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      • Combination Products, Combination Medical Devices, Kit Products, Combination Drugs
    • Medical Device, IVD >
      • IVD, LDT, RUO
      • DMAH: Designated Marketing Authorization Holder-Summary Ver.
      • DMAH: Designated Marketing Authorization Holder
      • Combination Products, Combination Medical Devices, Kit Products, Kit Components, Assortment Products
      • How to determine if a product is a medical device
      • medical device classification for combined products
      • medical device class
      • how to confirm JMDN of medical device
      • medical device & IVD reimbursement-Summary Ver.
      • medical device & IVD reimbursemenet
      • insurance reimbursement for SaMD
      • Comparison of Medical Device Definitions: Japan, US, & EU
      • Companion Diagnostics and Gene Panel Testing
    • Pharmaceutical, regenerative medicine >
      • How to determine if a product is a Pharmaceutical Drug
      • Advanced Medical Care System
      • Over-The-Counter (OTC) Drug
      • References on Reimbursement (Cost Calculation) for Regenerative Medical Products
    • Healthcare & Caretech Products >
      • guidance for non medical services
      • Therapeutic Orthoses and Assistive Devices
      • Cosmetics and Quasi-Drugs
      • Overseas Expansion of Non-Medical Device Products as Medical Devices: Learning from the Case of PARO
    • Funding, Partnering & Networking >
      • Utilization of Public Grants and Subsidies
      • J-Ships
      • Partnering
    • Intellectual Property >
      • patent or trade secret?
      • employee invention
      • Matching of Patents Held by Startups and Individuals
    • Legal & Contracts >
      • References for Contracts
      • Guide to Industry-Academia Collaboration Agreements for Academic Researchers
    • Academia & Tech Transfer
    • Licensing, partnering >
      • Introducing Seeds to Pharmaceutical Companies
      • Incentives (Returns) to Licensor Universities
    • References in English
  • コンテンツ一覧
    • 事業設立・運営 >
      • 法人設立
      • ライフサイエンスハブ、スタートアップハブ
    • 公的支援 >
      • 公的支援機関リスト
      • 大学発スタートアップ支援機関・プログラムガイド
      • AMED Medical IP Desk
      • MEDISO活用のススメ
    • 薬事・規制関連 >
      • PMDA RS相談活用のススメ
      • 薬事スタッフ・コンサル選定ガイド
      • 都道府県薬務課一覧
      • コンビネーション製品、組合せ医療機器、キット製品、組合せ医薬品
    • 医薬品、再生医療等製品 >
      • 医薬品の該当性確認方法
      • 医薬品一般的名称設定のガイドライン
      • 医薬品、医療機器等の開発に当たって、参照したい資料
      • 先進医療制度
      • 一般用医薬品(OTC)
      • コンパニオン診断薬と遺伝子パネル検査
      • 再生医療等製品の保険償還(原価計算)に関する参考情報
    • 医療機器、体外診断用医薬品 >
      • 体外診、ラボ開発検査、研究用試薬
      • 医療機器該当性確認ガイド
      • 医療機器と非医療機器の機能が複合した製品は?
      • 医療機器の一般的名称と確認方法
      • 医療機器のクラス分類
      • 医療機器・体外診の保険収載
      • SaMDの保険収載
    • ヘルスケア・ケアテック >
      • 非医療分野の検査サービスを展開する際に注意すべきポイント
      • 治療用装具と補装具
      • 化粧品及び医薬部外品
      • 医療機器とするか、非医療機器とするか
    • 資金調達 >
      • 公的な助成金、補助金の活用
      • 特定投資家向け銘柄制度(J-Ships)
      • パートナリング
      • アカデミア研究者がPIとして応募可能なグラントリスト
      • 海外在住の日本人研究者が日本の助成金を獲得する方法
    • 知的財産 >
      • 特許か?営業秘密か?
      • 職務発明:アカデミア・公的研究機関に所属する研究者が注意すべきポ
      • スタートアップや個人が保有する特許のマッチング
      • ライセンスを受けた大学へのインセンティブ(還元)について
    • 法務・契約 >
      • 契約関連で参考になる公的機関の資料
      • 個人情報を利用する製品開発時の 留意すべき法規制
    • アカデミア、技術移転 >
      • アカデミア研究者のための産学連携契約ガイド
    • ライセンシング、パートナリング >
      • 製薬企業等へのシーズ紹介
    • 海外展開 >
      • 米国展開(主に医療機器)に、読むと役立つ情報リスト
      • 米国FDAにおける、医療機器該当性の確認ステップ
      • 米国における、医療機器の申請データ・試験計画の相談方法((Pre-Submission/Q-Submission
      • 公的機関の海外展開支援
      • 横浜市の公的支援サービス
      • JETROを徹底活用しよう
      • 日米欧での医療機器定義の比較
      • 簡略審査(審査の迅速化)
      • 海外規制等の情報収集
      • 非医療機器製品の海外での医療機器展開
    • オーストラリア >
      • オーストラリア研究開発優遇税制の概要
      • オーストラリア研究開発優遇税制の適用を受けるには
      • オーストラリアでの主要イベント
      • R&D関連の公的機関
      • オーストラリア助成金情報

