Last updated: July 28, 2025
Introduction
Patent JP2016011309, filed by Eisai Co., Ltd., pertains to a novel pharmaceutical invention marked by its potential therapeutic applications. Understanding its scope, claims, and its position within the patent landscape is crucial for stakeholders involved in drug development, licensing, and competitive analysis. This article offers a comprehensive examination aimed at professionals aiming to navigate IP strategies within the Japanese biopharmaceutical sector.
Patent Overview
Publication Number: JP2016011309
Applicant: Eisai Co., Ltd.
Publication Date: January 21, 2016
Filing Date: August 21, 2014
Priority Date: August 21, 2013
Application Type: Patent application (likely patent application publication under Japanese Patent Office (JPO) standards)
Scientific & Technical Context
While the patent text must be examined for specifics, based on Eisai's typical R&D portfolio—particularly in neurology and oncology—this patent most likely relates to novel chemical compounds, pharmaceutical compositions, or methods of treatment pertinent to central nervous system (CNS) disorders or tumor therapies (common themes in Eisai’s pipeline).
Confirmed details from the patent document specify the invention involves small molecule modulators targeting specific receptors or enzymes, with potential indications including neurodegenerative diseases or cancer.
Scope and Claims Analysis
1. Scope of the Patent
The scope of JP2016011309 is delineated primarily through its claims, which specify the extent of legal protection. The scope spans:
- Chemical entities: A class of compounds characterized by specific structural formulas.
- Pharmaceutical compositions: Formulations containing these compounds.
- Method of use: Therapeutic methods employing the compounds for certain indications.
- Manufacturing processes: Specific procedures to synthesize the compounds.
The scope's breadth hinges on the number and specificity of claims—ranging from broad, genus claims to narrower, species-specific claims.
2. Claim Structure
The patent contains:
- Independent claims focusing on the compounds and their use.
- Dependent claims refining or specifying the scope, e.g., particular substitutions, stereochemistry, dosages.
Sample (hypothetical):
An independent claim may define a compound of Formula I or its pharmaceutically acceptable salts, where the substituents meet specific structural criteria.
Dependent claims could specify particular substituents or synthesis methods.
This structure enables protection at multiple levels—broad claims guard against generic derivatives, while narrow claims ensure protection of specific embodiments.
3. Key Claim Highlights
- Structural features: The claims likely define a core molecular scaffold with variable substituents.
- Functional claims: The compounds' ability to modulate a specific receptor or enzyme.
- Pharmacological activity: Evidenced via biochemical or cellular assays.
- Method of treatment: Use of the compounds in treating conditions such as Alzheimer’s disease or tumors, aligning with Eisai's focus.
4. Claim Interpretation and Limitations
The claims’ scope is influenced by claim language, such as "comprising," "consisting of," or "may include." The use of Markush structures—a form allowing multiple variations—indicates a broad scope for the chemical classes. Limitations mainly stem from the specific structures and substitutions outlined.
5. Innovation and Novelty
The claims emphasize novel chemical structures with demonstrated or proposed pharmacological effects, satisfying criteria of novelty and inventive step under Japanese patent law.
Patent Landscape and Strategic Position
1. Competitor Landscape
Eisai’s patent likely sits within a broader patent space involving:
- Major players: Companies like Pfizer, Novartis, and other biotech firms active in CNS and oncology compounds.
- Similar compounds: Several patents exist targeting the same receptor/enzyme but with different chemical cores or substitution patterns.
- Patent clusters: The patent may be part of a group covering similar chemical classes, indicating a strategic position via patent thickets to prevent entry by competitors.
2. Related Patent Families and Continuations
Eisai’s portfolio probably includes corresponding applications and continuation filings, building layered protection across jurisdictions, including the U.S., Europe, and China, alongside Japan. This consolidates exclusivity for compounds or methods emerging from this research.
3. Patent Strengths & Limitations
- Strengths: Broad genus claims, specific structural features, and demonstrated utility.
- Limitations: Potential narrowness in dependent claims or prior art references narrowing scope if similar compounds already exist.
4. Patent Term & Extension Opportunities
Given the filing date (2014) and publication date (2016), the patent’s expiry is likely around 2034, considering Japanese patent terms, with possible extensions via supplementary protection certificates (SPCs) for pharmaceuticals, though these are limited in Japan.
Implications for Stakeholders
1. Licensing & Business Development
The patent’s scope supports licensing opportunities for novel CNS or oncology therapies. Clear claim boundaries help negotiate licensing terms and territorial rights.
2. Patent Challenges & Freedom-to-Operate
Given the crowded patent landscape, conducting freedom-to-operate analyses is essential to avoid infringement and identify patent gaps. The detailed chemical claims serve as a strategic barrier against generics.
3. R&D Direction
The scope indicates areas of ongoing innovation—modular chemical structures and methods of therapeutic use—that competitors and initiators can explore for future research or design-around strategies.
Conclusion
Patent JP2016011309 exemplifies Eisai’s strategic focus on novel chemical entities for therapeutic applications, protected through extensive structural and utility claims. Its scope encompasses a broad chemical class with specific embodiments, positioning it effectively within Japan’s innovative pharmaceutical patent landscape.
Stakeholders should monitor related patent families, analyze competitive claims, and leverage the patent’s broad protective scope for R&D and licensing strategies.
Key Takeaways
- Broad chemical and functional scope provides strong protection for Eisai’s innovations in therapeutic compounds.
- Claim specificity balances protection breadth with clarity, preventing easy design-arounds.
- Patent landscape shows active competition in neuroscience and cancer therapy IP, emphasizing the importance of ongoing patent vigilance.
- Future licensing and patent strategies depend on continued patent prosecution, potential extensions, and monitoring of competing patents.
- Filing date advantage positions Eisai’s patent well into its validity horizon, providing sustained market exclusivity.
FAQs
Q1: What is the primary innovation protected by JP2016011309?
A1: The patent protects a class of novel chemical compounds with specific structural features and their therapeutic application, likely targeting CNS disorders or cancer.
Q2: How broad are the claims within this patent?
A2: The claims encompass a range of compounds characterized by a core structure with variable substituents, along with methods of treatment and formulations, offering significant coverage within the chemical class.
Q3: Can this patent be challenged or work around?
A3: While broad, the patent could be challenged if prior art demonstrates earlier invention or obviousness. Design-around strategies might involve modifying structural features outside the scope of claims.
Q4: How does this patent fit into Eisai’s global patent portfolio?
A4: It likely forms part of a strategic patent family, complemented by applications in other jurisdictions, consolidating patent rights in key markets.
Q5: What is the potential expiry of this patent, and how can rights be extended?
A5: Anticipated expiry is around 2034, with limited extensions possible via Japanese patent term adjustments, but extensions comparable to Supplementary Protection Certificates are limited in Japan.
References
- Japanese Patent Office (JPO). JP2016011309 patent publication.
- Eisai Co., Ltd. Corporate information and patent filing records.
