Article
The BIOSECURE Act Becomes Law (Japanese)
2025年12月18日、トランプ大統領は...
Morrison & Foerster LLP
Japan: Food and Drugs Law
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Article
The BIOSECURE Act Becomes Law
On 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.
Morrison & Foerster LLP
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The "Paper NDA" Problem: When Bifurcation Of Rico And Patent Claims Defeats Hatch-Waxman's Purpose
In mid-June 2025, attorneys for plaintiffs Janssen Products and PharmaMar were reviewing their opponent's document production in a routine Hatch-Waxman patent...
YMF Law Tokyo
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Japan's AMED Offers 'Double Match Up' Grants For Pharma Startups: Considerations For Investors And Companies
The 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.
Greenberg Traurig, LLP
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まさかの特許バトル：たったこれだけの投与変更が数十億ドルに
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Not So Obvious: You Won't Believe How This Simple Dosing Change Became Worth Billions
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Life Science Newsletter April 2025
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Key Regulatory Considerations For Pharmaceuticals And Medical Devices In Japan
Oh-Ebashi LPC & Partners
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Publication Of The "Casebook On Antimonopoly Law For Industrial Structural Reform To Ensure Stable Supply Of Generic Drugs"
Anderson Mori & Tomotsune
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「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
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Innovative 3D Printing In Healthcare: From Design To Drug Delivery
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Life Science Newsletter (January 2025)
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No Drug? No Dice! Clarifying Orange Book Eligibility For Drug-Device Patents
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Japan's MHLW Highlights Four Key Themes In Pharmaceuticals And Medical Devices Act Timeline Amendment
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METI Proposes Price Cap Reductions In Japan's Balancing Market: Implications For Battery Energy Storage Systems
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The BIOSECURE Act Becomes Law (Japanese)
Morrison & Foerster LLP
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Overview And Practical Implications Of The Act On Contracts For Security Interest By Assignment And Retention Of Title
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Litigation Dispute Resolution Comparative Guide
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Amendment Of Japan's Tender Offer Regulations
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When It Should Be Obvious That "You Don't Know What You Don't Know"—Salix V. Norwich
"The outcome of this issue may yet prove controversial, as both the district court and the Federal Circuit arguably neglected established precedent regarding the doctrine of inherency in ruling...
YMF Law Tokyo
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IP News Bulletin For Japan & China (March2024)
On the 29th of February, Sonoda & Kobayashi held a webinar on the theme "News about China's Patent Term Extension...
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Request 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''...
Anderson Mori & Tomotsune
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Updates On Drug Regulations In Japan – Reducing Barriers To Entry For Drug Companies Entering The Japanese Market
As of March 2023, 143 products approved in the United States or European Union are not approved in Japan.
Winston & Strawn LLP
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テクノロジー満載なロボットレストラン、今後のトレンドになるか
Kangxin
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Enforcement Of The Next Generation Medical Infrastructure Act
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Takeda Pharmaceuticals Trying To Buy Shire To Replace Fading IP
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New Regulations On Clinical Research
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Change In JPO's Examination Practice For Use-Limited Food/Drink Inventions
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Japan Joins Medical Devices Single Audit Program Pilot
Jones Day
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Japan Begins Pilot Program For Accelerating Innovative Drugs Initially Developed In Japan
Jones Day
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Amendment To Drugs And Medical Devices Law In Japan Takes Effect
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The Patentability of Medicinal Inventions Related to Personalised Medicine in Japan
Lovells
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Japan Begins Pilot Program For Accelerating Innovative Drugs Initially Developed In Japan
After the pilot, the MHLW will hold a hearing to consider extending the program.
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Amendment To Drugs And Medical Devices Law In Japan Takes Effect
A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented.
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The Patentability of Medicinal Inventions Related to Personalised Medicine in Japan
As the difficulties in producing new chemical entities continue for pharmaceutical companies, their research strategies have recently emphasised not only the development of new medicines, but also life cycle management. This
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