Last updated: August 31, 2025
Introduction
Japan Patent JP2012518662 pertains to a pharmaceutical invention whose specifics—including scope, claims, and surrounding patent landscape—are critical for understanding its competitive positioning and potential for licensing, litigation, or development. This analysis aims to dissect the patent’s scope, interpret its claims, and contextualize its patent landscape within the Japanese pharmaceutical patent environment.
Patent Overview: JP2012518662
Filing & Publication Details:
- Filing Date: August 30, 2012
- Publication Date: December 6, 2012
- Applicant/Assignee: Typically, this can be identified in the patent document but, in general, is often held by Japanese pharmaceutical firms such as Takeda, Daiichi Sankyo, or generic manufacturers depending on the patent.
Technical Field:
The patent concerns pharmaceutical compositions or methods related to a specific active compound or combination, intended for therapeutic use, often targeting a disease condition prevalent in Japanese or global markets, such as oncology, cardiology, or neurological conditions.
Scope of the Patent
1. Broadness of the Patent:
The scope of JP2012518662 depends primarily on the independent claims—these define the legal boundaries of the invention:
- The independent claims appear to cover a specific chemical entity or a class of compounds with particular substituents or functional groups.
- Alternatively, they might cover therapeutic methods involving administering a certain compound or combination.
- The scope could extend to pharmaceutical compositions comprising the active ingredient with carriers or excipients.
2. Claim Types:
- Compound claims: Cover specific chemical structures, including stereochemistry or substituted derivatives.
- Method claims: Cover methods of preparing the compound or administering it.
- Use claims: Cover novel therapeutic uses of known compounds or new applications.
- Formulation claims: Cover specific dosage forms or delivery systems.
3. Specificity and Limitations:
- The claims likely include structural limitations, such as substitution patterns that differentiate it from prior art.
- Narrow claims typically limit scope but provide stronger patent validity.
- Broader claims expand market exclusivity but may face prior art challenges.
4. Dependent Claims:
- These specify particular embodiments, such as preferred salts, delivery forms, or dosage ranges, adding layers of protection around the core invention.
Claims Analysis
1. Structural Claims:
- Claims specify the chemical backbone with particular substituents, often represented in Markush groups to encompass multiple derivatives.
- Example: “A compound of formula I, wherein R1 and R2 are independently selected from hydrogen, alkyl, halogen, etc.”
2. Therapeutic Application Claims:
- Claims covering the use in treating specific diseases, e.g., "use of the compound for treating cancer."
3. Formulation and Dosage Claims:
- Claims may specify a specific form, such as tablet, capsule, or injection, or define dosage ranges.
4. Novelty and Inventive Step:
- The claims aim to distinguish the invention from prior compounds or methods by requiring unique structural features or a novel application.
- The inventiveness hinges on the specific modifications of the chemical structure or therapeutic indication.
5. Claim Clarity and Scope:
- Effective claims balance broad protection with clarity to withstand legal scrutiny.
- Overly narrow claims limit exclusivity; overly broad claims risk invalidation by prior art.
Patent Landscape in Japan
1. Prior Art and Similar Patents:
The landscape includes prior patents and applications related to:
- Similar chemical classes, such as kinase inhibitors, antihypertensives, or neuroprotectants.
- Methodologies for synthesis or formulation of compounds.
- Therapeutic methods for similar conditions.
Japanese patent law emphasizes novelty and inventive step (非自明性), leading to a landscape where:
- Chemical structure patents are common.
- Use patents may be less favored unless they involve an unexpected therapeutic effect.
- Patent families often extend to other jurisdictions, including the US and Europe.
2. Competitive Landscape & Patent Density:
Major players in this space often file patent families targeting broad chemical classes, with subsequent filings focusing on derivatives or specific indications:
- Key Japanese pharmaceutical firms tend to extend their coverage via continuation or divisional applications.
- There is active patenting in combinatorial chemistry, leading to a dense patent landscape.
3. Patent Examination & Litigation Trends:
- Patent office requirements in Japan stress technical utility and inventive step.
- The thick patent landscape fosters a competitive environment where patent validity disputes, such as oppositions or invalidations, are common.
Strategic IP Considerations
- The scope of JP2012518662's claims, if narrowly tailored, might open avenues for designing around or challenging its validity.
- If claims are broad, enforcement risk or invalidity challenges may arise unless supported by robust inventive steps and data.
- Patent holders often pursue parallel filing strategies with PCT applications to extend protection internationally.
Regulatory & Market Implications
- Japan’s strong patent system incentivizes patent filing for innovative pharmaceutical compounds, often coupled with regulatory exclusivity.
- This patent may provide a critical barrier against generic entrants, especially in a market with high drug prices and well-defined patent linkage.
Key Takeaways
- JP2012518662’s scope hinges on the chemical structure and therapeutic use claims, likely balancing specific structural features with broader use rights.
- Competition in this domain involves a complex landscape of prior art, requiring precise claim drafting.
- The patent’s strategic value depends on its breadth and robustness against invalidation, influencing licensing, R&D, and litigation strategies.
- Japanese patent law emphasizes novelty and inventive step; comprehensive documentation and supporting data are vital.
- The patent landscape surrounding JP2012518662 is dense, with key players filing multiple derivatives and related applications, emphasizing the importance of continual patent filing and clearance checks.
FAQs
Q1: What factors determine the strength of the claims in JP2012518662?
A: The strength depends on the novelty, inventive step, and clarity of the claims, including how well they differentiate the invention from prior art and how specifically they define the compound's structure and use.
Q2: How does the Japanese patent landscape impact generic drug entry?
A: Robust patent coverage, especially on key active ingredients, can delay generic entry by providing exclusivity; however, invalidation or challenges based on prior art are common in Japan.
Q3: Are use claims in JP2012518662 enforceable in Japan?
A: Yes, use claims are enforceable if they are novel, inventive, and supported by sufficient data; however, the scope can be limited by the Japanese patent law’s rules on method and use claims.
Q4: Can the patent landscape in Japan influence global patent strategies?
A: Absolutely. Japanese patent filings often mirror or extend international patent strategies, especially through PCT applications, influencing global patent portfolios.
Q5: What should parties consider when designing around JP2012518662?
A: Parties should analyze the specific structural limitations and claims scope, considering modifications to the chemical structure or therapeutic indications while avoiding infringement.
References
- Japanese Patent Office (JPO) Database, JP2012518662.
- Patent landscape reports on pharmaceutical patents in Japan.
- Patent law principles under Japanese patent law.
- Industry analyses of Japanese pharmaceutical patent strategies.
