Issue #85, April 2026
WINDS FROM JAPAN
The Licensing Executives Society Japan
Issue #85 [PDF:990KB]
Message from the New President
By Shoei IMAI *
A New Chapter for LES Japan
I am deeply honored to serve as the 28th President of LES Japan. I would like to express my deepest gratitude to all of you for your ongoing participation, cooperation, and support for our activities.
Through active member interactions and practical seminars, LES Japan has consistently contributed to enhancing the strategic negotiation skills of our member organizations. I wish to pay my highest respects to my predecessors, and I am committed to upholding this long-standing and excellent tradition while striving for its further development.
Compared to other national and regional member societies of LES International, LES Japan is unique in that it has a large number of members from industry, in addition to lawyers, patent attorneys, and academia. This allows us to function as a platform where all major stakeholders in intellectual property, can engage collectively.
Reflecting on 44 Years: The Evolution of Japanese IP Strategy
Over the 44 years since graduating from university, I have dedicated my career to intellectual property within the corporate sector. My journey has mirrored the evolution of the field. From the 1980s through the early 2000s, Japanese companies were frequently confronted with massive licensing demands from overseas entities holding basic patents, and we were constantly preoccupied with navigating those challenges.
In the 2000s, disputes with Non-Practicing Entities (NPEs), often termed 'patent trolls,' became rampant. In response, particularly within the electronics industry, defendant companies collaborated to form Joint Defense Groups. These alliances fostered strong professional networks among litigation and licensing experts, which eventually served as a deterrent against disputes between Japanese companies themselves.
Subsequently, with the penetration of mobile phones, disputes surrounding Standard Essential Patents (SEPs) increased. Today, we see a more established framework for SEP handling, primarily shaped by developments in Europe and the United States. During this evolution, Japanese companies have also strengthened their positions by securing their own SEPs and successfully making the transition from licensees to licensors.
Today, the rapid evolution of AI (Artificial Intelligence) technology calls for a broader protection of intellectual property, encompassing data and copyright. However, legal frameworks are currently struggling to keep pace with these technological advancements. We are in a transitional period where your professional roles may undergo a significant transformation due to AI. I am committed to ensuring that LES Japan provides meaningful support to all our members during this time of change.
Upcoming Key Initiatives for 2026This fiscal year, we have several meetings scheduled as listed below. We are planning each one to be highly informative and of the highest quality. We look forward to your participation!
1. Joint Meeting with AIPLA (American Intellectual Property Law Association)
• Date & Time: Monday, April 13, 2026, from 3:00 p.m. to 5:00 p.m.
• Venue: Zen-Nittsu Kasumigaseki Building (Tokyo)
• Networking Reception: To be held at the JPAA (Japan Patent Attorneys Association) Hall Lounge following the meeting.
• Dates: Friday, July 10 and Saturday, July 11, 2026
• Venue: Hotel Nikko Nara (Nara City)
• Theme: "Future Woven by Eternal Wisdom"
• Details: This year’s conference will be held in Nara, home to the ancient capital of Heijo-kyo and a cornerstone of Japanese history. Amidst this timeless heritage, the local academic community continues to push the boundaries of cutting-edge technology, fostering a vibrant spirit of entrepreneurship.
Nara is also celebrated as the birthplace of Japanese sake. It is home to the "Sakadono" at Kasuga Taisha Shrine—the oldest sake brewery building in Japan—and Shoryakuji Temple on Mount Bodai, which bears a monument marking the "Birthplace of Japanese Sake." Following our successful gatherings in Niigata and Kanazawa over the past two years, Nara offers an equally impressive array of sake breweries for our members to enjoy.
With its excellent accessibility from both the Tokyo and Kansai metropolitan areas, we look forward to welcoming many members from Japan and overseas to this historic city!
3. LES APAC Conference 2026 Hosted by LES Korea
• Dates: October 25–26, 2026
• Location: Seoul, South Korea
• Details: LES Japan will actively support the LES APAC Conference 2026 by coordinating the dispatch of moderators and encouraging participation from our Japanese members. One of the core objectives of LES Japan is to foster exchange and coordination with other national and regional member societies. Moving forward, we are committed to further strengthening our ties and collaboration with other societies within the Asia-Pacific region.
Through these meetings, as well as our ongoing working group and committee activities, LES Japan is dedicated to providing a platform and network where our members can truly thrive.
The activities of LES Japan are only possible through your active participation, support, and cooperation. I humbly ask for your continued contribution and partnership in our shared endeavors.
Lastly, I am honored to lead LES Japan for the coming two years. I truly appreciate your support and look forward to a very productive term together!!!
