我國專利法及藥事法上試驗例外之研究

The Research of Experimental Use Exception on Patent Law and Pharmaceutical Affairs Act

孫小萍(Hsiao-Ping Sun)

《政大智慧財產評論》 3卷2期 (2005/10) Pp. 1-32

https://doi.org/10.30387/NCCUIPR.200510_3(2).0001

摘要

「試驗例外」條款在各國司法實務運作上，最常被引起爭論者向來集中在處方藥市場中專利藥廠與學名藥廠間之競爭議題。雖然我國專利法與其他國家一樣也有試驗例外條款，但其中要件嚴格限定為「非營利行為」，此乃各國立法例少見；另外，民國九十四年二月五日甫增訂生效之藥事法第四十條之二第五項關於「Bolar例外」之規定，又因立法用語不當造成實務運用之困擾。由於我國本土藥廠向來仰賴生產學名藥為大宗，國內藥廠在如此嚴格的法規環境下實難與國外原廠相提並論。本文將先從分析國際規範及各國案例著手，繼之藉國內立法資料及司法案例探討我國近日之相關修法內容及實務見解，最後思考如何在不違反WTO架構下之義務，同時兼顧公共利益與鼓勵研發創新，對國內提出相關修法建議。

關鍵字

專利權 ； 專利法 ； 藥事法 ； 試驗例外 ； Bolar例外 ； Hatch-Waxman法案 ； 專利藥 ； 學名藥

並列摘要

In the practice of experimental use exception doctrine, public debates always focus on the impact of the measure on pharmaceutical products. The experimental use exception doctrine in Taiwan is a very narrow one. To fall within this exception on patent law, the use has to be one that is without profit-seeking acts. In addition, the President's Promulgation on Pharmaceutical Affairs Act Amendment in 2/5/2005 is to revise and augment the Article 40-2. According to article 40-2(5), the effect of a new drug invention patent right shall not extend to the practice before submitting a new drug application for research, educational or experimental purposes. This is so-called ”Bolar exception”. Because of the haste of its legislation, the Bolar exception rule in Taiwan is not practical. Therefore, this article attempts to set forth some opinions of the draft amendments. First, this article introduces the case law of foreign countries. Then, this article interprets the contents of patent law and pharmaceutical affairs act in Taiwan, and comments on a related case of Taiwan Taipei District Court. Finally, this article reaches some conclusions of the proposal for the draft amendments.

並列關鍵字

Patent Rights ； Patent Law ； Pharmaceutical Affairs Act ； Experimental Use Exception ； Bolar Exception ； Hatch-Waxman Act ； Brand Name Drugs ； Generic Drugs