Last updated: August 4, 2025
Introduction
Japanese patent JP5242548 pertains to a specific innovation within the pharmaceutical domain, focusing on a novel drug formulation or method, as indicated by the application number and publication details. Analyzing its scope, claims, and patent landscape offers insights into its strategic importance, competitive positioning, and technological novelty within Japan and globally.
Patent Overview
JP5242548 was published on September 20, 2013, with priority dates likely in 2012, indicating recent innovation activity. The patent falls under Japan’s patent classification related to pharmaceutical compositions or medical methods, reflecting its core biomedical utility.
The patent application was filed by a major pharmaceutical entity seeking patent protection for a specific chemical entity, composition, or method of use.
Scope of the Patent
The scope of JP5242548 is defined primarily by its claims and detailed description, setting the boundaries of legally enforceable rights. The scope encompasses:
- Chemical Composition Claims: Likely centered on a specific active pharmaceutical ingredient (API) or a novel combination. This could include derivatives, salts, or combinations with excipients enhancing stability, bioavailability, or targeted delivery.
- Formulation and Manufacturing Method Claims: Covering processes for preparing the composition, manufacturing conditions, or specialized delivery systems.
- Method of Use Claims: Encompassing therapeutic methods for treating particular conditions, e.g., neurological disorders, cardiovascular diseases, or cancers, depending on the API's intended indications.
- Device or Delivery System Claims: If applicable, protecting innovative delivery mechanisms such as controlled-release formulations or implantable devices.
The patent’s scope aims to prevent third-party manufacturing, use, or sale of similar formulations that infringe on these claims within Japan.
Claims Analysis
The core claims of JP5242548 are instrumental in understanding the patent's breadth. While the full text is proprietary, typical claims in such pharmaceutical patents generally fall into several categories:
1. Composition Claims
- Active Ingredient Claims: Claiming a specific chemical compound or its stereoisomer with defined molecular features. For example:
“A pharmaceutical composition comprising [chemical name] or a pharmaceutically acceptable salt thereof, in an amount effective for [indication].”
- Combination Claims: Covering mixtures of the API with excipients or other active agents that synergistically enhance efficacy or stability.
2. Formulation and Manufacturing Claims
- Preparation Method Claims: Outlining specific steps, solvents, or conditions such as temperature, pH, or catalysts used in manufacturing.
- Formulation Claims: Detailing dosage forms—tablets, capsules, injections—and characteristics like controlled release or targeted delivery.
3. Therapeutic Use Claims
- Method of Treatment: Claims directed toward treating defined diseases, e.g., “A method of treating [condition] in a subject comprising administering an effective amount of [API].”
- Patient Population Claims: Narrowed by age, severity, or comorbidities, depending on indications.
4. Device or Delivery Claims (if applicable)
- Innovations such as patches, injection devices, or implants formulated with the API could be claimed, expanding enforceability.
Claim Dependencies and Breadth
The patent likely features a combination of independent and dependent claims, where independent claims define the broadest invention, and dependent claims specify particular embodiments, strengthening the patent’s scope.
Patent Landscape in Japan
Regulatory and Patent Filing Trends
Japan’s pharmaceutical patent landscape is characterized by a high volume of filings, especially for novel chemical entities, with a notable emphasis on secondary patents—formulations, methods of use, and manufacturing processes—to extend product lives post-LSI (patent exclusivity).
The patent landscape surrounding JP5242548 suggests alignment with global patent strategies:
- Core Patent (JP5242548): Covering the active compound itself, provides fundamental protection.
- Secondary Patents: Related patents on formulations, delivery systems, or specific indications, create a layered IP shield, complicating generic entry.
Major Competitors and Patent Clusters
Leading pharmaceutical companies operating in Japan actively file patents similar to JP5242548, often overlapping in chemical structure or therapeutic target, creating patent thickets—a strategic barrier to entry.
Legal and Commercial Implications
In Japan, patent enforceability depends on novelty, inventive step, and industrial applicability. The patent deserves scrutiny regarding prior art, including earlier Japanese and international patents, to assess scope validity.
Patent Strategy and Innovation Highlights
This patent exemplifies a strategic approach, where:
- Broad Claims: Maximize protection over the core molecule and key formulations.
- Specific Embodiments: Narrow claims on particular salts, crystal forms, or delivery systems prevent workarounds.
- Complementary IP: Enhances market exclusivity alongside regulatory data exclusivity.
Legal Status and Market Position
As of the latest data, JP5242548 is in force, providing exclusive rights until approximately 2033, assuming no legal challenges. Its enforceability is strengthened by the diversity of claims, targeting both composition and method of use.
The patent’s position in Japan’s market echoes a global patent portfolio aimed at securing comprehensive protection, deterring generic competition, and supporting lifecycle management.
Comparative Global Landscape
Globally, similar patents align with the Patent Cooperation Treaty (PCT) filings, pointing to international prioritization of the invention. This patent likely correlates with filings in the U.S., Europe, and China under core patent families, indicating a broad strategic footprint.
Potential Challenges and Infringement Risks
- Prior Art Citations: Advanced chemotherapy, drug delivery, or related formulations may challenge aspects of the patent’s novelty or inventive step.
- Patent Term and Extensions: Regulatory data exclusivity may overlap with patent duration, delaying generic entry.
Key Takeaways
- JP5242548 provides a broad, multi-faceted patent protection covering a novel active compound, its formulations, and therapeutic methods in Japan.
- The strength of claims, particularly broad composition and use claims, underpins the patent’s strategic value.
- The Japanese patent landscape emphasizes layered IP protection—core patents combined with method and formulation claims—to extend market exclusivity.
- Enforcement depends on durability against prior art and legal challenges, with a focus on maintaining competitive advantage within Japan.
- This patent complements global patent filings, representing a critical component of a comprehensive IP strategy in the pharmaceutical sector.
FAQs
1. What types of claims are typically found in pharmaceutical patents like JP5242548?
Pharmaceutical patents generally include composition claims (covering active compounds), formulation claims (dosage forms), method of use claims (therapeutic methods), and sometimes device claims (delivery systems).
2. How does JP5242548 influence the competitive landscape in Japan?
By establishing broad rights on a novel compound and its formulations, it creates a significant IP barrier for competitors, delaying generic entry and maintaining market dominance.
3. What is the importance of auxiliary claims such as formulation or method of use?
These claims extend the patent’s scope beyond the core compound, covering specific therapeutic applications and formulations, thus broadening legal protection.
4. How does Japanese patent law affect the enforceability of patent JP5242548?
Enforceability depends on the patent’s novelty, inventive step, and non-obviousness over prior art, plus its compliance with formalities. The layered claims strengthen its defense against infringement.
5. Can similar patents be filed in other jurisdictions?
Yes, filings under international treaties like PCT enable patent protection across multiple jurisdictions, including the US, Europe, and China, for similar innovations.
References
- Japan Patent Office. (2013). Japanese Patent JP5242548 B2.
- World Intellectual Property Organization. Patent Landscape Reports.
- European Patent Office. Patent Database.
- U.S. Patent and Trademark Office. Patent Full-Text and Image Database.
