The Research Of Judgment Rules About The Infringement Of Medicine Patent

This article discusses the judgment rules for medicine patent infringement and consists of six sections.In its first chapter the author analyzed the substantial particularity of medicine,introduced the special systems in the protection of medicine patent overseas and briefed the domestic actuality in the medicine patent protection.Based on this,the following three chapter expound the judgment rules of patent infringement in medical product patent,process patent and use patent.The second chapter explored the judging rule for chemical medicine product patent according to the type of compound,namely the compound expressed in form of Markush claims,crystal compound and drug composition.Specific to the rules for drug composition,the author believes that it should also take the description in claims concerning the content of compound into consideration,further,the claims described in form of absolute content is not clear enough to be the base for the infringement judgment which should be decided according to specification,plea in technology in public domain or the result of invalidity procedure.This chapter also involves the rules for TCM product patent,where the author mainly discussed the identity principle and the application of plea in technology in public domain.The opinion brought forward here is that the plea in technology in public domain may be supported through the compare between the technology alleged infringement and the technology in public domain in the aspect of identity in inventive step. As to the rules for process patent relating to medicine,the third chapter analyzed the case in similar process patent,drug preparation process patent where the author,based on international operation in relation to the definition and judgment rule of "directly obtained", enumerated the exceptions to facilitate the infringement judgment,and drug detecting process patent where the author advanced a simplified judgment rule that is referred to the compare between the quality standard of alleged infringement product and claim.The detail discussion on rules for use patent is in the fourth chapter, which explores the ways for infringement judgment in first use patent and second use patent.The fifth chapter analyzed the issues on the application of evidence in the infringement judgment of medicine patent.It involves the function of trail data,the effectiveness of medicine standard and the converted burden of proof during judgment.The final chapter analyzed the exception to the questioned infringement,including the trial and clinical observation carried out for market access of medicine.In addition,the article gives an introduction to the pharmaceutical patent linkage system in USA,and further more, discusses the feasibility and necessity of such system in China.In the conclusion of this article,an emphasis is given on introducing the pharmaceutical patent linkage system as a whole instead of in part. Meanwhile,the author also believes that the structure feature of TCM and chemical medicine as well as the effect of preparation process and use should be considered in the infringement judgment of patent.