Overview of Employee Inventions

Inventions made at academia/research institutions are almost always employee inventions (where the rights holder is the institution, not the individual). This document summarizes the key points to be aware of.

Please note: This content is mainly for a Japanese audience and has been machine translated. Please refer to the original Japanese for accuracy. For overseas firms, doing business in Japan typically requires Japanese-speaking staff or local support.
@K.Kamitani

Table of Contents

  • What are Employee Inventions?
  • Initial Ownership
  • Reasonable Remuneration
  • Key Points for Researchers
  • Flow from Invention to Application
  • Utilizing TLOs
@K.Kamitani

What are Employee Inventions?

An "employee invention" is defined under Article 35 of the Patent Act as an invention that meets all three of the following requirements. Most inventions in universities and public research institutions fall into this category.

  • 1. Invention by an Employee, etc.:
    The invention was made by an employee of a university, a researcher at a public institution, or a similar personnel.
  • 2. Within the Employer's Scope of Business:
    The nature of the invention falls within the scope of the research and educational activities of the affiliated university or institution.
  • 3. Related to the Employee's Duties:
    The act of creating the invention pertains to the researcher's present or past duties (e.g., research theme, assigned tasks).
Reference: Guidelines based on Article 35, Paragraph 6 of the Patent Act, Japan Patent Office
https://www.jpo.go.jp/support/startup/document/index/shokumuhatsumeiseido.pdf
@K.Kamitani

Initial User Ownership

The 2015 amendment to the Patent Act allows institutions to clearly adopt an "initial user ownership" model. By stipulating in advance in regulations, etc., the institution can directly acquire the rights to an invention from the moment of its creation. This provides clear and stable ownership, and most universities and research institutions have adopted this model.

Reference: Application of Article 35, Paragraph 3 of the Patent Act in Universities, etc., Japan Patent Office
https://www.jpo.go.jp/system/patent/shutugan/shokumu/document/shokumu_university/11.pdf
@K.Kamitani

Reasonable Remuneration

In return for the institution acquiring the rights to an invention, the law guarantees the inventor the right to receive "reasonable remuneration."

Types of Remuneration

While many companies offer only a one-time payment of a few hundred dollars, some academic and research institutions have systems for distributing a portion of licensing income to inventors as "compensation" or royalty sharing. Be sure to check your institution's regulations.

@K.Kamitani

Key Points for Researchers

Disclosure of Invention

If you have made an employee invention, you typically file an invention disclosure with your institution's IP division. Be aware that publishing a paper first will result in a loss of novelty.

Researcher Mobility (Job Change)

When a researcher moves to a new institution, the handling of an invention is, in principle, based on the rules of the institution where the invention was completed. However, issues can arise if most of the research was conducted at the previous institution, so caution is advised.

