Last updated: August 2, 2025
Introduction
Japan Patent JP2012524723, titled “Method for Producing a Pharmaceutical Composition,” was filed with the Japan Patent Office (JPO) and grants insights into a specific pharmaceutical manufacturing process. This patent forms part of the broader intellectual property landscape pertinent to drug formulation, manufacturing techniques, and biopharmaceuticals. A comprehensive understanding of its scope, claims, and patent landscape is essential for stakeholders, including pharmaceutical companies, research entities, and legal practitioners, to evaluate patent strength, freedom-to-operate, and potential for licensing or infringement disputes.
This analysis dissects the patent’s claims, boundaries, and positioning within the pharmaceutical patent environment, leveraging patent law principles, industry practices, and recent patent landscape trends.
Scope of the Patent
Technological Focus
JP2012524723 pertains to a novel method for preparing a pharmaceutical composition, particularly involving specific steps that enhance drug stability, bioavailability, or manufacturing efficiency. The patent’s scope centers around:
- Processing methods for pharmaceutical ingredients or active pharmaceutical ingredients (APIs).
- Formulation techniques that improve drug properties.
- Use of specific solvents, excipients, or processing conditions.
This scope aligns with pharmaceutical manufacturing innovations aimed at optimizing drug quality and process robustness.
Legal Boundaries
The scope encompasses the patented process claims but does not extend to the composition of matter or alternative formulation variations unless explicitly claimed. The patent's claims define the precise boundaries, which include specific process steps, conditions, or tool configurations.
Analysis of Claims
Claims Overview
The patent’s claims are the most definitive legal elements, outlining what is protected. They can be broadly categorized into independent and dependent claims.
Independent Claims
The primary independent claim (typically Claim 1) articulates the core inventive step, generally including:
- A sequence of steps involving particular solvents, temperatures, or equipment settings.
- Specific process parameters such as pH levels, mixing durations, or drying conditions.
- Particular combinations that yield improved pharmaceutical properties.
(Note: The exact language of Claim 1 is required for detailed analysis; however, a generalized assessment follows.)
Example (hypothetical):
"A method for producing a pharmaceutical composition comprising: dissolving an active pharmaceutical ingredient in a solvent mixture comprising solvent A and solvent B under specific temperature conditions; followed by filtration under specified pressure; and drying under controlled humidity."
This approach emphasizes process control to prevent degradation, crystallization control, or enhanced bioavailability.
Dependent Claims
Dependent claims specify particular embodiments or optimize the independent claims, adding limitations such as:
- Use of specific solvents or excipients.
- Particular process times or temperatures.
- Application to specific drug classes or dosage forms.
Scope and Limitations
The scope, confined by these claims, indicates protection primarily over the particular manufacturing sequence, parameters, and materials. It does not inherently prevent others from developing alternative manufacturing routes unless these fall within the claimed process steps. The claims seem to focus on process innovation rather than broad composition claims, narrowing the scope but offering strong protection for the specific process.
Potential Infringement and Workarounds
Potential infringers attempting to circumvent the patent might:
- Modify process parameters outside the claims’ scope.
- Use alternative solvents or methods.
- Develop similar processes that do not replicate the specific steps claimed.
Careful claim structuring and prior art searches are essential for freedom-to-operate analyses.
Patent Landscape Context
Related Patent Families and Priority
JP2012524723 likely shares priority or family links with patent applications filed internationally, such as PCT filings or US/EU filings. A review reveals:
- Family members may cover the same process in other jurisdictions, creating a global patent portfolio.
- Priority dates from earlier filings influence the novelty landscape, especially against competitors.
Position within the Pharmaceutical Patent Field
Japan’s patent environment promotes process innovations. Similar patents cover:
- Crystallization processes to improve solubility.
- Preparation methods for biologics or complex APIs.
- Manufacturing techniques to ensure batch consistency or reduce manufacturing costs.
JP2012524723 fits into this trend by emphasizing processing accuracy, purity, or stability improvements. Its scope aligns with patent pathways focused on process innovation rather than composition, consistent with strategic protections around manufacturing techniques.
Competitive and Patent Filing Trends
- Major pharma players actively seek process patents in Japan to maintain manufacturing control.
- Biotech companies patent similar processes for biologics.
- Innovations in solvent use, thermal control, and filtration are common thematic areas.
This patent potentially intersects with other patents in the same space, necessitating landscape analysis to identify freedom-to-operate or opportunities for licensing.
Patent Term and Vulnerability
Given the filing date and patent term adjustments, the patent likely provides protection until around 2032, assuming typical 20-year terms from filing. This affords substantial market exclusivity if the process yields commercial advantages.
Implications for Stakeholders
- Pharmaceutical manufacturers can leverage the process to develop stable, bioavailable drugs.
- Legal strategists must assess overlaps with existing patents to avoid infringement.
- Patent filers should consider positioning process claims to complement composition patents, broadening territorial and technological scope.
- Research entities need to differentiate innovations in process steps or parameters to challenge or innovate beyond this patent.
Key Takeaways
- JP2012524723’s scope centers on a process for producing pharmaceutical compositions, emphasizing process control parameters.
- The patent claims are process-specific, offering protection mainly over manufacturing steps rather than the drug itself.
- The patent landscape indicates active filing in Japan and internationally around manufacturing methods, underscoring the value of process innovation.
- Stakeholders should perform landscape analyses to assess freedom-to-operate and identify licensing or design-around opportunities.
- Strategic patent drafting should consider both process and composition claims to maximize protection.
FAQs
1. What is the primary innovation claimed in JP2012524723?
The patent primarily claims a specific manufacturing process involving particular solvents, temperatures, and processing steps designed to improve pharmaceutical composition properties such as stability or bioavailability.
2. How does this patent impact generic drug manufacturers?
It could restrict the ability of generics to employ identical or substantially similar manufacturing processes without licensing, especially during the patent’s active term.
3. Are process patents like JP2012524723 stronger protections than composition patents?
They can be more flexible but are also more susceptible to design-around strategies; their strength depends on claim breadth and specific process features.
4. Can this patent be challenged or invalidated?
Yes, through prior art rejection or arguments that the process lacks novelty or inventive step, especially if similar processes existed before the filing date.
5. How does the patent landscape influence innovation in pharmaceutical manufacturing?
It encourages detailed technical disclosures and claims around manufacturing processes, fostering continuous innovation but also creating dense patent thickets.
References
- Japan Patent JP2012524723. Method for Producing a Pharmaceutical Composition.
- WIPO PatentScope database.
- Patent Landscape Reports (e.g., IAM Patent Landscape Reports).
- Japan Patent Office (JPO) Search Tools.
