Intellectual Property High Court Issues Ruling on Drug Use Patent Infringement Related to Oral Antipruritus Medication REMITCH^®

Tokyo, Japan, May 27, 2025 – Toray Industries, Inc., announced today that Japan’s Intellectual Property High Court has issued a ruling on the company’s claim related to the oral antipruritus medication REMITCH®. Toray had filed a lawsuit against Sawai Pharmaceutical Co., Ltd. (hereinafter, “Sawai Pharmaceutical”) and Fuso Pharmaceutical Industries, Ltd. (“Fuso Pharmaceutical”), requesting damages for infringement of its drug use patent (Patent No. 3531170, with patent term extension registration: Application Nos. 2017-700154 and 2017-700310; hereinafter, “the Patent”; the extended patent term ended in November 2022), related to the oral antipruritus medication REMITCH® OD Tablets. The lawsuit [2021 (Ne) 10037] concerned the generic products Nalfurafine Hydrochloride OD Tablets 2.5 µg [SAWAI] (“Sawai Product”) and Nalfurafine Hydrochloride OD Tablets 2.5 µg “FUSO” (“Fuso Product”). Today, Japan’s Intellectual Property High Court handed down its ruling in this case. The court recognized that the manufacture and sale of the Sawai and Fuso Products during the extended patent term constituted infringement of the Patent. The court upheld Toray’s claim for damages and ordered Sawai Pharmaceutical to pay damages of 14,290,939,291 yen, and Fuso Pharmaceutical to pay damages of 7,472,878,838 yen, along with interest for delay. On the same day, the court also issued a decision rejecting Sawai Pharmaceutical’s claim in a separate lawsuit [2024 (Gyo-Ke) 10033] seeking to overturn the decision to maintain the patent term extension registration (Application No. 2017-700154). As for other patent term extension registration related to the Patent (Application Nos. 2015-700061, 2017-700309, and 2017-700310), invalidation trials requested by Sawai Pharmaceutical had previously concluded with final decisions to maintain the extensions. Toray will keep upholding its corporate philosophy, “Contributing to society through the creation of new value with innovative ideas, technologies and products,” by making ongoing investments in research and development to deliver innovative products that meet customer expectations. The company holds numerous intellectual property rights and will continue to take appropriate measures, in accordance with its fundamental policy on rightful enforcement of its own rights, to protect its intellectual property from infringement as necessary. Note: REMITCH® is a registered trademark of Torii Pharmaceutical Co., Ltd. Supplemental Note: Patent Term Extension Registration Patent term extension registration for pharmaceutical inventions is a system that allows a patent term to be extended — by up to five years beyond the standard 20-year term — to compensate for periods during which the patent could not be commercially exploited due to the need to obtain regulatory approval (e.g., marketing authorization) for pharmaceuticals. A patent is deemed to be in an extended term while the extension application is under review.

The release as fetched from its publisher. toray.com ↗