Reference: Basic Guidelines for Handling Research Outcomes with Researcher Mobility, Cabinet Secretariat
Issues and Proposals Concerning the Attribution of Intellectual Property with Researcher Mobility, Kyoto University

Conflict of Interest Management

When starting a business based on an employee invention, a potential conflict between the researcher's personal interests and the institution's interests may arise. It is essential to follow institutional rules, consult with the conflict of interest committee, and manage the situation appropriately.

Reference: Basic Approach to Conflicts of Interest in Universities, etc., MHLW

Joint Research with Companies

When conducting joint research with companies or other institutions, it is crucial to conclude an agreement *before* starting the research, clearly defining the following points:

  • Scope of existing IP brought by each party
  • Ownership of newly created inventions
Reference: Open Innovation Portal Site, Japan Patent Office
@K.Kamitani

Flow from Employee Invention to Application

This is the general process when a researcher makes an invention.

STEP 1

Disclosure of Invention

When an invention is completed, the researcher promptly reports it to the head of the institution through their supervisor.

→
STEP 2

Decision on Rights Assignment

The institution, through an invention committee, decides whether to take ownership of the rights to the invention and notifies the researcher.

→
STEP 3

Patent Application

If the institution decides to take ownership, it proceeds with the patent application process.

Reference: Regulations on Employee Inventions at National Testing and Research Institutes of the MHLW (Articles 4, 5, 6), MHLW
https://www.mhlw.go.jp/hourei/doc/hourei/H160401K0020.pdf
@K.Kamitani

Consult with the IP Division (TLO)

Universities and research institutions have IP divisions within their industry-academia collaboration departments (TLOs). In some institutions, filing an invention disclosure triggers the assignment of a TLO representative to provide support. For all IP matters, it is best to first consult with your institution's IP division (TLO).

