Research On The Post-filing Experimental Data In Pharmaceutical Patent

Medicines are indispensable public products,which is related to the health of the whole society and even the whole mankind.The research and development of new drugs is difficult,the cycle is long,and the dependence on patent protection is high.Based on the importance and particularity of drugs,our country attaches great importance to the improvement of the drug patent system.The post-filing experimental data is one of the issues that needs to be improved and refined.Accepting the post-filing experimental data conforms to the characteristics of drug patents,but it will impact the patent’s first application principle and the principle of"publicity for protection" to a certain extent.This article mainly discusses the examination standards for the post-filing experimental data.On the basis of national conditions and learning from the strengths of all countries,relevant suggestions for improvement are put forward.By combing through the changes in our country’s previous review standards,it provides a reference for the future improvement process of the post-filing experimental data.The article sorts out the provisions of the various versions of the"Patent Examination Guidelines",our country’s examination standards for the post-filing experimental data have gone through a process from loose to strict and then gradually loose.There are also special provisions for the post-filing experimental data,which also prompts our country to further relax the restrictions on the post-filing experimental data.The latest version of the "Patent Examination Guidelines" stipulates that the post-filing experimental data after the application date can be used to prove the full disclosure of the patent specification and creativity,and it is clear that the examination standard is "technical effects can be obtained from the contents disclosed in the original application documents",but the standard of how to judge "obtained" has no specific regulations.Chapter 3 of this article provides a detailed explanation of the requirements for full disclosure of the specification of a patent application and the criteria for determining the requirements for creativity.Full disclosure of the specification must be "clear,complete,and enablement",and creativity requires the patent to have "Outstanding substantive features and significant technological progress".Then it explained the role of the post-filing experimental data in the above two aspects.In the last part of this article,the problems existing in the post-filing experimental data at this stage are summarized and targeted suggestions are put forward.At this stage,the main problems of the system include:whether the examination standards for fully disclosed dimensions and creativity dimensions should be consistent,the specific applicable standards for "it can be obtained from the disclosure of patent applications" are not clear,and the examination standards at this stage in our country are relatively strict.In response to the above-mentioned problems,this article believes that when improving the examination standards for the post-filing experimental data,the specificity of drug patents and the reality of our country’s pharmaceutical industry should be fully considered,and the examination standards should be refined.When comprehensively judging from the data itself and the relevance,on the one hand,we should examine the authenticity and rationality of the experimental data itself;on the other hand.we should examine the relationship between the technical effects proved by the experimental data and the disclosure of the patent application.It is to fully consider the particularity of drug patents when judging the standard of "obtained".