Study On The Iventive Steps For Crystalline Form Patents

In recent years,some crystalline form patents of several popular drugs such as Imatinib,Efavirenz,Cinepazide maleate,Canagliflozin,Ceritinib,and Eltrombopag have been declared invalidity or the applications have been rejected for having no “inventive steps”.The creative standard for pharmaceutical crystalline form patent has attracted widespread attention and discussion in the pharmaceutical industry.The applicants are generally confused about how to meet the creative standard for crystalline form patent.Through statistics of reexamination and invalidity cases of crystalline form patents in China in the past 10 years,it has been found that the rate of invalidity and maintenance of the rejection in reexamination based on having no “inventive steps” is as high as 90% or more.In the face of such high rate of invalidity and maintenance of the rejection,how to clearly define the creative standard for crystalline form patents,and improve the quality of crystalline form applications and the patent stability have become an urgent problem to be solved in the field of patent protection for pharmaceutical crystalline form.This article analyzes the reasons for the extremely high rate of invalidity and maintenance of the rejection in reexamination of crystalline form patents and tries to reveal the creative considerations of Chinese pharmaceutical crystalline form patents.This article also sorts out “creative” related laws and regulations,scholars' viewpoints,and statistically analyses a large number of reexamination and invalidity cases,as well as considers European patent examination practices.This article is divided into five chapters.The first chapter introduces the importance of crystalline form patents and points out the high rate of invalidity and maintenance of the rejection in reexamination in China and analyzes the reasons behind it;Chapter 2 reviews laws,regulations,scholars' perspectives and studies reexamination and invalidity cases and attempts to reveal the creative standard for crystalline form patents.The third chapter focuses on the examination practices of European crystalline form patents and compares them with the Chinese examination practices.Chapter 4 refines the considerations of the "unexpected technical effects" which is critical in the patentability of crystalline form patents,and makes recommendations to applicants and the Chinese Intellectual Property Office.The fifth chapter is the conclusion.Emphasis was placed on the main considerations of “unexpected technical effects”;and suggestions were given on improving the quality of crystalline form patents and post-authorization stability from the source.