鑒於方法專利之專利權人難以舉證證明被告(被控侵權行為人)之實施行為侵害其方法專利,世界貿易組織協定(WT O Agreement )之與貿易有關之智慧財產權協定(TRIPs )第34條第1 項規定,於TRIPs 第28條第1 項第(b) 款所定之專利權(即方法專利專屬權)受侵害之民事訴訟,於符合一定要件時,推定被告之物品係以專利權人之方法專利所製造。此特定要件之類型有二,由會員國擇一制定於內國法,以衡平分配專利權人與被告間之舉證責任:(a) 依該方法專利所製成之物品為新的(if the product obtained by the patented process is new );(b) 被告之物品以該方法專利製成之可能性相當高,而專利權人已盡合理努力仍無法證明被 告確實使用該方法專利(if there is a substantial likelihood that the identical product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used.)。