| In 2017,at the national level,from the perspective of “improving drug accessibility”,“protecting drug innovation” and “accelerating the listing of generic drugs”,the legislative requirements for improving the patent linking system in China were proposed.The core issue in improving the patent linking system is how to “link” the patent examination process and the drug administrative approval process.The qualitative study of the “patent challenge”behavior in the application for generic drug listing,that is,the qualitative study of the“non-infringement” or “invalid patent” behavior proposed by the imitation party in the drug listing application is the key to solving the aforementioned “core problem”.There is currently no regulation on this issue in China.There are two main modes of legal property of the application for generic drug listing in the theory and practice of each country.The first type is the “infringement mode”,which is typical of the United States,South Korea,and Canada;the second is the “non-infringement model”,which is typical of the European Union and India.This paper believes that the "infringement mode" is more in line with China's current national conditions and future development needs.Under the “infringement mode”,there are two alternative ways of “legal interpretation” or “legal fiction”.From the perspective of legal stability and legislative economics,the "legal fiction" approach is more suitable for China's current national conditions and development needs.In addition to the introduction and conclusion,this thesis consists of four parts.The first part defines the concept of “patent challenge” and attribute in drugs and generic drugs,listing application behaviors;then introduces the status quo and differences of research on the behavioral attributes of generic patents in patents and practices at home and abroad.The second part combines China's specific national conditions,cuts in from the opposition,and analyzes the necessity and feasibility of the generic patent infringement.The significance of generic patent "patent challenge behavior infringement qualitative" is reflected in the following aspects: providing jurisdiction for premature resolution of patent disputes between the two parties;helping to reduce the waste of social resources caused by excessive "sunk costs" in drug patent competition;It is conducive to promoting the transformation and implementation of pharmaceutical patents,enhancing the patent awareness and innovation ability of pharmaceutical companies;benefiting the continuous innovation of thepharmaceutical industry and the continuous supply of high-quality medicines,and improving the accessibility of medicines.The third part expounds the legal approach to the qualitative infringement of generic patent “patent challenge”.This part starts from "the stability of the law is the core meaning of the rule of law." Specific to the patent law level,the statutory principle of patent rights is an important mechanism to balance the interests of patent holders and the public,and to ensure the stability of the patent legal system.Under this principle,giving the generic drug listing application an infringing attribute and making it suable is tantamount to “expanding” the scope of the patent right,and thus may be in conflict with the current Patent Law,so the legislation or interpretation activities are necessary.Resolving such conflicts becomes inevitable.Legal fiction and legal interpretation are two feasible approaches at present,and the article has conducted a more in-depth analysis and reflection on the two approaches.The fourth part compares the effects of the above two approaches,and cuts into the advantages and disadvantages of the two approaches from the perspectives of institutional economics,international law,legal doctrine,and legal policy.And draws the conclusion that the legal fiction approach is more feasible.Finally,comprehensively consider the status of China's patent system to give advice on the improvement of legal advice and support mechanisms. |
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