Thematic-based: Legal Practice in the Healthcare Business

Chapter 1 Healthcare and M&A

Chapter 2 Healthcare and Patents

Chapter 3 Healthcare and Licensing

Chapter 4 Healthcare and Product Liability/Recall

Chapter 5 Healthcare and the Anti-monopoly Act

Chapter 6 Healthcare and Compliance with Laws and Regulations

Please see further details on this book at the website of CHUOKEIZAI-SHA HOLDINGS, INC.: Here

Authors： Hirotake Tanaka Toshiya Furusho Takashi Koyama Takashi Hirose Yugo Komori Kosuke Yoshimura Shingo Yamada Yuki Kuroda
Publisher：CHUOKEIZAI-SHA HOLDINGS, INC.
Practice： Protection of Personal Information Research and Development Marketing Regulation Labelling and Advertising regulation Dispute Resolution Crisis Management M&A Cosmetics & Health/Beauty Care Products Intellectual Property Transactions Unfair Competition Intellectual Property Dispute Resolution Competition/Consumer Protection Compliance
Date of publication： July 28, 2023

Other publications by Hirotake Tanaka

2023.08.08
Bankruptcy of a Party that Agreed to Resolve Disputes through Arbitration Proceedings
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A Case in Which the Right of Avoidance was Held to be Established with Respect to a Notice of Shortfall in So-called “Kizoku-seisan (Liquidation of Security While Retaining Ownership)” (Judgment by the Osaka District Court on December 20, 2019)
2020.08.11
Points to Consider for Open Innovation from the Perspective of Insolvency Law (Referring to a Joint R&D Agreement with a Start-up)
2020.03.10
Bankruptcy of Licensor and the Consequences for License Agreements
2019.12.10
Various Aspects of the US Bankruptcy Law #6 –Validity of Contract Termination on the Basis of “Filing Bankruptcy”
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Various Aspects of the US Bankruptcy Law #5 –Venue for Chapter 11 filings
2019.06.11
Various Aspects of the US Bankruptcy Law #4 –Can Receivables be Collected through Offsetting?
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Various Aspects of the US Bankruptcy Law #3 – Automatic Stay Ⅱ
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FAQ on Investments in Medical Organizations
2018.12.11
Various Aspects of the US Bankruptcy Law #2 – Automatic Stay I
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Various aspects of US Bankruptcy Law #1 - How bankruptcy is viewed differently in Japan and the United States
2015.12.15
Commentaries on the Bankruptcy Act (Vol. 1)
2014.02.25
New Approach for the Use of Corporate Reorganization Proceedings – The case in which, after having been shifted from a civil rehabilitation case to a bankruptcy case, the bankruptcy trustee filed a petition to commence corporate reorganization proceedings and, under such corporate reorganization proceedings, the trustee successfully formed an agreement with secured creditors and disposed the building built on leased land, including completed parts of construction (concrete basement and the like) thereof

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Other publications by Toshiya Furusho

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JAPAN: An Introduction to Intellectual Property: Bengoshi
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The Intellectual Property and Antitrust Review 5th edition Japan Part
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International Legal Practice
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Supreme Court Decision on the Fifth Requirement of the Doctrine of Equivalents - DKSH Japan K.K. et al. v. Chugai Pharmaceutical Co. Ltd. (the "Maxacalcitol Case")
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Unfair Competition
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Other publications by Takashi Koyama

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Dictionary of Contract Terms (Revised Edition)
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Business and IP commitments in Economic Partnership Agreements (EPAs)
2017.05.01
JAPAN Section/Protection and Disclosure of Trade Secrets and Know-How
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The Existence of a “Dispute” and the Prima Facie Test for a Tribunal to Have Jurisdiction
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Handbook on Joint Research and Development Agreement
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Reading of U.S. Supreme Court Cases: Commentary on Intellectual Property and Business Cases in the 21st Century
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Indirect Expropriation, Fair and Equitable Treatment Obligations, and Valuation Standards and Methods of Damages under CAFTA
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Dictionary of Contract Terms
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Intellectual Property Commitments in Japan's Economic Partnership Agreements (EPAs)
2010.01.01
Negotiations regarding Intellectual Property in Economic Partnership Agreements (EPAs), [1] - [9]
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Other publications by Takashi Hirose

