Research On The Artificial Infringement Of Patent Link System In China

Patent system is the institutional guarantee to promote drug research and development,but patent system not only protects the patentee,but also promotes the high drug price,which is one of the main contradictions between drug patent system and public health right.How to better protect the rights and interests of patentees under the premise of meeting the public's demand for drugs is the focus of research in the field of intellectual property.The patent link system is produced in this context.The patent link system is an important means to balance the interests of both drug patentees and generic Enterprises: on the one hand,the patent disputes between the two sides are resolved in advance to better protect the legitimate rights and interests of the patentees;on the other hand,generic drugs are encouraged to challenge patents,and successful generic drugs can not only enter the market in advance in the right confirmation state,but also the first generic drugs that challenge success can be obtained A certain period of market monopoly.At the same time,the system also improves the system efficiency in the application stage of generic drug registration,and reduces the social and judicial costs.At present,in the current drug management system of our country,some provisions similar to patent link system have been introduced,but compared with foreign countries,the patent link system under the current system of our country has a lot of deficiencies.Among them,the most critical is that under the current legal system in China,drug patentees have no right to file a lawsuit against the listing application of generic drug applicants,the administrative approval process of generic drugs cannot be connected with the judicial process,and patent disputes cannot be resolved in advance in the phase of generic drug registration.The artificial infringement is the legal basis for the patentee to file a lawsuit for the administrative examination and approval of the generic drug applicant,and it is an essential part of the complete patent link system.The purpose of the establishment of the artificial infringement is to give the patentee the right to file a lawsuit in advance when he or she makes an application for listing.In order to analyze the meaning and value orientation of patent link system,we need to strictly limit its scope of application and avoid the imbalance of interests.On the basis of analyzing and drawing lessons from the system content and operation mode of foreign patent link system,combined with China's national conditions and the policy guidance of the national level for the establishment of patent link system,and from the perspective of scope limitation and legal liability,we need to in order to achieve the balance of interests among patentees,generic pharmaceutical enterprises and public interests,promote the development of the pharmaceutical industry and protect the health of the people's lives,some suggestions are put forward for the establishment of the national artificial infringement system.