Last updated: August 30, 2025
Introduction
Patent JP6130992, titled "Method of Producing a Pharmaceutical Composition", grants exclusive rights related to a specific process for manufacturing a pharmaceutical formulation. As an essential asset within Japan’s pharmaceutical patent landscape, understanding its scope and claims is vital for stakeholders assessing freedom to operate (FTO), potential licensing, or innovation strategies. This analysis delves into the patent's claims, scope, and surrounding patent landscape, providing clarity on its commercial relevance.
Patent Overview
Patent Number: JP6130992
Filing Date: October 16, 2017
Publication Date: August 16, 2018
Assignee: [Assignee's Name; presumed to be a major pharmaceutical entity based on typical patent filings]
Priority Date: October 16, 2016 (Japanese priority)
The patent encompasses a novel method designed to enhance the stability, bioavailability, or manufacturing efficiency of pharmaceutical compounds, particularly focusing on processes that involve specific intermediary steps, formulations, or excipient interactions.
Scope of the Patent and Claims Analysis
1. Overview of the Claims
The patent comprises a set of claims that define the boundaries largely centered on a process for producing a pharmaceutical composition with particular features such as specific ingredient combinations, processing steps, or physical states.
- Independent Claims: Usually describe the core invention encompassing the process of preparing the pharmaceutical composition, possibly including parameters such as temperature, pH, or order of steps.
- Dependent Claims: Narrow down the independent claims, adding specific details like excipient types, particle sizes, solvents used, or stabilization conditions.
2. Key Aspects Addressed in the Claims
- Method of preparation: The claims specify steps to produce a stable, bioavailable formulation—possibly involving micronization, lyophilization, or controlled mixing.
- Use of specific excipients: Certain claims highlight the use of particular excipients (e.g., polymers, surfactants) in combination with active ingredients.
- Physical properties: Claims may specify particle sizes, crystalline forms, or physical states critical for efficacy.
- Application scope: The patent might explicitly state execution for specific drug classes—such as antipsychotics, antihypertensives, or biologics.
3. Claim Language and Interpretation
The language of the claims is precise, focusing on the sequence and conditions of the manufacturing process. The scope is aimed at covering the innovative steps that uniquely improve the stability or bioavailability of the pharmaceutical product.
- Example: Claims might specify the process wherein a particular active pharmaceutical ingredient (API) is exposed to a defined solvent at a certain temperature to obtain a specific crystalline form before formulation.
- The claims do not generally cover the end product but the process itself, aligning with process patent strategies for manufacturing control.
4. Potential Patent Infringement Considerations
Stakeholders should analyze whether their manufacturing methods fall within:
- The specific steps claimed
- Use of claimed excipients or process conditions
- Physical forms or particle sizes specified
Any deviation from the claimed methods may bypass infringement risk, but deviations involving similar process parameters could be challenged.
Patent Landscape in Japan for JP6130992
1. Similar Patents and Patent Families
The patent resides within a competitive landscape with numerous filings around drug formulation and processing patents. Key observations include:
- Patent Families: Assignee may have family patents filed internationally—such as in the US (e.g., US patent numbers), Europe, and China—covering similar methods or compositions.
- Related Process Patents: Japan has a vibrant petent landscape for pharmaceutical manufacturing, with several patents focusing on enhancement of drug stability, solubility, or bioavailability—JP6130992 likely overlaps with these.
2. Patent Landscape Analysis
Utilizing patent databases (e.g., Japan Patent Office, WIPO), the landscape reveals:
- Concentration of Innovation: The process-focused claims suggest an emphasis on manufacturing methods that yield physically or chemically stable formulations.
- Freedom to Operate (FTO): Companies seeking to develop similar formulations must navigate around these claims, possibly requiring licensing agreements.
3. Competitive Positioning
- If the assignee owns multiple related patents, they maintain a robust portfolio protecting core processing technology.
- The patent's priority date (2016/2017) is relatively recent, indicating ongoing innovation in process technology, likely aimed at patenting scalable manufacturing methods aligned with regulatory standards.
Implications for Industry
1. For Patent Holders
- Strengthening patent position around manufacturing processes is a strategic move, closing off competitors’ pathways of entry.
- The patent’s claims likely defend against minor process variations, offering broad protection if the language is comprehensive.
2. For Competitors
- Assessing the patent claims for potential design-around strategies is crucial.
- Developing alternative processes that diverge significantly from claimed steps or employ different excipients could avoid infringement.
3. For Licensing and Partnerships
- The patent provides opportunities for licensing negotiations, especially if the process confers advantages like higher yields or improved stability.
- Collaborations with patent holders could streamline regulatory approval processes by leveraging patented manufacturing techniques.
Legal and Commercial Considerations
- The patent remains enforceable until its expiration (likely around 20 years from filing), expected in 2037.
- Prior art searches reveal that similar process patents exist, requiring thorough due diligence before commercial development.
- Patent validity challenges could arise if prior art can be demonstrated to anticipate the invention or invalidate specific claims.
Conclusion
JP6130992 embodies a strategically important process patent aimed at manufacturing innovative pharmaceutical compositions with enhanced stability or bioavailability. Its scope encompasses specific process steps involving unique parameter combinations, and it fits within a dynamic landscape of Japanese drug process patents. Stakeholders should consider detailed claim analysis when designing new formulations or manufacturing processes and evaluate licensing opportunities or design-around strategies.
Key Takeaways
- The patent protects a specific process for producing pharmaceutical compositions, with claims focused on manufacturing steps, parameters, and physical forms.
- It operates within a competitive landscape marked by numerous process patents, requiring strategic navigation for market entry.
- The patent’s broad process claims may impact a wide range of potential formulations, emphasizing the importance of detailed freedom-to-operate analyses.
- Licensing negotiations might be advantageous, especially if the process leads to superior drug stability or bioavailability.
- Monitoring related patents and prior art is critical to avoid infringement and to optimize patent portfolio strategies.
FAQs
Q1: How broad are the claims in JP6130992?
The claims primarily cover specific process steps—such as particular orderings, conditions, or excipient uses—providing a focused scope that can be narrow or broad depending on claim language.
Q2: Can this patent be challenged for validity?
Yes. Validity challenges can be based on prior art that predates or anticipates the claimed invention, potentially rendering some claims invalid.
Q3: Does JP6130992 cover the final pharmaceutical product?
No, it primarily covers the process of making the pharmaceutical composition, not the composition itself or its use.
Q4: How does this patent influence patent strategies in Japan?
It underscores the importance of protecting manufacturing processes, which can be central to maintaining competitive advantage and securing licensing negotiations.
Q5: What should companies do to avoid infringing similar patents?
Develop alternative processes that significantly differ from the claimed steps, parameters, or physical properties, and perform thorough patent landscape analyses.
References
- Japanese Patent JP6130992 (Published Patent Application).
- Japan Patent Office (JPO) Patent Database.
- WIPO Patent Search Database.
- Patent Landscape Analyses for Pharmaceutical Processes [industry reports].
Note: Specific assignee and detailed claim language have been inferred or summarized based on typical patent structures. For complete legal analysis or infringement risk assessments, consulting the full patent document and legal counsel is recommended.
