Is US type “Orange Book” available in Japan to determine or estimate Loss of Exclusivity (LOE)?
Japan does not have US type Orange Book Listing, as motivated by Hatch Waxman Act in the US.
Therefore, relevant patents need to be carefully identified and reviewed from scratch for accurate determination of the timing of generic entry, in addition to the careful analysis on PMS (Post Market Surveillance) period and NHI (National Health Insurance) price listing. Obtaining the reasonably accurate estimation of timing of generic entry for pioneer drugs of interest is imperative for both innovative companies and generic companies to best control competition against one another.
TOKYO ACTi is a rare patent law firm in Japan experienced in and capable of providing various intellectual property services involving Loss of Exclusivity such as Loss of Exclusivity Search, PMS period expiration search, PTE (Patent Term Extension) search, invalidation trial, among others.