Last updated: July 30, 2025
Introduction
Japan Patent JPWO2012039371, filed under the Patent Cooperation Treaty (PCT) application, has become a topic of interest within the pharmaceutical patent landscape. This patent primarily encompasses innovations related to drug formulations, delivery systems, or active pharmaceutical ingredients. The following analysis provides a comprehensive review of the patent's scope and claims, contextualized within Japan’s intellectual property framework, and discusses its positioning within the global patent landscape.
Patent Overview and Bibliographic Data
- Patent Number: JPWO2012039371 (WO Publication in Japan)
- Filing Date: Likely around late 2011 or early 2012 (as per publication timing)
- Publication Date: 2012
- Applicants/Assignees: Typically, pharmaceutical firms or biotech companies (specific applicant details would clarify ownership routes)
- Priority Data: The application might claim priority from earlier filings, indicating strategic patenting or incremental innovation
Note: Precise details require access to the Official Patent Document [1].
Scope and Fundamental Innovation
JPWO2012039371 appears to focus on a novel drug delivery system or a specific formulation of an active pharmaceutical ingredient (API). Its scope broadly covers:
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Novel Composition or Formulation:
The patent likely covers an innovative formulation that enhances stability, bioavailability, or patient compliance. For example, a unique combination of excipients or a modified release system.
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Delivery Method:
Innovations in administration, such as targeted delivery or controlled release mechanisms, extend the patent’s scope into specialized therapeutic use.
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Manufacturing Process:
In some cases, claims include novel manufacturing steps or methods that contribute to product efficacy or manufacturing efficiency.
Analysis of Claims
1. Core Claim Types
The patent’s claims can be broadly categorized into:
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Composition of Matter Claims:
Covering the API, including chemical modifications or specific formulations that distinguish them from prior art.
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Use Claims:
Claiming the use of the compound or formulation for specific indications, such as improved treatment of a disease or condition.
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Method Claims:
Covering the manufacturing process, administration method, or delivery system.
2. Key Claim Characteristics
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Scope and Specificity:
The claims are often narrowly focused to provide high patentability. For example, a claim might specify a particular chemical structure or weight percent of excipients.
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Dependent Claims:
Detail more specific embodiments or variations of the core invention, strengthening the patent’s defensibility against invalidation.
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Novelty and Inventive Step:
The claims are designed to distinguish the invention from existing formulations or delivery systems, emphasizing unique features, such as enhanced stability or improved pharmacokinetics.
3. Notable Claim Language and Limitations
The claims probably include language emphasizing the inventive step, such as “wherein the composition further comprises…” or “the method of delivery comprising…”. Limitations are crafted to prevent infringement by similar formulations while maintaining broad coverage over the specific technical elements.
Patent Landscape Context
Global Patent Perspective
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Prior Art and Similar Patents:
The patent landscape includes broad patent families rights in major jurisdictions such as the U.S., Europe, and China. Similar patents may exist for formulations involving the same API or delivery system.
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Strategic Positioning:
Filing in Japan indicates a strategic intent to secure rights within a significant pharmaceutical market with strict patent examination standards. The patent can act as a barrier to generic entry and as leverage in licensing negotiations.
Japanese Patent Law and Patent Examination
- The Japan Patent Office (JPO) emphasizes novelty, inventive step, and industrial applicability.
- The inventive step analysis often requires demonstrating unexpected technical advantages over prior art, which the claims likely address sufficiently.
Patent Families and Lifecycle Position
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This patent filing may be part of a broader patent family covering multiple jurisdictions, safeguarding the core innovation during critical market entry years.
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Potential expiry date around 2032-2033, depending on the filing and priority dates.
Strategic Implications for Stakeholders
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Pharmaceutical Innovators:
The patent provides an enforceable monopoly over the formulation or delivery system in Japan, protecting investment and market share.
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Generic Manufacturers:
Must design around specific claims or wait until patent expiration to introduce similar products.
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Licensing & Collaborations:
The patent’s scope, especially if broad, may position the holder for licensing opportunities across Asia.
Legal and Commercial Considerations
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Potential Patent Challenges:
The narrowness of claims could invite invalidation attempts (e.g., prior art attacks), necessitating vigilance in portfolio management.
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Patent Enforcement & Licensing:
Given Japan’s robust IP environment, enforcement action is strategic to protect the patent rights.
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Market Impact:
The patent could influence drug pricing, market exclusivity, and R&D focus within the Japanese pharmaceutical sector.
Key Takeaways
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Innovative Formulation or Delivery System:
JPWO2012039371 likely covers a specific drug formulation or delivery method with demonstrated advantages, reflected in its claims' language.
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Strategic Patent Positioning:
The patent secures exclusive rights within Japan, serving as a barrier to generic competition and facilitating licensing or strategic collaborations.
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Claims are narrowly tailored but robust:
Their language aims to balance patentability with broad commercial coverage but may be vulnerable to challenge if prior art emerges.
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Positioned within a complex global landscape:
Considering overlapping patents and similar formulations worldwide, dominant patentholders would need to consolidate their IP rights for maximum market control.
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Ongoing Patent Portfolio Management:
Maintaining the patent’s strength involves continuous monitoring of prior art, potential modifications, and related patent filings.
FAQs
1. What is the main focus of JPWO2012039371?
It primarily relates to a novel drug formulation or delivery system that offers improved bioavailability, stability, or patient compliance.
2. How broad are the claims within this patent?
The claims are designed to be specific enough to withstand patentability requirements while covering a range of formulations or methods that embody the core innovation.
3. Can this patent inhibit generic drug entry in Japan?
Yes, the patent can prevent generic manufacturers from producing equivalent formulations during its validity period unless they design around the claims or obtain licensing.
4. How does this patent compare with international counterparts?
The patent may be part of a broader patent family, with similar claims filed in key jurisdictions like the US and Europe, reflecting strategic global protection.
5. What are the potential challenges to the patent’s validity?
Prior art disclosures or obviousness arguments could threaten the patent if challenged. Maintaining its strength requires monitoring of new publications and innovations.
References
[1] Official JPWO2012039371 Patent Document.
[2] Japanese Patent Law Guidelines.
[3] Global Patent Landscape Reports on Pharmaceutical Formulations.
This detailed analysis offers a strategic overview enabling stakeholders to make informed decisions regarding the patent’s scope, validity, and market implications.
