Abstract
The objectives of qualitative research are as follows: 1) to analyze the connection between drug registration and drug patent applications, and 2) to examine the details of the contents within patent applications that can contribute to the advancement of drug research and development within the domestic pharmaceutical industry. The study involved searching for the number of new drug and new generic drug registrations, exploring related patent applications, and analyzing these connections by creating a timeline for drug registration and pharmaceutical patent applications for each drug. The analysis of the content of patent applications was carried out with the participation of three researchers from the drug industry sector and two researchers from the academic sector. They scrutinized the details of the content within 29 patent applications from six drug lists to assess their adequacy for further research and development. The study results indicated that: 1. Patent applications are positively correlated with new drug registrations. The relationship between new generic drug registrations and patent applications varies depending on the extent of patent coverage. A higher number of patent applications for a specific drug item can pose an obstacle to the availability of new generic drugs. Some medicines experienced delayed registration compared to the time of patent application submission. Notably, there were several drug listings for which a significant number of patent applications were initially filed, but some of these applications were later abandoned. Moreover, it was observed that patent applications were submitted for certain drug listings even when there were no corresponding pharmaceutical products on the market. Lastly, it was found that no new generic drugs were domestically produced within the Chemotherapy. 2. In the analysis of patent applications, it was determined that researchers reached a consensus on 14 patent applications. Among these, 10 applications were deemed to contain sufficient content for replication or further research and development. For the remaining 4 patent applications, a consensus was reached that the content was insufficient for replication or further research and development. The inadequacies in these patent applications included the absence of chemical structure formulas and physical characteristics of the synthesized substance, a failure to specify appropriate synthesis conditions such as temperature and time, and the lack of precise formulation details for important drug substances and various excipients in the cases of composite drug formulations. The research recommendations are as follows: The essential content that must be included in the invention details should be specified according to the various types of patent application claims. Additionally, it is recommended to expedite the integration of database related to drug registration and the patent search database. Furthermore, there should be encouragement for the Department of Intellectual Property and the Food and Drug Administration to collaborate in jointly verifying the accuracy and completeness of patent application notifications from drug registration applicants, starting from October 13, 2019, onwards.
