Study On The Legal Status Of The First Generics In China And Its Countermeasures

The arrival of the patent cliff period will be of great influence in the pharmaceutical industry. As a special kind of generic drugs, the first generics is the most representative generic drugs, and it is worth to be encouraged. Because it is directly related to the time when public can have access to affordable medical services. However, the legal system of the first generics is imperfect in our country. The lack of related theory and policy support makes this study full of research value.The USA, by contrast, has the perfect system of generic drug laws and regulations. The system is composed of three parts:Hatch-Waxman Act, FDA’s New Rule on Patent Listing Requirements and30-month Stays and GIVE. On the basis of studying these advanced policy, the paper summed up the current problems that exist in the legal system of generics in China. At the end of the paper, I try my best to put forward the corresponding suggestions according to the challenges that mentioned previously...