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...

The charts below illustrate what kinds of bio-related inventions are deemed as satisfying inventive step.

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

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.

Title of Invention: PTH-containing therapeutic/prophylactic agent for osteoporosis, characterized in that PTH is administered once a week in a unit dose of 100-200 units.

Japan's healthcare market is undergoing a significant transformation driven by an aging population and technological innovation.

The Tokyo District Court's ruling in Tokai Medical Products Inc. v. [Defendant], Case No. 2022 (wa) 5905 (Tokyo Dist. Ct. Mar. 2024) raises significant questions about patent enforcement 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

2025 年 2 月 13 日、公正取引委員会が医療機器等の製造販売業者の確約計画を認定しました。

厚生労働省及び公正取引委員会（以下「公取委」という。）は、2025 年 2 月 17 日、「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

厚生労働省及び経済産業省は、2025 年 3 月 28...

. . . Viewed in this light, the court's extended analysis of "drug" versus "device" components of an approved drug product may thus introduce unnecessary inconsistencies and complications in future evaluations...

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

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" ...