The Case Study On Inversion Of The Evidential Burden In The Infringement Of Pharmaceutical Manufacturing Process Patent

By applying the inversion of the evidential burden in the infringement of pharmaceutical manufacturing Process patent, the plaintiff, as the patentee, must prove that his manufacturing drug is a new one at the very start; the product, which is known to the general public both at home and abroad, and which can be manufactured by the general technical staff without creative work prior to the date of application, shouldn't be a new one; we cannot consider the"new drug"as the criterion of the"new product".Then, the patentee has to provide proof that the infringing product is the same as the patented product, in which the key is how to define"the product manufactured directly with the process patent", which can be deduced by"The Rule of Genetic Connection". We ought not only distinguish bulk drug and pharmaceutic preparation, but also consider the difference among pharmaceutic preparations.At last, the inversion of burden of proof will turn to the defendant if the plaintiff fulfills his burden of proof. The defendant, taking the responsibility if he fails to supply the manufacturing method which ought to be substantially consistent with the one recorded in the application data, must continue to put to the proof if the plaintiff insists upon the equivalent infringement, which, among the traditional Chinese medicine which can be divided into assistant and guide, should be determined by the comprehensive modern pharmacodynamic tests rather than the proportion of the difference.