Research On Pharmaceutical Patent Linkage System

Pharmaceutical research needs a large investment with high risk. Without the protection of the patent system, the inventor will not be able to recover the high cost, even lose the motivation to research and develop. But the patent system leads to high price of patent medicines while giving the patentee monopoly right, which results in the contradiction between the patent system and the right of public health. Therefore, vigorous development of generic drugs has become an important way to solve the problem of the right of public health at the moment. Pharmaceutical patent linkage system is based on the respect of drug patents, which reduces the risk of infringement of generic drugs and accelerates its speed of entering the market. It will finally achieve the goal to reduce the drug price and to enhance the drug accessibility.The Patent Law and Regulations for the Registration and Management of Drugs in China contain related terms of pharmaceutical patent linkage system, but they still have some shortcomings. This paper gives reasonable suggestions of the improvement of the pharmaceutical patent linkage system in our country through theoretical analysis of the system and the research of foreign law.The first part of this paper mainly introduces the pharmaceutical patent linkage system. First of all, it gives a textual research on the creation and development of the system. The background of the system reflects the necessity and good effects of the implementation of pharmaceutical patent linkage system. Then it analyzes the value of the system, points out its role in the balance between patent right and the right of public health. And then it researches on the theoretical basis of the system from the angle of law economics and the theory of balancing of interests.The second part of this paper mainly introduces and analyzes the foreign law. Starting from the pharmaceutical patent linkage system of the United States, Canada and international treaty, it gives detailed introduction of the background, the concrete content and the evolution of the system. This part also gives a deep analysis of the benefit balance mechanism in the system.The third part of this article analyzes the legal status in our country at present. It mainly studies and evaluates the patent linkage terms and clauses in Regulations for the Registration and Management of Drugs in order to find out problems existing in current regulations. The patent linkage provisions are too board in China’s current law, which are lack of maneuverability, and to a certain extent, overly protect the patent holder.Based on the reference of foreign law, the fourth part of this paper gives advices on perfection of patent linkage system of our country combining the current legal situation in China. The author thinks that we should strengthen the supervision of production of generic drugs, reform the pricing and procurement mechanism, establish a complete drug patents registration data base, promote the application system of generic drugs. We should gradually improve the system of pharmaceutical patent linkage system in order to protect the citizen’s health right.