疾病管制署採購愛滋治療之學名藥與專利侵權風險

Abstract

疾病管制署為降低國庫對於愛滋病治療藥物的支出，正評估是否以集中採購的方式購買學名藥，以供指定醫院使用。假設原藥廠擁有關於愛滋病藥物之物品專利或製造方法專利，則本文認為該集中採購行為有可能讓疾管署承擔侵害專利的風險。醫院或醫生使用藥物來治療病患是所謂「使用系爭專利之行為」，即侵害專利權行為之一種型態。該行為之發生源自於疾管署的採購行為，因此，儘管疾管署的採購行為本身不是侵權行為，但因為其乃造成 使用系爭專利藥物行為之原因，故疾管署將負有共同侵權人之責任。對此，本文建議疾管署可透過「強制授權」和「取得授權」等工具來避免侵權風險，並以給予原藥廠合理的愛滋病用藥市佔率、有限制的授權範圍等條件，讓原藥廠有不得不接受專利授權之結果。

To reduce the cost of AIDS medicines for treating AIDS patients, the Centers for Disease Control is evaluating whether to buy those generic drugs through government procurement to supply the drugs to designated hospitals. If a pioneer drug company owns a product patent or process patent covering AIDS medicine purchased, it is highly possible that the CDC may be liable as a patent infringer. Using drugs to treating patients constitutes ＂using the patent at dispute＂ as a form of patent infringement. The act of using results from the CDC`s drug purchase. So, while the CDC`s act of purchasing drugs is not patent infringement, the CDC may be liable as a joint infringer of the patent because the CDC causes the use of the patent at dispute. To resolve this issue, this paper suggests that ＂compulsory licensing＂ and ＂licensing acquisition＂ may be one way to avoid the risk of patent infringement. It is possible to make a pioneer drug company reluctantly have to accept the licensing request by offering a reasonable market share of AIDS medicines and limited licensing scope as reasonable conditions.