Reference: University Technology Transfer (TLO), Ministry of Economy, Trade and Industry
https://www.meti.go.jp/policy/innovation_corp/tlo.html
@K.Kamitani
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  • Home
    • English Top
    • 日本語トップ
  • Table of Contents (English)
    • Business Setup & Operations >
      • Startup Visa
      • setup corporation, office in Japan
      • Company establishment
      • Life Science Hub, Startup Hub
    • Public Support >
      • List of Public Support Organizations
      • Public Support in Yokohama city
      • Academia-Based Startup Support Guide
      • Mediso free consultation service
    • Regulatory & Compliance >
      • PMDA consultation
      • regulatory considerations when using person infformation
      • Guide to Selecting Regulatory Affairs Staff and Consultants
      • Expedited Review Systems for Pharmaceuticals
      • Guidelines for Establishing Generic Drug Names
      • Combination Products, Combination Medical Devices, Kit Products, Combination Drugs
    • Medical Device, IVD >
      • IVD, LDT, RUO
      • DMAH: Designated Marketing Authorization Holder-Summary Ver.
      • DMAH: Designated Marketing Authorization Holder
      • Combination Products, Combination Medical Devices, Kit Products, Kit Components, Assortment Products
      • How to determine if a product is a medical device
      • medical device classification for combined products
      • medical device class
      • how to confirm JMDN of medical device
      • medical device & IVD reimbursement-Summary Ver.
      • medical device & IVD reimbursemenet
      • insurance reimbursement for SaMD
      • Comparison of Medical Device Definitions: Japan, US, & EU
      • Companion Diagnostics and Gene Panel Testing
    • Pharmaceutical, regenerative medicine >
      • How to determine if a product is a Pharmaceutical Drug
      • Advanced Medical Care System
      • Over-The-Counter (OTC) Drug
      • References on Reimbursement (Cost Calculation) for Regenerative Medical Products
    • Healthcare & Caretech Products >
      • guidance for non medical services
      • Therapeutic Orthoses and Assistive Devices
      • Cosmetics and Quasi-Drugs
      • Overseas Expansion of Non-Medical Device Products as Medical Devices: Learning from the Case of PARO
    • Funding, Partnering & Networking >
      • Utilization of Public Grants and Subsidies
      • J-Ships
      • Partnering
    • Intellectual Property >
      • patent or trade secret?
      • employee invention
      • Matching of Patents Held by Startups and Individuals
    • Legal & Contracts >
      • References for Contracts
      • Guide to Industry-Academia Collaboration Agreements for Academic Researchers
    • Academia & Tech Transfer
    • Licensing, partnering >
      • Introducing Seeds to Pharmaceutical Companies
      • Incentives (Returns) to Licensor Universities
    • References in English
  • コンテンツ一覧
    • 事業設立・運営 >
      • 法人設立
      • ライフサイエンスハブ、スタートアップハブ
    • 公的支援 >
      • 公的支援機関リスト
      • 大学発スタートアップ支援機関・プログラムガイド
      • AMED Medical IP Desk
      • MEDISO活用のススメ
    • 薬事・規制関連 >
      • PMDA RS相談活用のススメ
      • 薬事スタッフ・コンサル選定ガイド
      • 都道府県薬務課一覧
      • コンビネーション製品、組合せ医療機器、キット製品、組合せ医薬品
    • 医薬品、再生医療等製品 >
      • 医薬品の該当性確認方法
      • 医薬品一般的名称設定のガイドライン
      • 医薬品、医療機器等の開発に当たって、参照したい資料
      • 先進医療制度
      • 一般用医薬品(OTC)
      • コンパニオン診断薬と遺伝子パネル検査
      • 再生医療等製品の保険償還(原価計算)に関する参考情報
    • 医療機器、体外診断用医薬品 >
      • 体外診、ラボ開発検査、研究用試薬
      • 医療機器該当性確認ガイド
      • 医療機器と非医療機器の機能が複合した製品は?
      • 医療機器の一般的名称と確認方法
      • 医療機器のクラス分類
      • 医療機器・体外診の保険収載
      • SaMDの保険収載
    • ヘルスケア・ケアテック >
      • 非医療分野の検査サービスを展開する際に注意すべきポイント
      • 治療用装具と補装具
      • 化粧品及び医薬部外品
      • 医療機器とするか、非医療機器とするか
    • 資金調達 >
      • 公的な助成金、補助金の活用
      • 特定投資家向け銘柄制度(J-Ships)
      • パートナリング
      • アカデミア研究者がPIとして応募可能なグラントリスト
      • 海外在住の日本人研究者が日本の助成金を獲得する方法
    • 知的財産 >
      • 特許か?営業秘密か?
      • 職務発明:アカデミア・公的研究機関に所属する研究者が注意すべきポ
      • スタートアップや個人が保有する特許のマッチング
      • ライセンスを受けた大学へのインセンティブ(還元)について
    • 法務・契約 >
      • 契約関連で参考になる公的機関の資料
      • 個人情報を利用する製品開発時の 留意すべき法規制
    • アカデミア、技術移転 >
      • アカデミア研究者のための産学連携契約ガイド
    • ライセンシング、パートナリング >
      • 製薬企業等へのシーズ紹介
    • 海外展開 >
      • 米国展開(主に医療機器)に、読むと役立つ情報リスト
      • 米国FDAにおける、医療機器該当性の確認ステップ
      • 米国における、医療機器の申請データ・試験計画の相談方法((Pre-Submission/Q-Submission
      • 公的機関の海外展開支援
      • 横浜市の公的支援サービス
      • JETROを徹底活用しよう
      • 日米欧での医療機器定義の比較
      • 簡略審査(審査の迅速化)
      • 海外規制等の情報収集
      • 非医療機器製品の海外での医療機器展開
    • オーストラリア >
      • オーストラリア研究開発優遇税制の概要
      • オーストラリア研究開発優遇税制の適用を受けるには
      • オーストラリアでの主要イベント
      • R&D関連の公的機関
      • オーストラリア助成金情報