Research On The Legal Issues Of Indian Generic Drugs

India is a major exporter of generic drugs,and its generic drug exports account for about20% of the world’s total,so it is called the “world pharmacy”.Most of the impressions of Indian medicines on people are bad impressions such as “violation of patents”.Indian generics have had a lot of impact.On the one hand,low-cost drugs have met the needs of the broad masses of low-and middle-income countries,including the Indian people,while the Indian pharmaceutical industry has been established and developed rapidly.On the other hand,for the original pharmaceutical company whose product patent is still in the validity period,its patent right is infringed,and the interests of the enterprise and its host country are damaged.The conflict between intellectual property protection and public health rights arising from the issue of generic drugs in India has always been a hot topic.This paper attempts to sort out the changes in the patent system of Indian generic drugs and explore its causes,analyze the positive and negative effects of Indian generic drugs,combine Indian domestic law and related international law sources,examine Indian drug patents grant scope and the Indian drug patent compulsory licensing system with the consideration of the legislation and practice of other countries and regions,and to explore the value orientation conflicts generated by Indian generic drugs and propose solutions.This paper adopts historical analysis method,normative analysis method and comparative analysis method to research the scope of patent granting of Indian drugs,the compulsory licensing system of Indian drugs,the reasons for the change of Indian drug patent system and the conflict of public health rights and drug patent rights behind Indian generic drugs.This article is mainly composed of the following parts:The first part is “Basic Theory of Indian Generic Drugs”.It mainly defines the research objects of this paper and expounds the relevant definitions,introduces the status quo of Indian generic drugs,summarizes the trajectory of Indian pharmaceutical patent system since 1970,explores its domestic and international reasons,and analyzes the positive and negative impact of the patent system.The second part is “Scope of Patent Grants for Indian Medicines”.It discusses the conditions for granting pharmaceutical patents in India,analyzes their unreasonable aspects,and compares them with the legislation and practice of drug patent authorization in China and the United States.It pointes out that India has set standards for drug patent grants that exceed international standards and common sense,which is not conducive to innovation.The third part is “Indian Pharmaceutical Patent Compulsory License”.It mainly studies the meaning,characteristics and types of patent compulsory licenses,and demonstrates the legality of compulsory licenses from the perspective of international law.It analyzes the problems existing in the implementation of international compulsory licenses and analyzes the three kinds of patents in India.The conditions and procedures for the initiation of the license are compared with the legislation and practice of patent compulsory licenses in China and the United States to examine the inconsistency and irrationality of the relevant international treaties.The fourth part is “Conflict and Coordination between Health Right and Drug Patent Right under Indian Generic Drug Law System”.It mainly focuses on the intellectual property protection and the conflict of health rights generated by Indian generic drugs,examines the meaning of the right to health and its rationality and legitimacy,and analyzes several rights concerning health and medicine.The wrong view of the patent right,from the purpose of the establishment of the patent right,the particularity of the patent right of the drug,the health threat faced by human beings,the patent right and the right to health have the same value target,the patent patent right and the goal path relationship of the right to health,etc.It is argued that the right to health is not superior to the patent right of medicine.The fifth part is “Conclusions and Suggestions”.It gives the conclusion that the protection of pharmaceutical patents should be strengthened from the international law level and the domestic law level to promote innovation,puts forward proposals for protecting patents in India,and suggests that China should protect medicines more combining China’s national conditions.At the same time,comprehensive and multi-angle measures should be taken to lower the price of drugs to protect health right.The main conclusions of this paper: The current Indian patent law restricts the acquisition of pharmaceutical patents,and the conditions for the compulsory licensing of pharmaceutical patents are relatively loose.In the short term,it protects the right to health of asmall number of people,but in the long run,it seriously attacks pharmaceutical companies’ enthusiasm for research and development and harms the overall interests of the society;the scope of patent granting of drugs should be expanded;the patent right of drugs should be strictly protected and the compulsory license of patents for drugs should be strictly restricted;the right to health has its objective basis,rationality and legality.However,the right to health does not take precedence over patents for medicines;the path to protect public health should be explored on the premise of protecting patent rights;with reference to the development trend of international protection of intellectual property rights and internal environmental factors in China,China should continue to strengthen intellectual property protection.