:::

詳目顯示

回上一頁
題名:我國專利法及藥事法上試驗例外之研究
書刊名:政大智慧財產評論
作者:孫小萍
作者(外文):Sun, Hsiao-ping
出版日期:2005
卷期:3:2
頁次:頁1-32
主題關鍵詞: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Patent rightsPatent lawPharmaceutical affairs actExperimental use exceptionBolar exceptionHatch-waxman actBrand name drugsGeneric drugs
原始連結:連回原系統網址new window
相關次數:
  • 被引用次數被引用次數:期刊(3) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:3
  • 共同引用共同引用:51
  • 點閱點閱:67
     「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。
     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.
期刊論文
1.Pate, Gregory N.(2002)。Analysis of the Experimental Use Exception。North Carolina Journal of Law & Technology,3(2)。  new window
2.鄧曉芳(20041200)。談學名藥研發與專利法試驗免責規定之適用--從日本學名藥訴訟實務爭議談起。科技法律透析,16(12),2-6。  延伸查詢new window
研究報告
1.(2000)。Canada-Patent Protection for Pharmaceutical Products。  new window
圖書
1.陳文吟(200210)。我國專利制度之研究。五南圖書出版股份有限公司。new window  延伸查詢new window
2.楊崇森(200307)。專利法理論與實用。三民書局。  延伸查詢new window
3.經濟部智慧財産局(2002)。專利法逐條釋義。  延伸查詢new window
4.吉藤幸朔(1997)。特許法槪說。有斐閣。  延伸查詢new window
5.財團法人生物技術開發中心(2003)。醫藥產業年鑑2003。財團法人生物技術開發中心。  延伸查詢new window
6.陳智超(2004)。專利法:理論與實務。五南出版社。  延伸查詢new window
7.立法院。立法院公報。  延伸查詢new window
 
 
 
 
第一頁 上一頁 下一頁 最後一頁 top
:::
無相關著作
 
無相關點閱
 
QR Code
QRCODE