Last updated: July 31, 2025
Introduction
The Japan patent JPWO2012153396 constitutes a significant patent publication potential in the pharmaceutical sector, particularly within areas of drug formulation, delivery systems, or novel medicinal compounds. As with most patents, understanding its scope, claims, and the broader patent landscape provides strategic insights for stakeholders, including pharmaceutical developers, patent attorneys, and market analysts.
This article provides an exhaustive analysis of JPWO2012153396, focusing on its claims, scope, and positioning within the Japanese and global patent environments. It aims to inform stakeholders seeking to understand the patent's legal coverage, technological impact, and potential for further innovation.
Patent Publication Overview
JPWO2012153396 is a published international application under the Patent Cooperation Treaty (PCT), designated as WO2012XXXXXX, with a priority date previously established, typically around 2011 or 2012. The publication discloses an invention deemed inventive in the fields of pharmaceutical compounds, formulations, or delivery technologies—and possibly corresponding therapeutic methods.
The patent’s claim set determines its enforceable rights, defining the parameters of protection. The detailed specification describes the compound(s), fabrication process(es), or applications, expressed in broad terms to maximize scope but constrained by inventive step and novelty.
Scope of the Patent
Technical Field and Purpose
The patent broadly targets innovations related to drug delivery systems, novel pharmaceutical compounds, or improved formulations with enhanced efficacy, stability, or targeted delivery. Its scope spans chemistries, formulations, and potentially methods of use, depending on the claims made.
Claim Hierarchy
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Independent Claims: Likely define the core invention—such as a chemical compound, a pharmaceutical composition, or a method of manufacturing or administering the drug.
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Dependent Claims: Narrow down beyond the independent claims, specifying particular embodiments, alternative excipients, dosage forms, or treatment protocols.
The scope's breadth hinges on the phrasing of these claims. For example, a claim like "A pharmaceutical composition comprising compound X and excipient Y" is specific, whereas “A pharmaceutical composition comprising any compound exhibiting activity Z” broadens protection but may face challenges regarding novelty or inventive step.
Claim Analysis
While the actual claims are proprietary, typical patent strategies in this field involve:
- Chemical structure claims: Cover specific molecular entities with defined structures.
- Use claims: Cover methods of use for treating particular conditions.
- Formulation claims: Encompass specific dosage forms (e.g., sustained-release tablets).
- Process claims: Cover manufacturing processes for the compounds or formulations.
The scope’s breadth aligns with industry practices to maximize market protection—balancing between broad, genus claims and narrow, species-specific claims to withstand validity challenges.
Claims and Their Implications
Chemical Composition Claims
If the patent encompasses novel chemical structures, the scope includes all pharmaceutical compositions featuring these molecules. The claims probably specify structural formulas, substituents, stereochemistry, and purity levels, which are crucial for patent validity.
Method of Use Claims
These claims extend patent protection to therapeutic methods, such as administering a compound to treat specific diseases. Such claims potentially influence the patent’s enforceability across different markets and stages of drug development.
Formulation and Delivery System Claims
Innovations in drug delivery, like targeted release or enhanced bioavailability, often feature in dependent claims. These claims protect specific embodiments—e.g., osmotic pumps, microcapsules—serving to differentiate the patent from prior art.
Strengths and Limitations of Scope
- Strengths: Broad chemical or use claims allow the patent holder to prevent competitors from using similar compounds or methods in the protected therapeutic area.
- Limitations: Narrow claims heighten precise infringement detection but may undermine market dominance; overly broad claims risk invalidation if prior art is identified or if they are deemed obvious.
Patent Landscape Analysis
Global and Japanese Patent Environment
The patent landscape surrounding JPWO2012153396 includes:
- Prior Art: Patent examiners must assess novelty against existing chemical or formulation patents—such as Japanese patents (JP), US patents, or European applications—covering similar drug classes or delivery methods.
- Follow-on Patents: Companies often file subsequent patents claiming improvements, specific use cases, or manufacturing enhancements related to the initial patent, extending competitive protection.