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The Revised Civil Code and Practices on Insurance Business
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Other publications by Yugo Komori

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Extraterritorial Application of U.S. Cartel Regulations
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Cartel Regulation and State of Enforcement in Foreign Countries
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The Supreme Court Disallowed the Deletion of Google's Search Results
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Information Disclosure Requirements in the U.S. Healthcare Industry (under the U.S. Sunshine Act)
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2022.01.21
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2022.01.21
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2022.09.27
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The Legal 500 Country Comparative Guides - Japan CARTELS
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Antimonopoly Act Consultation Handbook
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2021.11.20
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2021.11.01
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2021.05.15
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2021.05.10
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2021.04.15
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2021.03.01
COVID-19 and Corporate Legal Affairs – Legal Issues during/after COVID-19
2021.02.15
[Series] E-Commerce Practices (No.6): Points to Keep in Mind regarding Application and Amendment of Terms and Conditions
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Special Topic: A Commentary on the Impact on Practices of the Judgment Rendered by the Tokyo High Court on November 5, 2020 on the Terms of Use ーFrom the Perspective of Business Practices under Consumer Laws (i.e. Business Operators’ Side)
2020.12.15
[Series] E-Commerce Practices (No. 5): Points to Note in Drafting Terms and Conditions (5)
2020.11.20
Corporate Compliance on Utilization of External Human Resources - Intersection of Antimonopoly Act and Employment Law
2020.11.15
[Series] E-Commerce Practices (No. 4): Points to Note in Drafting Terms and Conditions (4)
2020.11.11
Gun-jumping Rule and Examples of Enforcement Outside of Japan
2020.10.31
Practical Guide to the 2016 and 2019 Antimonopoly Act Amendments
2020.10.23
Flash Report on Anti-Monopoly Case: Justification of Voluntary Restrictions by Trade Associations Based on their Purposes and Methods ― Announcement of the JFTC on June 23, 2020
2020.10.21
The Eight Key Points that Should be Immediately Disseminated to Main Subcontracting Entrepreneurs - Compliance with the Subcontract Act and the Trends of the Anticipated Law Enforcement during the COVID-19 Pandemic (Business Homu, December 2020)
2020.10.15
[Series] E-Commerce Practices (No. 3): Points to Note in Drafting Terms and Conditions (3)
2020.09.25
Reduction System for Cooperation in Investigation
2020.09.15
[Series] E-Commerce Practices (No. 2): Points to Note in Drafting Terms and Conditions (2)
2020.08.21
Viewpoints in Reviewing Competition Law Compliance Systems at Companies
2020.08.15
[Series] E-Commerce Practices (No. 1): Points to Note in Drafting Terms and Conditions (1)
2020.06.27
Lawyers' Knowledge on Competition Law Practice
2020.04.25
Recent Developments Concerning the Subcontract Act and Points to Note in Terms of Compliance
2019.10.21
DOJ Dawn Raid Preparation and Response Checklist (Part 2) ~Contemplating Compliance Programs for Global Corporations based on Overseas Practice of Competition Laws~
2019.10.07
[Expert Analysis] Digital Platforms Must Heed Japanese Antitrust Law Updates
2019.09.21
DOJ Dawn Raid Preparation and Response Checklist (Part 1) ~Contemplating Compliance Programs for Global Corporations based on Overseas Practice of Competition Laws~
2019.07.01
To Operate a Business Properly - A Review of the Key Points of the Anti-Monopoly Act
2019.07.01
Points to Note in Employing Freelancers from the Perspective of the Anti-Monopoly Act and the Subcontract Act
2019.04.01
Competition Law Compliance Program for Companies Diversifying Globally
2019.03.01
Schmidt's Deodorant Company (Natural Deodorant Products), Report #6127, NAD/CARU Case Reports (10/27/2017) - A Case Study where Advertising Claims based on General Customers' Reviews were Found Inappropriate in the US -
2019.02.01
Introduction of the Commitment Procedure under the Anti-Monopoly Law
2018.10.03
Points to Note in the Consumer Contract Act Amended in 2018 and Measures Required of Corporations
2018.04.21
A Textbook for First-Year Legal Department Staff and In-house Lawyers – The Subcontract Act and the Antitrust Law
2017.10.25
Special Dialogue:Measures for the Changing Competition Environment – Clarification of the Safety Zone
2017.07.10
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2015.03.01
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2013.01.01
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2023.07.06
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2023.04.03
Handling of Personal Data in the “Metaverse”
2022.07.26
Standard Agreement on the Extraterritorial Transfer of Personal Information
2022.07.12
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2022.07.04
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2022.03.14
A Few Key Points of the China Personal Information Protection Law
2021.12.22
Personal Information Protection Law of China (2) – Processing of Personal Information and Consent by the Data Subject -
2021.11.24
Measures on Security Assessment of Cross-Border Data Transfers (Draft for Comment) - Basic Points to Note -
2021.11.15
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2021.10.15
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2021.09.15
[Series] E-Commerce Practices （Points to Note in Drafting Terms and Conditions.etc.） (No. 10) :Points to Note regarding Personal Data Protection (1)
2021.04.01
It is not Too Late to Learn: Cookie Compliance
2021.03.01
Corporate Governance and Internal Investigations in Europe (3) – Protection of Whistleblowers
2021.03.01
Corporate Governance and Internal Investigations in Europe (2) – Protection of Personal Data
2021.03.01
Corporate Governance and Internal Investigations in Europe (1) - Overview
2021.03.01
COVID-19 and Corporate Legal Affairs – Legal Issues during/after COVID-19
2017.04.01
Decision by the Third Petty Bench of the Supreme Court on January 31, 2017 and “Right to be Forgotten”

