The Case Analysis Of Patent Problem In The Drug Registration

This article is a case analysis on patent dispute between eleven pharmaceutical companies and Guangzhou Welman. This case lasted a long time and was in the revision process of the national patent system and the drug registration administration. It reflects the characteristics of China's drug intellectual property protection during the transition period. The purpose of this article is to study the national patent system and the China's drug registration administration through the case's analysis, and put forward related problems and strategies.Chapter 1:firstly, the details of this case are presented. Eleven pharmaceutical companies applied for the drug registration for "Piperacillin Sodium and Sulbactam Sodium for Injection", but found that Guangzhou Welman owned of the pharmaceutical patent. So the eleven pharmaceutical companies requested that the pharmaceutical patent should be declared invalid. And during this period, they suited for confirming no tort, handled patent permission and other episodes. Secondly, the legal issues concerning this case are put forward:during the procedures for examining the request for invalidation, did Guangzhou Welman have the patent right? Is this drug patent an invalid patent? Did the patentee abuse the power? Is there any loophole in the patent law on suspension of the patent invalidation procedure? Is the suit for confirming no tort applied to this case? Is there any loophole in pharmaceutical patent linkage?Chapter 2:the non-critical legal issues and the critical legal issues concerning this case are analyzed separately. By analyzing the non-critical legal issues, we come to the following conclusion:during the procedures for the request for invalidation, Guangzhou Welman have the patent right; this patent in fact is an invalid patent; the patentee abuse patent law; there are some loopholes in the relevant provision in the patent law; the suit for confirming no tort is not applied to this case. By analyzing the critical legal issues, we come to the conclusion that there are some loopholes in pharmaceutical patent linkage. Chapter 3:put forward related problems and strategies on the patent in the drug registration, mainly including the quality of paten drugs, the intellectual property rights consciousness of pharmaceutical companies and pharmaceutical patent linkage in China.