ArticleEnforcement Of The Next Generation Medical Infrastructure ActThe Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field ("Next Generation Medical Infrastructure Act") ...JapanFood, Drugs, Healthcare, Life SciencesJones Day
ArticleJapan Launches Agency For Medical Research And DevelopmentThe Japanese government has established the Agency for Medical Research and Development ("AMED") to promote medical research and development more efficiently and comprehensively. JapanFood, Drugs, Healthcare, Life SciencesJones Day
ArticleJapanese Firms Bring Nano-Enabled Clothing From The Athletic Field To The OfficeKonaka, a Japanese men’s clothing retailer and Phiten, a Japanese holistic products company announced their collaboration and introduction of "Konaka X Phiten Dress Shirt" on July 5, 2011. JapanFood, Drugs, Healthcare, Life SciencesDay Pitney LLP
ArticleJapan Tightens Foreign Direct Investment Regulations On Life Science CompaniesOn June 15, 2020, the Japanese government implemented new regulations that designate the manufacture of pharmaceuticals for infectious diseases and the manufacture ...JapanGovernment, Public SectorJones Day
ArticleResearchers Of Cancer Detection Dispute Over IP RightsBiotechnology venture company MYTECH of Kobe, Japan filed a patent application for early detection technology for cancer. JapanIntellectual PropertyKeisen Associates
ArticleEnactment Of Clinical Research ActDue to the uncovering of clinical research misconduct in the past few years, the Clinical Research Act was enacted on April 7, 2017, and was promulgated on April 14, 2017.JapanFood, Drugs, Healthcare, Life SciencesJones Day
ArticleGenus Claiming (Including Means Plus Function “MPF” Claiming) In Biotech And Pharma: Doctrinal Trajectory And Drafting StrategiesFinnegan attorney Chiaki Kobayashi explores the complex landscape of genus claiming in biotechnology and pharmaceutical patents, examining doctrinal developments and practical drafting approaches. The article, edited by partner John D. Livingstone, provides strategic guidance for navigating means-plus-function claiming methodologies in life sciences intellectual property. JapanIntellectual PropertyFinnegan, Henderson, Farabow, Garrett & Dunner LLP
ArticleBiosimilar Manufacturers To Expand Offerings In Europe And JapanOn June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. GlobalFood, Drugs, Healthcare, Life SciencesGoodwin Procter LLP
ArticleEnactment Of Next Generation Medical Infrastructure ActThe "Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field" ("Next Generation Medical Infrastructure Act" or "Act") was enacted in Japan on April 28, 2017...JapanFood, Drugs, Healthcare, Life SciencesJones Day
ArticleUnusually High Damages In Japanese Infringement Suit For Massage ChairsOn October 21st, the Nikkei Keizai Shimbun reported on the outcome of a patent infringement law suit between Fuji Medical Devices and Family Inada. JapanIntellectual PropertySonoda & Kobayashi Intellectual Property Law
ArticleLife Science Newsletter (January 2025)Newsletter "Life Science Newsletter (January 2025)" has been published. Contents 1. Release of Summary Report on the Amendments to the Pharmaceuticals Act 1.1 Reinforcement of Quality Assurance.JapanFood, Drugs, Healthcare, Life SciencesAnderson Mori & Tomotsune
ArticleJapan's MHLW Highlights Four Key Themes In Pharmaceuticals And Medical Devices Act Timeline AmendmentOn September 12, 2024, the Pharmaceutical and Medical Device System Subcommittee (the "Subcommittee") of the Japanese Ministry of Health, Labor and Welfare ("MHLW")...JapanFood, Drugs, Healthcare, Life SciencesRopes & Gray LLP
ArticleUS FTC Agrees Consent Order With DNA Testing Companies On Privacy Breaches Over Data On Genetic And Health Information, Including 20 Years Of Improved Management本稿では、米国の連邦取引委員会...JapanFood, Drugs, Healthcare, Life SciencesAnderson Mori & Tomotsune
ArticleThe BIOSECURE Act Becomes LawOn December 18, 2025, President Trump signed into law the BIOSECURE Act as part of the National Defense Authorization Act (NDAA), which is the U.S. Congress's annual defense policy bill.JapanFood, Drugs, Healthcare, Life SciencesMorrison Foerster
ArticleJapan's AMED Offers 'Double Match Up' Grants For Pharma Startups: Considerations For Investors And CompaniesThe Japanese government is aware of the challenges in securing funds for drug development within Japan's biopharmaceutical startup ecosystem, especially compared to Europe and the United States.JapanFood, Drugs, Healthcare, Life SciencesGreenberg Traurig
Articleパテントリンケージ制度導入2年、国家知識産権局が実績発表医薬品特許紛争の早期解決メカニズムとして知られるパテントリンケージ制度が導入されてから2年が経過した。国家知識産権局(CNIPA)がこӗJapanIntellectual PropertyKangxin
ArticleThe BIOSECURE Act Becomes Law (Japanese)2025年12月18日、トランプ大統領は...JapanFood, Drugs, Healthcare, Life SciencesMorrison Foerster
ArticleRequest For Public Comments On The Revised Draft "Guidelines For Distribution Stakeholders To Adhere To For Improving The Distribution Of Medical Pharmaceuticals"On January 15, 2020, the Ministry of Health, Labor and Welfare announced the ``Guidelines that distribution personnel should follow to improve the distribution of medical drugs''...JapanFood, Drugs, Healthcare, Life SciencesAnderson Mori & Tomotsune
ArticleBalancing Safety And Efficiency: Updating The Regulation On Pharmaceuticals And Medical DevicesIt's been five years since both the name and the content of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "Act")JapanFood, Drugs, Healthcare, Life SciencesHogan Lovells
ArticleLife Science Newsletter February 2025On February 13, 2025, the Japan Fair Trade Commission ("JFTC") approved a commitment plan prepared by a marketing authorization holder of medical devices, etc.JapanFood, Drugs, Healthcare, Life SciencesAnderson Mori & Tomotsune