授權學名藥與藥業產品跳躍行為之合法性分析：以競爭法為中心

Abstract

本文在探討近年來專利藥廠新興的「授權學名藥」與「產品跳躍行為」這兩個策略，是否有違反競爭法。透過相關規範、實際案例、相關見解之介紹，並藉由實證訪談國內藥廠實務界人士，以了解藥廠對這兩議題的立場，及其支持或反對之理由，最終找出合適的競爭法評析。研究結果顯示，在180天獨家銷售期內，若有授權學名藥加入市場競爭，可壓低獨家銷售期內的藥品價格，實際上有促進競爭之效，惟若授權學名藥與逆向和解協議協同操作時，會造成學名藥上市時間的遲延，此種逆向和解協議，應受到競爭法合理原則（rule of reason）之規範；產品跳躍行為本身應為中性行為，不應逕以競爭法全面加以禁止，以免造成寒蟬效應，而應採取合理原則判斷標準，充分衡量個案產品跳躍行為所帶來的市場正面效益和競爭損害孰輕孰重。希冀本文有對「授權學名藥」與「產品跳躍行為」這兩個議題之探討做出具體貢獻。

"Authorized Generics" and "Product Hopping" are two new strategies that the patented pharmaceutical companies used in recent years. People still argue whether these two new strategies are violations of competition law or not. To research these issues, the author introduced the relevant norms, the actual case, the other relevant opinion, and interviewed several attorneys, representatives of local Pharmaceutical companies and Big Pharma to find what they think about these issues. Hope to find the right way to analyze these two issues. The results showed if authorized generics entering the market competition in 180 days exclusive period could drive down the drugs' price. Only while authorized generics came along with reversely settlements will delay generic drugs to enter the market, this non-compete agreement shall use “rule of reason” to regulate. On the other hand, the results showed that in order to avoid a chilling effect, product hopping should not be totally prohibited by competition law. After the author compared different judgment standards, finally found product hopping should use “rule of reason” to balance the positive benefits and the competitive harms brought from the behavior. Hope this paper has some contributions in "authorized generics" and "product hopping" these two issues.