醫藥品專利權期間延長─國內外法制與爭議案例比較研究

Abstract

依我國藥事法規，醫藥品須經中央衛生主管機關審查並核發許可證後，始得製造或販賣。專利權人申請發明專利之時點往往早於取得藥品許可證之時點，於取得許可證前，專利權人無法任意實施其發明。專利權期間延長制度即為補償醫藥品發明專利之專利權人無法實施發明期間所創設。為了解我國與他國專利權期間延長相關法制之差異，本文以美國專利權期間延長與歐洲補充保護證書制度為研究對象，並研析各該制度運作實務上重要爭議案例，將各案例事實置於我國專利權期間延長制度下探討，以審視我國現行專利法規與審查基準之規範完整性。本文結合美國與歐洲爭議案例所建立之判斷標準及我國藥品查驗登記審查制度規範，對我國現行專利權期間延長制度提出修正建議與方向，期能提供學術與實務界更多元之思考面向。

According to the current Article 39 of Pharmaceutical Affairs Act in Taiwan, no manufacturing or importation of drugs shall be allowed until a drug permit license is approved and issued. Pharmaceutical products must undergo regulatory examination by central health competent authority to make sure that these products are both safe and effective. Patent term extension for pharmaceutical products aims to compensate the loss of patent lifetime due to extensive testing and lengthy regulatory examination prior to obtaining a drug permit license.\nThis study begins with registration and market approval of pharmaceutical products in Taiwan. In order to understand the differences between domestic and foreign regulations, a comparative review of the patent term extension related regulations and controversial cases in United State and European had been made. This study also brings forward some legislative recommendations for Patent Act, Regulations Governing the Determination of Patent Term Extension and Guidelines for Patent Examination.