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Other publications about Research and Development

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2022.02.21
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2022.01.21
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2021.11.24
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2021.10.28
Legal Affairs for Chinese Life Sciences and Healthcare (Part 3) – Approaching the implementation of China GVP (Good Pharmacovigilance Practice) (effective from December 1, 2021) (2)
2021.09.30
Legal Affairs for Chinese Life Sciences and Healthcare (Part 2) –Approaching the implementation of China GVP (Good Pharmacovigilance Practice) (effective from December 1, 2021) (1)
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Other publications about Crisis Management

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2023.08.24
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2022.03.20
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2022.01.21
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Other publications about Cosmetics & Health/Beauty Care Products

2023.08.24
Thematic-based: Legal Practice in the Healthcare Business
2023.02.27
China’s Life Science and Healthcare-No.3 Amendment of the Regulations on Cosmetics in China
2023.01.20
Legal Affairs for Chinese Life Sciences and Healthcare No.15: System of the Person Responsible for the Production Safety (Safety Officer) of Food and Food-related Products in China
2022.07.04
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2022.05.26
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2022.04.27
Legal Affairs for Chinese Life Sciences and Healthcare (Part 9) - [Subsidiary Regulations on Administrative Measures for Monitoring of Adverse Reactions to Cosmetics] Overview
2022.03.24
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A Legal Review of China’s Life Sciences and 2 Healthcare- No.1 －General Introduction and MAH System
2022.02.21
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2022.01.21
Legal Affairs for Chinese Life Sciences and Healthcare (Part 5) - Amendment to the Cosmetic Supervision and Administration Regulation for the First Time in 30 Years, and the Subsidiary Regulations on Administrative Measures for Cosmetic Registration, the Subsidiary Regulations on Administration Measures for Cosmetics Manufacture and Operation and the GMP for Cosmetics (1)
2021.11.24
Legal Affairs for Chinese Life Sciences and Healthcare (Part 4) – Developments in Amendment of Regulations Concerning Wholesaling/Retailing of Pharmaceutical Products, Etc. (Measures on Supervision and Control of the Drug Business and Usage Quality (Draft for Comment))
2021.10.28
Legal Affairs for Chinese Life Sciences and Healthcare (Part 3) – Approaching the implementation of China GVP (Good Pharmacovigilance Practice) (effective from December 1, 2021) (2)
2021.09.30
Legal Affairs for Chinese Life Sciences and Healthcare (Part 2) –Approaching the implementation of China GVP (Good Pharmacovigilance Practice) (effective from December 1, 2021) (1)
2021.08.30
Legal Affairs for Chinese Life Sciences and Healthcare

