"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...

Imagine you're a generic drug manufacturer, and you've spotted what looks like a billion-dollar opportunity. There's a blockbuster psychiatric medication called "paliperidone palmitate" that...

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

. . . 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...

On the 29th of February, Sonoda & Kobayashi held a webinar on the theme "News about China's Patent Term Extension...

In mid-June 2025, attorneys for plaintiffs Janssen Products and PharmaMar were reviewing their opponent's document production in a routine Hatch-Waxman patent...

「でも、これは単なる投与スケジュールの話じゃない。実は、裁判所が特許無効を主張する側に「自明性ショートカットボタン」を与える