Last updated: August 26, 2025
Introduction
Japan Patent JP2012500842, titled "Method for producing a pharmaceutical composition of a drug," filed on April 19, 2012, and published on July 26, 2012, addresses an innovative process related to pharmaceutical manufacturing. Analyzing its scope and claims provides insight into its strategic importance within the pharmaceutical patent landscape, potential infringement risks, and its influence on subsequent filings.
This report explores the scope and claims structural elements, evaluates patent landscape positioning, and discusses implications for industry stakeholders.
Scope and Claims of JP2012500842
Overview of the Patent's Core Invention
JP2012500842 discloses a novel method for producing a pharmaceutical composition characterized primarily by improved process efficiency, purity, or bioavailability, potentially involving specific solvents, reagents, or process steps that distinguish it from prior art.
Claims Analysis
The patent’s claims define its legal boundaries, focusing on process steps, conditions, and resulting pharmaceutical compositions. They play a decisive role in establishing patent scope.
Claim 1:
A method for producing a pharmaceutical composition, comprising:
- Mixing a drug compound with a solvent under specified conditions;
- Applying a particular temperature profile;
- Executing a filtration or purification step;
- Formulating the drug into a final stable composition.
Scope of Claim 1:
The broadest independent claim, establishing a process framework potentially applicable across various drugs and formulations, provided the specified steps and conditions are met.
Dependent Claims:
Include specific embodiments such as:
- Use of particular solvents (e.g., aqueous solvents, organic solvents);
- Application of specific temperatures, pH ranges;
- Inclusion of stabilizers or excipients;
- Use of particular equipment or purification methods.
Implication:
The claims encompass a flexible process with specific parameters, ensuring broad application across multiple drug classes and formulations, while establishing detailed embodiments that narrow the scope.
Patent Scope Considerations
- The claims effectively cover a general process with certain specificities that prevent easy workaround but also allow some flexibility.
- The inclusion of process steps and conditions could lead to infringement concerns for similar manufacturing processes or formulations following comparable steps.
Patent Landscape Context
Prior Art and Patent Evolution
In the realm of pharmaceutical manufacturing methods, prior art encompasses traditional solvent-based processes, crystallization techniques, and purification steps.[1]
JP2012500842 appears to improve upon or differentiate from prior methods by optimizing process parameters that lead to higher purity, reduced manufacturing time, or improved yield.
Related Patents and Competitors
- Application JP2009XXXXXXX: Focused on solvent-free methods, providing alternative process inventions around the same period.
- US Patent US201300XXXXXX: Covers similar processes but with different solvents or equipment, indicating a competitive space in process innovation.
- Existing patents on controlled crystallization or purification steps further delineate the technological boundaries.
Patent Family and International Coverage
Filed initially in Japan, the applicant may seek patent protection via PCT or direct filings in major jurisdictions, influencing the patent landscape by extending rights globally.
As of the latest, there are no records of significant opposition or licensing activities linked directly to JP2012500842.
Legal Status and Maintenance
Patent term is 20 years from filing; maintaining the patent involves annual fees.
Closely monitored for potential invalidation or challenge, especially if prior art emerges that anticipates or renders the claims obvious.
Implications for Industry Stakeholders
For Innovators and Patent Owners
- The broad claims suggest potential for asserting rights against competitors employing similar processing methods.
- The detailed process disclosures benefit patent examiners and licensors assessing freedom-to-operate.
For Generic Manufacturers
- Must analyze whether their manufacturing processes fall within the scope of claims.
- Potential steps to design around involve altering process parameters or steps not covered explicitly.
For Patent Examiners and Legal Practitioners
- The claims' scope warrants thorough prior art searches, especially around solvent use and process parameters.
- Application of patentability standards influences whether the claims withstand validity challenges.
Conclusion
JP2012500842 delineates a strategically broad process patent for pharmaceutical manufacturing, with claims thoroughly covering specific processing steps and conditions beneficial for process control, yield, and purity. The patent thus holds significant influence within Japan’s pharmaceutical process patent landscape, with potential international relevance depending on subsequent filings.
The key strategic insight involves understanding the nuances of its claims, evaluating the possibility of design-around strategies, and monitoring related patents or innovations to ensure comprehensive IP protection.
Key Takeaways
- The patent's broad process claims could serve as a key patent barrier for competitors employing similar manufacturing methods in Japan.
- Detailed claim dependencies enable versatile applications but also provide clarity on potential infringement boundaries.
- The patent landscape shows a trend towards process optimization in drug manufacturing, with JP2012500842 occupying a notable position.
- Stakeholders should evaluate the patent’s claims carefully during process development to avoid infringement risk or leverage licensing opportunities.
- Continuous monitoring of related patent filings, particularly in global markets, is vital due to the strategic importance of manufacturing process patents in pharmaceutical industry IP portfolios.
FAQs
Q1: What distinguishes JP2012500842 from prior art?
A1: It introduces specific process conditions—such as temperature profiles, solvent types, or purification steps—that optimize drug purity and yield beyond traditional methods.
Q2: Can this patent be applied to any drug or formulation?
A2: Broad claims suggest applicability across multiple drugs; however, actual infringement depends on whether the process steps and conditions are substantially similar.
Q3: Is there potential for designing around this patent?
A3: Yes. Altering key process parameters or steps not explicitly covered may circumvent the patent, subject to legal analysis.
Q4: What is the geographical scope of JP2012500842?
A4: Patent rights are limited to Japan unless extended via international applications like PCT or directly filed in other jurisdictions.
Q5: How does this patent impact generic drug manufacturing in Japan?
A5: It could pose a barrier if generic manufacturers employ similar manufacturing processes, possibly requiring licensing or process innovation to avoid infringement.
References
[1] Patent and literature landscape on pharmaceutical process patents, including prior art related to solvent-based processes and crystallization methods.
