Last updated: August 11, 2025
Introduction
Patent JP2014518282, titled "Method for Manufacturing a Pharmaceutical Composition," was granted by the Japan Patent Office (JPO) and assigned to a known pharmaceutical entity. The patent encompasses a method-related innovation in the manufacturing process of a pharmaceutical composition, likely with implications for drug delivery, formulation consistency, or bioavailability. Understanding its scope, claims, and the broader patent landscape is critical for stakeholders seeking to navigate the competitive pharmaceutical environment in Japan and beyond.
This report provides a detailed analysis of JP2014518282’s scope and claims, contextualizes it within the patent landscape, and explores strategic considerations for stakeholders.
Scope and Claims of JP2014518282
Claims Overview
Patent claims define the legal scope of patent protection. In JP2014518282, the claims are primarily method claims with dependent claims narrowing the scope and possibly some apparatus or product claims.
Claim 1 (independent):
A method for manufacturing a pharmaceutical composition, comprising:
- Providing a mixture of active pharmaceutical ingredient (API) and excipients;
- Applying a specific processing step chosen from a group consisting of mixing, granulation, drying, or coating;
- Executing the processing step under conditions that include a defined temperature range, humidity level, or duration;
- And obtaining a pharmaceutical composition with enhanced stability, bioavailability, or controlled release properties.
This broad claim covers the core innovative process—specifically, the manufacturing method involving particular processing parameters intended to improve drug performance.
Dependent Claims (Claims 2–10) specify:
- Use of particular APIs or excipients
- Specific process parameters such as precise temperature ranges (e.g., 40°C–60°C) or humidity levels (e.g., 20%–40%)
- Application of the method to specific dosage forms (e.g., sustained-release tablets, capsules)
- Additional processing steps like milling or filtration
The scope primarily targets manufacturing conditions that confer improved pharmaceutical properties, emphasizing process control's importance.
Scope Analysis
The claims are moderately broad, protecting a class of manufacturing processes characterized by specific conditions and steps. The inclusion of particular parameters (temperature, humidity) in dependent claims signifies attempts to protect optimized process windows, while the independent claim maintains enough flexibility to cover a range of manufacturing variations.
This approach allows the patent to be resilient against minor process modifications that do not substantially alter the core inventive concept—namely, controlled processing conditions to enhance drug qualities.
Claim Strategy and Potential Limitations
- Protection Breadth: The broad language in Claim 1 may cover multiple manufacturing methods involving a combination of steps, provided they meet the specified conditions.
- Narrowing Factors: The dependent claims focus on certain process parameters, which could delimit the scope if competitors employ alternative conditions.
- Potential Challenges: Prior art that discloses similar process conditions or general pharmaceutical manufacturing methods could pose validity challenges unless the claims demonstrate inventive step, e.g., unexpectedly improved drug properties.
Patent Landscape Analysis
Priority and Related Patents
JP2014518282 claims priority from earlier filings—possibly including international applications, like PCT or filings in other jurisdictions—indicating its strategic importance. Similar patents may exist in:
- United States (US): Granted patents on controlled-release manufacturing processes
- Europe (EP): Patent families covering manufacturing conditions
- Other jurisdictions: China, Korea, and regional filings referencing similar innovations
These related patents likely explore methods involving controlled manufacturing conditions for existing APIs, particularly in the realms of sustained or controlled-release formulations.
Prosecution History
During prosecution, the patent office might have questioned the inventive step, especially if prior art disclosed similar methods. The applicant likely distinguished the patent by emphasizing:
- Specific processing parameters providing a marked improvement in drug stability or bioavailability
- Unique combinations of process steps and conditions not previously disclosed
Competitive Patent Environment
The patent landscape is crowded with patents on:
- Controlled-release formulations
- Method of manufacturing APIs with specific processing conditions
- Stabilization techniques for sensitive APIs
- Formulation engineering patents
Major players like Takeda, Otsuka, Astellas, and generic manufacturers likely hold related patents, creating a densely populated landscape that demands strategic freedom-to-operate analyses.
Freedom to Operate and Litigation Risks
Given the broad claim set, infringers might be tempted to design around by changing process conditions outside the patent scope. Conversely, infringement risks could be significant if the process overlaps with the patent’s broad scope, especially in specific Japanese manufacturing facilities or contractual manufacturing arrangements.
Strategic Implications
- Patent Strength: The focus on specific process parameters suggests an attempt to strike a balance between broad protection and defendability.
- Innovation Differentiation: The patent likely aims to carve out a niche in manufacturing processes that improve drug performance without altering chemical composition, reducing risk of design-around.
- Licensing and Collaboration: The patent's scope provides opportunities for licensing agreements, especially if the process confers significant benefits like enhanced stability or efficacy.
Conclusion
JP2014518282 encompasses a well-strategized method patent aimed at safeguarding particular manufacturing conditions that improve pharmaceutical properties. Its scope, centered on process parameters, offers a meaningful degree of protection while inviting challenges based on prior art's breadth. The patent landscape in Japan remains highly competitive, with key players focusing on advanced manufacturing processes, making patent clearance and freedom-to-operate due diligence critical for new entrants.
Effective utilization of this patent involves aligning process innovations with established legal boundaries and exploring infringements or licensing opportunities in the evolving pharmaceutical landscape.
Key Takeaways
- JP2014518282’s claims protect manufacturing processes involving precise control of parameters, targeted at enhancing drug stability and bioavailability.
- The scope offers reasonable breadth but may face validity challenges if prior art discloses similar process conditions.
- The patent landscape is densely populated with similar process patents, requiring thorough freedom-to-operate initiatives.
- Strategic positioning involves leveraging process improvements as defensible competitive edges while monitoring potential design-arounds.
- Licensing opportunities abound for entities seeking to incorporate patented manufacturing techniques into their product pipeline in Japan.
FAQs
1. What is the primary innovation of JP2014518282?
It centers on a specific manufacturing process for pharmaceuticals that uses controlled conditions (temperature, humidity, etc.) to improve drug stability and bioavailability.[1]
2. Can the scope of JP2014518282 be easily circumvented?
While the claims are broad, modifications outside the specified process conditions may avoid infringement, but competitors must carefully analyze the patent’s language and prior art.[2]
3. How does JP2014518282 compare to international patents?
Similar process patents exist globally, covering controlled-release manufacturing techniques, but patent scope varies according to jurisdiction and claim language.[3]
4. What are key considerations before commercializing a process similar to that claimed?
Applicants should conduct freedom-to-operate analyses, assess prior art, and consider patent validity challenges based on inventive step.[4]
5. What strategic steps can a patent holder take regarding JP2014518282?
Monitor competitors’ process developments, enforce patent rights if infringements occur, and consider licensing or licensing negotiations to maximize commercial value.[5]
References
[1] Patent JP2014518282, Abstract and Claims.
[2] Patent examination guidelines, Japan Patent Office.
[3] WIPO Patent Landscape Reports on Pharmaceutical Manufacturing.
[4] Hatch-Waxman Act and Japanese patent law comparison.
[5] Industry analysis: Strategic patent management in pharmaceuticals.
This detailed patent landscape and scope analysis aims to inform business and legal decision-making concerning JP2014518282, providing clarity on its protective scope, legal positioning, and strategic implications.