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Other publications about Intellectual Property Transactions

2024.09.27
Some Legal Issues Concerning the Use of Copyrighted Works in the Development and Learning Phases of Generative AI
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Judgment in Which the Court Determined Whether or Not the Relevant Act Constitutes an Indirect Infringement by a Non-Exclusive Article (Item 2, Article 101 of the Patent Act) Pertaining to Invention of a Product- Requirements for Indirect Infringement by Non-Exclusive Article -
2024.04.10
Foreign Filling Restrictions of Major Countries －Mechanisms to Restrict Foreign Filing of Sensitive Inventions－
2023.11.20
Inventions Made Across Boarders and the Attachment Foreign Filling Restrictions: Conflicts in the Restrictions and How They Are Handled
2023.08.24
Thematic-based: Legal Practice in the Healthcare Business
2023.05.20
Japan M&A - Key Intellectual Property Issues in M&A Transactions -
2023.04.03
Avatarization of Celebrities and Contractual Practices in the Metaverse
2023.02.28
National Comparison Tables - Japan part
2022.12.16
JAPAN: An Introduction to Intellectual Property: Bengoshi
2022.10.03
Protection of Image Designs and Spatial Designs - Status and Practical Response after the 2019 Amendment to the Design Law
2022.07.15
The Intellectual Property and Antitrust Review 7th edition Japan Part
2022.05.18
Japan M&A - Key Intellectual Property Issues in M&A Transactions -
2022.03.11
A study of the secret patent systems of various countries, and the introduction of the same system in Japan (No.2)(end)
2022.03.01
Summary of Countermeasures for Counterfeit Products in the US
2022.02.17
NFT Mechanism and Legal Issues of NFT Transactions
2022.02.14
A study of the secret patent systems of various countries, and the introduction of the same system in Japan (No.1)
2022.02.04
A Case in Which the Applicability of Article 3, Paragraph 1, Item 3 of the Trademark Act was Disputed with Respect to the Trademark “VEGAS” (Intellectual Property Newsletter (2022 February Issue))
2022.01.12
Subject Matter of License and “Implied License” under Patent License Agreements Written in English
2021.12.23
Latest Developments in the Japanese Patent Practice
2021.12.01
A Detailed Explanation of Economic Partnership Agreements
2021.10.01
Obligation to Conclude Multilateral Treaties in the Field of Intellectual Property through FTA/EPA - Efforts to Strengthen Protection of Rights and to Achieve International Harmonization of Systems -
2021.08.05
A Case in Which a Court Admission Rendered in the First Trial was Overturned upon Considering Issues of Conventional Technology and Revising Judgment Based on the Fulfillment Theory (Intellectual Property Newsletter (2021 August Issue))
2021.07.15
The Intellectual Property and Antitrust Review 6th edition Japan Part
2021.05.07
A Case in Which the Japan Patent Office and the Court Reached Different Decisions Regarding Similarity in the Inventive Step of Two Inventions (Intellectual Property Newsletter (2021 May Issue))
2021.05.01
Japan M&A - Key Intellectual Property Issues in M&A Transactions -
2021.03.31
Protection of Geographical Indications under the TPP and Japan-EU Economic Partnership Agreement (EPA)
2021.03.05
A Case Involving a Dispute Over Similarity of Trademarks and Other Matters Related to Services Supporting Job Seeking Activities by Currently Unemployed Recent Graduates with Work Experience (Intellectual Property Newsletter (2021 March Issue))
2021.01.26
Intellectual Property Newsletter (Digest version) (2021 Winter Issue) Key Points in Reading Case Reports
2020.12.21
2021 Book Guide for Legal Affairs "Updates to Common Business Sense in Response to Changes in the Social Environment" -Business Law Journal, February 2021 Issue
2020.07.31
How to Proceed with Joint Research and Development and Legal Points to Note therein（Chapter 4: Section 1 "Points on Patent License Agreement and Way of thinking on Provisions"）
2020.07.01
The Intellectual Property and Antitrust Review 5th edition Japan Part
2019.01.01
Business and IP commitments in Economic Partnership Agreements (EPAs)
2018.09.06
Points on Provisions of Patent License Agreement - Based on Revision of Civil Code -
2018.08.28
The Act on Special Measures for Productivity Improvement (Part 2) - Outline of the System to Facilitate Data Sharing and Collaboration
2018.08.10
The Act on Special Measures for Productivity Improvement (Part 1) - What does the “Regulatory Sandbox” mean?
2018.03.21
The Compass for Intellectual Property Law - The Supreme Court Ruled on a Re-defense based on a Correction of Claims against a Patent Invalidity Defense in a Patent Infringement Case
2018.03.01
IP Laws of the Philippines
2018.02.19
Q&A on the Actual Practice of Employee Inventions (Keiso’s Law and Practice Series)(co-author)
2017.05.01
JAPAN Section/Protection and Disclosure of Trade Secrets and Know-How
2015.03.01
Handbook on Joint Research and Development Agreement
2015.02.01
Reading of U.S. Supreme Court Cases: Commentary on Intellectual Property and Business Cases in the 21st Century
2010.09.01
Intellectual Property Commitments in Japan's Economic Partnership Agreements (EPAs)
2010.01.01
Negotiations regarding Intellectual Property in Economic Partnership Agreements (EPAs), [1] - [9]
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Commentary on FTA/EPA Negotiations

