Last updated: August 11, 2025
Introduction
Japan Patent JP2009511602, titled "Method for Producing a Pharmaceutical Composition," was filed to protect a specific method related to pharmaceutical manufacturing processes. As with many patents in the pharmaceutical sector, its value hinges on the scope of its claims, potential for licensing, and position within the patent landscape. This analysis offers a comprehensive review of the patent’s scope, claims, and assessment of its strategic patent landscape.
Patent Overview and Publication Details
Patent Number: JP2009511602
Filing Date: October 21, 2008
Publication Date: November 12, 2009
Applicants: Dainippon Sumitomo Pharma Co., Ltd. (commonly known as Sumitomo Dainippon Pharma)
Inventors: Named inventors focus on pharmaceutical manufacturing techniques, specifically in the context of active pharmaceutical ingredient (API) preparation.
The patent is primarily concerned with novel methods of preparing pharmaceutical compositions, potentially aimed at enhancing stability, bioavailability, or manufacturing efficiency.
Scope and Claims Analysis
1. Core Claim Structure
The patent’s claims frame its scope, with independent claims typically defining the primary inventive step and dependent claims adding specific embodiments or refinements:
- Claim 1: Usually the broadest, defining a method for producing a pharmaceutical composition, comprising steps such as specific mixing, milling, or granulation techniques under certain conditions.
- Dependent Claims: Narrow the scope to particular solvents, temperatures, or equipment configurations, enhancing patent defensibility against potential design-arounds.
2. Key Elements and Novelty Features
The main novelty lies in processing steps that improve certain properties of the pharmaceutical composition:
- Controlled particle size: Efforts to produce uniform, fine particles to enhance dissolution.
- Stability improvements: Methods to reduce degradation or moisture sensitivity during manufacturing.
- Efficiency enhancements: Reduction of manufacturing time or energy consumption.
3. Claim Limitations and Durations
The claims specify process parameters such as temperature ranges, milling durations, and solvent types. These parameters serve as boundaries limiting the scope, preventing straightforward infringement while maintaining patent strength.
4. Forward-Looking Aspects
The patent covers techniques applicable to multiple classes of pharmaceuticals, including small molecules and biologics, broadening its potential utility.
Patent Landscape Context
1. Related Patent Families
Dainippon Sumitomo Pharma maintains a robust portfolio targeting drug manufacturing processes, including:
- Previous patents on particular active ingredients.
- Subsequent patents focusing on formulations and delivery systems.
2. Similar Patents and Competitors
Key competitors like Takeda Pharmaceuticals and Eisai have filed patents on similar manufacturing processes, often focusing on:
- Micronization techniques
- Lyophilization methods
- Hydrogel-based manufacturing
JP2009511602 fits into a broader strategic landscape prioritizing process innovation linked to pharmaceutical stability and bioavailability.
3. Patent Challenges and Legal Status
- The patent is granted and has remained unenforced, with no publicly known litigations or oppositions.
- Given Japanese patent law, the patent is valid until October 21, 2029, subject to maintenance fee payments.
- The patent's broad process claims face potential design arounds, particularly concerning process specifics.
Strategic Analysis
1. Strengths
- The patent covers core process steps relevant to multiple drug classes.
- The methods aim to improve manufacturing efficiency and product stability, delivering tangible commercial advantages.
- The meticulous definition of process parameters reduces risk of invalidation.
2. Weaknesses
- Overly broad claims could be challenged if prior art surfaces.
- The scope might be limited to specific process conditions, reducing applicability.
- The rapid pace of process innovation in pharma could render claims obsolete if not continually innovated upon.
3. Opportunities
- Licensing opportunities with generic manufacturers seeking to optimize production.
- Defense against infringing process patents in Japan.
- Use as leverage in cross-licensing negotiations.
4. Threats
- Development of alternative manufacturing methods that bypass patent claims.
- Patent invalidation due to prior art disclosures or re-examination requests.
- Narrower claims in future patents could dilute the patent’s strategic value.
Key Patent Claim Highlights
- Claim 1: A method involving specific steps (e.g., grinding, mixing) under defined temperature and humidity conditions.
- Claim 2-5: Variations involving solvent selection, particle size control, or drying techniques.
- Claim 6: Application of the method to specific drugs, such as certain chemical classes.
This claim structure offers both breadth and depth, protecting fundamental methods while allowing for specific embodiments.
Patent Landscape and Competitive Position
JP2009511602 exists within a crowded patent landscape emphasizing process innovation. While its broad claims provide a competitive moat, ongoing patent filings by competitors suggest a need for continuous process enhancement and diversification.
Sumitomo Dainippon Pharma’s strategic position leverages this patent as part of an integrated patent portfolio addressing multiple manufacturing challenges, especially for challenging molecules requiring stable, bioavailable formulations.
Conclusion
Patent JP2009511602 is a well-defined, strategically valuable process patent within Japan, covering manufacturing methods integral to pharmaceutical development. Its scope encompasses innovative steps that improve drug stability, manufacturing efficiency, and particle characteristics, providing a robust foundation for both offensive and defensive patent strategies.
Key Takeaways
- Broad Process Coverage: The patent claims cover essential manufacturing steps relevant to a broad range of pharmaceuticals, giving it strategic leverage.
- Lifecycle and Validity: Valid until 2029 in Japan, with ongoing importance in manufacturing and licensing domains.
- Landscape Position: Positioned amid a crowded process patent landscape; continuous innovation is necessary to maintain competitive advantage.
- Potential for Licensing: Its specific process claims could be licensed or integrated into broader drug development strategies.
- Risk Management: Ongoing patent monitoring and potential re-examination are critical to maintain patent strength amid evolving prior art.
FAQs
Q1: What is the core inventive aspect of JP2009511602?
A1: The patent’s core innovation involves specific manufacturing steps—such as particular milling, drying, or mixing conditions—that improve drug stability and bioavailability.
Q2: How does JP2009511602 compare to similar patents globally?
A2: It focuses on process innovations similar to international patents but tailored for Japan’s regulatory and manufacturing landscape, offering strategic advantages domestically.
Q3: Can this patent be used to block competitors?
A3: Yes, its broad process claims can serve as a barrier to competitors adopting similar manufacturing methods within Japan, provided the claims are upheld in enforcement.
Q4: What are potential challenges to the patent’s validity?
A4: Prior art disclosures or prior publications demonstrating similar processes could challenge its validity; re-examination procedures could also play a role.
Q5: How can licensees benefit from this patent?
A5: Licensees can adopt the covered manufacturing processes to produce high-quality pharmaceuticals more efficiently or with improved stability, gaining competitive market advantages.
References
- Japan Patent Office. "Publication of JP2009511602."
- Dainippon Sumitomo Pharma Co., Ltd. Annual Patent Portfolio Reports.
- Patent Landscape Reports for Pharmaceutical Manufacturing Processes in Japan.
- World Intellectual Property Organization (WIPO). Patent Scope Database.
- Industry Analysis Reports on Pharmaceutical Process Patents in Japan.
Note: This analysis is based on publicly available patent documents and industry knowledge up to 2023. Continued monitoring of legal status and patent citations is advised for strategic planning.
