標題: 逆向給付爭議——競爭法與專利法之交錯
Reverse Payment Controversy: Interaction between Competition Law and Patent Law
作者: 蔡鎛宇
Bo-Yu Tsai
關鍵字: 學名藥;逆向付款;推定違法;合理原則;專利權利範圍法;eneric Drug;Reverse Payment;Pay for Delay;Rule of Reason;Presumptively Illegal
公開日期: 七月-2015
出版社: 交通大學科技法律研究所
Institute of Technology Law
摘要: 在探討與專利有關的協議是否違反競爭法時,不論在歐盟或是美國,專利權利範圍說原本都是實務上所常見的判斷方式。逆向給付協議亦為一種專利協議,在歐盟或美國皆屢見不鮮,係指原藥廠對於學名藥廠進行給付以換取學名藥延後進入市場。然而,饒富趣味的是,在逆向給付協議究竟應以推定違法、專利權利範圍說,抑或合理原則,來判斷是否違反競爭法的這個問題上,歐盟以及美國實務卻都不採取專利權利範圍說。歐盟執委會在最近幾年的逆向給付協議案件之判斷上採取了推定違法,而2013年美國聯邦最高法院所做出Actavis之判決則是以合理原則來判斷。本文將探討歐美間之差異,兼論我國之相關競爭法制。
In Europe and in the United States, the reverse payment settlements reached between pharmaceutical manufacturers have been heard over and over again. Reverse payment settlement refers to the payment made to the ge-neric drug manufacturers in exchange for delaying generic drug’s entrance into market. Interestingly, Europe and the United States provide different an-swers as to construing the reverse payment settlement as a matter presumptive-ly illegal or as a matter to be judged based on rule of reason when it comes to ruling whether or not a reverse payment settlement is in violation of anti-competition law. In recent years, EU Commission ruled most cases related to reverse payment settlement presumptively illegal. In 2013, however, the Su-preme Court of the United States used rule of reason in Actavis. Both of them concurrently abandoned the “Scope of the Patent” test. With the discussions stated above, this paper focused on the difference between Europe and the United States regarding reverse payment settlements for the reference of Tai-wan.
URI: http://dx.doi.org/10.3966/181130952015121202003
http://www-old.itl.nctu.edu.tw/tlr_n/papers/ch_paper/12_2/12_2_3.pdf
http://hdl.handle.net/11536/136985
ISSN: 1811-3106
DOI: 10.3966/181130952015121202003
期刊: 科技法學評論
Technology Law Review
Volume: 12
Issue: 1
起始頁: 127
結束頁: 164
顯示於類別:科技法學評論


文件中的檔案:

  1. 1811-3095-150706.pdf