Japan: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

The CRISPR Patent Wars Hit Japan: A High-Stakes Battle Over Gene-Editing's Future

"This brings us to Japan, where patent law has its own unique peculiarities—and where this particular battle just reached a crucial milestone. . . ."

YMF Law Tokyo

Biosimilar Manufacturers To Expand Offerings In Europe And Japan

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe.

Worldwide Healthcare

GP

Goodwin Procter LLP

Life Science Newsletter May 2025

The Act Partially Amending the Act on the Safety of Regenerative Medicine, etc., and the Clinical Trials Act was promulgated on June 14, 2024...

Japan Healthcare

AM

Anderson Mori & Tomotsune

Life Science Newsletter April 2025

The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) have revised the Guidelines for New Business Activities in the Healthy Life Extension Industry Sector...

Japan Healthcare

AM

Anderson Mori & Tomotsune

Life Science Newsletter April 2025 (Japanese)

Japan Healthcare

AM

Anderson Mori & Tomotsune

Key Regulatory Considerations For Pharmaceuticals And Medical Devices In Japan

Japan Healthcare

Oh-Ebashi LPC & Partners

「後発医薬品の安定供給等の実現に向けた産業構造改革のための独占禁止法関係事例集」の公表

Japan Healthcare

AM

Anderson Mori & Tomotsune

Life Science Newsletter February 2025 (Japanese)

Japan Healthcare

AM

Anderson Mori & Tomotsune

Life Science Newsletter February 2025

Japan Healthcare

AM

Anderson Mori & Tomotsune

Life Science Newsletter (January 2025)

Japan Healthcare

AM

Anderson Mori & Tomotsune

No Drug? No Dice! Clarifying Orange Book Eligibility For Drug-Device Patents

Japan Healthcare

YMF Law Tokyo

Japan's MHLW Highlights Four Key Themes In Pharmaceuticals And Medical Devices Act Timeline Amendment

Japan Healthcare

RG

Ropes & Gray LLP

In Vivo Production And Patent Infringement—An Issue Of First Impression In Japan's IP High Court

YMF Law Tokyo

Request For Public Comments On The Revised Draft "Guidelines For Distribution Stakeholders To Adhere To For Improving The Distribution Of Medical Pharmaceuticals"

Japan Healthcare

AM

Anderson Mori & Tomotsune

Are You Underestimating Japan's Video Game Legal Landscape?

Japan Media & IT

G

Gamma Law

Key Regulatory Considerations For Pharmaceuticals And Medical Devices In Japan

Japan Healthcare

Oh-Ebashi LPC & Partners

Not So Obvious: You Won't Believe How This Simple Dosing Change Became Worth Billions

YMF Law Tokyo

Introduction Of "Simplified" Type 1 License

AM

Anderson Mori & Tomotsune

Recruiting In Japan: Key Considerations For Employers

Japan Employment

IL

Ius Laboris

US 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...

Japan Healthcare

AM

Anderson Mori & Tomotsune

Digital Healthcare 2023

While Japanese law does not provide formal definitions of digital healthcare and digital medicine, there is a difference in those terms based on whether a product constitutes a "pharmaceutical" or a "medical device" ...

Japan Healthcare

AM

Anderson Mori & Tomotsune

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ӗ

K

Kangxin

Unusually High Damages In Japanese Infringement Suit For Massage Chairs

On October 21st, the Nikkei Keizai Shimbun reported on the outcome of a patent infringement law suit between Fuji Medical Devices and Family Inada.

SK

Sonoda & Kobayashi Intellectual Property Law

IP High Court Case: Determination Of Inventive Step Regarding Unexpected Advantageous Effects

SI

Shiga International Patent Office

Determining Inventive Step Regarding Pharmaceutical And Biotech Patents – Judgement Criteria On Whether Or Not A Present Invention Has An Unexpected Advantageous Effect

SI

Shiga International Patent Office

Japan Tightens Foreign Direct Investment Regulations On Life Science Companies

Japan Government

JD

Jones Day

Balancing Safety And Efficiency: Updating The Regulation On Pharmaceuticals And Medical Devices

Japan Healthcare

HL

Hogan Lovells

Enforcement Of The Next Generation Medical Infrastructure Act

Japan Healthcare

JD

Jones Day

Researchers Of Cancer Detection Dispute Over IP Rights

KA

Keisen Associates

Enactment Of Next Generation Medical Infrastructure Act

Japan Healthcare

JD

Jones Day

Enactment Of Clinical Research Act

Japan Healthcare

JD

Jones Day

New Regulations On Clinical Research

Japan Healthcare

MF

Morrison & Foerster LLP

Japan Launches Agency For Medical Research And Development

Japan Healthcare

JD

Jones Day

Enactment Of Next Generation Medical Infrastructure Act

The "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...

Japan Healthcare

JD

Jones Day

Enactment Of Clinical Research Act

Due 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.

Japan Healthcare

JD

Jones Day

New Regulations On Clinical Research

On April 7, 2017, the 193rd Diet of Japan passed a legislation regarding clinical researches – this "Law on Clinical Research (rinsho kenkyu hou)" will come into effect within one year.

Japan Healthcare

MF

Morrison & Foerster LLP

Japan Launches Agency For Medical Research And Development

The Japanese government has established the Agency for Medical Research and Development ("AMED") to promote medical research and development more efficiently and comprehensively.

Japan Healthcare

JD

Jones Day

Japanese Firms Bring Nano-Enabled Clothing From The Athletic Field To The Office

Japan Healthcare

DP

Day Pitney LLP

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RHTLaw Taylor Wessing

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Nishith Desai Associates

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