Hidenori Hamai
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Can a Later Patent Term Extension Re-Establish Protection for a Product After an Earlier Extension has Expired? – Amitiza® Case
On March 3, 2026, the Osaka District Court issued a noteworthy decision concerning the scope of patent rights where the same patent has received multiple term extensions based on separate marketing approvals for different dosage strengths of the same drug.The case concerned Amitiza (lubiprostone). T
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Generic Drug Companies Ordered to Pay Largest Damages Ever
Summary of the JudgmentOn May 27, 2025, the IPHC ruled that the manufacturing and sales of "Nalfurafin Hydrochloride OD Tablets" by generic drug manufacturers Sawai and Fuso constitute infringement of the patent rights in question, and granted Toray a claim for damages. Sawai was ordered to pay appr
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Preliminary Injunction against Generic Manufacturer Allegedly Infringing BMS Patent
On November 29, 2023, the Japanese subsidiary biopharmaceutical corporation, Bristol Myers Squibb (BMS), announced that the Tokyo District Court issued a preliminary injunction order against Sawai Pharmaceutical Co., Ltd., a Japanese generic drug manufacturer, that prohibits sales and manufacture of