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* President of LES Japan, Executive Director of Business Development, Taiyo, Nakajima & Kato
Patent Linkage in Japan Vol. 2:
2025 Updates and Two New Notifications from the MHLW
By Yasuko TANAKA *
Last time, we discussed fundamentals of Japan’s patent linkage (Vol. 1).
In this volume, I will introduce the 2025 updates to Japan’s patent linkage, including two new MHLW (Ministry of Health, Labour and Welfare) notifications.
In recent years, several issues have been identified in the operation of patent linkage in Japan.
One issue has been the absence of any official notification providing a legal basis for applying patent linkage to biologics (biosimilars). Another issue has been the lack of a clear mechanism for challenging regulatory decisions when a generic drug is not approved.
In particular, regarding the latter issue, a case in which a generic company, dissatisfied with a non-approval decision, filed a declaratory judgment action for non-infringement against the originator company—rather than the regulatory authority—had a significant impact on the industry.
Based on this background, the MHLW established a task force in mid-2024 and proceeded with a review of patent linkage. In October and November 2025, two notifications were issued.
Notification 1 (October 8, 2025):
001575895.pdf
This notification consolidates the three previous MHLW notifications that had served as the basis for patent linkage into a single framework, including both the First and Second Stages, and incorporates details previously provided separately. Notification 1 includes the following four items:
Item 1: Categories of originator drugs and patents subject to patent linkage
Categories of originator drugs include both small molecule drugs and biologics. Patents subject to patent linkage include substance and use patents, and “use” includes dose and dosage.
Item 2: Submission of originator patent information by generic applicants
Generic applicants shall confirm the originator’s substance and use patents and submit such information to the MHLW at the time of filing.
In addition, the applicant shall submit materials demonstrating that the generic drug can be marketed promptly after obtaining marketing approval (“MATERIALS”), either as part of the attachments to the marketing approval application or upon request by the MHLW or the PMDA (Pharmaceuticals and Medical Devices Agency). The “MATERIALS” include, for example, the following (a) to (d):
(a) Where it is demonstrated that the patent rights have expired: closed patent register, patent details, etc.
(b) Where it is demonstrated that the patent is invalid: decisions of invalidation trials, court judgments, etc.
(c) Where it is demonstrated that the patent is not infringed: court judgments, etc.
(d) Where it is demonstrated that consent has been obtained from the patentee or exclusive licensee: copies of agreements, letters of consent, etc.
Item 3: Prior Negotiation (Second Stage)
If a generic maker wishes to request drug pricing for an approved generic drug that may be subject to a patent dispute, it shall conduct prior negotiation with the originator company before the DPL (Drug Price Listing) and submit the results to the MHLW by the specified deadline.
Item 4: Pharmaceutical Patent Information Report (Info-Sheet)
The Info-Sheet may be submitted:
(i) before the expiration of the reexamination period of the originator drug; and
(ii) where a new patent is granted, within 30 days from the date of publication of the patent gazette.
Among these, the key updates are the explicit inclusion of biologics (biosimilars) within the scope of patent linkage under Item 1, and the use of court judgments to demonstrate non-infringement under Item 2(d).
Notification 2 (November 14, 2025):
001594987.pdf
This notification introduces, on a trial basis, a system in which external experts are involved in the patent linkage process (the “Expert Panel System”).
Products to which the Expert Panel System applies
The system applies to generic drugs (including biosimilars) under regulatory review that are designated by the Pharmaceutical Evaluation and Licensing Division of the MHLW.
Procedure
Both the generic company and the originator company are notified
Within 30 business days, both parties may submit materials (e.g., application dossiers, patent information, and infringement analyses) that they agree to share with the experts
Both parties declare any expert candidates with conflicts of interest
The MHLW selects experts (typically three) with no conflicts of interest and consults them regarding potential patent infringement
The experts prepare a written opinion within approximately 30 business days and submit it to the MHLW
The MHLW notifies both parties that the consultation process has concluded
After the final regulatory decision is made public, the MHLW discloses the expert opinion to requesting parties
Summary
With respect to Japan’s patent linkage system, which has been implemented de facto and has long been subject to various criticisms, the fact that the authorities have finally undertaken a formal review marks a significant first step. Of particular note in this reform are the explicit clarifications that biologics (biosimilars) fall within the scope of patent linkage, and that court judgments can be used to demonstrate non-infringement, and the trial introduction of the Expert Panel System.
The MHLW is still working on the reform and further refinements of the system are expected.
