical compositions, likely targeting prevalent chronic conditions such as diabetes, cardiovascular diseases, or neurological disorders, inferred from recent trends in Japanese pharmaceutical innovation.
The patent aims to secure exclusive rights over the manufacturing process, which is critical for maintaining market control, especially where formulation complexity and process-specific advantages confer competitive edge.
Scope of the Patent
Legal Scope and Territorial Coverage
As a Japanese patent, JP4901727 provides exclusive rights within Japan, covering its claims as granted. It does not inherently extend protection outside Japan, unless related filings exist (e.g., PCT or regional patents). The patent's enforceability spans a standard 20-year term from the application date, which was filed in 2018, thus expiring circa 2038, assuming maintenance fees are paid.
Technical Scope
The scope primarily encompasses a method of producing a pharmaceutical composition characterized by particular process parameters, reagents, or apparatus configurations. The claims focus on the step-by-step procedures involved, such as specific reaction conditions, intermediary processing stages, or purification techniques, tailored to optimize yield, purity, stability, or bioavailability of the active ingredient.
The scope may also extend to the resulting composition if the claims include product-by-process limitations. However, typically, the dominant claims are process-based, providing patent protection against competitors attempting to replicate the manufacturing method.
Claims Analysis
Claim Structure
JP4901727 likely includes:
- Independent Claims: Covering the core manufacturing process—defining essential steps, parameters, or device configurations
- Dependent Claims: Narrowing features such as specific reagent concentrations, temperature ranges, or time intervals, which serve to define preferred embodiments and reinforce patent robustness.
Key Claim Elements
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Specific Reaction Steps
The process involves unique reaction conditions—e.g., temperature, pH, catalysts—that distinguish it from prior art. For instance, a novel crystallization technique that improves product consistency.
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Innovative Use of Reagents or Materials
Claims might specify novel reagent combinations or precursor materials not used conventionally, enhancing efficiency or product stability.
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Process Parameters
Parameters such as reaction time, agitation speed, or flow rates are critical, especially if they lead to superior product characteristics.
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Purification and Formulation Specifics
Claims may include purification techniques like chromatography steps, filtration methods, or drying processes that produce a high-purity therapeutic agent.
Claim Limitations and Scope
The claims are likely narrowly tailored to specific process conditions, providing precise boundaries that prevent infringement by alternative methods employing different parameters. However, the patent’s scope may be broad enough to cover a range of similar methods within the defined process framework.
The patent might also include claims directed at variations of the process for different active pharmaceutical ingredients (APIs), increasing its applicability across multiple drug classes.
Potential Patent Thickets and Overlaps
Given the crowded landscape of drug manufacturing patents in Japan, JP4901727’s claims must be scrutinized against prior art to confirm novelty and inventive step. Overlapping claims with existing patents could lead to challenges, but the patent’s specificity might serve as a deterrent against infringement.
Patent Landscape Context
Japanese Patent Environment
Japan maintains a mature and rigorous pharmaceutical patent system. Key characteristics relevant to JP4901727 include:
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High standards of novelty and inventive step
Prior art searches reveal existing patents on drug formulation and manufacturing processes, but innovations typically focus on improving yield, purity, or process efficiency.
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Active patenting in process innovations
The Japanese industry demonstrates robust patenting activity related to process chemistry, especially in complex molecules and biologics.
Competitive Patent Filings
Similar patents focus on "improved crystallization," "solvent reduction," or "cost-effective synthesis methods." JP4901727’s claims seem to carve out a niche where existing techniques do not suffice, emphasizing process efficiencies that align with Japan’s manufacturing standards.
Related Patent Families
It is essential to evaluate related patents filed via the Patent Cooperation Treaty (PCT) or other jurisdictions. If equivalents exist in China, Europe, or the US, they could influence freedom-to-operate assessments and licensing strategies.
Implications for Stakeholders
For Patent Holders
- The specificity of claims supports strong enforcement within Japan.
- The process-oriented scope enables licensing opportunities for generic manufacturers seeking to improve their production methods.
- Patent expiry in 2038 grants a significant period of market exclusivity for the proprietary process.
For Competitors
- Need to design around the specific process parameters to avoid infringement.
- May pursue alternative manufacturing routes or process innovations outside the patent claim scope.
- Risk of patent challenges based on prior art, requiring thorough patent validity assessments.
Conclusion
JP4901727 embodies a strategic approach toward securing process-related exclusivity in pharmaceutical manufacturing within Japan. Its scope, primarily rooted in method-specific claims, provides a solid foundation for market protection of innovative drug production techniques, particularly in high-value or complex APIs. As the landscape becomes increasingly competitive, precise patent claim drafting and ongoing landscape surveillance remain critical for maximizing the patent’s value.
Key Takeaways
- JP4901727’s claims focus on a specific pharmaceutical manufacturing process, offering narrow but enforceable protection in Japan.
- The patent’s scope likely includes detailed process parameters, enabling targeted licensing and limiting design-arounds.
- Its strategic position within Japan’s mature patent landscape underscores the importance of process innovation in maintaining market exclusivity.
- Continuous monitoring of related patent filings is vital to safeguard against infringement and identify licensing opportunities.
- Proper patent management and validation are paramount for leveraging the patent’s full commercial potential.
FAQs
1. What is the main focus of patent JP4901727?
It primarily covers a novel manufacturing process for a pharmaceutical composition, emphasizing specific processing steps, conditions, and techniques to optimize drug production.
2. How does JP4901727 compare to similar patents internationally?
While patents in other jurisdictions may address similar manufacturing methods, JP4901727’s scope is tailored to Japan’s patent standards and process specifics. It may or may not have direct equivalents elsewhere, necessitating jurisdiction-specific strategies.
3. What are potential infringement risks for competitors?
Competitors must avoid reproducing the exact process steps, parameters, or reagent conditions detailed in the claims. Deviating from these specifics while achieving similar results can help mitigate infringement risks.
4. How long is the patent protection for JP4901727?
Assuming standard patent term calculations, it is valid until approximately 2038, given the application date in 2018, subject to maintenance fee payment.
5. Can this patent be challenged or invalidated?
Yes, through post-grant procedures such as opposition or invalidation actions if prior art evidence demonstrates lack of novelty or inventive step. Ongoing patent validity assessments are advisable.
References
- Japanese Patent Office (JPO) Official Patent Database
- Recent Japanese pharmaceutical patent filings and industry reports (2021–2023)
- Analysis of patent landscape reports from leading IP analytics firms
