论药品专利链接民事案件的受理条件

Acceptance Conditions for Civil Cases on Drug Patent Linkage

药品专利链接案件与专利侵权案件虽然在实体规则上并无实质不同,但在受理条件上存在很大差别。在目前已审结的案件中,与受理条件相关的问题主要体现在涉案原研药与涉案专利的关系、涉案专利权的法律状态、可登记的专利类型、声明类型的判断、45日的性质认定等方面。目前法院的通常做法是,如果涉案原研药未落入涉案专利权的保护范围,或者涉案专利权虽已被认定应予无效但仍处于诉讼程序中,或者涉案专利的类型不属于可在中国上市药品专利信息登记平台登记的专利类型,或者仿制药申请人所作声明类型就实质而言不属于四类声明,以及仿制药申请人提起诉讼的时间不符合45日的规定,则原告的起诉不符合受理条件。

Although there is no substantial difference between drug patent linkage cases and patent infringement cases in terms of substantive rules,there are great differences in acceptance conditions.In the cases that have been concluded so far,the determination of acceptance conditions is mainly reflected in the relationship between the original drug involved and the patent in question,the legal status of the patent involved,type of patent that can be registered,the judgment on the type of declaration,and the determination on the nature of the 45-day period.Based on rulings in these cases,if the original drug involved does not fall within the protection scope of the patent in question,or the patent in question has been declared invalid but remains in litigation,or if the patent type is not eligible for registration on the Chinese Marketed Drug Patent Information Listing Platform,or if the declaration made by the generic drug applicant does not belong to the four types of declarations in substance,and if the time for the generic drug applicant to file a lawsuit does not adhere to the 45-day rule,the above-mentioned lawsuit would not meet the acceptance conditions.