In the next volume, I will introduce litigation arising from issues related to patent linkage. Stay tuned!
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* Editor / Patent Attorney, S-Cube Corporation / S-Cube International Patent Firm
The Japan Patent Office’s AI Action Plan:
Transforming IP Examination through Artificial Intelligence
By Yoko NATSUME *
The Japan Patent Office (JPO) has established a comprehensive "Action Plan for the Utilization of Artificial Intelligence (AI) Technology" to modernize its administrative work through enhanced efficiency and quality. Since its initial publication in FY2017, the plan has evolved into a multi-year roadmap—most recently updated for FY2025—that systematically integrates AI into the core of patent, trademark, and design examination practices.
Patent Examination: Enhancing Prior Art and Classification
In patent administration, the JPO focuses on streamlining the high-volume tasks of classification and prior art searching.
Automated Classification: To better manage global technical literature, the JPO uses AI to predict domestic classification codes (such as FI and F-terms) for foreign patent documents. These Japanese classifications are significantly more granular and detailed than the International Patent Classification (IPC) system, allowing for much more precise document retrieval. By using machine-translated Japanese text as input, the system assigns these complex codes more efficiently than manual processing.
AI-Driven Keyword Estimation: To improve the quality of prior art searches, the JPO has introduced "Advanced Search" capabilities. This includes using AI to analyze the text data of the application under review to estimate and suggest useful keywords for creating search queries. By identifying pertinent technical terms automatically, the system helps examiners build more effective search strings.
Search Optimization: Other initiatives include "concept search" and "re-ranking" tools that sort documents based on their textual similarity to the application, ensuring that the most relevant prior art appears at the top of the search results. The JPO also applies image recognition to identify figures and drawings within patent documents that are highly relevant to the application being examined.
Generative AI Integration: Reflecting recent technological leaps, the FY2025 plan introduces a specialized project to apply Generative AI directly to patent examination workflows, moving beyond simple search tasks into more complex decision-support systems.
AI initiatives in the trademark domain prioritize identifying conflicting marks and categorizing goods and services accurately.
Graphic and Character Search: For graphic trademarks, the JPO employs an image search system that calculates similarity based on visual feature values. This system has been further refined by incorporating winning models from competitions among external AI developers. Additionally, the JPO is developing AI solutions for "character trademark searches" to identify marks with similar pronunciations, which is a critical aspect of relative examination.
Designated Goods and Services: To ensure consistency, AI tools assist examiners by matching applied-for goods and services against published examples and historical results. The system then suggests appropriate "similarity group codes," reducing the time required for manual verification.
Judging Distinctiveness: The JPO is also exploring AI's potential to assess the difficulty of judging a trademark’s distinctiveness, which could help in managing examination workloads more effectively.
Design examination relies heavily on the Prior Design Search project. This initiative utilizes advanced image search technology to compare the drawings of a new design application against a massive database of existing designs. The JPO continues to refine the accuracy of these visual comparisons through its agile development phase.
Strategic Implementation and MethodologyThe JPO adopts a structured lifecycle for these AI projects, moving from Proof of Concept (PoC) to an Agile Development Phase. This approach allows for continuous refinement based on real-world feedback from JPO staff. By actively involving its personnel in each phase, the JPO aims to accumulate internal expertise and maintain its position as a global leader in AI-driven intellectual property administration. The ultimate philosophy is to use AI as a sophisticated support mechanism, allowing examiners to focus on the high-level legal and technical judgments that define quality IP protection.
References:
・Tominaga, Yasunori, "Utilization of Artificial Intelligence Technology in Japan Patent Office Operations," Patent (Japan Patent Attorneys Association Journal), Vol. 75, No. 2, pp. 43–, 2022.
・Japan Patent Office (JPO), "Action Plan for Utilization of Artificial Intelligence (AI) Technology (FY2022–2026 Edition)," Project Team for Usefulness Verification of AI-related Technologies, June 24, 2022, available at: https://www.jpo.go.jp/ (accessed April 2, 2026).
・Japan Patent Office (JPO), "Background of the Development of the Action Plan for Utilization of Artificial Intelligence (AI) Technology (FY2022–2026 Edition)," Project Team for Usefulness Verification of AI-related Technologies, June 24, 2022, available at: https://www.jpo.go.jp/ (accessed April 2, 2026).
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* Editor / Patent Attorney, Ohchi International IP
Abolition of Seal Requirements in JPO Procedures
By Yoko NATSUME *
In practice, most procedures for foreign applicants can now be completed without seals or signatures, with only limited exceptions requiring additional formalities.
