Research On Drug Patent Linkage System

Generally, a national drug regulator approves a new drug only when it meets the standards of safety, efficacy and quality required by laws. Whether an applicant infringes others’patent right will not be considered during drug examination procedure. Because this is not a drug regulatory duty, and whether the infringement of the patent medicines, belong to dispute of private rights, and should resolve through court actions, court actions. However, in resent years linking drug marketing approval to the patent status of the originator’s product was Widespread concern in the pharmaceutical industry and the legal profession.The core of the system is that the drug regulatory not allowing the grant of marketing approval to any third party prior to the expiration of the patent term. Thus avoiding the generic drug to market before the expiration of the patent term, while reducing the the generic drug manufacturers charged with the patent infringement after the listing of generic drug.There exist some provisions related to the drug patent linkage system in the Drug Registration regulation and the Patent Law.However, the provisions are disqualified and need some improvements.Firstly, the paper introduces a case occurred in India to clarify the basic concepts and the origin of the drug patent linkage system.Take into consideration the system established at the earliest in the United States and influencing other countries greatly, the paper places emphasis on the system in the United States. Furthermore, the paper explains the reason for the establishment of the system in Canada and the rejection to the system in India and EU.Finally, taking into consideration the condition of country, the paper gives advices to rebuild the drug patent linkage system in our country.