Research On China’s Generic Drug Patent Challenge Rules

The China’s generic drug patent challenge rules are composed of a series of specific rules related to generic drug applicants’ patent challenges,including the type four patent declaration and notification obligation,relief mechanism for patent,approval waiting period,classification of examination and approval,and incentive policy for patent challenge.Generic drug patent challenge rules are the core content of the interest game between generic drug manufacturers and innovative drug manufacturers in the drug patent linkage system.China’s generic drug patent challenge rules are currently in the preliminary application stage.Generic drug applicants are cautious about patent challenges.Most of the generic drug applicants who conduct patent challenges are domestic powerful pharmaceutical enterprises,and the innovative drugs targeted by their patent challenges have great market interests.Besides,generic drug applicants are inclined to conduct patent challenges by claiming that their generic drugs do not fall within the scope of relevant patent protection.The implementation of the generic drug patent challenge rules is indeed conducive to balancing the interests between generic drug manufacturers and innovative drug manufacturers in the long term,but the relevant rules must be continuously improved in practice so as to truly achieve the purpose of promoting the development of the pharmaceutical industry and protecting citizens’ rights of life and health.Therefore,based on the current implementation situation of generic drug patent challenge rules in China and in view of the main problems,the following suggestions are put forward.Firstly,in terms of the type four patent declaration and notification obligation,it puts forward some suggestions on clarifying the content of the declaration basis and setting the notification obligation reasonably.Secondly,in terms of the legal basis of the relief mechanism,it advocates the establishment of the proposed infringement rules,and puts forward other proposals to solve the contradiction of the legal basis.Finally,in terms of identification of the success of patent challenge,it expounds the improvement suggestions about specifying the circumstances in which a patent challenge is successful and concretizing the relevant provisions of joint patent challenge to clarify the identification standard of the success of patent challenge.