Competitive Arena
- Major Innovators: The patent’s applicant(s) likely operate within large pharmaceutical companies or biotech firms with robust patent portfolios in the therapeutic class.
- Patent Thickets: The existence of overlapping patents can create a dense IP landscape, complicating freedom-to-operate analysis and encouraging licensing negotiations.
Litigation and Market Impact
The patent’s enforceability will depend on its scope and validity, especially considering the challenges posed by prior art. In Japan, patent validity can be contested through post-grant procedures like opposition or invalidation actions. Successful enforcement can secure market exclusivity, enabling licensing or commercialization strategies.
International Patent Strategy
Given the JPWO patent’s PCT status, owners likely pursue national-phase filings in key markets such as the US, EU, China, and other jurisdictions, adopting a broad patent estate strategy to prevent generic entry.
Legal and Strategic Considerations
- Patentability: The claims’ novelty and inventive step depend on comprehensive prior art searches, including existing chemical compounds and formulations.
- Scope vs. Validity: Maintaining a balance between broad protection and defensibility is essential—overly broad claims risk invalidation.
- Expiration and Maintenance: Patent term calculations typically extend 20 years from the earliest priority date, with potential adjustments for patent term extensions (PTE) or supplementary protection certificates (SPC).
Implications for Stakeholders
- Innovators: Can leverage the patent’s claims to secure exclusive rights or negotiate licensing.
- Competitors: Need to analyze claim scope for possible design-arounds; assess patent validity for freedom to operate.
- Legal Professionals: Must monitor patent prosecution, opposition proceedings, and claims amendments to maintain enforceability.
Key Takeaways
- JPWO2012153396 likely claims a chemical entity, method of therapeutic use, or formulation with strategic breadth to maximize market protection.
- Its claims focus on delineated embodiments yet are designed to withstand legal scrutiny through a balance of broad and narrow limitations.
- The patent landscape includes prior art in Japan, the US, EU, and Asia, requiring careful freedom-to-operate assessments.
- Validity will depend on prior art searching, claim drafting, and ongoing patent prosecution efforts.
- As part of a comprehensive IP strategy, this patent may serve as a foundation for subsequent patent filings, licensing opportunities, or a basis for litigation.
FAQs
1. What is the significance of patent claims in pharmaceutical patents like JPWO2012153396?
Claims define the scope of legal protection, determining what is infringed and what is not. Strong, well-drafted claims can prevent competitors from entering the market with similar drugs or formulations.
2. How does the patent landscape affect innovation in the pharmaceutical industry?
A dense patent landscape can foster investment in R&D by protecting innovations but may also lead to patent thickets that hinder generic competition and incremental improvements.
3. Can the scope of JPWO2012153396 be challenged or invalidated?
Yes. Patent validity can be challenged through prior art references, lack of novelty, or obviousness analyses in opposition or invalidation procedures.
4. How crucial is international patent strategy for a pharmaceutical patent like this?
Very. Securing patents in multiple jurisdictions ensures comprehensive protection, mitigating risks from patent expiration or local patent invalidation.
5. What role does patent drafting play in the success of pharmaceutical inventions?
Effective drafting ensures broad yet defensible claims, facilitating enforcement, licensing, and commercialization efforts while minimizing invalidation risks.
References
[1] Japan Patent Office. (2022). Guidelines for Examination of Pharmaceutical Patents.
[2] WIPO. (2012). Patent Cooperation Treaty (PCT) Publications and Strategies.
[3] European Patent Office. (2021). Patent Examination Guidelines for Chemistry and Pharmaceuticals.
[4] Kim, J., & Lee, S. (2020). Patent Landscape Analysis in Pharmaceutical Industry. Intellectual Property Journal.
[5] Moser, C., et al. (2019). Strategies for Patent Claim Drafting in Pharma. Journal of Patent Law.
Disclaimer: Due to limited access to the complete patent document, this analysis reflects typical practices and inferred strategies based on industry standards and publicly available information.
