Preliminary Research On Drug Approval-Patent Challenge System In China

In recent years,China has constantly proposed policy documents to establish the drug approval-patent linkage system.As an important part of the drug approval-patent linkage system,the drug approval-patent challenge system has also been discussed.The drug approval-patent challenge system is a kind of linkage between FDA and the justice department,which is intended to resolute the patent dispute between the brand drug and the generic drug before the generic drugs appear on the market.From the perspective of benefits balance,this paper analyzes the benefits balance between the benefits of generic drug applicants and the interests of patent owners in the drug approval-patent challenge system.and based on this,puts suggestions on how to establishment China’s drug approval-patent challenge system.The first part of the article is an overview of the drug approval-patent challenge system.This part defines the concepts of the drug approval-patent challenge system and its related words,then discusses the rationality and necessity of building the drug approval-patent challenge system in China.The drug approval-patent challenge system achieves a balance of interests between drug patent holders,generic drug manufacturers and public health rights,and on this basis reduces the risk of generic drugs being listed during the patent period.Therefore,it is reasonable to construct adrug patent challenge system.At present,China’s handling of the problem of coordination between imitation application and patent protection is not unreasonable,and the dispute of patent infringement on generic drugs cannot be effectively solved,but the consequences of the approval of generic drugs are actually shelved.From the perspective of solving the problem of the current coordination of generic drug application and patent protection in China,China has the necessity of constructing the drug approval-patent challenge system.The second part to the forth part of the article introduces and analyses the foreign drug approval-patent challenge system.The article introduces the foreign drug approval-patent challenge system from the three stages that drug approval-patent challenge certification,pre-market patent dispute resolution and incentives of first generic drug,and Analyses and evaluates the foreign drug approval-patent challenge system from the perspective of balance of interests.I think that in the drug approvalpatent challenge certification and the pre-market patent dispute resolution stage,the drug approval-patent challenge system provides the patentee with the right to pre-protect before the listing of the generic drug,which conflicts with the interest of the generic drug applicant to list generic drugs earlier.It need to balance the interests of patent owners and generic drug applicants.In the stage of incentive the first generic drug,the drug approval-patent challenge system balance the benefits among the applicant,other applicants,patent holders and public health by granting the first generic market exclusivity period to whom challenge patent successfully.And the first generic market exclusivity period compensates the first generic drug for the risks and costs of lawsuit which incurred before.The fifth part of the article is giving some advice for establishing Chinese drug approval-patent challenge system.Based on the foreign drug approval-patent system and the consideration of benefits balance,in combination with the current situation of establishing the drug approval-patent challenge system in China,from the legislative and judicial aspects,the author puts forward some opinions and suggestions on establishing the drug approval-patent challenge system in China.The author hopes that by establishing Chinese drug approval-patent challenge system gradually,China can realize that the benefits among patentees,generic drug applicants and public health rights is balance.On the basis of realizing the benefits balance,China can realize the development of the pharmaceutical industry,the innovation of medicine,the increase of drug accessibility.