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 Dasatinib Tablets: 20 mg, 50 mg “Sawai” (hereinafter “Subject Product”). BMS filed a request for preliminary injunction with the Tokyo District Court on July 18 alleging that the Subject Product infringes a patent (Japanese Patent Number 3989175, hereinafter “Patent”) owned by BMS Ireland–one of the effects or efficacy thereof is to treat chronic myelocytic leukemia (except for imatinib-resistant chronic myelocytic leukemia). The patent term of the Patent was extended, and the “use specified in a product that became the subject of the disposition” in the patent term extension application was chronic myelocytic leukemia (except for imatinib-resistant chronic myelocytic leukemia).
Sawai announced on its website on October 4 that the company received supplemental approval of the Subject Product’s use and dosage for chronic myelocytic leukemia, and accordingly, the Subject Product can be taken just as the original drug is taken by resolving the use application discordance. In response to the court order of the preliminary injunction, the company retorted that the injunction order is quite unfair and they will immediately raise an opposition with the Court.
Because the patent expiration date is January 27, 2024, the preliminary injunction prohibits the sale and manufacture of the subject product until that date. Sawai plans to sell the product immediately after the end of the patent term.