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Other publications about Marketing Regulation

2024.01.24
Legal Affairs for Chinese Life Sciences and Healthcare No. 21: Revision to the Administrative Regulation on Wholesale, Retail, etc., of Pharmaceutical Products (Establishment of the Regulation on Supervision and Administration of Business Management and Quality of Pharmaceutical Products)
2023.11.28
Legal Affairs for Chinese Life Sciences and Healthcare No. 20: Notice on Enhancing the Supervision and Administration of Contract Manufacture of Drug Marketing Authorization Holders (No. 132 of 2023)
2023.08.24
Thematic-based: Legal Practice in the Healthcare Business
2022.07.04
China’s Life Sciences and Healthcare-No.2 －The Good Vigilance Practice rule in China
2022.05.26
Legal Affairs for Chinese Life Sciences and Healthcare (Part 10) - Toward the Enforcement of the New Cosmetics GMP
2022.03.24
Legal Affairs for Chinese Life Sciences and Healthcare (Part 8) - Amendment to the Cosmetic Supervision and Administration Regulation for the First Time in 30 Years, and the Subsidiary Regulations on Administrative Measures for Cosmetic Registration, the Subsidiary Regulations on Administration Measures for Cosmetics Manufacture and Operation and the GMP for Cosmetics (3)
2022.02.21
Legal Affairs for Chinese Life Sciences and Healthcare (Part 7) - Amendment to the Cosmetic Supervision and Administration Regulation for the First Time in 30 Years, and the Subsidiary Regulations on Administrative Measures for Cosmetic Registration, the Subsidiary Regulations on Administration Measures for Cosmetics Manufacture and Operation and the GMP for Cosmetics (2)
2022.01.21
Legal Affairs for Chinese Life Sciences and Healthcare (Part 5) - Amendment to the Cosmetic Supervision and Administration Regulation for the First Time in 30 Years, and the Subsidiary Regulations on Administrative Measures for Cosmetic Registration, the Subsidiary Regulations on Administration Measures for Cosmetics Manufacture and Operation and the GMP for Cosmetics (1)
2022.01.21
Legal Affairs for Chinese Life Sciences and Healthcare (Part 6) - Trial Program for Cross-border E-commerce Retail Import of Drugs in Henan
2021.11.24
Legal Affairs for Chinese Life Sciences and Healthcare (Part 4) – Developments in Amendment of Regulations Concerning Wholesaling/Retailing of Pharmaceutical Products, Etc. (Measures on Supervision and Control of the Drug Business and Usage Quality (Draft for Comment))
2021.10.28
Legal Affairs for Chinese Life Sciences and Healthcare (Part 3) – Approaching the implementation of China GVP (Good Pharmacovigilance Practice) (effective from December 1, 2021) (2)

