Judicial Application Of The Principle Of Equivalence In Patent Infringement Of Traditional Chinese Medicine Compound

At present,the development of traditional Chinese medicine(TCM)industry in our country faces two major problems: one is the low quality of TCM patents,the other is the insufficient protection of TCM patents.The establishment of the judicial protection system for patents of TCM compound will affect the quality of patents of TCM compound and the public interest in obtaining medicines.The judicial application of the principle of equivalence in Chinese medicine compound patent is an important part of the judicial protection system of Chinese medicine compound patent.The reason lies in that the principle of equivalence is one of the important principles in judging patent infringement.In current judicial practice,the specific criteria for determining the application of the principle of equivalence in patent infringement can be summarized as "three identical" criteria: comparing the technical characteristics of the accused infringement with those of the patent protection involved,if the accused infringement can achieve basically the same function and achieve basically the same effect in basically the same way,and the technical characteristics of the accused infringement belong to what the ordinary technicians in the field can imagine through non-creative work.The dilemma of the application of the principle of equivalence in the determination of patent infringement of TCM compound lies in: firstly,The criterion of the principle of equivalence in judicial practice has not been unified,which makes the conclusion of the identification of equivalence in patent infringement litigation inconsistent.Secondly,Due to the particularity of substance and function of TCM compound,it is more professional and challenging to identify the same in patent infringement litigation.Chinese medicine prescription includes Chinese medicine unilateral and Chinese medicine compound.In the practice of TCM,TCM compound is more widely used.In the field of TCM compound prescriptions,patents for TCM compound products can be obtained through the substitution of components of TCM compound,the increase or decrease of components of TCM compound,the increase or decrease of dosage of componentsof TCM and the change of preparation technology in patent of TCM compound method.Because of the complexity of the components of traditional Chinese medicine,the difficulty to determine the effective components,and the individual differences of the drug users,it is more difficult to determine whether the new technical scheme constitutes the same infringement on the patent technical scheme.The triple test standard of "mode-function-result" of the principle of equivalence in the United States and the "five elements" of the principle of equivalence in Japan can provide theoretical support for the identification of the principle of equivalence and help to improve the judicial application of the principle of equivalence in China.On this basis,combined with the mode,function and technical effect of the technical characteristics of TCM compound patents,we are committed to the theoretical construction of the application of the principle of equivalence in patent infringement of TCM compound patents.Through the research of the judicial practice and theoretical on the application of the principle of equivalence in the patent infringement of TCM compounds,the judgment of the patent infringement of TCM compounds is improved from the following three aspects:Reasonable application of predictable rules clearly defines the protection scope of TCM compound patent.In the identification of patent infringement of TCM compound prescription,"the relationship of fingerprint and efficacy of TCM" is introduced to judge the functional equivalence.Through the establishment of TCM database,the standard of "common technical personnel in this field" for determining patent infringement of TCM compound medicine is refined.