Comparative Study On Examination Practice Of Chinese Medicine Invention Patents In China And The United State

objective:Compares the differences between China and the United States in the regulations and practice of examination of traditional Chinese medicines patent,helps Chinese applicants understand the regulations of the United States patent examination,and provides Chinese medicine companies,medical schools,and related scientific research institutions with patent application experience that applicable to US examination rules,And put forward proposals for the improvement of China’s patent examination standards for SIPO.Methods:case study method:Taking US traditional Chinese medicine patents published from 2007-2014 and priority patents in China as examples,review and analysis of examination opinions and statements of US traditional Chinese medicines patents and Chinese priority patents.select typical cases for analysis.Comparative research method:Compared the differences between Chinese and US patent examination on regulations and practices,includes patent subject matter eligibility,unity,novelty,inventiveness,and requirements for specification.contents:Comparing the differences between China and the United States in patent examination regulations.combining specific cases,analyzed the differences between China and the United States in practices from five aspects:patent subject matter eligibility,unity,novelty,inventiveness,and requirements for specification.Discussion and suggestion:The issue of the "2014 Interim Guidance on Patent Subject Matter Eligibility" has an impact on the Chinese medicine development and patent application strategies.At present,Chinese composition,modified compounds,and treating method of Chinese medicines can be granted patents.However single herbal extracts and natural compounds cannot be granted patents,which will seriously damage the long-term interests of the Chinese medicine industry.There is a big difference between the United States and the China on regulations of unity.The United States’ unity regulations make TCM patents have to face the problems of giving up part of the technical solutions or applying for divisional applications.Domestic applicants should properly use the rejoin procedure to reduce losses.The search results of reference by Chinese examiners on TCM patents are more accurate than those in the United States.The different reference is one of the main reasons that China and the United States have different results in novelty and inventiveness examination.For the novelty,due to the "inherent features" in the US guidelines,the United States has higher standards of novelty examination on new use patent than China.China’s examination standards for the specification are much higher than those in the United States."comprise" claims and the claims for which the composition has no specific ratio range are difficult to be granted.In China’s patent examination guideline,there is no provision for the examiner’s burden of proof,and the examiner’s burden of proof should be clearly defined in order to avoid the abuse of Patent Law 26.4 in the examination practice.in addition,the level of technical person in the art are conflicting in the examination practices of inventiveness and specification.