Review and Discussion on Drug Data Protection and Patent Protection Period Compensation

After years of exploration, relatively complete and scientific systems for patent protection of new drugs have been established in various countries. Due to the long development cycle of new drugs and their lengthy evaluation timelines, the postmarketing patent protection period is significantly shorter. Countries with more mature and better developed pharmaceutical markets have already implemented Patent Term Adjustment and Extension mechanisms, which can effectively protect innovative drugs. In addition, institutional arrangements such as an "exclusivity period", encourage the marketing of first-copy generic drugs, which provide a balance between innovation and antitrust. This article starts with foreign drug patents and administrative protection, reviews different administrative protection measures in China for new and generic drugs in different periods, and introduces the Regulations on the Protection of Traditional Chinese Medicines. Combining with the redefinition of drug in the new version of the Drug Administration Law and Drug Registration Management Measures, and utilizing the experienced practices of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as required by industry development and policy environment, the article puts forward the patent policy design for drug market supervision as well as suggestions including one that different types of drug innovation activities should be given appropriate protection, with an aim to provide a reference for continuous improvement of relevant supporting measures of the new version of the Drug Administration Law, and to encourage the competition of generic drugs and promote the healthy development of the industry while protecting innovation.