Regulations Governing the Determination of Patent Term Extension Article 8
Where the commencement of a domestic or foreign test predates publication of a patent application, the time period in which the invention cannot be exploited for the purpose of obtaining a regulatory approval shall be calculated from the publication date; where the commencement of a domestic or foreign test is predated by publication of a patent application, the time period shall be calculated from the commencement of the test.The expiration of the time period in which the invention cannot be exploited for the purpose of obtaining a regulatory approval shall be one day before such approval is obtained.
中文原文 專利權期間延長核定辦法第8條
為取得許可證而無法實施發明之期間，其國內外試驗開始日在專利案公告日之前者，自公告日起算；國內外試驗開始日在專利案公告日之後者，自該試驗開始日起算。
為取得許可證而無法實施發明期間之訖日，為取得許可證之前一日。
為取得許可證而無法實施發明期間之訖日，為取得許可證之前一日。