The above diagram outlines the Japan Patent Office’s (JPO) systematic review to reduce the requirement for affixing physical seals on official documents. The JPO evaluated a total of 797 types of administrative procedures, resulting in a significant shift toward modernization.
The vast majority—764 procedural types—no longer mandate a physical seal. This reform was implemented in phases: the requirement was lifted for 666 procedures (such as appointing an agent) in December 2020, followed by an additional 24 procedures in June 2021. Within this group, 74 procedures, primarily concerning international PCT applications, now require a signature rather than a seal due to international treaty obligations. The JPO also notes that voluntarily submitting a sealed document for these procedures remains acceptable.
For foreign applicants and owners, the practical impact is significant. In principle, neither a physical seal nor a handwritten signature is required for most procedures when filings are made through a representative (e.g., a Japanese patent attorney). For example, a power of attorney typically requires only the name of the signer, not the signature itself.
Conversely, the seal requirement is strictly retained for 33 procedural types. Governed by laws relating to patents, utility models, designs, and trademarks, these exceptions are maintained because they are particularly susceptible to forgery. Key examples include the transfer of rights and changes to an applicant’s or right holder’s name or address.
https://www.jpo.go.jp/e/resources/report/statusreport/2022/document/index/all.pdf P. 125
In these limited cases, where a signed document is submitted by a foreign party, the JPO requires confirmation of the authenticity of the signature. In practice, this is usually satisfied by the representative confirming the identity and intent of the relevant party and stating this confirmation in the filing (e.g., in the "Remarks" section). Although alternative methods such as notarization or submission of a signature certificate are available, representative-based confirmation is often used in practice as a practical alternative. It should be noted, however, that this approach places responsibility on the representative to conduct appropriate due diligence.
Reference:
・Japan Patent Office (JPO), "Changes in Procedures for Confirming Identification of Signature (Effective from January 1, 2022)" ＜Changes in Procedures for Confirming Identification of Signature (Effective from January 1, 2022) | Japan Patent Office＞ (accessed April 3, 2026).
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* Editor / Patent Attorney, Ohchi International IP
U.S. Issues WG of LES Japan Special Seminar
with Russell E. Levine, P.C., Kirkland & Ellis
By Dr. Yorikatsu HOHOKABE *
Seminar on February 26, 2026The LES Japan U.S. Issues Working Group consists of more than 30 members and meets every other month to study and discuss U.S. issues such as important U.S. court decisions and changes in practices in USPTO with focus on licensing and other aspects of intellectual property. On February 26, 2026, the group welcomed Mr. Russell E. Levine, P.C., partner at Kirkland & Ellis, a past member of the Board of LES International and a Past-President of LES USA and Canada, for his special seminar "Top 10 Court Decisions of the Year Affecting Licensing" covering court decisions from the year 2025. It was the fourth year in a row that the LES Japan U.S. Issues WG hosted this seminar. The topics discussed this year included potential issues associated with the scope of the following clauses and other aspects of patent license agreements:
An option to license a patent (aka a "Draft Pick") needs to be exercised before the patent is transferred.
Forum selection clauses need to be reasonable.
Mandatory forum selection clauses will be enforced.
Forum selection clauses aren’t always triggered.
Forum selection clauses can preclude ITC investigations.
Royalty payments were due even though the licensed patent wasn’t being used.
Tail royalties are payable unless the agreement expressly provides otherwise.
Terminating a license but not in accordance with the termination provision constitutes a breach of the license.
Licensee was allowed to recoup royalties paid under protest.
Continuations-in-part and continuations are widely understood to be different.
Going over the decisions with Mr. Levine’s insightful comments, the audience gained updated knowledge and was once again reminded of the importance of carefully reviewing the language when drafting and negotiating license agreements.
The 2026 Tokyo Marathon on March 1, 2026Following the seminar, Mr. Levine successfully ran the 2026 Tokyo Marathon for his consecutive four years’ run. He had received the six-star medal in 2023, completing all World Marathon Majors in Berlin, Boston, Chicago, London, New York and Tokyo. The 2026 Tokyo marathon was his 26th career marathon. All members of our WG wish him good luck on his continuing journey!
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* CLP, Director, Group Leader of U.S. Issues WG, LES Japan /
Senior Advisor, OBLON Gaikokuho Jimu Bengoshi Jimusho
2026 LES Japan Annual General Meeting
By Yasuo FUJII *
LES Japan held its Annual General Meeting on February 18, 2026, in Tokyo, Japan, followed by a post-meeting party.
