The Group changed the estimated useful lives of servers to reflect the most recent condition of use. Due to this change in estimates, loss from operating activities decreased by 471million yen for the three months ended March31, 2019 compared to the previous method.
The first biological product determined to be interchangeable with a branded product for any condition of use is also entitled to a period of exclusivity, during which time the FDA may not determine that another product is interchangeable with the reference product for any condition of use. This exclusivity period extends until the earlier of: (1)oneyear after the first commercial marketing of the first interchangeable product; (2)18months after resolution of a patent infringement suit instituted under 42 U.S.C. §262(l)(6)against the applicant that submitted the application for the first interchangeable product, based on a final court decision regarding all of the patents in the litigation or dismissal of the litigation with or without prejudice; (3)42months after approval of the first interchangeable product, if a patent infringement suit instituted under 42 U.S.C. §262(l)(6)against the applicant that submitted the application for the first interchangeable product is still ongoing; or (4)18months after approval of the first interchangeable product if the applicant that submitted the application for the first interchangeable product has not been sued under 42 U.S.C. §262(l)(6).