Research On The Coordination Of The Pharmaceutical Registration Administration And Pharmaceutical Patent Protection

Protection of the drug patents is closely related with the behavior ofthe drug registration management regulatory agency. But there are stillsome problems on coordination between the existing drug registrationmanagement system and drug patent protection system, Mainly lie in thefollowing three aspects:Firstly, the drug is a kind of special goods, and it needs to be approvedby the pharmaceutical supervisory and administrative department of itssecurity、 effectiveness on the judgment、the approval to production、sale;If drug supervision and administration department for examination andapproval of the drug involving others drug patents, it will affect thebehavior of examination and approval of the drug patent protection status；Secondly, because of the particularity of the drug, drug comparedother commodities listed in a longer administrative experience; And drugpatents in the development of new drugs is granted early, much earlier thanthe drug approval time to market. Therefore, new drug was listed on themarket after approval of the exclusive time may be obvious less than20years the "effective patent period".Thirdly, in accordance with drug registration management measures,the production of generic drugs also need to get the administrative licensing,therefore also need to experience the certain time administrativeexamination and approval procedures for permission, and if only in patentprotection after the expiration of the other company is allowed to put forward an application for registration of generic drugs; Or suppose that theacts as following manufacture、use、 import patent drugs for gettingrequired information or data for a generic drugs approval of the applicationfor registration are considered infringement, the generic drugs medicaldevice will be delayed; on the other hand it will also cause the patentee togain an extra market monopoly interests, the patent protection against thetenet of value. This is the third performance about the discordant betweendrug registration management and patent protection.How to deal with therelationship between drug patent protection and drug registrationmanagement has become a problem to be solved.This paper is divided into five chapters.The first chapter basically analysis drug the basic concept of thepatent protection and drug registration management system and theirrespective development process, relevant content system, and theinharmonious situation classification between the existing drug registrationmanagement and drug patent protection.The second chapter based on chapter1analysis the necessity andbasic ideas of the coordination between drug registration management anddrug patent protection.Chapter three introduce coordination system and related content ofdrug registration management and drug patent protection in the UnitedStates briefly introduces drug patents link system, drug patents for a longerperiod system, bolar exception system etc.The fourth chapter basically overview of our country’s existing drugregistration management and drug patent protection coordination systemand the defects of the system.Chapter5mainly discussed how to perfect coordination systembetween our drug registration management and patent protection. Thispaper discusses the system based on the balance of interests, perfect ourcountry’s existing drug patents link system, discusses whether our country need to build a drug patent protection system, and improve the extension inthe current Bolar exception system.