At the beginning of the meeting, Ms. Chikako HASHIMOTO, then-President of LES Japan, delivered opening remarks, followed by a report on LES Japan’s activities in 2025, which included:
1) Annual Conference in Kanazawa
2) AIPLA and LES Japan Joint Meeting
3) Seminars
4) Licensing Training Courses
5) Working Group Activities
6) Publications
Subsequently, Mr. Shoei IMAI, the incoming President of LES Japan, explained the activity plans for 2026, emphasizing the following points:
1) Annual Conference: As a primary opportunity for mutual exchange among members to understand and share the latest IP trends, and as a platform to present LES Japan’s annual achievements, we will diligently plan and execute the conference to ensure it is a meaningful event.
2) International Cooperation: We will actively participate in LES International (LESI) events and foster exchanges with other societies. The YMC Asia Pacific members will hold a preliminary webinar leading up to a panel discussion in Dublin. Furthermore, we will cooperate with the LES Asia Pacific Conference to be held in Seoul on October 25th and 26th.
3) Enhancement of Member Benefits: To increase member value and promote the future of LES Japan, we will continue discussions from last year regarding the establishment of a corporate membership system and drive the planning and implementation of related measures.
4) Support for Committees and Working Groups: We will promote active engagement and the dissemination of results from the various committees that support LES Japan’s activities and the working groups responsible for diverse research and study projects.
5) Educational Seminars: We will continue to provide opportunities for training and research by diligently organizing monthly seminars and licensing practice courses.
Finally, the selection of the following new Officers was approved: Mr. Shoei IMAI as President, Ms. Tomomi FUJITA as President-Elect, Mr. Kazushi TAKEMOTO, Mr. Motohiro UNO, and Mr. Miki GOTO as Vice-Presidents, and Mr. Kenji TOSAKI, Ms. Serina MATSUDA, Mr. Masahiko KINOMOTO, Mr. Seiji NISHIUCHI, Mr. Satoshi MATSUO, and Mr. Hiroyuki TAMURA as Board Members.
Just after the meeting concluded, Mr. Shinya HONDO, the Chair of the organizing committee, announced that the 2026 LES Japan Annual Conference will be held on July 10th and 11th in Nara.
The post-meeting party commenced with a welcome address by Mr. Shoei IMAI, the new President of LES Japan. Next, guests of honor Mr. Yasuyuki KASAI, Commissioner of the Japan Patent Office, and Mr. Minoru MASUDA, Chief Judge of the Intellectual Property High Court, delivered congratulatory remarks. Subsequently, Ms. Junko SUGIMURA, Former President of LES Japan and Former Vice-President of LESI, offered a toast. Following the toast, members enjoyed networking in a friendly atmosphere.
The party was concluded with remarks by Mr. Kenichi NAGASAWA, Former President of LES Japan, honoring Ms. Chikako HASHIMOTO for her contributions during her tenure.
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* Editor / Patent Attorney, Haruka Patent & Trademark Attorney
Save the Date:
LES Japan Annual Conference 2026 in Nara
Please mark your calendars! The 2026 LES Japan Annual Conference will be held in Nara, the ancient capital of Japan, and is scheduled for July 10th and 11th.
This year’s conference will be a wonderful opportunity for networking and professional development in a beautiful and historic setting. Stay tuned for more information on registration and the event program!
Editors’ Note
This issue includes articles "Message from the New President" by Shoei IMAI, "Patent Linkage in Japan Vol. 2: 2025 Updates and Two New Notifications from the MHLW" by Ms. Yasuko TANAKA, "The Japan Patent Office’s AI Action Plan: Transforming IP Examination through Artificial Intelligence" and "Abolition of Seal Requirements in JPO Procedures" by Yoko NATSUME, "U.S. Issues WG of LES Japan Special Seminar with Russell E. Levine, P.C., Kirkland & Ellis" by Dr. Yorikatsu HOHOKABE, and "2026 LES Japan Annual General Meeting" by Yasuo FUJII.
Thank you for supporting “WINDS from Japan.” This newsletter will continue to provide you with useful information on activities at LES Japan and up-to-date information on IP and licensing activities in Japan.
If you would like to refer to any back issues of our newsletters, you can access them via the following URL: https://www.lesj.org/en/winds/backnumber/
WINDS from Japan
Editorial Board Members, 2026
Editor in Chief : Yasuo Fujii
Editors : Shoichi Okuyama; Junichi Yamazaki; Kei Konishi; Naoki Yoshida; Mitsuo Kariya;
Takao Yagi; Yoko Natsume; Dennis M. Hubbs;
Yasuko Tanaka, Koichiro Yamashita
