Research On The Declaration System Of The First Generic Drug Under Pharmaceutical Patent Linkage

With the acceleration of the internationalization of pharmaceutical industry,the contradiction between the huge demand of China's pharmaceutical market and the lagging development level of related industries becomes more and more prominent.Compared with western countries,which hold the vast majority of new drugs in the world,and India,which has realized the transformation from imitation to innovation and has become a powerful pharmaceutical country,China,on the one hand,contributes very little to the innovation of international drugs.On the other hand,drug companies make a living by imitation,and have the characteristics of low-end imitation and repeated imitation.Just like the vivid picture in the movie "I am not the god of medicine",numerous patients,with the hope of survival,are willing to take the risk of illegal and criminal activities and buy new drugs from overseas regardless of means,which indicates the urgent need of the public to make new drugs,copy good drugs,and carry out fundamental industrial reform to improve the accessibility of drugs in China.To improve drug accessibility,on the one hand,we should protect drug intellectual property rights,stimulate innovation and enhance drug affordability.On the other hand,generic drugs should be promoted to enter the market as soon as possible to reduce drug prices and improve availability.In August 2015,the official issuance of document [2015] no.44 marked the beginning of China's drug regulatory reform,which was hailed by the outside world as "the most thorough food and drug regulatory reform in China's history".Since the beginning of 2017,China has issued a number of policy documents in succession,emphasizing the establishment of drug patent link system.Due to the dual-track characteristics of patent protection and administrative management,listed drugs must meet the double requirements of safety,effectiveness in pharmaceutical sense and non-infringement of patent right of new drugs,which has caused lots of patent disputes between patentees of new drug and generic drugmakers.According to the above problem,the drug patent linkage system forces the patentee to register the patent right involved in the new drug.Any generic drug that applies for listing must be on the basis of above registration information,make a declaration to the drug approval authority and the patentee whether the application involves registered patents or infringes that rights.Where the patentee disputes the declaration of non-infringement,it is not required to wait for the generic drug to be marketed and sold,and it has the right to directly file a patent infringement lawsuit against the generic drug listing application on the basis of "artificial infringement".The authority can make approval decision based on the result of effective infringement lawsuit,and take the relationship between generic drug and patent right of new drug into consideration in the approval of listing.On the one hand,this system enables both drug approval and patent dispute settlement procedures to solve the dual problems of drug listing as soon as possible and advance the entry time of generic drugs into the market on the basis of patent protection.On the other hand,it is of far-reaching significance for China's pharmaceutical reform to avoid that the generic drugs that have obtained the market approval will be sued for infringement by the patentee upon their entry into the market,which leads to the failure of generic drugs' true marketing and delay of time for the public to use cheap and high-quality generic drugs.At present,only administrative regulations or documents at a lower level are required for the above systems,and they are "revised draft" or "draft for solicitingopinions".There are still a lot of disputes in the academic circle about which system model and specific system design to adopt,in particular,it is not clear whether to adopt the "approval waiting period",add the type of "fictitious infringement" and connect with Bolar exception.Drug patent linkage system includes many subsystems,such as patent registration,generic drug declaration(including prosecution period,approval waiting period),market exclusive period,and in a broad sense,data protection and patent extension,etc,content is big,only under the background of patent link system,this paper focuses on generic declaration system,by analyzing the basic concept of the system and its parent system,legal theory significance and practice value of analysis system,comparing China's current system with the system contents of typical overseas countries,on the basis of the analysis of the controversial core issues,in order to put forward views and Suggestions on China's system construction.The first part of the article first from the generic declaration system involving the core concepts and basic theories,introduces the generic declaration system,patent link system and the relationship between the two,then from the point of view of the particularity of drug patents,the legal theory including the interests balance theory and legal economics,and public health point of view,to argumentation of the necessity of establish a generic statement,especially its significance in the field of patents,answer the question that the system is not a simple medical procedures but a patent system.Finally,the paper introduces the most mature and typical patent declaration system in the United States and Canada,which lays a foundation for the comparison between national conditions and system details.The second part of this paper discusses the development status of the generic drug declaration system in China.Firstly,it introduces the current laws and regulations in China,including the relevant provisions of the issued revision opinions,affirming the rationality and analyzing the defects and inappropriateness,and analyzing the questionable contents in the system design.Then introduces the countries-American and Canadian that have most mature and typical patentdeclaration system,the content of the last is on the basis of the different national conditions,comparing the the content of the system for the United States,Canada and China with main body,object,type,time,effect and other various angles to explore the content which is not suitable for our country into the contents and operable,has the reference value of parts.The third part takes the necessity and value of the introduction system as the background,and is based on the analysis of the contents of system in countries outside the region and China,the author puts forward suggestions on the construction of China's first generic drug patent declaration system from four aspects.First,the content of the patent declaration of the first copy drug should be detailed,including the subject and object of the declaration,the type of declaration and the standard of proof,the time requirement for the declaration and the supervision mechanism for the non-compliance declaration.The second is about the setting of "approval waiting period" and "prosecution period",in the context of considering the litigation cycle,coordinating the advantages and disadvantages of the patent link and claim system,it is suggested to adopt the declaration system centering on the statutory notification obligation,but it is possible to implement the patent declaration system in stages under the premise of optimizing litigation cycle and incorporating patent effectiveness into judicial functions of judicial organs.In addition,on the basis of the current notification-obligation-centered model,it is suggested to extend the "prosecution period" and make clear that the legal effect of the expiration of the period is that the patentee has no negative legal liability and the applicant of generic drug listing has the right to file A lawsuit confirming that a patent is not infringed.The third is to set up the approach of "fictitious infringement",so as to achieve a good connection with the current patent law.Firstly,clarify the legal principle problem that there is no contradiction between patent challenge and Bolar exception,and then elaborate on how to make specific provisions on "fictitious infringement".Finally,it is the overall guarantee of the patent declaration system of the first genericdrug—establishing the functional link between administrative organs,in order to enforce the cooperation between CFDA and CNIPA from the institutional level.This paper hopes to,by establishing the patent declaration system of the first generic drug,improve the protection level of drug patents,encourage pharmaceutical company to actively research and develop new drugs,promote the transformation and upgrading of China's pharmaceutical industry,and make a leap in "quality".On the other hand,we should encourage generic drugs to challenge drug patents and enter the market as soon as possible to improve the accessibility of drugs,so that the safe,effective,cheap and high-quality generic drugs will benefit all the people.