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Other publications about Dispute Resolution

2023.08.24
Thematic-based: Legal Practice in the Healthcare Business

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Other publications about Intellectual Property Dispute Resolution

2024.05.01
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2024.04.20
Judgment in Which the Court Determined Whether or Not the Relevant Act Constitutes an Indirect Infringement by a Non-Exclusive Article (Item 2, Article 101 of the Patent Act) Pertaining to Invention of a Product- Requirements for Indirect Infringement by Non-Exclusive Article -
2023.08.24
Thematic-based: Legal Practice in the Healthcare Business
2023.02.28
National Comparison Tables - Japan part
2022.03.01
Summary of Countermeasures for Counterfeit Products in the US
2022.02.04
A Case in Which the Applicability of Article 3, Paragraph 1, Item 3 of the Trademark Act was Disputed with Respect to the Trademark “VEGAS” (Intellectual Property Newsletter (2022 February Issue))
2021.12.01
A Detailed Explanation of Economic Partnership Agreements
2021.08.05
A Case in Which a Court Admission Rendered in the First Trial was Overturned upon Considering Issues of Conventional Technology and Revising Judgment Based on the Fulfillment Theory (Intellectual Property Newsletter (2021 August Issue))
2021.05.07
A Case in Which the Japan Patent Office and the Court Reached Different Decisions Regarding Similarity in the Inventive Step of Two Inventions (Intellectual Property Newsletter (2021 May Issue))
2021.04.01
Patent Enforcement Practices Before, During and After Patent Litigation Proceedings in Japan – A Comparative Analysis with Germany and the United States –
2021.03.05
A Case Involving a Dispute Over Similarity of Trademarks and Other Matters Related to Services Supporting Job Seeking Activities by Currently Unemployed Recent Graduates with Work Experience (Intellectual Property Newsletter (2021 March Issue))
2021.01.26
Intellectual Property Newsletter (Digest version) (2021 Winter Issue) Key Points in Reading Case Reports
2021.01.01
The Ways of Limiting Injunctive Relief in Patent Infringement Litigation and their Effects – Current Japanese Practices and Suggestions for their Future Improvements, based on the Recent Trends in Germany and the United States –
2019.01.01
Business and IP commitments in Economic Partnership Agreements (EPAs)
2018.03.21
The Compass for Intellectual Property Law - The Supreme Court Ruled on a Re-defense based on a Correction of Claims against a Patent Invalidity Defense in a Patent Infringement Case
2018.03.01
IP Laws of the Philippines
2018.02.19
Q&A on the Actual Practice of Employee Inventions (Keiso’s Law and Practice Series)(co-author)
2015.02.01
Reading of U.S. Supreme Court Cases: Commentary on Intellectual Property and Business Cases in the 21st Century
2007.05.01
Commentary on FTA/EPA Negotiations
2006.04.01
Guide to International Legal Practice (1) to (11)

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